Reported trial results for Hepatitis C

Every Hepatitis C trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.

191 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

NCT05376371 · results posted 17 November 2025

According to the results reported on ClinicalTrials.gov, this trial tested a program called CJC-TraC, which used nurse case managers to support people with chronic (long-term) health conditions as they were released from prison. The program involved sessions with a nurse before release and follow-up phone calls after release. A total of 219 people were enrolled in the study, and 209 of them completed the full trial period. There was only one group — everyone received the CJC-TraC intervention, so the trial was designed to assess whether the program was practical to run and acceptable to participants, rather than comparing it against a different approach. The reported data shows that, on average, each participant completed approximately 3.1 sessions with the nurse case manager before their release from prison, and there were an average of 5.8 phone contact attempts made after release. Of the 219 people who started, 158 were still involved at the three-month follow-up point and completed the end-of-study assessment. When participants were asked for their views on the program, 116 reported that the number of pre-release sessions felt about right, and 123 reported that the number of post-release phone contacts felt about right. Data on any health outcomes beyond these participation and acceptability figures was not reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT06922643 · results posted 29 June 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 100 people who had Hepatitis C (a viral liver infection) and were treated with a medicine called Pegnano (peginterferon alfa-2a). Of the 100 who started, 97 completed the study and 3 did not. The trial was measuring whether the Hepatitis C virus became undetectable in participants' blood at several points during and after treatment — including at 4 weeks, 12 weeks, at the end of treatment, and 24 weeks after treatment finished. The main goal was to see how many participants had no detectable virus in their blood 24 weeks after completing treatment, which is known as a "sustained virological response" (meaning the virus stayed undetectable long after treatment ended). The reported data shows the following numbers of participants (out of 100) had no detectable virus at each checkpoint. At week 4 (an early check), 19 participants had undetectable virus, with 12 in one subgroup and 57 in another — though the data does not clearly label what these subgroups represent. At week 12, those numbers were 24, 13, and 63 participants respectively. At the end of treatment, 22, 13, and 62 participants had undetectable virus. For the main outcome — no detectable virus 24 weeks after finishing treatment — the reported figures were 17, 10, and 56 participants across those same groupings. For the safety measure, the reported data shows that all 100 participants were counted under the adverse events (unwanted side effects) assessment, though a breakdown of what specific events occurred and how severe they were was not reported in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04903626 · results posted 6 April 2025

According to the results reported on ClinicalTrials.gov, this trial enrolled 286 people, all of whom received a combination treatment called glecaprevir/pibrentasvir for hepatitis C. Of those who started, 278 completed the trial and 8 did not finish. The trial was primarily measuring how many participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a result known as SVR12, which simply means the virus could no longer be measured in the blood at that point in time. The reported data shows that 96.2% of all participants who started treatment had no detectable virus at the 12-week mark after finishing. A secondary analysis looked only at participants who did not have a treatment-related virus failure, and in that smaller group, 100% had no detectable virus at 12 weeks. The reported data also shows that 0% of participants experienced the virus bouncing back or becoming harder to detect *while still on treatment*, and 0% were recorded as having the virus return in the 12 weeks after finishing treatment. A small number — 0.7% — were recorded as having what appeared to be a new hepatitis C infection after treatment, meaning they were exposed to a different strain of the virus after completing the course. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03362476 · results posted 9 January 2025

According to the results reported on ClinicalTrials.gov, this trial involved 200 women living with HIV who drink alcohol — 98 in one group and 102 in the other. One group received a computer-based alcohol reduction program combined with a brief counselling session delivered by a clinician, while the other group received only the clinician-delivered counselling session (described as the standard of care). The trial was measuring alcohol use, HIV-related health indicators, and liver health over a period of up to nine months. The reported data shows that for the main outcome — a urine test called ethyl glucuronide (EtG), which detects recent alcohol use — 93 out of 98 participants in the combined program group and 99 out of 101 participants in the counselling-only group returned negative results (meaning alcohol was not detected above the threshold) across the follow-up timepoints. For a separate blood-based alcohol marker called phosphatidylethanol (PEth), 44 participants in the combined group and 43 in the counselling-only group returned negative results. Regarding HIV, 16 participants in the combined group and 26 in the counselling-only group had an undetectable level of HIV in their blood at nine months. The reported data also shows average immune cell counts (a measure of HIV disease progression) of 532 and 503 cells per cubic millimetre for the two groups respectively. For liver health, 24 participants in the combined group and 22 in the counselling-only group showed signs of severe liver damage on a blood test, while 84 and 90 participants respectively had liver stiffness measured by imaging. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04515797 · results posted 3 December 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 2 participants, both of whom completed the study. The trial was looking at the use of a direct-acting antiviral medication (a type of drug that targets the hepatitis C virus) in people who had received a kidney transplant from a donor who had hepatitis C. The main thing the trial was measuring was whether participants had no detectable hepatitis C virus in their blood 12 weeks after finishing their course of treatment. The reported data shows that both participants (2 out of 2) had undetectable hepatitis C virus levels in their blood at that 12-week mark after finishing treatment. For the secondary measurements — which were additional things the trial tracked — the reported data shows that 0 participants had adverse events (unwanted health effects) linked to the study drug or the virus itself. The average virus level in the blood at weeks 2 and 4 of treatment was reported as 0 copies per millilitre. The reported data also shows that 0 participants experienced any of the serious clinical events being tracked, such as death, transplant failure, rejection of the transplanted kidney, or significant liver enzyme elevations. The data for kidney function (measured by a value called eGFR, which reflects how well the kidneys are filtering the blood) was not reported in the submitted results. It is worth noting that because only 2 people took part in this trial, the numbers are very small and should be interpreted with that in mind. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02933970 · results posted 2 December 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 156 participants in total (52 in each of three groups). The trial was looking at care for hepatitis C — a liver infection caused by a virus — and compared two approaches: "usual care" (standard in-person medical visits) and "telemedicine" (remote care delivered via technology). Participants were assigned to different sequences that varied how long they spent in each type of care over a 36-month period. The trial measured whether the virus became undetectable in participants' blood, as well as how many people started and completed treatment, and how satisfied participants were with their care. The reported data shows that when it came to the primary measure — the number of participants whose virus became undetectable 12 weeks after finishing treatment — 106 participants were recorded in the usual care (control) group and 246 in the telemedicine (intervention) group. For the secondary measures, the reported data shows that 126 participants in the control group and 268 in the intervention group took at least one dose of medication (treatment initiation), while 116 in the control group and 261 in the intervention group completed their treatment course. Regarding satisfaction, participants were asked to fill in a questionnaire scored on a scale where a higher number means greater satisfaction; the reported data shows average satisfaction scores of 91.5% in the control group and 98.3%–98.7% in the telemedicine group at the measured time points. It is worth noting that the outcome data is presented as raw participant counts rather than percentages, so direct comparisons between groups need to account for the fact that group sizes and time periods varied across the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04798521 · results posted 8 October 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04798521) enrolled 203 people who had Hepatitis C virus (HCV). Participants were placed into one of two groups: 100 people received "Tele-HCV Treatment" (HCV treatment delivered remotely, such as via telehealth) and 103 people received "Community Linkage to Care" (being connected to existing community health services). The trial was measuring things like whether participants cleared the virus from their blood, whether they started and finished their HCV medication, and whether they engaged with harm reduction services (supports that help reduce risks associated with substance use). The reported data shows the following numbers across both groups. For the primary outcome — clearing the virus from the blood (called "sustained viral response") — 63 out of 100 people in the Tele-HCV group and 16 out of 103 people in the Community Linkage group reached this outcome. For the secondary outcomes: when it came to starting HCV treatment within four weeks of joining the study, 85 people in the Tele-HCV group and 13 in the Community Linkage group did so. For completing treatment (taking at least 90% of prescribed pills and filling the final prescription), 46 people in the Tele-HCV group and 9 in the Community Linkage group were recorded as having done so. Regarding engagement with harm reduction resources, surveys were completed at the start of the study (100 and 103 participants respectively), at 12 weeks (88 and 83), and at 36 weeks (61 and 68), though the specific survey findings beyond participation numbers were not reported in the submitted data. It is also worth noting that a large number of participants did not complete the study — 37 in the Tele-HCV group and 87 in the Community Linkage group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03221309 · results posted 3 September 2024

According to the results reported on ClinicalTrials.gov, 198 adults infected with Hepatitis C (HCV) were enrolled in this trial. The study was divided into two phases — 100 people took part in Phase 1 and 98 in Phase 2. Overall, 160 participants completed the trial and 38 did not. The trial was measuring several things at once: whether the Hepatitis C virus became undetectable in participants' blood 12 weeks after finishing treatment (known as a "sustained virologic response," meaning the virus could no longer be detected), how many HIV-negative participants started a medication to reduce the risk of getting HIV (called PrEP), and how many participants started or stayed on a medication called buprenorphine, which is used to treat opioid dependence. The reported data shows that, for the primary measure, 158 out of 198 participants had undetectable HCV in their blood at the 12-week check after finishing treatment. For the secondary measures, 29 HIV-negative participants began taking PrEP during the first 24 weeks of the study, and of those, 8 were reported to still be taking PrEP at week 48. Separately, 61 participants who were not already on opioid treatment started taking buprenorphine during the first 24 weeks, and 41 of those were reported to still be in the buprenorphine programme at week 48. The data was not reported in a way that breaks down results by other characteristics such as age or gender. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04042740 · results posted 11 July 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 45 adults in a single group who received a four-week course of a combination medicine called glecaprevir/pibrentasvir (also referred to as G/P) for hepatitis C virus (HCV) infection. The trial was measuring whether the virus became undetectable in participants' blood 12 weeks after they finished treatment — a milestone researchers call SVR12 — as well as how many people experienced side effects and how many completed the full four weeks of treatment. Participants were followed for about 24 weeks after treatment, and those who needed it were offered a second round of treatment in a separate step of the trial. The reported data shows that 84.4% of participants (roughly 38 out of 45) reached the SVR12 milestone, meaning the virus was undetectable in their blood 12 weeks after finishing treatment. All 45 participants who started the four-week treatment course completed it without stopping due to side effects. The reported data also shows that 60% of participants (27 out of 45) experienced at least one side effect that met the trial's reporting threshold — these included side effects rated as moderate or above, or those serious enough to require special reporting. Six participants were recorded as having what the trial called "virologic failure," meaning the virus did not become undetectable or increased again during the study. Four participants went on to a second step of the trial to receive further treatment, and three of those four completed that second step. The reported data also shows how often the virus was undetectable at various points during and after treatment, with figures ranging from about 51% of participants at an early check to around 97% near the end of the treatment period, before dropping back to around 81% at a later follow-up visit. It is worth noting that the trial team flagged that disruptions caused by the COVID-19 pandemic led to a significant amount of missing data at some of these time points, which affected their ability to analyse these figures as fully as originally planned. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02292706 · results posted 4 October 2023

According to the results reported on ClinicalTrials.gov, this registry study (NCT02292706) followed 1,609 people across eight groups over approximately 240 weeks (around four and a half years). Each group had previously been treated for hepatitis C (a liver virus infection) with one of several different antiviral medicine combinations in an earlier ("parent") trial. The study was tracking three main things over time: whether participants kept undetectable levels of the hepatitis C virus in their blood, whether they experienced any liver-related health events, and whether they developed a type of liver cancer called hepatocellular carcinoma (HCC). The reported data shows that the vast majority of participants across all treatment groups maintained what is called a "sustained virologic response" — meaning the hepatitis C virus remained undetectable in their blood — through to week 240. The reported figures ranged from 98.9% to 100% across the different groups. Regarding liver-related health events, the reported percentages varied more noticeably between groups, ranging from around 15% to approximately 38% of participants experiencing at least one such event over the follow-up period. For the development of new liver cancer (HCC), the reported figures ranged from about 5% to just over 15% depending on the group. On the secondary measures, the reported data shows that no participants in any group had the hepatitis C virus return due to the original virus re-emerging. Two participants across all groups had detectable resistance mutations (changes in the virus that can affect how medicines act on it), and two participants — one each in two different groups — were recorded as having a re-infection with a different hepatitis C virus strain. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03801707 · results posted 13 September 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people who received a kidney transplant from a donor who had hepatitis C, even though the recipients themselves did not have hepatitis C. After the transplant, participants were given antiviral medicines to treat the hepatitis C they acquired through the donated kidney. The trial was measuring whether the virus could be cleared from the body and tracking a number of other health indicators over time. Thirty of the 36 participants completed the study, with 6 not completing it (the reasons were not detailed in the data provided here). The reported data shows that 28 out of 30 participants who completed the study had no detectable hepatitis C virus in their blood 12 weeks after finishing their antiviral treatment. Regarding liver-related events that were tracked, the reported data shows that 2 participants had a significant rise in liver enzymes (more than 5 times the normal upper limit), while no participants developed a condition called acute cholestatic hepatitis (a type of liver inflammation affecting bile flow) and no participants were unable to tolerate the antiviral medicines. A kidney function measure called eGFR — which gives an estimate of how well the kidneys are filtering the blood — was reported as 54 ml/min/1.73m² at 6 months and 46 ml/min/1.73m² at 12 months after transplant (higher numbers generally indicate better filtering, though what these numbers mean for any individual is a matter for their doctor). The reported data also shows that all 30 participants who completed the study were alive at both the 6-month and 12-month marks, and all 30 still had a functioning transplanted kidney at both time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01226797 · results posted 27 July 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 24 people in total — 12 who received the study drug (called PF-04136309) and 12 who received a placebo (a dummy treatment with no active ingredient). Of those, 10 in the drug group and 11 in the placebo group completed the study. The trial was measuring changes in two liver enzymes — ALT and AST — which are proteins found in the blood that can indicate liver inflammation when they are elevated. The main question the trial asked was how many participants showed a meaningful drop (at least 30%) in their ALT level after four weeks. The reported data shows that for the primary measure — the proportion of participants whose ALT level dropped by 30% or more by Week 4 — 25% of people in the PF-04136309 group met this threshold, compared with approximately 36% in the placebo group. For the secondary measure looking at AST levels dropping by 30% or more, the reported figures were about 8% in the drug group and 36% in the placebo group. The reported data also shows average changes in ALT and AST levels at Weeks 1, 2, 3, and 4. In the drug group, ALT levels appeared to rise slightly at Week 1 (by about 12 units) before falling modestly by Weeks 2–4 (by around 8–10 units). In the placebo group, ALT levels fell at every time point, reaching a drop of approximately 33 units by Week 4. A similar pattern was reported for AST levels. Starting (baseline) ALT values were around 132 units for the drug group and 155 units for the placebo group; baseline AST values were around 97 and 111 units respectively. It is important to note that this was a small, early-phase trial with only 12 people in each group, so the numbers reflect a very limited snapshot. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01946516 · results posted 3 July 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT01946516) enrolled 3,051 people who had recently been diagnosed with cancer and were attending oncology clinics in the United States associated with the SWOG research network. The trial was not testing a treatment — instead, it was designed to measure how common three viral infections (hepatitis B or HBV, hepatitis C or HCV, and HIV) are among people newly diagnosed with cancer. Nearly all participants were tested for each virus, with 3,050 tested for HBV, 2,990 tested for HCV, and 3,045 tested for HIV. The reported data shows that, of those tested, 19 participants had signs of a current ("chronic") hepatitis B infection, while 197 had signs of a past ("previous") hepatitis B infection. For hepatitis C, 71 participants tested positive, and for HIV, 34 participants tested positive. The secondary outcomes looked at whether certain risk factors were more common among those who tested positive compared to those who tested negative for each virus. The reported data also described treatment patterns: for example, among those with a past hepatitis B infection, about 11.8% received antiviral treatment for the virus, while among those with a current hepatitis B infection, about 73.3% received antiviral treatment. For HIV-positive participants, about 66.7% received antiviral treatment. Some treatment data for other subgroups was not fully reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02219490 · results posted 7 April 2023

According to the results reported on ClinicalTrials.gov, this trial (known as TOPAZ-I) enrolled 1,596 people with hepatitis C who were treated with a combination of antiviral medicines (ABT-450/r/ABT-267 plus ABT-333, with or without ribavirin). Of those, 1,258 completed the study and 338 did not. The trial was designed to track longer-term liver-related health events — such as death from any cause, death specifically related to the liver, the liver losing its ability to function properly (called liver decompensation), liver transplant, and a type of liver cancer called hepatocellular carcinoma. Importantly, the reported outcome numbers were drawn from pooled data combining this trial with a companion study (TOPAZ-II), and participants were compared based on whether they achieved a measure called SVR12 — meaning no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — or did not achieve SVR12. The reported data shows the following estimated percentages of participants who experienced each event over the follow-up period. For all-cause death, the figures reported were 8.3% for those who did not achieve SVR12, compared to figures ranging from 0.1% up to 2.0% (across different time points) for those who did achieve SVR12. For liver-related death, 1.4% was reported for the non-SVR12 group, compared to 0% rising to 0.1% in the SVR12 group. For liver decompensation, the non-SVR12 group showed 4.5%, while the SVR12 group ranged from 0.2% to 0.5% across time points. Liver transplantation was reported at 0% for the non-SVR12 group and rose from 0% to 0.2% in the SVR12 group. For liver cancer, 0% was reported in the non-SVR12 group, while the SVR12 group ranged from 0.2% to 0.9%. When all these events were combined into a single measure, the non-SVR12 group showed 11.4%, and the SVR12 group ranged from 0.5% to 3.2% across the measured time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01667081 · results posted 6 June 2022

According to the results reported on ClinicalTrials.gov, this long-term follow-up study enrolled 2,435 people in total — 1,909 in a group that had previously received a combination of grazoprevir (GZR) and elbasvir (EBR), with or without ribavirin (RBV), and 526 in a group that had received other GZR-containing treatment regimens. The study was measuring two main things over time: whether the hepatitis C virus (HCV) came back after treatment had finished, and whether certain viral changes — called resistance-associated substitutions (RASs), meaning alterations in the virus that can make it harder to treat — persisted in people's bodies after treatment. The reported data shows that for the question of viral relapse (the virus returning), the result was listed as "NA" (not available) for both groups, meaning this figure was not reported in the submitted data. For the tracking of viral changes (RASs) in people whose virus was still detectable, the reported data shows varying numbers of participants across different virus subtypes (called genotypes). For example, among people with genotype 1a, between 22 and 25 participants were found to have certain viral changes (NS3 or NS5A RASs) at the start of follow-up, with those numbers reducing over time to as few as 6–22 participants at later time points. Smaller numbers were seen for genotypes 1b and 4. Regarding unintended health events during follow-up, the reported data shows that 1 participant in each group experienced an adverse event (an unwanted health occurrence) considered by the study investigator to be related to the study drug, and 1 participant in each group experienced a serious adverse event considered drug-related. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02939989 · results posted 4 May 2022

According to the results reported on ClinicalTrials.gov, this trial looked at a combination of three antiviral medicines — glecaprevir/pibrentasvir, sofosbuvir, and ribavirin — given to people with hepatitis C. A total of 33 participants took part: 5 people received the combination for 12 weeks, and 28 people received it for 16 weeks. All 33 participants completed the study with no drop-outs reported. The main thing the trial was measuring was whether the hepatitis C virus became undetectable in participants' blood 12 weeks after they finished treatment — a result doctors call SVR12, which simply means the virus was no longer detectable at that follow-up point. The reported data shows that, for the primary measure, 100% of participants in the 12-week group and 96.4% in the 16-week group had undetectable virus levels at 12 weeks after finishing treatment. Across both groups combined, that figure was reported as 97.0%. For the secondary measures, the reported data shows that 0% of participants in either group experienced what the trial defined as treatment failure while still taking the medicines. Regarding relapse after finishing treatment (the virus becoming detectable again before the 12-week follow-up check), 0% of the 12-week group and 3.6% of the 16-week group were reported to have relapsed, giving an overall combined figure of 3.0%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02625909 · results posted 24 November 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02625909) enrolled 188 people with a recent hepatitis C virus (HCV) infection. Participants were randomly assigned to take a combination medicine called sofosbuvir/velpatasvir (SOF/VEL) for either 6 weeks (93 people) or 12 weeks (95 people). The main thing the trial was measuring was how many people in each group had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a point often called SVR12, which simply means the virus could no longer be found at that time. The reported data shows that, looking at all participants who were enrolled regardless of what happened during the trial (called the "intention-to-treat" group), 76 out of 93 people in the 6-week group and 86 out of 95 people in the 12-week group had undetectable virus levels at 12 weeks after finishing treatment. When the researchers also checked virus levels at the actual end of treatment, the reported data shows 85 out of 93 people in the 6-week group and 87 out of 95 people in the 12-week group had undetectable virus at that point. A further analysis looking only at people who closely followed the treatment schedule (the "per protocol" group) reported 69 out of those in the 6-week group and 77 out of those in the 12-week group had undetectable virus at 12 weeks after treatment ended. The numbers for the secondary "modified intention-to-treat" analysis — which excluded people lost to follow-up and similar cases — were reported as the same figures as the main analysis (76 and 86 respectively), though a full breakdown was not separately detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03781726 · results posted 11 May 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people who had received a kidney transplant from a donor who tested positive for the hepatitis C virus (HCV). All 30 participants were given a fixed-dose combination medicine called glecaprevir/pibrentasvir (also known as G/P). The trial was measuring whether the hepatitis C virus became undetectable in participants' blood after treatment, and whether the virus came back either during or after treatment. Twenty-eight of the 30 participants completed the study, with two not completing it (the reasons were not detailed in the reported data). The reported data shows that, for the primary goal — checking whether the hepatitis C virus was undetectable in the blood 12 weeks after the last dose of medicine — 30 participants were recorded as having undetectable virus levels at that point. For the secondary measures, the reported data shows that 12 participants were recorded as having detectable virus levels at some point *during* treatment (described as "on-treatment virologic failure," meaning the virus was still measurable while they were taking the medicine). Zero participants were recorded as having the virus return after treatment had finished (described as "post-treatment virologic relapse"). It is worth noting that the participant numbers across these different measures appear inconsistent — for example, 30 participants are listed as achieving undetectable virus levels at 12 weeks, yet 12 are also recorded as having detectable virus during treatment — and no further explanation for this is provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03501550 · results posted 28 April 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants, all of whom received a combination of two treatments: an experimental drug called CDI-31244 together with an existing hepatitis C medicine known as SOF/VEL (sofosbuvir/velpatasvir). All 12 participants completed the trial. The study was measuring two main things: how many participants experienced unwanted side effects (called adverse events) during treatment, and how many had what is known as a "sustained virologic response" — meaning the hepatitis C virus became undetectable in their blood and stayed that way after treatment ended. The reported data shows that 10 out of 12 participants experienced at least one treatment-emergent adverse event (that is, an unwanted health event that occurred during or after starting the treatment). Regarding the virus levels in the blood, 8 out of 12 participants had undetectable hepatitis C virus 12 weeks after finishing treatment. As a secondary (follow-up) measure, the same 8 out of 12 participants still had undetectable virus levels when checked again 24 weeks after finishing treatment. It is worth noting that this was a very small study involving only 12 people, so the numbers above reflect a limited group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03487848 · results posted 20 April 2021

According to the results reported on ClinicalTrials.gov, this trial involved 5 people who received a combination of two antiviral medicines — daclatasvir and sofosbuvir. Four of the five participants completed the study, and one did not finish. The trial was primarily focused on measuring how these medicines moved through the body — specifically, how much of the drug daclatasvir was present in the bloodstream at various points after taking a dose. The reported data shows the following measurements for daclatasvir in the bloodstream: the lowest recorded level (the "trough," meaning the amount left just before the next dose) was 152.94 ng/mL (nanograms per millilitre, a measure of concentration); the highest recorded level after a dose was 1,215.32 ng/mL, reached at around 2 hours after taking the medicine; and the total drug exposure over one dosing period — a way of capturing the overall amount of drug in the body across time — was 11,535.45 h·ng/mL. The reported rate at which the body appeared to clear the drug was 86.69 mL/min. As a secondary outcome, the trial also recorded how many participants experienced side effects (called adverse events). The reported data shows that 4 out of 5 participants experienced at least one adverse event of any kind, while none were reported to have experienced more serious categories of adverse events — though the specific details of those categories were not fully described in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03619837 · results posted 3 March 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 122 people during an initial screening phase, of whom 24 went on to take part in the main study — and all 24 completed it. The trial was measuring what happened to levels of hepatitis C virus (HCV) in the blood of participants after they received antiviral treatment, specifically looking at whether the virus became undetectable at 12 weeks after finishing treatment (a milestone researchers call SVR12). It also tracked whether participants stopped treatment early, and whether both the patients and their transplanted organs were still surviving six months after the transplant. The reported data shows that 23 out of 24 participants had HCV RNA (the measure of virus in the blood) below the detectable limit at 12 weeks after finishing treatment. Regarding early stopping of treatment, the reported data shows that 1 out of 23 participants discontinued antiviral therapy before completing the planned course — the reported description notes this was due to a serious complication unrelated to the antiviral medication itself. For the six-month survival measure, the reported data shows that 23 out of 24 participants, along with their transplanted organs, were alive and functioning at that point. Where specific numbers for some secondary outcomes (such as the 24-week virus check or viral relapse rates) were described in the outcome definitions but not separately reported as numerical results, that detailed breakdown was not provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02002767 · results posted 16 November 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02002767) enrolled 19 adults in total — 9 with normal kidney function and 10 with severe kidney impairment. All 19 participants completed the study with no dropouts. The trial was measuring how the body processes a medicine called velpatasvir, by looking at how much of the drug gets into the bloodstream and how quickly, comparing the two groups. The reported data shows that people with severe kidney impairment had somewhat higher levels of velpatasvir in their blood compared to those with normal kidney function. Specifically, the overall exposure to the drug over time (a measure called "area under the curve," which reflects the total amount of drug the body is exposed to) was reported as approximately 5,598 and 5,652 units in the normal kidney group, versus approximately 7,972 and 8,108 units in the severe kidney impairment group. The peak level of the drug in the blood (the highest concentration reached) was reported as 703 units in the normal kidney group and 732 units in the severe kidney impairment group — a smaller difference. For protein binding (how much of the drug attaches to proteins in the blood), the reported data shows the figures were virtually identical between the two groups, at approximately 99.7% bound in both cases. Regarding unwanted events that occurred during the study, none (0%) of the participants in the normal kidney group reported a treatment-emergent adverse event, while 20% of those in the severe kidney impairment group did. Laboratory abnormalities of varying levels were also reported in some participants, particularly in the severe kidney impairment group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03093415 · results posted 12 November 2020

According to the results reported on ClinicalTrials.gov, this trial looked at hepatitis C treatment across three different clinic settings in the United States: a medication-assisted therapy clinic (Old Town Clinic), a needle exchange programme (Outside In Clinic), and a hospital liver specialist clinic (OHSU). In total, 350 people were assessed for eligibility across the three sites, and 100 people were enrolled — 25 from Old Town Clinic, 25 from Outside In Clinic, and 50 from the hospital clinic. The trial was primarily measuring how many participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment (called SVR12), and also tracked results at 48 weeks, medication-taking habits, and other factors. The reported data shows that for the primary measure (virus undetectable at 12 weeks after treatment), 24 out of 25 participants from Old Town Clinic, 15 out of 25 from Outside In Clinic, and 47 out of 50 from the hospital clinic recorded this result. For the secondary measure at 48 weeks, the reported data shows 17 participants from Old Town Clinic and 3 from Outside In Clinic had results recorded; no 48-week data was reported for the hospital clinic group. Regarding how consistently participants took their medication (self-reported), at Old Town Clinic 23 out of 25 reported taking 100% of their pills, while at Outside In Clinic 8 out of 25 reported taking less than 90%. No medication adherence data was reported for the hospital clinic group. Data for injection drug use relapse was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02441283 · results posted 21 September 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02441283) enrolled 377 people who had previously been treated for Hepatitis C (a liver infection caused by a virus) in an earlier study using medicines that included ABT-493 and/or ABT-530. Of those 377 participants, 287 completed the follow-up study and 90 did not. The trial was designed to track whether people who had already cleared the Hepatitis C virus in that earlier study continued to show no detectable virus over time, and to look at any signs of the virus returning or a new infection occurring. The reported data shows that 99.5% of participants who had cleared the virus in the prior study continued to show no detectable Hepatitis C virus throughout this follow-up period. The reported data also shows that 0.3% of participants experienced a relapse (meaning the virus was detected again after treatment ended) and 0.3% were recorded as having a new Hepatitis C infection. Among those who did experience the virus returning, 1 participant was found to have certain virus changes (called resistance-associated variants) that persisted. For the secondary outcomes, 7 participants were reported to have had some form of medical event related to liver disease progression during the study. Two additional measures — a blood marker called IP-10 (used to assess liver scarring) and a FibroTest score (a scored scale from 0 to 1 where higher numbers suggest more liver damage) — were tracked over time across multiple study visits. The reported FibroTest scores across visits ranged from approximately 0.19 to 0.41, and IP-10 levels ranged from approximately 121 to 224 ng/L, though the data was not reported in a way that allows straightforward before-and-after comparison. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03820258 · results posted 31 August 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 21 participants, all of whom completed the study — none dropped out. The trial tested a single combination tablet containing three antiviral medicines (referred to as SOF/VEL/VOX) in people with hepatitis C. The main thing the trial was measuring was how the body processed the drugs — specifically, how much of each medicine was present in the bloodstream over time (a measurement called "drug exposure" or AUCtau). The trial also tracked whether participants' hepatitis C virus became undetectable in the weeks and months after finishing treatment. The reported data shows the following drug exposure figures for each component of the tablet: SOF had a value of 2,474.8 hours·nanogram/millilitre, its breakdown product (GS-331007) had a value of 14,890.2, VEL had a value of 6,773.0, and VOX had a value of 2,205.8. These numbers describe how much of each medicine was circulating in the blood during the dosing period, as measured through blood samples taken during the study. Regarding the virus levels, the reported data shows that 100% of participants had hepatitis C virus below the detectable limit at 4 weeks, 12 weeks, and 24 weeks after finishing treatment. No participants stopped taking the study drug early due to a side effect, and 0% of participants experienced what the trial defined as overall virologic failure (meaning the virus returning or not responding during treatment). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03089944 · results posted 13 July 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03089944) enrolled 343 adults with chronic hepatitis C virus (HCV) infection across several different strains of the virus (known as genotypes 1, 2, 3, 4, 5, and 6). All participants received the same combination treatment — glecaprevir and pibrentasvir — taken for 8 weeks. Of the 343 people who started the trial, 331 completed it and 12 did not. The trial was primarily measuring how many participants had no detectable virus in their blood 12 weeks after finishing treatment — a result researchers call SVR12, or "sustained virologic response at 12 weeks." The reported data shows that, among participants with genotypes 1, 2, 4, 5, and 6, 100% of those assessed using a stricter "per protocol" group (people who followed the study rules closely) and 98.2% of all enrolled participants had undetectable virus levels at 12 weeks after treatment. When all genotypes including genotype 3 were included, the reported figures were 99.7% and 97.7% respectively for those same two groups. The reported data also shows that 0% of participants had the virus rebound or remain detectable at the end of their 8-week treatment course (called "on-treatment virologic failure"), and 0.3% of participants who finished treatment and had undetectable virus at the end were found to have detectable virus again within 12 weeks after stopping (called "post-treatment relapse"). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02402452 · results posted 20 March 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02402452) involved 20 adults in total — 10 with severe kidney (renal) impairment and 10 with normal kidney function. All 20 participants completed the study. The trial was measuring how a drug called voxilaprevir moves through the body differently depending on kidney function. To do this, researchers tracked the drug's concentration in the blood over time using standard measurements used in drug studies. The reported data shows that participants with severe kidney impairment had higher levels of voxilaprevir in their blood compared to those with normal kidney function. Specifically, the total amount of drug measured in the blood over time (one way of measuring this gave 662.7 units for the kidney-impaired group versus 383.3 for the normal group; another calculation gave 772.1 versus 450.8). The peak blood concentration — the highest level the drug reached — was reported as 49.2 units in the severe kidney impairment group compared to 33.9 units in the normal kidney function group. Regarding side effects and laboratory changes, the reported data shows that 20% of the kidney-impaired group and 50% of the normal kidney function group experienced side effects, while laboratory abnormalities were reported in 70% of the kidney-impaired group and 30% of the normal kidney function group. No further detail about the nature of these events was included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02886624 · results posted 29 January 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 30 participants who took a combination treatment called grazoprevir/elbasvir — two antiviral medicines given together — for 8 weeks to treat hepatitis C (HCV). All 30 participants completed the treatment phase. The trial then followed participants for 12 weeks after treatment ended, and again at 48 weeks after treatment. The study was measuring whether the hepatitis C virus became undetectable in participants' blood after treatment, as well as several other things including treatment adherence, HIV-related measures (as some participants also had HIV), and whether re-infection with hepatitis C occurred later on. The reported data shows that 28 out of 30 participants had undetectable hepatitis C virus in their blood at 12 weeks after finishing treatment — this is called SVR12, which is the main result the trial was designed to measure. One participant was reported as a virological failure, meaning the virus was still detectable and showed signs of resistance to the medicines. Two participants were recorded as having missed doses of their study medicine in the final four days of the treatment period. Among those who also had HIV, the reported data shows that 27 participants had undetectable HIV levels at 12 weeks post-treatment, and the average CD4 count (a measure of immune cell levels) was reported as 655 cells per cubic millimetre. Regarding re-infection with hepatitis C at the 48-week follow-up, the data shows figures of 2 and 1 participants reported across what appear to be two separate measurements, though the distinction between these two figures was not clearly explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02940691 · results posted 30 December 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 32 people in a single group who all received a combination tablet containing two medicines — grazoprevir and elbasvir — taken once daily for 12 weeks. The trial was measuring whether the hepatitis C virus (HCV) became undetectable in participants' blood 12 weeks after they finished treatment, a point in time often called SVR12. Of the 32 people who started, 26 completed the study and 6 did not. The reported data shows that for the main measure — having no detectable hepatitis C virus in the blood 12 weeks after finishing the course of tablets — 24 participants recorded an undetectable result. The data also lists smaller numbers (2, 5, and 1) alongside this outcome, though the breakdown of what each of those figures specifically represents was not clearly labelled in the submitted results. For the secondary measures, 26 participants completed the full 12-week course of tablets as prescribed, and 24 participants also had no detectable virus at the actual end of treatment (before the 12-week follow-up point). The reported data also includes figures for a finger-prick blood test (the Xpert® HCV Viral Load assay) used during the study: sensitivity — meaning how well the test picked up the virus when it was present — was reported at 100%, and specificity — meaning how well it correctly identified when the virus was absent — was reported at 95.7%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03222583 · results posted 23 December 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT03222583) enrolled 546 people who had been diagnosed with the hepatitis C virus (HCV). Participants were split into two groups: 363 people were assigned to Arm A, where they received the active combination medicine glecaprevir/pibrentasvir straight away, and 183 people were assigned to Arm B, where they first received a dummy (placebo) treatment before later switching to the active medicine. The trial was mainly measuring whether the active medicine could clear the hepatitis C virus from participants' blood — specifically, whether the virus was undetectable 12 weeks after finishing treatment (called SVR12, or "sustained virologic response at 12 weeks"). The reported data shows that, looking at all hepatitis C strains (genotypes 1 through 6) together in Arm A, 97.2% of participants had undetectable virus levels at 12 weeks after treatment ended. When broken down by strain, the reported figure was 99.4% for those with genotype 1, and 97.8% for those with genotype 2. For the secondary measures in Arm A, the reported data shows that 0.6% of participants experienced what the trial called an "on-treatment virologic failure" — meaning the virus either rebounded or did not clear while they were still taking the medicine — and 1.7% experienced a "post-treatment relapse," meaning the virus became detectable again after finishing treatment. The reported data for participants who had both hepatitis C and HIV at the same time was not available in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02590068 · results posted 18 December 2019

According to the results reported on ClinicalTrials.gov, this trial was designed to compare responses to the shingles (zoster) vaccine between people living with hepatitis C and healthy volunteers. It looked at several things, including antibody levels in the blood after vaccination, activity of certain immune-related genes, and various measures of how immune cells responded. The reported data shows that 14 healthy volunteers started and completed the study, while zero participants in the hepatitis C group were enrolled at any point. The reported data shows that no numerical results were submitted to ClinicalTrials.gov for any of the outcome measures — including the primary measure (antibody levels after vaccination) or any of the secondary measures (immune gene activity, immune cell markers, specific immune cell counts, or interferon responses). This applies to both the healthy volunteer group and the hepatitis C group. Because no measurement data was reported, it is not possible to describe what the numbers showed for any of these outcomes. It is also worth noting that, because no one with hepatitis C was enrolled, the trial's original goal of comparing the two groups was not able to be completed as planned. The reason for this was not explained in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03117569 · results posted 11 December 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 380 people with hepatitis C (HCV) across two groups: 127 people followed a standard monitoring schedule during their treatment, and 253 people followed a simplified (less frequent) monitoring schedule. The trial was measuring whether people on the two different monitoring schedules had undetectable levels of the hepatitis C virus in their blood after treatment — meaning the virus could not be detected by a blood test. Most participants completed the study: 123 out of 127 in the standard group, and 241 out of 253 in the simplified group. The reported data shows that, for the primary outcome, 121 out of 127 participants in the standard monitoring group and 233 out of 253 in the simplified monitoring group had undetectable HCV in their blood. The trial also looked at several secondary outcomes. For treatment and visit adherence, 125 people in the standard group and 241 in the simplified group were recorded as adherent, while 2 and 12 people respectively discontinued treatment early. For self-rated quality of life (measured on a scale from 0 to 100, where 100 is the best imaginable health), the reported data shows scores went from around 80 before treatment to 85 in the standard group and 89 in the simplified group after treatment. A small number of participants in both groups — 1 in the standard group and 4 in the simplified group — had detectable viral resistance markers at various points, though the full breakdown across the different categories was not fully consolidated in the data. For patient satisfaction with their follow-up plan, the reported data shows the majority of participants across both groups indicated they were satisfied or very satisfied with their monitoring schedule, with most responses falling in the higher satisfaction categories. Specific satisfaction rating breakdowns were reported across multiple response levels, but a plain summary of each category label was not included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03036852 · results posted 12 November 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 59 people, all of whom received a single treatment called SOF/VEL (a combination of two antiviral medicines taken together). Of those 59 participants, 53 completed the trial and 6 did not. The trial was looking at people with hepatitis C (a viral infection of the liver) across several different strains of the virus, known as genotypes 1, 2, 3, 4, and 6. The main things being measured were: how many participants had hepatitis C virus levels drop below a detectable threshold in their blood at 12 weeks after finishing treatment (called SVR12, a standard way of checking whether the virus remains undetectable), and how many stopped taking the study drug permanently because of an unwanted side effect. The reported data shows that, overall, 94.9% of participants reached the SVR12 target — meaning the virus was undetectable in their blood 12 weeks after finishing treatment. When broken down by virus strain, the reported figures were: 92.0% for genotype 1, 100% for genotype 2, 93.8% for genotype 3, 100% for genotype 4, and 100% for genotype 6. On the second primary measure, 0% of participants permanently stopped taking the study drug due to an adverse (unwanted) event. For the secondary outcomes, the reported SVR4 rate (virus undetectable 4 weeks after finishing treatment) was 96.6% overall, and the SVR24 rate (24 weeks after finishing) was 94.9% overall — with similar breakdowns by genotype as the SVR12 results. The reported data also shows that by the end of the treatment period, 100% of participants across all measured genotype groups had virus levels below the detectable threshold while still on the drug. A separate measure tracked the change in virus levels from the start of the study to during treatment, recorded on a scientific scale; the overall average change was reported as −4.54 log₁₀ IU/mL (meaning virus levels in the blood fell substantially on that scale, though the raw numbers carry technical meaning beyond the scope of this summary). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01707472 · results posted 9 October 2019

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called simtuzumab in 18 people who had liver scarring (fibrosis) linked to viral infections. Participants were split into three groups: 4 people with HIV only, 6 people with Hepatitis C (HCV) only, and 8 people with both HIV and HCV. All 18 participants completed the trial. The trial was primarily measuring how many people experienced side effects while taking the medicine, and secondarily tracking changes in liver scarring and related measures over 24 weeks. The reported data shows that 100% of participants in every group experienced at least one treatment-emergent adverse event — that is, a health issue that appeared or worsened after starting the medicine. This was the case across all three groups. For the liver scarring score (called the Ishak fibrosis score, which runs from 0 to 6, where lower is better), the reported data shows that in the HIV-only group, 2 out of 4 participants stayed the same and the remainder saw small changes; in the HCV-only group, results were mixed across the 6 participants; and in the HIV/HCV group, the majority of the 8 participants showed no change or small shifts. For other measures — including liver pressure (HVPG), liver stiffness measured by a scan (MRE), and two markers of liver tissue activity (MQC and alpha-SMA) — small numerical changes from the start of the trial to week 24 were reported across all three groups, with some values going slightly up and some slightly down depending on the group. The full breakdown of individual participant changes in the Ishak score was not clearly separable from the data as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02971488 · results posted 13 September 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 529 participants from a marginalised community called Cañada Real Galiana in Spain. All 529 participants completed the study with none dropping out. The trial was measuring how well a hepatitis C virus (HCV) screening and care programme worked across several steps — from testing people for HCV, to delivering their results, to getting them assessed at a specialist clinic, to starting antiviral treatment, and finally to seeing whether the virus was no longer detectable in their blood after treatment (called a "sustained virological response," meaning the virus could not be found in blood tests taken weeks after treatment ended). The reported data shows that out of the 529 people screened, 122 were found to have an active HCV infection. Of those with a positive result, 101 had their test results successfully delivered to them. According to the results reported on ClinicalTrials.gov, 63 of the HCV-infected participants went on to be assessed at a specialist HCV clinic, and 52 of those went on to start antiviral treatment. Of the 52 who started treatment, 38 were reported to have achieved a sustained virological response — meaning the virus was undetectable in their blood at the follow-up check after finishing treatment. The reported data also shows that among all 529 people screened, 35 were found to have HIV, 23 had hepatitis B, and 2 had hepatitis D. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02636608 · results posted 26 July 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 244 people with hepatitis C, of whom 243 received the study treatment — a combination regimen that could include the medicines paritaprevir/ritonavir, ombitasvir, dasabuvir, and/or ribavirin, depending on each participant's circumstances. Eleven people did not complete the trial. The main thing the trial was measuring was whether the hepatitis C virus became undetectable in participants' blood 12 weeks after finishing treatment — a result researchers call SVR12, which essentially means the virus could no longer be detected at a very low threshold (less than 50 IU/mL) at that point in time. The reported data shows that 94.5% of participants had undetectable virus levels at 12 weeks after finishing treatment. A similar measure taken 24 weeks after treatment showed 96.6% of participants (among those with enough follow-up data) had undetectable virus at that later time point. At the time treatment ended, 97.1% of participants had undetectable virus levels. The reported data also shows that 1.3% of participants had a "relapse" — meaning the virus became detectable again after the end of treatment — and that zero participants experienced a "breakthrough," which refers to the virus becoming detectable again during treatment itself. Among those who did not reach the 12-week undetectable result, the reported data shows 2 had a treatment failure during the course of treatment, 3 had a relapse, 3 died, 2 stopped treatment early without a treatment failure, and 3 either did not meet any of those specific categories or had missing data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02569710 · results posted 16 July 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02569710) enrolled a total of 161 participants across ten separate groups (called cohorts). Each cohort differed in the length of treatment they received (6, 8, or 12 weeks) and the type of hepatitis C virus they had (referred to as genotypes 1, 2, or 3), as well as whether participants had advanced liver scarring (F4). The trial was measuring a range of physical and safety-related markers during and after treatment, including the number of participants who experienced medical events during the study period, body weight, body mass index (BMI — a number calculated from height and weight), blood pressure and heart rate readings, heart pump function, and certain blood test results. The reported data shows that, of the 161 people who started the trial, 155 completed it. Regarding medical events that occurred during the treatment period, the numbers of participants who experienced at least one such event ranged from 4 (out of 5 or 14 participants in some smaller cohorts) to 19 (out of 25 participants in one cohort). Average body weight at the end of treatment ranged from approximately 70 kg to 86 kg across the different groups, and average BMI figures ranged from roughly 23.6 to 28.4. For blood pressure and heart rate readings, abnormal results were reported in only one cohort — 3.3% of participants in one group had a notable heart rate reading. For the measure of heart pump function (ejection fraction), the reported data shows 0% of participants across nearly all groups had a decrease recorded, with one cohort showing 4% with a decrease. For blood test markers (such as haemoglobin and platelet levels), the percentages of participants with results graded as abnormal were generally low, with most cohorts reporting 0% and two cohorts reporting 5% for one particular blood marker. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02966795 · results posted 10 July 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 84 people in total — 23 with a type of hepatitis C called genotype 5, and 61 with a type called genotype 6. Nearly all participants finished the trial (23 out of 23 in the genotype 5 group, and 60 out of 61 in the genotype 6 group). The trial was primarily measuring what is called SVR12 — which means whether the hepatitis C virus was undetectable in a person's blood 12 weeks after they finished treatment. This is a commonly used way of checking whether the virus has cleared. The reported data shows that in the genotype 5 group, 95.7% of participants had undetectable virus levels at the 12-week post-treatment check, compared with 98.4% in the genotype 6 group. For the secondary outcomes, the reported data shows that none of the genotype 5 participants (0.0%) experienced what the trial called "on-treatment virologic failure" — meaning the virus did not rebound to detectable levels while they were still taking the study drug — while 1.6% of the genotype 6 group did. When it came to "relapse" — meaning the virus becoming detectable again after treatment ended — 4.3% of the genotype 5 group were recorded as having relapsed, while 0.0% of the genotype 6 group did. These numbers reflect what was measured and recorded within this particular trial, in these specific groups of participants, under the conditions of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02600325 · results posted 8 July 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 80 adults who received a combination tablet containing two medicines — grazoprevir (100mg) and elbasvir (50mg) — used to treat hepatitis C. All 80 participants who started the trial also completed it. The trial was measuring whether participants' hepatitis C virus became undetectable in their blood 12 weeks after finishing treatment — a result known as SVR12 (sustained viral response at 12 weeks), which is simply a measure of whether the virus was still detectable at that point in time. The reported data shows that for the main (primary) outcome, 79 out of 80 participants had undetectable hepatitis C virus at 12 weeks after finishing treatment, when cases where someone caught the virus again (reinfection) were not counted as a treatment failure. For the secondary outcome, measuring the same thing but counting any reinfections as failures, the reported data shows 75 out of 80 participants had undetectable virus at that 12-week mark. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03426787 · results posted 5 July 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT03426787) tested a decision-support tool called the "Project HELP Decision Aid," designed to help people with both hepatitis C (HCV) and chronic kidney disease (CKD) understand their condition and feel more prepared when thinking about treatment choices. A total of 70 people started the study, 56 completed it, and 14 did not finish. The reported data shows three main things were measured before and after participants used the decision aid. First, knowledge was tested with eight questions — scores (out of 100) went from an average of 53.54 before using the tool to 65.74 afterwards. Second, a scale called the SURE Test measured how confident people felt about having enough information and support to make a choice — scores (out of 4) moved from an average of 2.64 before to 3.13 after. Third, a "decision self-efficacy" scale measured how confident people felt in their own ability to make a decision — scores (out of 100) went from an average of 84.42 before to 86.62 after. As a secondary measure, participants also rated how easy the website tool was to use; the reported average score was 69.86 out of 100, just above the benchmark of 68 that the scale's guidelines describe as adequate usability. The reported data shows changes in scores before and after using the tool across these measures. No data was reported comparing these results to a control or comparison group, as all participants were in a single group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03144635 · results posted 3 June 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 80 adults who were treated with a combination of two antiviral medicines — grazoprevir and elbasvir — for hepatitis C virus (HCV) infection. The trial was looking at two main things: whether levels of a protein in the blood called endostatin changed over three months, and whether kidney function (measured using a calculation called eGFR, which estimates how well the kidneys filter blood) changed over the same period. Several secondary measurements were also taken, including whether the hepatitis C virus became undetectable in the blood 12 weeks after finishing treatment, and whether certain liver-related markers in the blood changed. The reported data shows that average blood endostatin levels were 156 ng/mL at the start of the study and 176 ng/mL at three months. Average kidney function scores were 52 at the start and 53 at three months (higher numbers generally indicate better kidney filtering, though the data does not include statistical context to interpret this difference). For the secondary outcomes, the reported data shows that 76 out of 80 participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — this was true in both the full group and the group who completed the protocol as planned. A liver enzyme called ALT, which can indicate liver stress, was reported at an average of 47 U/L at the start and 21 U/L at three months. Another liver marker, alpha-fetoprotein, was reported at an average of 10.7 ng/mL at the start and 4.6 ng/mL at three months. Among participants who had certain virus mutations at the start of the study, 15 were reported to have had undetectable virus at 12 weeks after treatment. It is worth noting that the trial recorded zero participants as having "completed" the study in the participant flow data, which may reflect how completion was defined, and no explanation for this was provided in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02817594 · results posted 17 May 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 51 participants, of whom 50 received the study treatment — a combination antiviral regimen used to treat hepatitis C (referred to as Paritaprevir/Ritonavir + Ombitasvir, with or without Dasabuvir and/or Ribavirin). Forty-eight participants completed the study. The trial was primarily measuring what is called SVR12 — a standard hepatitis C benchmark that checks whether the virus is undetectable in the blood (below 50 IU/mL) at 12 weeks after finishing treatment. This is often used as an indicator that the virus has cleared. The reported data shows that 89.6% of participants had undetectable virus levels at 12 weeks after finishing treatment (the primary measure). When looking only at participants who had enough follow-up data to make that assessment, the figure was reported as 91.5%. At the end of treatment itself, 95.8% of participants had undetectable virus levels. The reported data also shows that 6.8% of participants experienced what is called a "relapse" — meaning the virus became detectable again after it had been undetectable at the end of treatment. No participants showed a "breakthrough," which means no one had the virus reappear while still on treatment. Among those who did not achieve the 12-week undetectable result, the breakdown reported was: 3 participants relapsed, 1 stopped treatment early without a treatment failure during the drug course, and 1 had missing or unclear follow-up data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02175758 · results posted 30 April 2019

According to the results reported on ClinicalTrials.gov, this trial looked at a combination of two antiviral medicines — sofosbuvir (SOF) and ribavirin (RBV) — in children and teenagers aged 3 to under 18 years old who had hepatitis C. Participants were split into age groups and received either 12 or 24 weeks of treatment. A small early phase (called a PK lead-in) measured how the medicines moved through the body in 34 children, while the main treatment phase enrolled a larger group totalling 106 children across all age and duration groups. The trial measured things like how the drug was absorbed, the proportion of participants who stopped treatment early due to a side effect, and how many had undetectable levels of the hepatitis C virus 12 weeks after finishing treatment — a result called SVR12. The reported data shows that for the main question about virus levels after treatment (SVR12), 98.1% of the 12-to-under-18 age group and 98.1% of the 3-to-under-12 age group had hepatitis C virus levels below the detectable limit at 12 weeks post-treatment. Breaking this down further, the reported figures were 100% for the 12-to-18 group on the 12-week course, 97.4% for the 12-to-18 group on the 24-week course, 100% for the 6-to-12 group on both course lengths, 80% for the 3-to-6 age group on the 12-week course, and 100% for the 3-to-6 group on the 24-week course. Regarding stopping treatment early due to a side effect, the reported data shows this occurred in 0% of participants in most groups, with the exception of the 3-to-under-6 age group on the 12-week course, where 20% (1 out of 5 participants) permanently stopped study medication for this reason. In the early drug-absorption phase, no participants in any age group stopped treatment due to a side effect. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02249182 · results posted 24 April 2019

According to the results reported on ClinicalTrials.gov, this trial looked at a combination antiviral treatment (ledipasvir/sofosbuvir, with or without an additional medicine called ribavirin) in children and teenagers with hepatitis C. Participants were split into age groups: 12 to under 18 years old, 6 to under 12 years old, and 3 to under 6 years old. In total, across all groups and both the lead-in and treatment phases, several hundred participants were enrolled — roughly 100 teenagers, around 90 children aged 6–12, a small number in the longer 24-week arms, and 34 young children aged 3–6. The trial measured how the drug moved through participants' bodies (pharmacokinetics), whether anyone stopped the drug due to a side event, and whether the hepatitis C virus became undetectable in the blood weeks after treatment ended. The reported data shows that in the short "lead-in" phase — where drug levels in the blood were measured — the amount of drug detected over a dosing period (a measure called AUCtau, essentially how much drug was present in the body over time) was broadly similar across the three age groups, ranging from around 8,200 to 12,700 units for one drug component and similar patterns for the others. Regarding stopping the treatment early due to an adverse event (an unwanted health occurrence), the reported data shows 0% of participants in most groups permanently stopped the study drug for this reason; in the youngest age group (3 to under 6), the figure was 2.9% during the full treatment phase and 5.9% during the lead-in phase alone. The reported data also shows results for whether the hepatitis C virus remained undetectable in the blood at 4 weeks and 12 weeks after finishing treatment — a measure called SVR (sustained virologic response). According to the results reported on ClinicalTrials.gov, SVR rates at both 4 and 12 weeks were 98.0% for the 12–18 age group on 12 weeks of treatment, 98.9% for the 6–12 age group on 12 weeks, 100% for both the 6–12 groups on 24 weeks of treatment, and 97.1% for the youngest group (3–6 years) on 12 weeks of treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03118843 · results posted 3 April 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT03118843) enrolled 31 participants, all of whom received a combination treatment referred to as SOF/VEL/VOX (a single group with no comparison group). All 31 participants completed the trial — none dropped out. The trial was primarily measuring two things: whether participants' hepatitis C virus (HCV) levels fell below a detectable threshold 12 weeks after finishing treatment (known as SVR12, a standard way of checking whether the virus is still detectable in the blood), and whether anyone had to permanently stop taking the study medication due to a bad reaction. The reported data shows that 100% of participants (all 31 people) had HCV levels below the detectable limit at both 4 weeks and 12 weeks after finishing treatment. The reported data also shows that 0% of participants permanently stopped the study medication due to an adverse event (an unwanted reaction). For the secondary measurements, the reported data shows that 0% of participants experienced what the trial defined as "virologic failure" — meaning the virus did not rebound or persist during treatment in any participant. During treatment itself, the proportion of participants with virus levels below the detectable limit rose over time, with figures reported at 51.6%, 96.8%, and 100% at successive measurement points. The reported data also includes measurements of how much HCV levels changed from the starting point during treatment, expressed as a log10 reduction (a technical way of describing a large drop in virus levels) — with reductions of around 5.16 to 5.34 log10 IU/mL reported across the on-treatment time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02725866 · results posted 15 March 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 216 people who had been diagnosed with hepatitis C (a viral infection of the liver) of a specific type — genotype 1 or genotype 4. Of those who started, 202 completed the trial and 14 did not. The trial was primarily measuring whether participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a result researchers call "SVR12" (meaning the virus is no longer measurable at that point in time). The reported data shows that, for the primary outcome, two figures were recorded for this single group of participants — 91.1% and 95.6% — representing the proportion of people with no detectable virus 12 weeks after finishing treatment, measured across slightly different definitions of who was included in the analysis. For the secondary outcomes, the reported data shows that 93.9% of participants had no detectable virus at the end of treatment itself. A very small percentage — 0.9% — were reported as having had a "relapse" (meaning the virus became detectable again after being undetectable at the end of treatment). The reported data also shows that 0.0% experienced what was called a "viral breakthrough" during treatment (where the virus rebounded while still on treatment), and 0.5% were recorded as having an on-treatment virologic failure overall. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01604291 · results posted 14 March 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 991 people in total across four groups. The largest groups received either two medications (peginterferon alfa-2a and ribavirin) or those same two medications plus a third drug — either telaprevir or boceprevir. A smaller group of 44 participants had no information recorded about which treatment they received. The trial was primarily measuring what is called a "sustained viral response" (SVR) — meaning whether the hepatitis C virus was undetectable in the blood 24 weeks after finishing treatment. The reported data shows that, for the primary measure (virus undetectable 24 weeks after treatment ended), the figures were: 87.2% of participants in the two-drug group, 94.8% in the two-drug-plus-telaprevir group, and 85.2% in the two-drug-plus-boceprevir group. The reported data also shows results for several secondary measures. At four weeks into treatment, the percentage of participants who already had undetectable virus levels was 61.2% (two-drug group), 70.9% (plus telaprevir), and 21.1% (plus boceprevir). At 12 weeks, those figures were 75.0%, 84.9%, and 62.0% respectively. For the two triple-therapy groups, around 72.7% (telaprevir group) and 70.7% (boceprevir group) had undetectable virus at the specific combined early time points measured for each regimen. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02996682 · results posted 26 February 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 102 people with hepatitis C, split evenly into two groups of 51. One group received a combination tablet called SOF/VEL (sofosbuvir/velpatasvir), while the other received SOF/VEL together with an additional medicine called ribavirin (RBV). The trial was primarily measuring how many participants had undetectable levels of the hepatitis C virus in their blood 12 weeks after finishing treatment — a result researchers call SVR12 — as well as how many participants stopped treatment early because of an unwanted side effect. The reported data shows that in both groups, 92.2% of participants had undetectable hepatitis C virus levels at 12 weeks after finishing treatment. At 4 weeks after treatment, the figures were 94.1% for the SOF/VEL-only group and 96.1% for the SOF/VEL plus ribavirin group, and at 24 weeks the results were again 92.2% in both groups. Regarding early treatment stops due to adverse (unwanted) events, the reported data shows that 0% of the SOF/VEL-only group stopped the SOF/VEL tablet early for this reason, compared with 3.9% in the combination group. For ribavirin specifically within the combination group, 17.6% stopped that particular medicine early due to an adverse event. The trial also tracked how quickly the virus became undetectable during treatment, and reported reductions in virus levels over time in both groups, though the specific visit-by-visit figures varied. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02717949 · results posted 8 January 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02717949) involved two groups of participants: one receiving a combination called Sofosbuvir/Ledipasvir, and another receiving Sofosbuvir and Ribavirin. Both treatments are used in the context of hepatitis C (HCV) infection. The trial was set up to look at two things: how many people experienced unwanted side effects during treatment, and whether the size of lymph nodes (small glands in the body that are part of the immune system) changed after treatment. The reported data shows that the number of participants recorded as having started, completed, or not completed the study was zero for both groups. This means no participant enrolment figures were submitted to ClinicalTrials.gov. Likewise, the results for both the primary outcome — side effects during treatment — and the secondary outcome — changes in lymph node size — contain no reported measurements. In other words, the actual result figures for these outcomes were not reported in the data submitted to ClinicalTrials.gov. Because no numerical results were provided for any of the outcome measures, it is not possible to describe what the trial found regarding side effects or lymph node size changes. The reported data simply does not include this information. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02021656 · results posted 28 December 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 384 participants across China, Korea, and Taiwan who had hepatitis C virus (HCV) infection. They all received a combination treatment called LDV/SOF (ledipasvir/sofosbuvir). The trial was mainly measuring two things: how many participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment (called SVR12, a standard way of checking whether the virus is still present), and how many participants had to stop taking the study drug early because of an unwanted side effect. The reported data shows that, across all 384 participants overall, 99.2% had no detectable virus in their blood at 12 weeks after finishing treatment. For participants in China specifically, that figure was reported as 100%. Regarding stopping the treatment early due to an adverse event (an unwanted or harmful reaction), the reported data shows this occurred in 0.5% of participants overall, and 0% among the China group specifically. Of the 384 people who started the trial, 378 completed it and 6 did not. The reported data also shows results for several secondary measures — that is, additional things the trial tracked. At both 4 weeks and 24 weeks after finishing treatment, the percentage with no detectable virus was reported as 100% for the China group and approximately 99% overall. The percentage of participants who experienced "viral breakthrough" (the virus becoming detectable again during treatment) was reported as 0% in both groups. "Viral relapse" (the virus returning after treatment ended) was reported as 0% in the China group and 0.5% overall. For the China group only, the starting level of virus in the blood and the change in that level over 12 weeks of treatment were also recorded, though these figures are in a technical unit and were not described further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02076100 · results posted 28 November 2018

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called ruzasvir in people with hepatitis C virus (HCV) infection. A total of 22 participants took part, divided into seven small groups based on the dose of ruzasvir they received (10 mg, 30 mg, 60 mg, or 120 mg) and the specific type — or "genotype" — of hepatitis C they had (genotypes 1a, 2b, or 3). All 22 participants who started the trial completed it. The main thing the trial was measuring was how much the level of hepatitis C virus in the blood changed over the first five days of treatment, as well as tracking any unwanted medical events (called adverse events) that occurred. The reported data shows that the virus level in the blood — measured on a scientific scale called log10 — dropped by varying amounts across the different groups over those five days. A reduction of 3.0 or more on this scale was the target the trial had set. The reported reductions were: 2.84 for the 10 mg genotype-3 group, 3.03 for the 30 mg genotype-3 group, 3.36 for the 60 mg genotype-3 group, and 1.81 for the 120 mg genotype-3 group. For the genotype-2b groups, reductions of 3.82 (10 mg) and 3.62 (60 mg) were reported. For genotype-1a (60 mg), the reported reduction was 3.63, and for a genotype-1b group included in the analysis, it was 3.82. Regarding adverse events, the reported data shows that 9 out of the 22 participants across the groups experienced at least one unwanted medical event, and no participant stopped taking the study drug because of an adverse event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01938625 · results posted 21 November 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 35 participants in total — 10 in a group taking cyclosporine and 25 in a group taking tacrolimus. Both cyclosporine and tacrolimus are medicines commonly used in transplant patients to prevent organ rejection. The trial was measuring how well a hepatitis C treatment worked alongside these two different anti-rejection medicines, by tracking the level of hepatitis C virus in participants' blood at various points during and after treatment. All 10 participants in the cyclosporine group completed the trial, while 23 of the 25 in the tacrolimus group completed it. The reported data shows that the main outcome being tracked was the proportion of participants whose hepatitis C virus levels dropped to a very low or undetectable level 12 weeks after finishing treatment — a measure called SVR12. In the cyclosporine group, 100% of participants reached this level, compared with 88% in the tacrolimus group. The reported data shows the same figures held at both 4 weeks and 24 weeks after the end of treatment. At week 4 during treatment, 100% of participants in both groups had virus levels below a set threshold of 100 IU/mL. The trial also tracked participants who experienced what was called "on-treatment failure" — meaning their virus levels did not reach the target by the actual end of treatment. The reported data shows zero such cases in the cyclosporine group and three in the tacrolimus group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01753570 · results posted 26 October 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 74 people with hepatitis C (a liver virus infection). They were split into three groups: 30 people with a type of hepatitis C called genotype 1 who received a three-drug combination including MP-424 (also known as telaprevir), ribavirin, and interferon beta; 30 people with genotype 1 who received only ribavirin and interferon beta (no MP-424); and 14 people with genotype 2 who received the three-drug combination. The main thing the trial was measuring was whether the hepatitis C virus became undetectable in participants' blood 24 weeks after they finished taking the study drugs — a result called a "sustained viral response" or SVR. The reported data shows that, for the primary measurement (SVR at 24 weeks after finishing treatment), 63.3% of genotype 1 participants on the three-drug combination had undetectable virus, compared with 20.0% of genotype 1 participants on the two-drug combination. Among the genotype 2 group on three drugs, 71.4% had undetectable virus at that point. The reported data also shows earlier measurements: at just 4 weeks into treatment, 70.0% of the genotype 1 three-drug group and 92.9% of the genotype 2 three-drug group had undetectable virus, versus 6.7% in the genotype 1 two-drug group. At the end of treatment itself, those figures were 76.7%, 85.7%, and 30.0% respectively. Regarding virus variants that could signal reduced response to MP-424, the reported data shows that small numbers of participants in the genotype 1 group (ranging from 0 to 5 participants across different variant types) showed such variants, while in the genotype 2 group the numbers were 0 or 1. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01429792 · results posted 23 October 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,013 participants who were treated with a medication called pegylated interferon alfa-2a (also known as peginterferon). The participants had hepatitis C virus (HCV) infection across different genetic types of the virus: 687 had genotype 1, 305 had genotype 2 or 3, and 5 had genotype 4. The trial was measuring how the virus responded to treatment at several points in time — at week 4, week 12, and week 24 — by checking whether the virus could still be detected in participants' blood. A total of 607 participants completed the trial, while 406 did not complete it. The reported data shows the following results. At week 4, around 48% of participants had no detectable virus in their blood (called a rapid virologic response), while roughly 52% still had detectable virus. By week 12, about 50.8% had no detectable virus (called a complete early virologic response), and about 15.7% showed a large drop in virus levels — at least a hundredfold reduction — but the virus was still detectable (called a partial early virologic response). Among those who still had detectable virus at week 4, about 6.9% went on to have no detectable virus by week 24. Separately, about 15.6% of participants showed a specific response pattern where virus levels dropped significantly by week 12 but were still detectable, and then became undetectable by week 24. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02666352 · results posted 17 September 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 24 people in total — 8 with moderate liver impairment (referred to as "moderate HI"), 8 with severe liver impairment ("severe HI"), and 8 healthy participants with normal liver function. All 24 completed the study with no dropouts. The trial was measuring how the body absorbed and processed a single dose of a drug called uprifosbuvir (taken together with another drug, ruzasvir), by tracking how much of the drug appeared in the blood over time and how quickly it reached its peak level. These measurements are commonly used to understand whether a medical condition — in this case, liver impairment — changes the way a drug moves through the body. The reported data shows the following figures for the amount of drug in the blood over time (a measure called "area under the curve," which essentially reflects total drug exposure): in the moderate liver impairment group the value was 5.34, in the severe liver impairment group it was 8.02, and in the healthy group it was 3.74 (all in units of µM\*hr). Similar patterns appeared in the related exposure measures. The reported data also shows that the peak blood concentration of the drug (the highest level recorded after the dose) was 1,560 nM in the moderate impairment group, 2,130 nM in the severe impairment group, and 1,180 nM in the healthy group. The time it took to reach that peak was reported as 1.00 hour for the moderate group, 0.50 hours for the severe group, and 1.25 hours for the healthy group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02781571 · results posted 21 August 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 79 participants, all of whom received a treatment referred to as SOF/VEL (a combination of two antiviral medicines). All 79 participants completed the study — none dropped out. The trial was measuring how many people had the hepatitis C virus reduced to an undetectable level in their blood at various points during and after treatment, as well as how many people stopped taking the study medication early due to a side effect. The reported data shows that the main result the trial was designed to measure — known as SVR12 — found that 96.2% of participants had undetectable levels of hepatitis C virus in their blood 12 weeks after finishing treatment. A secondary measure taken at 4 weeks after finishing treatment (SVR4) showed 97.5% of participants had undetectable virus levels at that earlier time point. During treatment itself, the reported data shows that 40.5% of participants had undetectable virus at week 2, rising to 85.9% at week 4, and 98.7% at week 8. Regarding early stopping of the medication, the reported data shows that 1.3% of participants (approximately 1 person out of 79) discontinued the study drug early due to an adverse event (an unwanted reaction). These numbers reflect what was measured and recorded in this particular group of participants under the conditions of this specific trial. It is important to note that these figures describe a single study group and do not represent a comparison with a placebo or alternative treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01958281 · results posted 8 August 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01958281) enrolled 38 people with hepatitis C who also had reduced kidney function. Participants were split into three groups: 10 received a lower dose of sofosbuvir (SOF 200 mg) combined with ribavirin (RBV), 10 received a standard dose of sofosbuvir (SOF 400 mg) combined with ribavirin, and 18 received a combination tablet of ledipasvir and sofosbuvir (LDV/SOF). The trial was measuring how well the virus was suppressed after treatment ended, as well as tracking side effects, laboratory changes, heart rhythm readings, and how the drugs moved through the body. The reported data shows that the main marker of viral suppression — called SVR12, meaning the hepatitis C virus was undetectable in the blood 12 weeks after finishing treatment — was recorded as 40% in the SOF 200 mg + RBV group, 60% in the SOF 400 mg + RBV group, and 100% in the LDV/SOF group. Regarding side effects that appeared during treatment, the reported figures were 100% of participants in the SOF 200 mg + RBV group, 90% in the SOF 400 mg + RBV group, and 72.2% in the LDV/SOF group. Changes in laboratory test results (such as blood tests) that worsened by at least one level from the starting point were reported in 100% of participants across all three groups. Clinically significant changes on heart rhythm (ECG) tests were reported in 0% of participants in the two SOF + RBV groups and 5.6% in the LDV/SOF group. Changes in vital signs (such as blood pressure or pulse) were reported in 10% of the SOF 200 mg + RBV group, and 0% in the other two groups. The reported data also includes measurements of how much of the study drugs were present in participants' blood over time (a measure called AUCtau), though this was only measured in the two SOF + RBV groups and the figures varied between dose levels — higher doses were associated with higher drug exposure levels in the blood. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02707952 · results posted 23 July 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 295 participants in total, spread across four groups (called Arms A, B, C, and D). Arm A had 129 people, Arm B had 53, Arm C had 103, and Arm D had 10. The trial was measuring how many participants had undetectable levels of the hepatitis C virus in their blood 12 weeks after finishing treatment — a result researchers call "SVR12" (which simply means the virus was no longer detectable at that point in time). Different arms included different sub-groups of participants, such as those with liver scarring (cirrhosis), people who had previously tried certain antiviral treatments, those with particular virus strains, and people with serious kidney problems. The reported data shows that in the main (primary) measurement combining Arms A and B, 99.1% of Arm A participants and 100% of Arm B participants had undetectable virus levels at 12 weeks after treatment ended. When Arm A was looked at separately as a secondary measure, the reported figure was 99.2%. For Arms C and D, which covered several specific sub-groups, the reported percentages of participants with undetectable virus at 12 weeks ranged from 83.3% to 100%, depending on the sub-group. The reported data also shows that the proportion of participants whose virus levels rose or remained detectable *during* treatment (called "on-treatment virologic failure") was 0% in Arms A, B, and D, and 1.0% in Arm C. The proportion whose virus returned in the 12 weeks *after* treatment ended (called "post-treatment relapse") was reported as 0% in Arms A, B, and D, and 3.0% in Arm C. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02722837 · results posted 17 July 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 119 participants, all of whom received a combination treatment referred to as SOF/VEL (sofosbuvir/velpatasvir). All 119 participants completed the study. The trial was measuring how many people had undetectable levels of the hepatitis C virus in their blood at various points after finishing treatment, as well as whether anyone had to stop taking the study drug due to a medical side effect. The reported data shows that the main goal of the trial was to look at two things: the proportion of participants with undetectable hepatitis C virus levels 12 weeks after finishing treatment (called SVR12), and the proportion who had to permanently stop taking the drug because of an adverse event (an unwanted medical occurrence). For SVR12, the reported figure was 99.2% of participants. The reported figure for permanent discontinuation due to an adverse event was 0% — meaning none of the 119 participants stopped the drug for that reason, according to the submitted data. For additional measurements taken at other time points, the reported data shows that 100% of participants had undetectable virus levels at 4 weeks after finishing treatment, and 99.2% at 24 weeks after finishing treatment. During treatment itself, 21.0% of participants had undetectable virus levels at week 1, rising to 64.7% at week 2. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01355289 · results posted 22 February 2018

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called avatrombopag in people with chronic hepatitis C who had low platelet counts (platelets are tiny blood cells that help with clotting). Low platelet counts can make it difficult to start antiviral treatment for hepatitis C, so the trial was testing whether avatrombopag could raise platelet counts high enough to allow that treatment to begin. In the main part of the trial (the "core study"), 65 people took part — 17 received a placebo (a dummy treatment with no active ingredient), and 48 received avatrombopag at one of three different daily doses: 10 mg, 20 mg, or 30 mg. A further 62 people then continued into an open-label extension phase, where everyone received avatrombopag. The reported data shows that the main thing being measured was how many participants reached a platelet count of 100 or above (measured in units of cells × 10⁹/L, a standard way of counting blood cells) by day 21. According to the results reported on ClinicalTrials.gov, 1 out of 17 placebo participants reached this level, compared with 6 out of 16 in the 10 mg group, 12 out of 18 in the 20 mg group, and 9 out of 14 in the 30 mg group. The reported data also shows that the average change in platelet count from the start of the study to day 21 was −0.2 for the placebo group, and 29.2, 57.2, and 55.4 for the 10 mg, 20 mg, and 30 mg avatrombopag groups respectively. Regarding antiviral treatment being started by day 21, the numbers reported were 1 (placebo), 6 (10 mg), 13 (20 mg), and 9 (30 mg) participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02613871 · results posted 13 February 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 111 adults who were given a combination tablet known as LDV/SOF (ledipasvir/sofosbuvir), a treatment for hepatitis C. The trial was measuring whether participants' hepatitis C virus (HCV) became undetectable in the blood after finishing treatment, and whether any participants had to stop taking the study drug because of an unwanted reaction. Of the 111 people who started, 108 completed the study and 3 did not complete it. The reported data shows that 100% of participants had what is called an SVR12 — meaning the hepatitis C virus was undetectable in their blood 12 weeks after finishing treatment. The same 100% result was also reported at 4 weeks after finishing treatment (SVR4). The reported data also shows that 0% of participants permanently stopped taking the study drug due to an adverse event (an unwanted reaction). During treatment, the proportion of participants with undetectable virus levels rose over time — from around 33% early in treatment to 100% by a later time point. After treatment ended, 100% of participants continued to show undetectable virus levels across all follow-up check points measured out to approximately two years (weeks 24 through 108 after stopping treatment). The virus levels in the blood also dropped on average by around 4.1 to 4.7 log10 IU/mL (a measure of how much the virus count fell) during treatment, though the meaning of these specific numbers was not further explained in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02465203 · results posted 12 January 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 105 participants across three groups: 56 people from a study called "Study 2210," 36 from "Study 2301," and 13 from "Study 2211." All participants are recorded as not having completed the study, though no further explanation for this is provided in the reported data. The trial was looking at participants who had previously been treated with a medicine called alisporivir (a hepatitis C treatment that was being investigated), and it tracked certain features of the hepatitis C virus in their blood over time, as well as monitoring their liver health. The reported data shows that the main (primary) thing being measured was whether certain changes in the hepatitis C virus — called "resistance-associated variants" (meaning small alterations in the virus that can affect how it responds to treatment) — were still present in participants over time. Out of all participants combined, 4 people were reported as having these viral variants detected. For the secondary outcomes — which included laboratory tests of liver function, liver scans, and an assessment of how the virus behaved against alisporivir in a lab setting — no numerical results were reported in the data submitted to ClinicalTrials.gov. Because most of the secondary outcome measures have no figures recorded, a full picture of what was observed across those areas is not available from this submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02487030 · results posted 14 December 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 255 people in total across seven groups. All participants had hepatitis C (genotype 1) and were being treated with a combination antiviral regimen. Some groups received two medicines (ledipasvir and sofosbuvir, often written as LDV/SOF), while others received those two medicines plus a third called ribavirin (RBV). Treatment courses lasted either 8 or 12 weeks. Some participants had never been treated before (labelled "treatment-naïve"), while others had been treated previously (labelled "treatment-experienced"). The trial's main goals were to measure how many people had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a result called SVR12 — and to track how many people stopped taking the study medicines early due to a side effect. The reported data shows that SVR12 rates — meaning the percentage of people in each group with no detectable virus 12 weeks after finishing treatment — ranged from 90.5% to 100% depending on the group. Specifically: the 8-week treatment-naïve groups reported 95.3% and 90.5%; the 12-week treatment-naïve groups reported 97.7% and 97.6%; the 12-week treatment-experienced groups reported 94.4% and 100%; and the group with prior experience of these specific medicines reported 100%. Regarding stopping the medicines early due to a side effect, the reported data shows this occurred in 0% of participants across three of the four reported groups, and in 1.1% of participants in the 12-week LDV/SOF-plus-ribavirin treatment-naïve group. The reported data for the SVR24 outcome (no detectable virus at 24 weeks after treatment) appears incomplete in the submitted results, with figures only available for some groups, so a full comparison across all groups cannot be made from the data provided. The reported data also shows that overall "virologic failure" — meaning the virus remained detectable or returned during or after treatment — ranged from 0% to 9.5% across the seven groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02607735 · results posted 13 December 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02607735) tested a combination tablet called SOF/VEL/VOX (sofosbuvir/velpatasvir/voxilaprevir) for hepatitis C. The main part of the study enrolled 264 people who received the active treatment and 152 people who received a placebo (a dummy tablet with no active medicine). A further 147 participants took part in a follow-on substudy where those who had originally received the placebo were then offered the active treatment. The trial was primarily measuring how many people had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a result researchers call SVR12 — and also tracking how many people stopped taking the study drug early because of an unwanted side effect. The reported data shows that in the main treatment group, 96.2% of participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment, and this same figure (96.2%) was also recorded at the 24-week mark. At the earlier 4-week check, 97.7% of the active treatment group had no detectable virus, compared with 0% in the placebo group (which is expected, as the placebo contained no active medicine). Regarding people who permanently stopped taking the study drug due to an unwanted effect, the reported data shows this occurred in 0.4% of the active treatment group and 2.0% of the placebo group. The reported data also shows that the level of hepatitis C virus in the blood dropped by around 4.2 to 5.1 units (on a scientific measurement scale) in the active treatment group during treatment, while it remained essentially unchanged in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01439373 · results posted 11 December 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01439373) enrolled 16 people in total — 11 received the investigational drug GSK2336805 (60 mg) combined with two existing hepatitis C medicines (pegylated interferon and ribavirin, often shortened to PEG and RIBA), and 5 received a placebo combined with those same two medicines. The trial was primarily measuring whether, after 28 days of treatment, the hepatitis C virus became undetectable in participants' blood — a result called a "rapid virological response" (RVR). The focus was particularly on participants whose hepatitis C was of a type known as genotype 1. The reported data shows that, looking at the genotype 1 participants specifically, 7 out of 11 people in the GSK2336805 group had undetectable virus levels at around Day 28 (using a slightly wider measurement window of plus or minus 2 days), compared with 1 out of 4 in the placebo group. Using a stricter count taken exactly on Day 28, 3 out of 11 in the GSK2336805 group and 3 out of 4 in the placebo group had undetectable virus — though 2 people in the GSK2336805 group did not complete this phase of the trial and were counted as not responding. The trial also measured how the virus level changed in the first 24 hours after a single dose of GSK2336805 on Day 1 (before the other medicines were added); the reported data shows the virus level in the GSK2336805 group fell by about 2.38 units on a logarithmic scale (a scale used to measure very large or small numbers) by the 24-hour mark, while the placebo group showed a change of around −0.11 units over the same period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00244751 · results posted 11 December 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 265 people across three groups: 88 received a placebo (a dummy treatment with no active ingredient), 89 received a low dose (0.5 mg) of the investigational drug GI262570, and 88 received a higher dose (1.0 mg) of GI262570. The trial ran for 52 weeks and was measuring changes in liver tissue in people with liver disease — specifically looking at signs of scarring (fibrosis) and the activation of certain liver cells (hepatic stellate cells) that are involved in that scarring process. Liver biopsies (small tissue samples) were taken at the start and again at 52 weeks to compare any changes. The reported data shows that for the main liver tissue measurements, all three groups showed a small increase in the ratio of scarred or activated tissue compared to their starting point. For the stellate cell activation marker, the placebo group's average change was 0.021, the low-dose group was 0.028, and the high-dose group was 0.029 (all expressed as a proportion of the total tissue area). For the collagen/fibrosis measure, the reported changes were very similar across all three groups: 0.025 for placebo, 0.026 for the low dose, and 0.025 for the high dose. The trial also recorded adverse events (unexpected medical occurrences during the study) — 75 people in the placebo group, 68 in the low-dose group, and 71 in the high-dose group experienced at least one adverse event. Serious adverse events were recorded in 7, 10, and 6 participants in each group respectively. Data on ECG (heart tracing) findings and certain laboratory test abnormalities were also collected and reported across all groups, with variation between groups noted in the submitted figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02202980 · results posted 17 November 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02202980) enrolled a total of 273 participants across 14 treatment groups. The trial tested different combinations and durations of antiviral medicines — including ledipasvir/sofosbuvir (with or without ribavirin) and sofosbuvir/velpatasvir/voxilaprevir — in people living with hepatitis C virus (HCV). Participants were divided into groups based on which medicine combination they received, how long they took it (ranging from 4 to 24 weeks), and their hepatitis C virus "genotype" (a way of categorising different strains of the virus). The main things the trial was measuring were: the proportion of people whose hepatitis C virus was undetectable in their blood 12 weeks after finishing treatment (called SVR12), and the proportion who had to permanently stop their medicine due to a side effect. The reported data shows that SVR12 rates — meaning the percentage of people in each group with no detectable virus 12 weeks after finishing treatment — varied considerably across groups. Rates ranged from 26.7% in one shorter-duration group (SOF/VEL+VOX for 4 weeks, genotype 1) up to 100% in two other groups (SOF/VEL+VOX for 8 weeks, genotype 1, in two separate cohorts). Other groups fell in between: for example, 92.9% in the LDV/SOF plus ribavirin 24-week group, 96.2% in one 12-week LDV/SOF group, 74.1% in an 8-week LDV/SOF group, and 76.9% in a 12-week group for genotype 3. Note that data for two of the 14 groups (Cohort 5 Groups 7 and 8) were not reported in the SVR12 results. Regarding treatment discontinuation due to side effects, the reported data shows that in 11 of the 12 groups where this was recorded the figure was 0%, with one group (LDV/SOF plus ribavirin, 24 weeks) reporting 7.1%. The secondary results also tracked virologic failure — that is, the virus returning or never falling to undetectable levels during or after treatment — with rates ranging from 0% in several groups up to 73.3% in the 4-week SOF/VEL+VOX group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02639338 · results posted 14 November 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02639338) enrolled 220 people with hepatitis C, split evenly into two groups of 110. One group took a three-drug combination tablet (sofosbuvir/velpatasvir/voxilaprevir, referred to here as SOF/VEL/VOX) for 8 weeks, while the other took a two-drug combination tablet (sofosbuvir/velpatasvir, or SOF/VEL) for 12 weeks. The trial's main goals were to measure how many participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment (called SVR12 — essentially a test of whether the virus was still present), and how many people stopped taking the study drug early because of an unwanted side effect. The reported data shows that in the 8-week group, 96.4% of participants had no detectable virus at the 12-week post-treatment check, compared with 96.3% in the 12-week group. No one in the 8-week group stopped their medication early due to an adverse (unwanted) event, while 0.9% in the 12-week group did. For the secondary (additional) measures, the reported data shows that around 97% of participants in both groups had no detectable virus at 4 weeks after finishing treatment, and those figures remained similar at 24 weeks post-treatment (96.4% and 96.3% respectively). The percentage of participants recorded as experiencing a "virologic failure" — meaning the virus was either not suppressed during treatment or came back afterwards — was reported as 1.8% in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02207088 · results posted 9 November 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 68 participants, all of whom received a three-drug combination treatment (referred to as 3-DAA), with or without an additional medicine called ribavirin. The trial was measuring how well the treatment cleared the hepatitis C virus from participants' blood, specifically by looking at whether the virus was undetectable 12 weeks after finishing treatment — a milestone known as SVR12 (sustained virologic response at 12 weeks). Sixty-six of the 68 participants completed the study, with two not completing it. The reported data shows that 94.1% of participants had no detectable hepatitis C virus in their blood at 12 weeks after finishing treatment. The reported data also shows that 0% of participants experienced what is called "on-treatment virologic failure" — meaning no participant's virus levels rebounded or remained persistently detectable while they were still taking the treatment. Additionally, 1.5% of participants who completed treatment and had undetectable virus at the end were reported to have experienced a "relapse" — meaning the virus became detectable again in the 12 weeks after finishing treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02607800 · results posted 8 November 2017

According to the results reported on ClinicalTrials.gov, this trial compared two antiviral treatment regimens for hepatitis C (a liver infection caused by the hepatitis C virus). One group of 502 people received a three-drug combination called SOF/VEL/VOX for 8 weeks, and another group of 441 people received a two-drug combination called SOF/VEL for 12 weeks. The trial's main goals were to measure how many participants had no detectable virus in their blood 12 weeks after finishing treatment (called SVR12, a standard way of measuring whether the virus is still present), and how many people stopped taking the study drug early due to side effects. The reported data shows that, for the SVR12 primary outcome, 95.2% of participants in the 8-week three-drug group and 98.2% in the 12-week two-drug group had no detectable virus at the 12-week follow-up point. Regarding stopping treatment early due to side effects, the reported figure was 0% in the 8-week group and 0.5% in the 12-week group. For secondary outcomes, the reported data shows that 4.2% of the 8-week group and 0.7% of the 12-week group experienced what the trial defined as "virologic failure" — meaning the virus was detected again or never reduced sufficiently during or after treatment. Similar virus-detection measures at 4 weeks and 24 weeks after finishing treatment followed a broadly comparable pattern to the 12-week results, with slightly higher figures in the 12-week treatment group across both timepoints. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02639247 · results posted 6 November 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02639247) enrolled 333 people with hepatitis C infection who had previously been treated with certain antiviral medicines but had not cleared the virus. Participants were split into two groups: 182 people received a three-drug combination called SOF/VEL/VOX for 12 weeks, and 151 people received a two-drug combination called SOF/VEL for 12 weeks. The trial was primarily measuring how many participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a result known as SVR12 (sustained virologic response at 12 weeks) — as well as how many people stopped their study medication early due to a side effect. The reported data shows that in the three-drug group (SOF/VEL/VOX), 97.8% of participants had no detectable virus at 12 weeks after treatment ended, compared with 90.1% in the two-drug group (SOF/VEL). Regarding stopping treatment early due to a side effect, the reported figure was 0% for the three-drug group and 0.7% for the two-drug group. For secondary outcomes, the reported data shows that virologic failure (the virus either not responding or returning during or after treatment) was recorded in 0.5% of the three-drug group and 9.9% of the two-drug group. Results at 4 weeks after treatment ended were 98.4% and 91.4% respectively, and at 24 weeks after treatment ended were 97.8% and 90.1% — broadly similar to the 12-week figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01364090 · results posted 18 October 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 93 people in total across three groups. The study was looking at treatment for hepatitis C virus (HCV) infection using a combination of two medicines — PEG-IFN alfa-2b (given under direct supervision) and ribavirin (self-administered). The key question was whether the length of treatment needed could be tailored based on how a person's body responded early on: those whose virus became very low or undetectable by week 4 received 12 weeks of treatment, while those who still had measurable virus at week 4 received 24 weeks. Six participants stopped treatment before the week 4 check-in point and formed a separate group. The main thing being measured was whether the virus was undetectable in the blood 12 weeks after finishing treatment — a result known as SVR12 (sustained virological response at 12 weeks), which essentially means no detectable virus in the blood at that time point. The reported data shows that, of the 61 people in the shortened 12-week treatment group, 51 had undetectable virus at 12 weeks after finishing treatment. Of the 26 people in the 24-week treatment group, 10 had undetectable virus at the same follow-up point. None of the 6 people who stopped before the week 4 check had undetectable virus at that stage. For the secondary outcomes — which looked at how well people stuck to their treatment schedule, whether the virus was undetectable at the end of treatment and at 24 weeks after finishing, and any changes in drug use, mental health, and quality of life — the reported data shows that no numerical results were submitted to ClinicalTrials.gov for these measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02480166 · results posted 19 September 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02480166) enrolled 60 people in total, split across three groups based on their treatment course: 20 people received 8 weeks of a combination medication called SOF/LED (sofosbuvir/ledipasvir), 36 people received 12 weeks of the same medication, and 4 people were moved from the 8-week group to an extended 12-week course. All 60 participants who started the trial completed it. The trial was primarily measuring how many people had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a result commonly called SVR12, which is a way of checking whether the virus remains at an undetectable level after treatment has ended. The reported data shows that in the 8-week group, 19 out of 20 participants had undetectable hepatitis C virus levels at 12 weeks post-treatment. In the 12-week group, 34 out of 36 participants had undetectable virus levels at that same point. All 4 participants in the extended treatment group also had undetectable virus levels 12 weeks after finishing treatment. As a secondary measure, the trial tracked how many participants experienced serious or notable unwanted health events (called adverse events) from the time they joined the study until 12 weeks after treatment. The reported data shows that zero participants across all three groups were recorded as having experienced such events. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02446717 · results posted 15 September 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 141 people across five groups (called Arms A through E), with group sizes ranging from 6 to 47 participants. The trial was studying treatments for hepatitis C, a virus that affects the liver. The main thing researchers were measuring was whether participants had what is called a "sustained virologic response" 12 weeks after finishing treatment — meaning that the hepatitis C virus could no longer be detected in their blood at that point in time. The reported data shows that, for the primary measure (undetectable virus 12 weeks after treatment ended), the percentages across the five groups were: Arm A – 100%, Arm B – 95.5%, Arm C – 86.4%, Arm D – 88.6%, and Arm E – 91.5%. A similar measure taken at 4 weeks after treatment showed figures of 100%, 95.5%, 95.5%, 90.9%, and 91.5% respectively. The reported data also shows the percentage of participants in whom the virus rebounded *during* treatment: 0% in Arms A and B, 4.5% in Arm C, 2.3% in Arm D, and 8.5% in Arm E. For virus returning *after* treatment ended (called post-treatment relapse), the reported figures were: 0% in Arms A and C and E, 4.8% in Arm B, and 9.3% in Arm D. It is worth noting that Arm A had only 6 participants, which is a very small number, so the 100% figure for that group reflects a very limited sample. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02442284 · results posted 30 August 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02442284) enrolled 99 adults who received a combination of three direct-acting antiviral medicines (referred to as 3-DAA), with or without an additional medicine called ribavirin, for either 12 or 24 weeks. The trial was measuring how well the treatment cleared the hepatitis C virus from participants' blood, including among those who also had ongoing mental health conditions. Of the 99 people who started the trial, 92 completed it and 7 did not. The reported data shows that the main thing being measured was whether participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a result called SVR12, which is essentially a measure of whether the virus was undetectable at that point in time. According to the results reported on ClinicalTrials.gov, 93.9% of all participants reached this outcome. Among the smaller group of participants who had an ongoing psychiatric (mental health) disorder, the reported figure was 95.8%. The reported data also shows that 1.0% of participants experienced what is called virologic failure during treatment — meaning the virus became detectable again while they were still on treatment — and 2.2% had a post-treatment relapse, meaning the virus became detectable again within 12 weeks of finishing treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01265511 · results posted 18 August 2017

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called SCY-635 (at a dose of 600 mg) compared to a placebo (a dummy treatment with no active ingredient) in people with hepatitis C virus (HCV) infection. A total of 10 people took part — 2 received the placebo and 8 received SCY-635. The trial was measuring changes in the level of hepatitis C virus detected in participants' blood at various points during and after treatment. The reported data shows that for the main (primary) outcome — whether the hepatitis C virus became undetectable in the blood — 0 out of 2 participants in the placebo group and 1 out of 8 participants in the SCY-635 group reached that point. For the secondary outcomes, the reported data shows that 0 out of 2 placebo participants and 3 out of 8 SCY-635 participants had undetectable virus at another measured time point, and 0 out of 2 placebo participants compared to 4 out of 8 SCY-635 participants showed a reduction in virus levels of at least 100 times (a "2 log reduction") from their starting level by week 12. A further secondary outcome reported that 5 out of 8 SCY-635 participants had undetectable virus at an additional time point; no corresponding figure for the placebo group was reported for that measure. It is also worth noting that none of the placebo participants and only 5 of the 8 SCY-635 participants completed the trial, so results are based on a very small number of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02300103 · results posted 28 July 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 69 people who received a combination treatment of sofosbuvir/velpatasvir plus ribavirin (referred to as SOF/VEL+RBV) for hepatitis C. Of those 69 participants, 63 completed the study and 6 did not. The trial was primarily measuring two things: how many participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment (known as SVR12, a way of checking whether the virus remained undetectable after stopping the medicine), and how many participants had to permanently stop taking the study drugs due to an unwanted side effect or reaction. The reported data shows that 91.3% of participants had no detectable hepatitis C virus in their blood at the 12-week post-treatment check. Separately, 5.8% of participants permanently stopped taking the study drugs because of an adverse event (an unwanted reaction). For the secondary measures, the reported figures show that 92.8% of participants had undetectable virus at 4 weeks after finishing treatment, and 89.9% at 24 weeks after finishing treatment. The reported data also shows that 7.2% of participants experienced what the trial defined as "virologic failure" — meaning the virus either bounced back during treatment or returned to detectable levels afterwards. During treatment itself, the proportion of participants with undetectable virus levels rose over time, reaching 100% at the later time points measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02219477 · results posted 11 July 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people in total across three groups, based on which strain (called "genotype") of hepatitis C virus they had. Nine participants had genotype 1B, 24 had genotype 1 non-B (other genotype 1 strains), and 3 had genotype 4. The trial was primarily measuring what proportion of people had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a result known as SVR12, or "sustained virologic response at 12 weeks." This is a commonly used marker in hepatitis C research to indicate whether the virus remains undetectable after treatment has ended. The reported data shows that, in the genotype 1B group, 100% of the 9 participants had undetectable virus at 12 weeks post-treatment. In the genotype 1 non-B group, 95.8% of 24 participants had undetectable virus at that point. For the genotype 4 group — which was a secondary outcome because the group was very small — the reported figure was 66.7%, meaning roughly 2 out of 3 participants had undetectable virus at 12 weeks. The reported data also shows that, across all three groups, 0% of participants experienced what is called "on-treatment virologic failure" (the virus becoming detectable again while still on treatment) or "relapse" (the virus returning in the 12 weeks after treatment ended). For some liver function tests measured 12 weeks after treatment, the reported data shows that between 77% and 78% of participants in the genotype 1B and 1 non-B groups, and 50% of those in the genotype 4 group, showed an improvement in a measure called albumin. Results for other liver function markers — including bilirubin, a liver scarring score called FibroTest, and platelet counts — were also reported across the groups, with varying proportions showing improvement; some of these figures were not reported for all groups in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02493855 · results posted 15 May 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT02493855) enrolled 46 people across three treatment groups, all receiving different ribavirin dosing approaches alongside other hepatitis C treatment. Arm A (ribavirin at full dose for the last 10 weeks) started with 21 participants and 19 completed; Arm B (ribavirin at full dose for 12 weeks) started with 19 and 18 completed; and Arm C (ribavirin at a lower dose for 12 weeks) started with 6 and all 6 completed. The trial was measuring how quickly the hepatitis C virus level in the blood declined during treatment — specifically, the slower, second wave of decline that happens after an initial rapid drop. The reported data shows the primary outcome was a number called the "slope of the second phase decline," measured in units of change per day — essentially a way of putting a number on how steeply the virus level was falling during that slower phase. According to the results reported on ClinicalTrials.gov, the reported slopes were 0.0036 per day for Arm A, 0.0046 per day for Arm B, and 0.0051 per day for Arm C. A higher number indicates a steeper rate of decline in virus levels as measured by the mathematical model used. No secondary outcome measures or additional figures appear to have been reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02319031 · results posted 27 January 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people with hepatitis C — 24 in a group that received a combination of three medicines (daclatasvir, sofosbuvir, and ribavirin) for 12 weeks, and 26 in a group that received the same combination for 16 weeks. The main thing the trial was measuring was whether the hepatitis C virus became undetectable in participants' blood 12 weeks after they finished treatment — a result doctors call SVR12, or "sustained virologic response at 12 weeks." One person in the 12-week group did not complete the treatment period; everyone else finished both the treatment and follow-up phases. The reported data shows that, for the primary measure (virus undetectable at 12 weeks post-treatment), 87.5% of participants in the 12-week group and 92.3% in the 16-week group met this result. For the secondary measures — checking the same thing at 4 weeks and 24 weeks after treatment — the reported figures were 87.5% (12-week group) and 96.2% (16-week group) at the 4-week follow-up, and 87.5% (12-week group) and 92.3% (16-week group) at the 24-week follow-up. The reported data also shows that the trial tracked unwanted medical events. One death was reported in the 12-week group and none in the 16-week group. Serious adverse events (significant medical problems requiring close attention) occurred in 2 participants in the 12-week group and 3 in the 16-week group. No one stopped treatment due to an adverse event in either group. Severe adverse events were recorded in 2 participants in each group, and severe laboratory abnormalities (unusual blood test results) were seen in 1 participant in the 12-week group and 2 in the 16-week group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01987453 · results posted 10 January 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01987453) enrolled 100 people in total across three groups, all of whom had a hepatitis C virus (HCV) infection. There were 51 people in Group 1 (who took a combination of two antiviral medicines, ledipasvir/sofosbuvir, plus ribavirin for 12 weeks), 41 in Group 2 (who took ledipasvir/sofosbuvir alone for 24 weeks), and 8 in Group 3 (who took ledipasvir/sofosbuvir plus ribavirin for 24 weeks). The trial was primarily measuring two things: how many participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment (known as SVR12, essentially a "no virus detected" result at that point in time), and how many stopped taking the study medicines early because of unwanted side effects. The reported data shows that, for the SVR12 measure, 98% of participants in Group 1, 70.7% in Group 2, and 100% in Group 3 had no detectable virus 12 weeks after finishing treatment. Regarding stopping treatment early due to side effects, the reported figures were 5.9% for Group 1, and 0% for both Groups 2 and 3. Looking at secondary outcomes, the reported data shows that virologic failure — meaning the virus was either not suppressed during treatment or came back detectable afterwards — was reported in 0% (during treatment) and 2% (after treatment) of Group 1 participants, 2.4% and 27.5% respectively in Group 2, and 0% in both categories for Group 3. It is worth noting that Group 3 was considerably smaller (only 8 participants started, 7 completed), so those percentage figures represent very few individuals. The reported data also shows that the number of virus particles measured in the blood dropped across all three groups during treatment, though the exact breakdown across multiple time points involves figures that are best interpreted by a medical professional. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02201901 · results posted 14 December 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 268 adults with hepatitis C (a liver virus infection) across three groups: 90 people received a two-drug combination called SOF/VEL for 12 weeks (Group 1), 88 people received SOF/VEL plus an additional medicine called ribavirin (RBV) for 12 weeks (Group 2), and 90 people received SOF/VEL for 24 weeks (Group 3). The trial's main goals were to measure how many participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a result known as SVR12, which stands for "sustained virologic response at 12 weeks" — and to track how many people had to permanently stop their medication due to unwanted side effects. The reported data shows that for the primary SVR12 measure, 83.3% of participants in Group 1, 94.3% in Group 2, and 87.8% in Group 3 had no detectable virus at the 12-week post-treatment mark. Regarding stopping medication early due to adverse events (unwanted effects), the reported figures were 1.1% in Group 1, 16.1% in Group 2, and 4.4% in Group 3. The reported data also shows that virologic failure (the virus becoming detectable again during or after treatment) was recorded in 12.2% of Group 1 participants, 3.4% of Group 2, and 8.9% of Group 3. For the secondary measures, the reported data shows similar SVR figures at 4 weeks and 24 weeks after treatment across all three groups, broadly consistent with the 12-week results. The proportion of participants with undetectable virus levels generally increased over the course of treatment in all three groups. Not all time-point measurements were fully detailed in the submitted data for every week assessed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01790633 · results posted 13 December 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 163 people in a standard blood testing group (using a laboratory method called ELISA) and 164 people in a rapid testing group, giving a total of 327 participants. The trial was looking at testing for three viruses — hepatitis B (HBV), hepatitis C (HCV), and HIV — and was comparing two different ways of delivering those tests. The main thing the researchers were measuring was how many people actually received their test results, and whether those who tested positive then went on to see a specialist for further assessment. The reported data shows that, when it came to people receiving their test results, the proportion was quite different between the two groups. In the standard ELISA testing group, approximately 64 in every 100 people (a proportion of 0.642) received their results. In the rapid testing group, that figure was approximately 98 in every 100 people (a proportion of 0.981). For the secondary outcome — looking at people who tested positive and then went on to get a full specialist assessment — the reported data shows the proportion was approximately 94 in 100 (0.938) in the standard testing group, and approximately 90 in 100 (0.900) in the rapid testing group. The reported data also shows that about 7 in every 100 rapid tests (a proportion of 0.074) gave inconclusive results and could not be used. It is also worth noting that far fewer people in the standard testing group completed the study (115 out of 163) compared to the rapid testing group (159 out of 164), though the reasons for this were not detailed in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01532973 · results posted 23 November 2016

According to the results reported on ClinicalTrials.gov, this trial looked at an experimental hepatitis C (HCV) treatment called elbasvir, tested in people who had two different strains of the virus — known as genotype 1 (including a subtype called genotype 1a) and genotype 3. The trial was run across several small groups of six participants each, with different doses of elbasvir being tested in each group. In total, 60 people took part across all groups and three parts of the trial. The main thing being measured was how much the level of the hepatitis C virus in participants' blood (called "viral load") changed after five days of taking the study drug or a placebo (a dummy treatment with no active ingredient). Viral load was measured on a logarithmic scale — a scale where each whole number step represents a tenfold change — which is a standard way researchers track changes in virus levels in the blood. The reported data shows that across all groups receiving elbasvir, there were reductions in virus levels in the blood compared to the placebo groups, where essentially no change was recorded (0.00 on the scale). For people with genotype 1 HCV, the reported reduction in virus levels at day 5 ranged from 3.56 (at the 5 mg dose) to 4.40 (at the 50 mg dose) on the logarithmic scale, compared to 0.00 for placebo. For genotype 3 HCV, the reported reductions ranged from 1.01 (10 mg dose) to 2.72 (100 mg dose), compared to 0.00 for placebo. For the genotype 1a subgroup, reductions of 3.20 (10 mg) and 3.95 (50 mg) were reported, again compared to 0.00 for placebo. When looking at the single largest drop in virus levels recorded at any point across the five days, the reported figures followed a similar pattern across all groups and doses. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02220998 · results posted 15 November 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 269 people with hepatitis C — 135 in a group receiving a combination called SOF/VEL (sofosbuvir/velpatasvir) and 134 in a group receiving a different combination called SOF+RBV (sofosbuvir plus ribavirin). Both groups took their treatment for 12 weeks. The trial was primarily measuring how many participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a result known as SVR12, sometimes called a "sustained virologic response" — as well as how many people stopped taking their study medicine early due to a side effect. The reported data shows that in the SVR12 primary outcome, 99.3% of participants in the SOF/VEL group and 93.9% in the SOF+RBV group had virus levels below the detectable limit at 12 weeks post-treatment. Regarding stopping treatment early due to an adverse (unwanted) event, 0.7% of the SOF/VEL group did so, compared with 0% in the SOF+RBV group. For secondary outcomes, the reported data shows that virologic failure — meaning the virus was still detectable or returned during or after treatment — was recorded in 0% of the SOF/VEL group and 4.5% of the SOF+RBV group. Virus levels during treatment (measured at weeks 1 through 12) and at 4 and 24 weeks after finishing treatment were also tracked, with the reported figures showing broadly similar patterns of virus reduction across both groups during treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02806505 · results posted 31 October 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 81 people in total — 38 in a group receiving a higher dose (135 micrograms) of a medicine called peginterferon alfa-2a, and 43 in a group receiving a lower dose (90 micrograms). The trial was looking at how the body responded to treatment for hepatitis C, a virus that affects the liver. Specifically, it measured whether the hepatitis C virus became undetectable in participants' blood at various points during and after treatment. Not everyone completed the trial — 10 people in the higher-dose group and 11 in the lower-dose group did not finish. The reported data shows that the main thing being measured — called a "sustained virological response" — refers to whether the virus was still undetectable in the blood about 24 weeks (roughly six months) after treatment ended. In the higher-dose group, this was reported in 39.5% of participants, and in the lower-dose group, 34.9% of participants. The reported data also shows that at the actual end of treatment, the virus was undetectable in 57.9% of the higher-dose group and 48.8% of the lower-dose group. At weeks 12 and 24 during treatment, between roughly 66% and 72% of participants across both groups showed a meaningful drop in virus levels or had the virus become undetectable or very low, according to the figures reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02201953 · results posted 26 October 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 278 people in one group and 280 in another, for a total of 558 participants. All participants had a hepatitis C virus (HCV) infection. The trial compared two treatment approaches: a 12-week course of a combination tablet (sofosbuvir/velpatasvir, referred to here as SOF/VEL) versus a 24-week course of a different combination (sofosbuvir plus ribavirin, SOF+RBV). The main things being measured were how many participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a result known as SVR12, which essentially means the virus was undetectable at that point — and how many people stopped their treatment early because of an unwanted side effect. The reported data shows that for the primary outcome of undetectable virus at 12 weeks after treatment, 95.3% of participants in the SOF/VEL 12-week group reached that result, compared with 80.7% in the SOF+RBV 24-week group. For the second primary measure — stopping treatment early due to an adverse (unwanted) event — 0% of the SOF/VEL group stopped early for this reason, compared with 3.3% of the SOF+RBV group. The reported data also shows that 4.0% of the SOF/VEL group and 14.2% of the SOF+RBV group experienced what the trial defined as virologic failure, meaning the virus either did not respond or returned during or after treatment. For the secondary outcomes, the reported figures for undetectable virus at 4 weeks after finishing treatment were 96.8% (SOF/VEL) and 82.2% (SOF+RBV), and at 24 weeks after finishing treatment were 95.3% (SOF/VEL) and 80.7% (SOF+RBV). Results for virus levels measured during treatment at multiple time points were also reported, showing progressively higher proportions of participants with undetectable virus as treatment continued in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01743521 · results posted 20 October 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01743521) enrolled 14 participants in total across three treatment groups and one group with no allocated group. Seven participants were assigned to Group A (8 weeks of therapy), three to Group B (12 weeks of therapy), and two to Group C (24 weeks of therapy), with two further participants listed under "no group allocated." All 14 participants who started the trial completed it. The trial was measuring whether the hepatitis C virus (HCV) became undetectable in participants' blood at various points during and after treatment — including at the end of treatment and at 12 and 24 weeks after finishing treatment. The reported data shows the following for the main (primary) outcome — the proportion of participants whose virus was undetectable 12 weeks after finishing treatment: 71% in Group A (8 weeks), 100% in Group B (12 weeks), and 100% in Group C (24 weeks). For the secondary outcome measured at 24 weeks after finishing treatment, the reported figures were 43% for Group A, and 100% for both Groups B and C. At the actual end of treatment, 100% of participants across all three groups were reported to have undetectable virus levels. Earlier in treatment (at weeks 1, 2, and 3), the reported data shows varying proportions across the groups, with Group A generally reaching undetectable levels sooner during treatment than Groups B and C. It is worth noting that the numbers in each group were very small — as few as two or three people — so these figures represent a very limited snapshot. The reported data shows what was measured in this particular group of participants only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01753557 · results posted 3 October 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 54 people with hepatitis C (a viral infection of the liver). Participants were split into two groups: 35 people who had never previously been treated for hepatitis C ("Treatment-Naive"), and 19 people whose hepatitis C had returned after a previous treatment ("Treatment-Relapsed"). All 54 participants completed the study. The trial was primarily measuring whether the hepatitis C virus became undetectable in the blood 24 weeks after finishing the medication — a result researchers call a "sustained viral response" or SVR, which simply means no virus could be detected in the blood at that point in time. The reported data shows that, for the primary measure at 24 weeks after finishing treatment, 85.7% of the Treatment-Naive group and 94.7% of the Treatment-Relapsed group had undetectable virus in their blood. For the secondary measures, the reported data shows that at 4 weeks into treatment, 88.6% of Treatment-Naive and 100% of Treatment-Relapsed participants had undetectable virus. At the end of the treatment period itself, those figures were 97.1% and 100% respectively. At 12 weeks after finishing treatment, the reported figures were 82.9% (Treatment-Naive) and 94.7% (Treatment-Relapsed). The trial also tracked virus levels in the blood over time and examined whether any virus changes (known as resistance-associated variants) appeared; the reported data shows a small number of participants — 1 in the Treatment-Naive group and 1 in the Treatment-Relapsed group — showed certain virus changes, with 3 additional Treatment-Naive participants recorded under a separate variant category. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01318694 · results posted 30 September 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,081 participants across four treatment groups (Arms A, B, C, and D), with roughly 270 people starting in each group. The trial was studying treatments for hepatitis C infection, and the main thing it was measuring was how many participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a result known as a "sustained virologic response at 12 weeks" (SVR12). Having undetectable virus at this point is generally used in hepatitis C research as a key indicator that treatment has cleared the infection, though what this means for any individual is a matter for their doctor to discuss. The reported data shows that for the primary measure (SVR12), the percentages of participants with undetectable virus 12 weeks after treatment ended were: Arm A — 68.6%, Arm B — 68.9%, Arm C — 69.4%, and Arm D — 52.5%. The reported data also shows similar figures at 24 weeks after treatment (SVR24): Arm A — 68.5%, Arm B — 69.0%, Arm C — 68.3%, and Arm D — 51.7%. For an earlier check at 4 weeks into treatment, the percentages with undetectable virus were: Arm A — 60.1%, Arm B — 72.5%, Arm C — 56.6%, and Arm D — 28.4%. For the remaining secondary measures, at 12 weeks into treatment, the reported data shows that the vast majority of participants across all arms showed a meaningful reduction in virus levels — between 89.8% and 99.6% depending on the group. When looking specifically at those whose virus had dropped to undetectable levels by week 12 of treatment, the figures were: Arm A — 89.6%, Arm B — 96.3%, Arm C — 89.1%, and Arm D — 70.3%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02201940 · results posted 16 September 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT02201940) enrolled 625 people who received a combination treatment called SOF/VEL (sofosbuvir/velpatasvir) and 116 people who received a placebo (a dummy treatment with no active ingredient). The trial was measuring whether people with hepatitis C virus (HCV) infection could clear the virus from their blood after a course of treatment. The main things being tracked were: whether the virus was still undetectable in the blood 12 weeks after finishing treatment (called SVR12 — essentially a marker that the virus is no longer found at that point), and how many people stopped taking the study drug early because of an unwanted side effect. The reported data shows that among those who received SOF/VEL, 99.0% had undetectable levels of the hepatitis C virus in their blood at 12 weeks after finishing treatment, compared to 0% in the placebo group. For stopping the study drug early due to an adverse (unwanted) event, the reported figures were 0.2% in the SOF/VEL group and 1.7% in the placebo group. Looking at earlier and later time points, the reported data shows that 99.2% of the SOF/VEL group had undetectable virus at 4 weeks post-treatment, and 99.0% at 24 weeks post-treatment. During treatment itself, the proportion of SOF/VEL participants with undetectable virus rose over time — from 18.8% at week 1 up to 100% at week 10. The reported rate of what the trial called "virologic failure" (the virus not being cleared or coming back) was 0.3% in the SOF/VEL group and 100% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01909804 · results posted 16 September 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 348 adults with chronic hepatitis C (a liver infection caused by the hepatitis C virus). Participants were divided into 12 groups based on their virus type (called "genotype" — essentially a strain of the virus), whether they had liver scarring (cirrhosis), and which combination and dose of two study medications — sofosbuvir (SOF) and velpatasvir (VEL), sometimes with a third drug ribavirin (RBV) — they received. The main thing the trial was measuring was whether participants' hepatitis C virus became undetectable in the blood 12 weeks after finishing treatment — a result known as SVR12, which researchers use as a marker to assess treatment outcomes. The reported data shows that SVR12 rates varied across the groups. Among participants with genotype 3 without cirrhosis, the figures ranged from 84.6% (SOF+VEL low dose) up to 100% (SOF+VEL high dose, with or without RBV). For genotype 3 participants with cirrhosis — generally considered harder to treat — the reported rates were lower overall, ranging from 57.7% (SOF+VEL low dose, no RBV) to 96.2% (SOF+VEL high dose with RBV). Among genotype 1 participants, the reported rates were between 96.4% and 100% across all groups. Regarding participants who stopped all study drugs early due to a side effect, the reported data shows this was 0% in three of the four combined treatment groups, and 1.2% in the low-dose plus RBV group. The reported secondary outcome data shows that SVR rates measured at 4 weeks after treatment ended were broadly similar to the 12-week figures. The proportion of participants whose virus returned or never responded (called "virologic failure") ranged from 0% in several higher-dose groups to 42.3% in the genotype 3 cirrhosis group receiving the lower dose without RBV. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01858766 · results posted 15 September 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 459 adults with chronic hepatitis C virus (HCV) infection across 19 different treatment groups. Participants were divided by the type (or "genotype") of hepatitis C they had (labelled GT1 through GT6) and were given different combinations of two antiviral medicines — sofosbuvir (SOF) and velpatasvir (VEL) — at different doses (25 mg or 100 mg of VEL), sometimes with an added medicine called ribavirin (RBV), and for different lengths of time (either 8 or 12 weeks). The main things the trial was measuring were: (1) how many participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment (called SVR12), and (2) how many participants had to permanently stop taking the study drugs because of an unwanted side effect. The reported data shows that SVR12 rates — that is, the percentage of people with no detectable virus 12 weeks after finishing treatment — varied across the groups. Among those treated for 12 weeks, the reported figures ranged from 85.7% to 100%, depending on the genotype and dose. Among the 8-week groups, the one result reported in the data was 86.7% (SOF + VEL 25 mg, genotype 1). It is worth noting that SVR12 results for several of the 8-week groups were not reported in the data provided. Regarding stopping treatment early due to an unwanted side effect, the reported data shows that this was recorded as 0% across most groups, with one group (SOF + VEL 25 mg for 8 weeks) recording 1.8%. The reported secondary outcomes looked at virus levels at 4 and 24 weeks after finishing treatment, and at how many people experienced "virologic failure" — meaning the virus either did not go away during treatment or came back afterwards. The reported virologic failure rates ranged from 0% in many groups up to 10% in one group (SOF + VEL 25 mg for 8 weeks, genotype 1), with genotype 3 groups on 12-week treatment each recording 7.4%. SVR4 and SVR24 figures closely mirrored the SVR12 results where data was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01878799 · results posted 15 September 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01878799) enrolled 50 adults who had both HIV and hepatitis C (HCV). Participants were split into two groups: 37 people who were already taking antiretroviral medications (drugs used to manage HIV) and 13 people who were not taking those medications at the time. The trial was measuring how many participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a result known as SVR12, or "sustained virologic response at 12 weeks." Reaching this point means the virus was undetectable in the blood at that time. The reported data shows that in the group taking antiretroviral medications, 97% of participants (roughly 36 out of 37) reached the SVR12 point. In the group not taking antiretroviral medications, 100% of participants (all 13) reached the SVR12 point. These numbers represent the proportion of people in each group whose hepatitis C virus was undetectable in the blood at the 12-week mark after completing treatment. No additional outcome measures were included in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01215643 · results posted 30 August 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 340 adults across five treatment groups, all receiving different combinations of medicines being tested against hepatitis C. The groups were: a medicine called ALV at 1,000 mg alone (83 people); ALV 600 mg combined with ribavirin, or RBV (84 people); ALV 800 mg combined with RBV (94 people); ALV 600 mg combined with pegylated interferon, or PEG (39 people); and a standard comparison group receiving PEG plus RBV (40 people). The trial's main focus was measuring how many participants had a "rapid viral response" after four weeks — meaning the hepatitis C virus in their blood had dropped below a certain detectable level. The reported data shows that for the main outcome (virus dropping below a low threshold of 25 IU/mL at four weeks), the percentages of participants reaching that level were: 28.4% in the ALV 1,000 mg alone group; 36.9% in the ALV 600 mg plus RBV group; 41.9% in the ALV 800 mg plus RBV group; 84.6% in the ALV 600 mg plus PEG group; and 72.5% in the standard PEG plus RBV group. For a stricter measure (virus below 10 IU/mL at four weeks), the reported figures were lower across all groups: 18.5%, 14.3%, 23.7%, 69.2%, and 60.0% respectively. Similar patterns in these numbers were reported when participants were looked at separately by hepatitis C virus type (genotype 2 and genotype 3). The reported data also shows that by 12 weeks, a much higher proportion of participants across all groups had their virus drop below the detectable thresholds, with figures ranging from approximately 83% to 95% depending on the group and the measure used. Separate results for genotype 2 participants at 12 weeks were also reported, with figures ranging from around 81% to 100% across the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02753699 · results posted 26 August 2016

According to the results reported on ClinicalTrials.gov, this follow-up trial (NCT02753699) enrolled a total of 723 participants across three groups — 164 from a study called 2210, 397 from study 2301, and 162 from study 2211. The trial was measuring what happened to participants' hepatitis C virus (HCV) levels over time after they had already completed earlier treatment studies involving a medicine called alisporivir. Specifically, the trial tracked whether the amount of hepatitis C virus in participants' blood stayed below a detectable level (called the "level of quantification") up to 48 weeks into this follow-up period, and also looked at a liver enzyme called ALT, where normal levels can indicate the liver is not under stress. The reported data shows that the vast majority of participants across all three groups maintained undetectable virus levels throughout the 48-week follow-up. The reported figures ranged from approximately 96.7% to 100% of participants in each group at various measurement points, depending on which earlier study they had come from. For the liver enzyme (ALT) measure — which was assessed at a point corresponding to roughly 96 weeks after participants had taken their last dose of alisporivir — the reported data shows that between approximately 82% and 96% of participants had normal ALT readings, again varying across the three groups and measurement points. Of the 723 people who started this follow-up study, 643 completed it, with 80 not completing it across the three groups; reasons for not completing were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01183169 · results posted 25 August 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 459 participants across five treatment groups (labelled Treatment A through D, and Treatment C split into two subgroups). The trial was investigating how well different treatment combinations reduced the level of hepatitis C virus (HCV) in participants' blood. The main thing being measured was whether, after 12 weeks of treatment, the amount of virus in a participant's blood had dropped below a level that standard tests could reliably detect — a point researchers called the "limit of quantification." Some participants in certain groups were later switched to a different treatment and then followed through a second phase of the trial. The reported data shows that at the 12-week mark, the percentage of participants whose virus levels fell below the detection threshold varied considerably between groups. For the primary measure, Treatment A recorded 48.2%, Treatment B 61.1%, Treatment C (combined) 35.5%, Treatment D 74.3%, and the two post-switch groups recorded 45.5% and 80.0% respectively. For the secondary measures looking at longer-term virus levels — checked 12 weeks and 24 weeks after treatment finished — the reported figures again varied by group, ranging roughly from around 14% to 65% across the main treatment groups, and from around 18% to 53% in the post-switch groups. Early response at 4 weeks was also measured, with figures ranging from approximately 7% to 56% depending on the group and the exact detection threshold used. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01447420 · results posted 24 June 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 129 people with chronic hepatitis C (a liver infection caused by the hepatitis C virus, genotype 1). All participants received the same treatment — a combination of two medicines called peginterferon alfa-2a and ribavirin — but they were divided into three groups based on a genetic marker called IL-28B. This marker comes in three variations, known as CC, CT, and TT. The trial was primarily looking at how many people in each genetic group had no detectable virus in their blood at least 24 weeks after finishing treatment (called a "sustained virological response"), and also how many developed anaemia (low red blood cell levels) during treatment. The reported data shows that, for the main outcome, 63.2% of participants in the CC group, 26.4% in the CT group, and 33.3% in the TT group had no detectable virus at the 24-week follow-up point after treatment ended. For anaemia, the reported data shows that 67.4% of all participants (combined across groups) developed this condition during treatment. For the secondary outcomes, the reported data shows differences between the three genetic groups at various earlier check-in points during treatment — for example, at week 4, 11 participants in the CC group, 3 in the CT group, and none in the TT group had undetectable virus. Numbers at other time points followed a similar pattern of variation across the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02010255 · results posted 20 June 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT02010255) enrolled people with hepatitis C virus (HCV) infection across a range of liver disease severities — including varying degrees of liver scarring (fibrosis) and liver function loss. Participants were divided into several groups depending on how advanced their liver disease was, and were assigned to either a 12-week or 24-week course of treatment. In total, across all groups, roughly 330 people started the study. The trial was primarily measuring two things: the proportion of participants whose hepatitis C virus was undetectable in the blood 12 weeks after finishing treatment (called SVR12, or "sustained virologic response"), and the proportion who stopped taking the study drug early due to an unwanted health event (an "adverse event"). The reported data shows that SVR12 rates — meaning the percentage of participants with no detectable virus 12 weeks after finishing treatment — varied considerably between groups. For participants with moderate liver function loss (CPT Class B) who took treatment for 24 weeks, the reported SVR12 rate was 96%. For those with the most severe liver function loss (CPT Class C) on 12 weeks of treatment, it was 81%, and on 24 weeks it was 76%. Among participants with less severe liver disease (F0–F3 fibrosis), SVR12 rates of 94.2% (12 weeks) and 100% (24 weeks) were reported. Results for the small group with a condition called fibrosing cholestatic hepatitis (FCH) were not reported for the 12-week arm in the dataset provided. The reported rates of stopping treatment early due to an adverse event were generally low across most groups — ranging from 0% to about 7.7% — though one small group (CPT Class C, 24 weeks) reported a rate of 20%, and that group contained only five participants. The reported data also shows SVR measurements taken at 2, 4, 8, and 24 weeks after finishing treatment, which were broadly similar to the 12-week SVR figures across most groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01070550 · results posted 15 June 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 4,680 people who had hepatitis C (a liver infection caused by a virus) and had not previously been treated for it. Participants were grouped by their hepatitis C "genotype" — essentially the strain or type of the virus they carried — with genotypes 1 through 6 represented. The trial was measuring what proportion of participants had no detectable virus in their blood 24 weeks after finishing treatment with a medicine called PEG-IFN alfa-2a. This is called a "sustained virological response" (SVR) — meaning the virus could no longer be found using a sensitive blood test. Of the 4,680 who started, 3,032 completed the study. The reported data shows that the percentage of participants with no detectable virus 24 weeks after finishing treatment varied depending on their virus genotype. Using the main analysis group, the reported figures were: Genotype 1 — 40.6%; Genotype 2 — 60.4%; Genotype 3 — 55.0%; Genotype 4 — 36.0%; Genotype 5/6 — 57.1%; and Unknown genotype — 44.4%. Using a slightly looser definition of "undetectable" (a different blood level threshold), the reported figures were a little higher across all groups, ranging from around 40% to 72%. A second way of counting participants — looking only at those who followed the study plan most closely — produced similar but slightly higher percentages across all genotype groups. The reported data also shows that researchers tracked whether a person's virus level had dropped by weeks 4 and 12 of treatment, and how well that early drop predicted the final outcome. According to the results reported on ClinicalTrials.gov, among participants whose virus became undetectable early (by weeks 4 and 12), between roughly 68% and 100% also had no detectable virus at the end of follow-up, depending on genotype. Among those whose virus did *not* become undetectable early, between roughly 34% and 70% also did not achieve that outcome at the end — again varying by genotype. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00192647 · results posted 14 June 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 448 people in each of two groups — a total of 896 participants — all of whom had hepatitis C. Both groups received a combination of two medicines (pegylated interferon alfa-2a and ribavirin) for 48 weeks, but one group received a higher "induction" dose at the start of treatment, while the other received a standard dose throughout. The main thing the trial was measuring was whether participants still had undetectable levels of the hepatitis C virus in their blood 24 weeks after finishing treatment — a result known as a "sustained virological response." The reported data shows that, for the primary measure, 53% of participants in the induction-dose group and 50% in the standard-dose group had undetectable virus levels at that 24-week follow-up point. Looking at secondary measures, at the end of the 48-week treatment period itself, 70% of the induction group and 66% of the standard group had undetectable virus levels. Among those who had undetectable virus at the end of treatment but were then checked again later, approximately 24% in the induction group and 22% in the standard group had detectable virus return (referred to as "relapse"). The trial also tracked virus levels at several points during treatment, with the induction group generally showing somewhat higher rates of undetectable virus at each time point measured. The reported data also shows that early virus results (at weeks 4 and 12) were examined as possible predictors of the final outcome. For example, having undetectable virus at week 4 was associated with a 76–80% chance of also achieving the 24-week follow-up result, depending on the group, while not having undetectable virus at week 4 was associated with a 60% chance of also not achieving it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01492426 · results posted 3 June 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 602 adults with hepatitis C — 402 in one group who received a combination of daclatasvir, pegylated interferon alpha-2a, and ribavirin, and 200 in a comparison group who received telaprevir, pegylated interferon alpha-2a, and ribavirin. The trial was looking at whether the virus became undetectable in participants' blood, both during treatment and at set check-in points after treatment ended. The main thing being measured was whether the virus remained undetectable 12 weeks after finishing treatment — a point often called SVR12, which stands for "sustained virologic response at 12 weeks." The reported data shows that, among participants with a specific hepatitis C type called "genotype 1b," 85.1% of those in the daclatasvir group and 81.3% of those in the telaprevir group had undetectable virus levels at 12 weeks after finishing treatment. At 24 weeks after treatment, the reported figures were 84.3% and 80.6% respectively. For participants with a different hepatitis C type called "genotype 1a," the reported figures at 12 weeks after treatment were lower — 64.9% in the daclatasvir group and 69.7% in the telaprevir group. The trial also measured how quickly the virus became undetectable during treatment itself: at week 4, 77.2% of the daclatasvir group and 79.1% of the telaprevir group had undetectable levels, and at both week 4 and week 12 combined, the figures were 75.0% and 73.1% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01428063 · results posted 27 May 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01428063) enrolled 227 people with hepatitis C across three treatment groups: 99 received daclatasvir plus asunaprevir; 122 received daclatasvir, asunaprevir, and two additional medicines (pegylated interferon and ribavirin); and 6 received daclatasvir with just the two additional medicines. The trial was measuring how many participants had undetectable levels of the hepatitis C virus in their blood at various points during and after treatment — including at 4 weeks, 12 weeks, and at the end of treatment. The main goal (the primary outcome) focused specifically on people with a genotype 1 strain of hepatitis C who had not responded to previous treatment. The reported data shows that for the primary outcome — participants in the daclatasvir plus asunaprevir plus interferon and ribavirin group who had previously not responded to treatment — 94.6% had undetectable virus levels at 12 weeks after finishing treatment (known as SVR12, meaning the virus was no longer detectable 12 weeks after the course ended). For the secondary outcomes, the reported SVR12 figures varied across different subgroups. For example, among those who had previously failed a different antiviral called asunaprevir, 100% reached SVR12, while among those who had previously failed daclatasvir, 40% did. Across other measures taken during treatment — such as how many people had undetectable virus at week 4 and week 12 of treatment — the reported figures generally ranged from around 64% to 100% depending on the group and the time point measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02648022 · results posted 20 May 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT02648022) involved 79 people in total — 40 in an "Integrated Care" group and 39 in a "Usual Care" group. All participants completed the study with no drop-outs recorded. The trial was measuring outcomes related to hepatitis C virus (HCV) treatment, specifically looking at how many people cleared the virus from their blood (called a Sustained Viral Response, or SVR — a test result showing no detectable virus around six months after finishing treatment), as well as how many people started and finished their prescribed treatment course. The reported data shows that for the primary outcome — SVR — 30% of participants in the Integrated Care group and 12.8% in the Usual Care group recorded this result. For the first secondary outcome, which tracked how many people both started and completed their interferon-based treatment, the reported figures were 45% in the Integrated Care group and 23.1% in the Usual Care group. For the second secondary outcome — which looked at whether people completed at least 80% of their planned treatment duration — the reported data shows 78% in the Integrated Care group and 63% in the Usual Care group reached that threshold. It is worth noting that this trial used an interferon-based treatment, which is an older type of hepatitis C therapy that is largely no longer used in Australia, so the treatment studied here differs from what is currently available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00635804 · results posted 4 May 2016

According to the results reported on ClinicalTrials.gov, this trial tested a medicine called MK-3281 in a total of 60 people across seven dosing groups, plus 14 people who received a placebo (a dummy treatment with no active ingredient). The dosing groups received different amounts of MK-3281 — ranging from 100 mg to 1,200 mg, taken twice a day — and included both people with hepatitis C and healthy volunteers. The trial was primarily measuring how many participants experienced any unwanted health changes while taking the medicine, and how many had to stop taking it because of those changes. It also measured how the medicine moved through the body — for example, how much of it got into the bloodstream and how quickly. The reported data shows that in terms of unwanted health changes (called adverse events), the numbers across the active treatment groups ranged from 2 to 12 participants out of the people in each group, while 12 out of 14 placebo participants also reported such events. Regarding stopping the medicine early because of these events, the reported data shows this occurred in only 1 participant (in one of the 800 mg groups), and zero participants in all other groups, including placebo. For the blood-level measurements, the reported data shows that the amount of MK-3281 detected in the bloodstream generally rose as the dose increased. For example, the total drug exposure over 12 hours ranged from 4.92 units in the lowest dose group up to 18.12 units in the highest dose group tested in healthy volunteers, while one hepatitis C group at 800 mg showed a notably higher figure of 61.08 units. The time it took to reach the highest blood concentration was broadly similar across groups, mostly between 2 and 5 hours. No blood-level data was reported for the placebo group, which is expected as there was no active medicine to measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01168856 · results posted 11 March 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01168856) enrolled 734 participants across two groups. One group, called the "Resistance Monitoring Arm," included 176 people and was focused on tracking the hepatitis C virus (HCV) in participants over time by measuring whether the virus could still be detected in their blood. The second group, called the "Sustained Virological Response (SVR) Durability Monitoring Arm," included 558 people and was focused on monitoring whether previous responses to HCV treatment held up over time. The reported data shows that in the Resistance Monitoring Arm, the percentage of participants who had detectable levels of HCV in their blood remained very high throughout the study — reported at 99.1% at 3 months, 99.3% at 6 months, 99.2% at both 9 and 12 months, and 100% at 18 months. In plain terms, this means that at each of those time points, nearly all or all participants in that group still had the virus present in their blood at measurable levels. The reported data also shows that the average level of HCV in the blood in that group at the 3-month mark was approximately 3,922,296 International Units per millilitre (IU/mL), which is simply a measure of how much virus was present. No outcome numbers were reported for the SVR Durability Monitoring Arm in the data submitted. It is worth noting that these measurements appear to describe a monitoring or observational study rather than a treatment trial, tracking virus levels in participants over time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00087594 · results posted 4 March 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 48 people with hepatitis C — 24 in a group who took their medication under direct supervision (Direct Observed Therapy) and 24 who managed their own medication at home (Self-Administration Therapy). The trial was measuring whether people completed their full course of treatment, how many had the hepatitis C virus become undetectable in their blood, and how their mood (specifically depression symptoms) changed over time. Of the 48 who started, 16 in the supervised group and 12 in the self-administration group finished the study. The reported data shows that, for the main measure — completing the prescribed course of treatment — the numbers were broadly similar between the two groups across different hepatitis C virus types. For the secondary measure looking at whether the virus became undetectable 24 weeks after finishing treatment (called a Sustained Virological Response), the reported figures varied: in one subgroup, 10 participants in the supervised group and 2 in the self-administration group had undetectable virus at that point, while in another subgroup the numbers were 4 and 5 respectively. For depression symptoms, scores were measured on a standard scale (where higher numbers mean more severe symptoms). The reported data shows that at one point during treatment, the self-administration group had a mean score of 22.8 (in the "moderate" range) compared to 13.6 in the supervised group (in the "mild" range), though scores at other time points differed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02556307 · results posted 15 February 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 270 people with Hepatitis C who were treated with a combination of two medicines: peginterferon alfa-2a and ribavirin. Of those, 268 actually received treatment and 217 completed the study, with 53 people not finishing. The trial was primarily measuring whether participants achieved what is called a "sustained virological response" (SVR) — meaning that the Hepatitis C virus could no longer be detected in their blood 24 weeks after finishing treatment. Results were broken down by the specific type (genotype) of the virus each person had, as well as other individual factors. The reported data shows that across the different subgroups measured, the percentage of participants with undetectable virus at 24 weeks after treatment ranged from 30% to 100%, depending on the virus genotype and other factors. For the secondary outcomes, the reported data shows that at various points during and after treatment, between 21% and 79% of participants had undetectable levels of the virus in their blood. The trial also tracked blood measurements over time, including platelet counts (cells that help blood clot), white blood cell counts, and haemoglobin levels (a measure related to red blood cells). These values were recorded at the start of the study and at several points during and after treatment — for example, haemoglobin levels were reported as starting at an average of 147 g/L and were measured as low as 122 g/L at one point during treatment, before returning toward 143 g/L afterwards. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01728324 · results posted 12 February 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01728324) enrolled 496 people with hepatitis C — a liver infection caused by a virus. Participants were divided into three groups based on whether they had liver scarring (cirrhosis) and how long they received treatment: 211 people without cirrhosis treated for 24 weeks, 213 people without cirrhosis treated for 16 weeks, and 72 people with cirrhosis treated for 24 weeks. The trial was mainly measuring what is called SVR12 — whether the hepatitis C virus had dropped to undetectable levels in the blood 12 weeks after finishing treatment. This is a commonly used marker in hepatitis C research to assess whether the virus remains undetectable after treatment ends. The reported data shows that, looking at SVR12 rates across the three groups separately, approximately 82% of the 24-week non-cirrhosis group, 75.6% of the 16-week non-cirrhosis group, and 73.6% of the cirrhosis group reached undetectable virus levels at 12 weeks after treatment. A similar pattern was seen at 4 weeks after treatment ended (around 83.9%, 80.3%, and 77.8% respectively) and at 24 weeks after treatment ended (around 81%, 74.2%, and 72.2% respectively). The reported data also shows that among participants who had undetectable virus at 12 weeks after treatment, approximately 98–99% across all three groups also had undetectable virus at 24 weeks after treatment. The reported data shows that not all participants completed treatment — for example, 38 of the 211 in the 24-week non-cirrhosis group did not complete their course. It is worth noting that these figures describe what was measured and recorded in this specific trial and its particular participants; they do not represent a guarantee of any outcome for any individual. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02515279 · results posted 10 February 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 463 people who had hepatitis C. Of those, 359 completed the study and 104 did not finish. The trial was measuring three things: how many participants experienced unwanted medical events (called adverse events) during the study, how many had no detectable hepatitis C virus in their blood at the end of treatment, and how many still had no detectable virus 24 weeks after finishing treatment. The reported data shows that 44.28% of participants experienced some kind of adverse event (an unexpected medical occurrence during the study), while 3.9% experienced a serious adverse event — meaning one that involved hospitalisation, was life-threatening, caused lasting disability, or was considered significant for another medical reason. When it came to virus levels in the blood, 83.8% of participants who had available test results showed no detectable hepatitis C virus at the end of their treatment, with 9.7% noted separately (the trial's data does not clarify what this second figure represents in full detail). At the 24-week follow-up point after finishing treatment, 26.6% of participants still had no detectable virus in their blood — this is referred to as a "sustained virologic response," meaning the virus remained undetectable for that longer period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01962441 · results posted 5 February 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01962441) enrolled 601 adults with hepatitis C (a liver virus infection). Participants were randomly placed into one of three treatment groups: one group received two medicines called sofosbuvir and ribavirin (SOF+RBV) for 16 weeks, a second group received the same two medicines for 24 weeks, and a third group received those two medicines plus a third called pegylated interferon (Peg-IFN) for 12 weeks. The main thing the trial was measuring was whether participants showed no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a result commonly called SVR12. The trial also tracked how many people stopped treatment early due to a side effect or unwanted reaction. The reported data shows that, for the primary goal of undetectable virus at 12 weeks after treatment ended, the figures were: 71.9% in the 16-week SOF+RBV group, 85.4% in the 24-week SOF+RBV group, and 92.9% in the 12-week SOF+RBV+Peg-IFN group. The reported data also shows that 1.5% of participants in each of the three groups permanently stopped taking their study medicine due to an adverse event (an unwanted reaction). As a secondary measure — looking at undetectable virus at 4 weeks after treatment — the figures were 73.0%, 85.9%, and 95.9% respectively. At 24 weeks after treatment ended, the reported figures were 71.9%, 84.4%, and 93.4%. The reported data also shows how quickly the virus became undetectable during treatment itself. By week 4 of treatment, 86.6%, 91.9%, and 97.4% of participants in each group respectively had virus levels below the detectable limit. By week 8, that figure was 99.5% across all three groups. Levels of virus in the blood (measured on a laboratory scale) also fell in all three groups from the very first week of treatment onward, though the exact starting (baseline) figures were not separately reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01132313 · results posted 1 February 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01132313) enrolled a total of 488 participants across four parts, testing different combinations and durations of two antiviral medicines — referred to as DBV and FDV — for the treatment of hepatitis C. The trial was divided into separate parts, each looking at slightly different doses, dosing schedules, or treatment lengths. The main things being measured were how many participants showed very low or undetectable levels of the hepatitis C virus in their blood — either after four weeks of treatment (called a "rapid virological response") or twelve weeks after finishing treatment (called a "sustained virological response," meaning the virus remained undetectable after treatment ended). The reported data shows the following for the primary (main) outcomes. In Part 1, which tested a shorter four-week course, 73.3% of participants on the lower dose and 100% on the higher dose had very low virus levels at the four-week mark. In Part 2, which tested longer treatment courses of 16 to 40 weeks, the percentage of participants who had undetectable virus levels twelve weeks after finishing treatment ranged from about 39% (in the group that did not receive an additional medicine called RBV) up to about 69% (in a group using a twice-daily dosing schedule). In Parts 3 and 4, the reported data shows figures ranging from about 12% to 66% across different groups, though results for two of the Part 4 groups were listed as not available. For several of the secondary (additional) outcome measures — such as how quickly virus levels dropped — only partial figures were reported in the submitted data, and some results were not reported at all. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00077636 · results posted 21 January 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,469 people with hepatitis C infection (specifically genotype 2 or 3, though this detail is noted in the trial design). Participants were split into two groups: 736 people received a combination of two antiviral medicines (pegylated interferon alfa-2a and ribavirin) for 16 weeks, and 733 received the same combination for 24 weeks. The trial's main goal was to measure what proportion of participants had no detectable hepatitis C virus in their blood 24 weeks after finishing treatment — a result researchers call a "sustained virological response," meaning the virus remained undetectable well after the treatment course ended. The reported data shows that, for the primary measure, 65% of participants in the 16-week group and 76% in the 24-week group had no detectable virus at that 24-week post-treatment check. Looking at secondary measures, the virus was undetectable at the end of treatment itself in 94% of the 16-week group and 92% of the 24-week group; at the 12-week post-treatment check, those figures were 59% and 69% respectively. The reported data also shows that untoward medical events (called adverse events — any unwanted sign or symptom recorded during the trial) were noted in 97% of the 16-week group and 99% of the 24-week group, while more serious adverse events were recorded in 5% and 6% of participants respectively. Marked abnormalities in blood test results were also recorded across both groups, with the most commonly noted being in a category of blood counts, reported in 64% and 71% of participants in the 16- and 24-week groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01471574 · results posted 17 December 2015

According to the results reported on ClinicalTrials.gov, this trial looked at a drug called daclatasvir, used alongside other treatments, in people who had both HIV and hepatitis C. A total of 301 participants were enrolled across four groups: some were taking a combination HIV treatment known as HAART (Highly Active Anti-Retroviral Therapy) and received daclatasvir at either 30 mg or 60 mg doses, while a smaller group was not on HAART. The main thing the trial was measuring was whether participants' hepatitis C virus levels dropped to very low or undetectable levels 12 weeks after finishing treatment — a point called "SVR12" (meaning the virus remained at very low levels 12 weeks after the end of the course). The reported data shows that, for the primary outcome at the 12-week follow-up point, between roughly 72% and 75% of participants in the HAART groups reached the SVR12 target, depending on their daclatasvir dose. When all HAART participants were combined, the reported figure was approximately 73%. In the smaller group not on HAART, the reported figure was 87.5%. For secondary outcomes, the reported data shows that hepatitis C virus levels fell progressively during treatment across all groups, with the non-HAART group generally recording higher percentages of participants reaching very low or undetectable virus levels at each measured point. Regarding the HIV side of things, the reported data shows that around 91% of HAART participants who had stable HIV levels at the start did not experience a significant rise in HIV levels during the study. Two deaths were reported across the combined HAART groups and none in the non-HAART group, while serious unwanted medical events were recorded in 24 participants across the HAART groups combined and none in the non-HAART group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01257204 · results posted 14 December 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 151 people with hepatitis C (a liver infection caused by a virus). Participants were divided into three groups: one group took the study drug daclatasvir for 12 weeks (50 people), another took it for 16 weeks (50 people), and a third group received a placebo — a dummy treatment with no active ingredient — (51 people). All groups also received other standard hepatitis C medicines alongside their assigned treatment. The trial was primarily measuring how many people in each group had no detectable hepatitis C virus in their blood 24 weeks after finishing treatment — a result the researchers called SVR24, which can be thought of as a "no virus detected" reading at the six-month follow-up mark. The reported data shows that for participants with a specific hepatitis C strain called genotype 2, 83.3% of those in the 12-week daclatasvir group, 82.6% in the 16-week daclatasvir group, and 62.5% in the placebo group had no detectable virus at the 24-week follow-up point. For some of the secondary measurements — things checked at earlier time points — the reported data shows that at week 4, 87.5% (12-week group), 73.9% (16-week group), and 41.7% (placebo group) with genotype 2 had no detectable virus; similar week-4 figures for those with genotype 3 were 84.6%, 74.1%, and 37.0% respectively. At week 12, the "no virus detected" rates for genotype 2 were 91.7%, 82.6%, and 75.0%, and for genotype 3 were 80.8%, 88.9%, and 59.3%. A separate 12-week follow-up "no virus detected" reading for genotype 2 participants was reported as 87.5%, 82.6%, and 70.8% across the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02159352 · results posted 30 November 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 28 people in total — 14 in each of two groups. One group took the drug daclatasvir together with a combination called darunavir/ritonavir, and the other group took daclatasvir together with a combination called lopinavir/ritonavir. The trial was measuring how daclatasvir behaves in the body (known as pharmacokinetics — basically, how the drug is absorbed and how much of it circulates in the bloodstream) when it is taken alongside these other medicines. By the end of the study, 11 people in the first group and 12 in the second group had completed all stages. The reported data shows that when participants took daclatasvir at the standard 60 mg dose on its own (during the first few days), the peak level of the drug measured in the blood was around 1,335–1,412 ng/mL (nanograms per millilitre — a very small unit of measurement). When the dose was halved to 30 mg and taken alongside darunavir/ritonavir or lopinavir/ritonavir, the reported peak blood levels were lower in absolute terms — around 493 ng/mL and 476 ng/mL respectively. The reported data also shows the total amount of drug in the bloodstream over a dosing period (a measure called AUC): roughly 12,677–13,799 units for the 60 mg dose alone, compared with around 8,295 and 7,855 units for the halved dose taken with the other medicines. For secondary measures, the time it took for the drug to reach its peak level in the blood was reported as approximately 2–3 hours across the different conditions, and the drug level remaining in the blood at 24 hours after a dose was reported as 225–280 ng/mL across all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01830205 · results posted 16 November 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people in total across four groups based on how well their kidneys were working: 12 people with normal kidney function or only mild impairment, 6 with mild-to-moderate impairment, 6 with mild-to-severe impairment, and 12 with end-stage kidney disease (meaning their kidneys had largely stopped working). All 36 participants completed the study. The trial was measuring how the body handles a single dose of a medicine called daclatasvir — specifically, how much of the drug gets into the bloodstream and how quickly, depending on a person's level of kidney function. The reported data shows the main measurement was the total amount of daclatasvir that circulated in the blood over time (a figure researchers call AUC, or "area under the curve"). For people with normal kidney function this figure was reported as approximately 11,215 units, rising to around 21,261 for those with mild impairment, 24,790 for moderate impairment, and 21,946 for severe impairment, then coming back down to about 14,257 for those with end-stage kidney disease. The highest blood level of the drug reached at any single point (called Cmax, or peak concentration) followed a broadly similar pattern — roughly 1,111 units in the normal-function group, rising to 1,620 (mild), 1,746 (moderate), then falling to 1,207 (severe) and 1,085 (end-stage). The time it took to reach that peak was between 1 and 1.5 hours across all groups. Separate measurements of only the "free" (unbound) portion of the drug in the blood were also reported and showed a similar pattern across groups, though at much smaller absolute numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00774397 · results posted 16 November 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 719 people across seven treatment groups to study a drug called BI 201335 (at different doses and schedules) compared to a placebo, all in people with hepatitis C. Participants were split into two broad categories: those who had never been treated before (TN = treatment-naïve) and those who had been treated previously (TE = treatment-experienced). The trial was measuring the level of hepatitis C virus in participants' blood at various points during and after treatment, to see how many people had the virus fall below detectable levels. The reported data shows that for the main outcome — the percentage of people whose hepatitis C virus was undetectable 24 weeks after finishing all treatment (known as SVR24, a standard measure used in hepatitis C trials) — the figures varied considerably across groups. In the placebo group, 56.3% reached this point. Among treatment-naïve participants receiving BI 201335, the reported figures ranged from 72.5% to 83.8% depending on the dose. Among previously treated participants receiving BI 201335, the reported figures ranged from 28.2% to 40.8%. A second primary measure looked at virus levels four weeks after stopping an early phase of treatment in a subset of participants; the reported rates there ranged from 0% (placebo and one BI 201335 group) up to 75% in one treatment-naïve BI 201335 group. The reported data also shows results for several secondary measures taken at earlier time points. At week 2, the percentage of people with virus below the detectable threshold ranged from 1.4% (placebo) to 82.4% across groups. By week 4, those figures rose, ranging from 16.9% (placebo) to 93.7%. Measures at week 12 and combined week 4-plus-week-12 responses followed similar patterns across the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01625338 · results posted 9 November 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01625338) enrolled 534 people in total across three treatment groups. One group of 114 people received sofosbuvir plus ribavirin (two antiviral medicines) for 12 weeks; a second group of 200 people received the same two medicines for 24 weeks; and a third group of 220 people received sofosbuvir, ribavirin, and an additional medicine called pegylated interferon for 12 weeks. The trial was primarily measuring how many participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a result known as a "sustained virologic response" or SVR12 — as well as how many people stopped treatment early due to a side effect. The reported data shows that, for the SVR12 measure, 71.9% of those in the 12-week two-medicine group, 77.5% in the 24-week two-medicine group, and 82.6% in the 12-week three-medicine group had no detectable virus at that 12-week post-treatment check. Regarding stopping treatment early due to a side effect, the reported figures were 0.9%, 1.0%, and 3.7% respectively across the three groups. For the secondary measures, the reported data shows that virus came back after treatment (called "viral relapse") in 25.7%, 20.6%, and 16.4% of participants across the three groups. The percentage of participants whose virus failed to respond or rebounded *during* treatment was reported as 0.9%, 0.5%, and 0% respectively. It is worth noting that not everyone who started the trial completed it — 32, 44, and 39 participants across the three groups did not finish, though the reasons were not detailed in the submitted data. The results at 4 weeks and 24 weeks after finishing treatment were also recorded as secondary measures, with similar patterns to the 12-week post-treatment figures reported above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01358864 · results posted 28 October 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 678 adults with hepatitis C (a liver infection caused by a virus) who had been treated before but had not cleared the virus. Participants were divided into groups based on how they had previously responded to treatment — "relapsers" (those who initially responded but then relapsed), "partial responders" (those who had some response), and "null responders" (those who had little or no response). Each group was given either a placebo (a dummy treatment with no active ingredient), or the study drug faldaprevir for either 12 or 24 weeks, alongside standard hepatitis C treatment. The main thing being measured was whether participants' hepatitis C virus levels in the blood dropped to an undetectable level 12 weeks after finishing treatment — a result called SVR12. The reported data shows that among relapsers and partial responders combined, approximately 10% of those who received the placebo achieved SVR12, compared with around 65% in the faldaprevir 12-week group and around 61% in the faldaprevir 24-week group. Among null responders (who were not given a placebo in this trial), approximately 34% in both the 12-week and 24-week faldaprevir groups achieved SVR12. A similar pattern was seen when the same groups were assessed 24 weeks after finishing treatment (SVR24). The reported data also shows that, at an earlier checkpoint during treatment (weeks 4 and 8), between roughly 52% and 87% of those in the faldaprevir groups had very low or undetectable virus levels, compared with around 3–4% in the placebo groups. Additionally, liver enzyme levels (a marker measured in blood to monitor liver health) were tracked, though the data for some sub-groups within this measure was not fully reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01125189 · results posted 23 October 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 395 adults with hepatitis C (genotype 1). Participants were split into three groups: 159 received a lower dose (20 mg) of daclatasvir combined with two other medicines (peginterferon alfa-2a and ribavirin); 158 received a higher dose (60 mg) of daclatasvir with the same two medicines; and 78 received a placebo (dummy pill) with those same two medicines. The trial was measuring how many people had undetectable levels of the hepatitis C virus in their blood at various points during and after treatment. The reported data shows the following for the main outcomes. For what the trial called an "extended rapid virologic response" — meaning the virus was undetectable at both week 4 and week 12 of treatment — the figures were approximately 54% in the 20 mg daclatasvir group, 54% in the 60 mg daclatasvir group, and 14% in the placebo group. For the key longer-term measure — virus still undetectable 24 weeks after finishing treatment — the reported figures were approximately 59% in the 20 mg group, 60% in the 60 mg group, and 38% in the placebo group. The trial also recorded serious medical events: 12 occurred in the 20 mg group, 13 in the 60 mg group, and 6 in the placebo group. Two deaths were reported in the 20 mg group and none in the other two groups, though the data as reported does not attribute these deaths to any specific cause. The reported data also shows results for earlier time points during treatment. At week 4 alone, undetectable virus levels were reported in around 60% (20 mg group), 57% (60 mg group), and 15% (placebo group). At week 12 alone, the figures were approximately 78%, 75%, and 43% respectively. At 12 weeks after finishing treatment, reported figures were around 65%, 60%, and 36%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01170962 · results posted 12 October 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 419 adults with hepatitis C who had not responded well to a previous course of treatment. Participants were split into three groups: 203 people received a lower dose (20 mg) of a medicine called daclatasvir, 199 received a higher dose (60 mg), and 17 received a placebo (a dummy treatment with no active ingredient). All participants also received two existing hepatitis C medicines alongside their assigned treatment. The trial was measuring whether the hepatitis C virus became undetectable in participants' blood at various points during and after treatment. The reported data shows the following for the main outcomes. When looking at whether the virus was undetectable at both week 4 and week 12 of treatment, the figures were: 18% (20 mg dose, prior non-responders), 19.7% (60 mg dose, prior non-responders), 25.7% (20 mg dose, prior partial responders), 35.8% (60 mg dose, prior partial responders), and 0% in the placebo group. For the key longer-term measure — whether the virus remained undetectable 24 weeks after finishing treatment — the reported figures were 18.8%, 22%, 24.3%, 43.3%, and 0% for those same groups respectively. Regarding serious unwanted medical events during the trial, 14 participants in the 20 mg group, 11 in the 60 mg group, and 3 in the placebo group experienced these. No deaths were reported in either daclatasvir group during treatment, while one death was reported in the placebo group. The reported data also shows results for several additional measurements taken at other time points. The proportion of participants with undetectable virus at week 4 alone ranged from 0% (placebo) to about 39% (60 mg, partial responders). At week 12 alone, the range was 0% (placebo) to about 57% (60 mg, partial responders). At 12 weeks after completing treatment, the figures ranged from 0% (placebo) to about 48% (60 mg, partial responders). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00793793 · results posted 17 September 2015

According to the results reported on ClinicalTrials.gov, this trial tested an investigational hepatitis C drug called BI201335 across 12 different groups, with a total of 96 people enrolled. Participants fell into three broad categories: people who had never been treated for hepatitis C before ("treatment naïve"), people who had received prior treatment but did not have liver scarring ("treatment experienced, non-cirrhotic"), and people who had received prior treatment and did have liver scarring ("treatment experienced, with cirrhosis"). The trial was measuring how much the hepatitis C virus level in the blood dropped after taking the drug at various doses, as well as tracking any unwanted medical events that occurred during the study. The reported data shows that for the primary virus-level measure — whether participants achieved at least a 100-fold drop (a "2 log10 reduction," meaning the virus level fell to less than one-hundredth of where it started) in hepatitis C virus in the blood — 0% of placebo participants reached this threshold, while 83% of those on the lowest active dose (20 mg once daily) and 100% of participants in all other active-dose groups reached it. Regarding unwanted medical events ("adverse events"), the reported data shows that between 57% and 100% of participants across the active-dose groups experienced at least one such event during the study, compared with 63% in the placebo group. Serious adverse events were reported in 0% of placebo participants, and ranged from 0% to about 29% across the active-dose groups, with the highest proportion (29%) seen in the treatment-experienced group with cirrhosis receiving the twice-daily capsule dose. Abnormal blood test results classed as severe (grade 3 or 4) were recorded in just one participant each in two of the twelve groups, and zero in all others. The reported data also shows that the maximum recorded drop in virus levels from the start of the study ranged from a very small change (−0.06 on a logarithmic scale) in the placebo group to as much as −5.48 in one of the higher-dose groups — the larger the negative number, the greater the reduction in virus detected in the blood. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01591460 · results posted 7 August 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01591460) enrolled 165 participants in total, all tracked as a single group. Of those, 139 completed the study and 26 did not finish. The trial was measuring how well participants with hepatitis C (a liver infection caused by the hepatitis C virus, or HCV) cleared the virus from their blood after treatment. The main thing being measured was whether the virus had become undetectable in the blood 12 weeks after finishing treatment — a result known as a "sustained virological response" or SVR, which simply means the virus could no longer be detected at that point in time. Participants were also grouped by features such as whether they had cirrhosis (liver scarring) or how they had responded to treatment at different stages. The reported data shows that, across all 165 participants, 81% had undetectable virus levels at 12 weeks after finishing treatment, and 80% still had undetectable levels at 24 weeks after finishing treatment. When broken down by subgroup, the reported 12-week figures were: 70% for those with cirrhosis; 75% for "poor responders" (those whose virus levels dropped slowly early in treatment); 88% for "late responders"; 95% for "early responders"; and 32% for a group described as "others." The reported data also shows that 7% of all participants who had undetectable virus at the end of treatment later had detectable virus return — described as a virological relapse. This figure was higher in some subgroups, for example 25% in the "others" group and 13% in those with cirrhosis. The reported data also tracked virus levels in the blood at various points during and after treatment, and recorded how many participants achieved significant drops in virus levels (for example, a tenfold or hundredfold reduction) during treatment. These figures varied considerably across the different subgroups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01685203 · results posted 4 August 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 316 people across seven different treatment groups (labelled Groups 1 through 8, with some group numbers not used), ranging in size from 40 to 52 participants per group. The trial was studying treatments for Hepatitis C, a viral infection of the liver. The main thing being measured was whether the hepatitis C virus became undetectable in participants' blood 12 weeks after they finished taking the study drug — a result known as a "sustained virologic response at 12 weeks" (meaning the virus stayed at undetectably low levels for at least 12 weeks after treatment ended). Several additional things were also tracked, including virus levels at 24 weeks after treatment, whether the virus came back during or after treatment, and whether participants experienced any unwanted health events while on the study drug. The reported data shows that, for the primary measure (virus undetectable at 12 weeks after treatment), the percentage of participants achieving this varied across the seven groups: 90.9%, 95.2%, 90.0%, 100%, 100%, 97.9%, and 98.1% respectively. For the secondary measure of virus being undetectable at 24 weeks after treatment, the reported figures were 86.4%, 92.9%, 90.0%, 100%, 100%, 97.9%, and 98.1% across the groups. The reported data also shows that the percentage of participants whose virus levels rebounded or failed to be suppressed *during* treatment was low — ranging from 0% in five of the seven groups, to 2.3% and 2.5% in the remaining two. The percentage who experienced a return of detectable virus *after* finishing treatment ranged from 0% in four groups to 7.7% at the highest, across the remaining three groups. Regarding unwanted health events that began or got worse after starting the study drug, the reported data shows these were recorded in a notable proportion of participants in every group — ranging from 71.2% to 88.1% across the seven groups. It is important to note that this figure captures any such event occurring during or shortly after treatment, and the data as submitted does not break down how serious those events were. No further detail on severity was reported in the structured results data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01570244 · results posted 3 August 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 16 participants, all of whom took part in two treatment periods. In the first period, participants took Microgynon (an oral contraceptive pill containing two hormones — ethinylestradiol and levonorgestrel) on its own. In the second period, they took Microgynon together with a drug called faldaprevir (an investigational hepatitis C treatment). The trial was measuring how the levels of the contraceptive hormones in the blood changed when faldaprevir was also being taken. The reported data shows that when faldaprevir was added, the measured blood levels of both hormones were higher compared to taking Microgynon alone. For ethinylestradiol, the total amount of the hormone detected in the blood over a dosing period (a measure called AUC) was reported as 1,010 units on Microgynon alone, rising to 1,450 units when faldaprevir was also taken. The peak blood level of ethinylestradiol went from 108 to 127 units, and the level measured at the end of the dosing period went from 19.1 to 33.2 units. For the other hormone, levonorgestrel, the total blood level over a dosing period rose from 83.3 to 120 units. Regarding secondary measures, the reported data shows that no participants had clinically notable abnormalities in physical checks or lab tests in either period. However, the number of participants recorded as experiencing drug-related side effects (as judged by the investigators) was 2 out of 16 in the Microgynon-alone period, compared to 15 out of 16 in the Microgynon-plus-faldaprevir period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01579474 · results posted 3 August 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 131 people in total across six groups. Participants were adults with hepatitis C who were divided into two main cohorts. Cohort I included people who had not previously been treated, receiving either a lower dose (120 mg) or higher dose (240 mg) of a drug called faldaprevir alongside other standard hepatitis C medicines. Cohort II included people who had been treated before but whose previous treatment had not fully worked — grouped as "relapsers," "partial responders," "null responders," and "breakthrough" patients — all receiving the higher 240 mg dose of faldaprevir. The trial was primarily measuring how many participants experienced side effects that investigators considered related to the study drugs. The reported data shows that when it came to drug-related side effects (the primary thing being measured), 43 out of 44 participants in the lower-dose Cohort I group, 43 out of 43 in the higher-dose Cohort I group, and 44 out of 44 in the Cohort II group were reported as experiencing at least one side effect considered by the investigator to be related to the study drugs. For the secondary measures, the trial also tracked what proportion of participants had no detectable hepatitis C virus in their blood at 12 and 24 weeks after finishing treatment — a marker researchers call "sustained virological response" (SVR). The reported data shows that for the lower-dose Cohort I group, 86.4% reached this point at both 12 and 24 weeks. In the higher-dose Cohort I group, 74.4% reached it at 12 weeks and 72.1% at 24 weeks. Among the previously-treated Cohort II groups, the figures reported were: relapsers 86.2%, partial responders 66.7%, null responders 40.0%, and breakthrough patients 50.0% — these percentages were the same at both 12 and 24 weeks for Cohort II. An earlier check at weeks 4 and 8 (called "early treatment success") showed higher proportions across most groups, ranging from 50% in the breakthrough group up to 100% in the partial responder group. The reported data also tracked a liver enzyme called ALT returning to normal levels by the end of treatment, broken down by whether or not the participant also achieved the 12-week virus-undetectable result. These figures were reported as raw numbers of participants rather than percentages, and varied across the groups. It is worth noting that the numbers of participants in some Cohort II groups were very small (as few as 2–3 people), so those figures reflect only a handful of individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02103439 · results posted 21 July 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT02103439) enrolled 140 people with Hepatitis C — 70 in each group. One group received a medicine called Algeron, and the other received a medicine called PegIntron. Both are types of a treatment known as pegylated interferon, used alongside other Hepatitis C therapy. The trial was mainly measuring how many participants showed a strong reduction in the Hepatitis C virus in their blood after 12 weeks of treatment (called an "early virological response"). Of the 140 who started, 134 completed the trial — 67 in each group. The reported data shows that after 12 weeks, 90% of participants in the Algeron group and 81.4% in the PegIntron group met the criteria for an early virological response (meaning the virus in their blood had either become undetectable or dropped very significantly). When broken down by the type — or "genotype" — of Hepatitis C, the reported figures were: for genotype 1, 82.4% (Algeron) versus 75.8% (PegIntron); for genotypes 2 or 3, 97.2% (Algeron) versus 88.5% (PegIntron). For a shorter-term measure at 4 weeks (called "rapid virological response"), the reported data shows 51.4% for Algeron and 37.1% for PegIntron had undetectable virus levels. A liver enzyme measure (alanine aminotransferase, a marker checked in blood tests) was within the normal range after 12 weeks in 68.6% of the Algeron group and 82.9% of the PegIntron group. Neither group recorded any "viral breakthrough" — meaning no participants whose virus had dropped were reported to have had it rise again significantly during the 12-week period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01783678 · results posted 30 April 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 275 people in total across six groups, each defined by their hepatitis C virus (HCV) genotype (a strain type) and whether they had received prior treatment. The breakdown was: 19 people with genotype 2 who had not been treated before, 112 with genotype 1 who had not been treated before, 6 with genotype 2 who had been treated before, 58 with genotype 3 who had not been treated before, 49 with genotype 3 who had been treated before, and 31 with genotype 4 who had not been treated before. The trial's main goals were to measure the proportion of participants whose hepatitis C virus became undetectable in the blood 12 weeks after finishing treatment (called SVR12), and to track how many people stopped taking the study drug permanently because of an unwanted side effect. The reported data shows that SVR12 rates — the percentage of participants with no detectable virus at 12 weeks after finishing treatment — ranged from around 83% to 91% depending on the group. Specifically, the figures reported were: genotype 2 (not previously treated) 89.5%, genotype 1 overall (not previously treated) 84.8%, genotype 1a 84.0%, genotype 1b 90.9%, genotype 2 (previously treated) 83.3%, genotype 3 (not previously treated) 91.2%, genotype 3 (previously treated) 85.7%, and genotype 4 (not previously treated) 83.9%. Regarding stopping the study drug early due to an unwanted effect, the reported figures were 0% for genotype 2 (not previously treated), 1.8% for genotype 2/3 (previously treated), and 3.5% for genotype 1/3/4 (not previously treated). The reported data also shows that levels of the hepatitis C virus in the blood dropped substantially within the first one to four weeks of treatment across all groups, with reductions of roughly 4.2 to 5.3 units on a logarithmic scale (a way of measuring very large changes in virus levels). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01485991 · results posted 10 April 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 385 people in the simeprevir group and 386 people in the telaprevir group — a total of 771 participants — all of whom had hepatitis C. The trial was comparing two different antiviral medicines (simeprevir and telaprevir), each given alongside two other standard medicines (peginterferon alfa-2a and ribavirin). The main thing the trial was measuring was whether the hepatitis C virus became undetectable in participants' blood and stayed that way for at least 12 weeks after treatment finished — a result known as SVR12 (sustained virologic response at 12 weeks). The reported data shows that 53.6% of participants in the simeprevir group and 54.7% in the telaprevir group met the SVR12 measure — meaning the virus was undetectable in their blood at that point. For a similar measure taken 24 weeks after treatment ended (SVR24), the reported figures were 53.3% for the simeprevir group and 55.2% for the telaprevir group. The trial also tracked how many participants had the virus return after initially becoming undetectable — this is called viral relapse. The reported data shows a relapse was recorded in 17.9% of the simeprevir group and 16.4% of the telaprevir group. It is worth noting that 32 people in the simeprevir group and 36 in the telaprevir group did not complete the study, though the reasons for this were not detailed in the data provided here. No other outcome figures beyond those described above were included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00674492 · results posted 9 March 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 21 participants, and all 21 completed the study — none dropped out. The trial was exploring the personal experiences and motivations of people undergoing antiviral treatment, specifically looking at the reasons why participants chose to continue with their treatment. This appears to have been a qualitative study, meaning it focused on understanding people's thoughts and feelings rather than measuring a medical outcome like a test result or symptom score. The reported data shows that researchers identified four main reasons participants gave for sticking with their antiviral treatment. Of the 21 participants, 14 reported wanting to cure their disease as a reason for continuing; 15 reported a concern about running out of time to act — in other words, a worry about avoiding a bad health outcome if they delayed; 7 reported a desire to demonstrate personal strength or resilience; and 9 reported a sense of wanting to make up for or come to terms with past behaviour. It is worth noting that because participants could report more than one reason, the numbers across these four categories add up to more than 21. No other outcome measures were included in the submitted data. The reported data does not include any measurements of whether the treatment produced a medical benefit, and no conclusions about treatment effectiveness or safety can be drawn from these figures alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01592006 · results posted 12 January 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 3 participants, and all 3 completed the study — none dropped out. The participants were liver transplant recipients who had hepatitis C (a viral infection affecting the liver). The trial was looking at a combination of three antiviral medicines — pegylated interferon alfa-2a (Pegasys), ribavirin, and telaprevir — given together. The main thing being measured was whether participants had no detectable hepatitis C virus in their blood 24 weeks after finishing treatment, which researchers call a "sustained virologic response" or SVR24. The reported data shows that 100% of participants (all 3 out of 3) had undetectable hepatitis C virus in their blood at that 24-week follow-up point. The secondary outcome measured was the number of participants who experienced serious adverse events (meaning significant unwanted medical events during the trial). The reported data shows that 0 participants had a serious adverse event recorded. It is important to note that with only 3 people taking part, this was an extremely small trial, and the numbers — while reported as submitted — should be understood in that context. No conclusions about how these medicines might perform more broadly can be drawn from such a small group alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01074008 · results posted 8 January 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 74 adults across nine groups to study three experimental hepatitis C antiviral medicines — ABT-450/r, ABT-072, and ABT-333 — each tested at different doses alongside a standard backbone treatment (pegylated interferon and ribavirin, often called pegIFN/RBV). A placebo group (11 people) received only the standard backbone. Most groups had 7–8 participants. The trial measured how much the level of hepatitis C virus in participants' blood changed, how the body processed ABT-450/r (how quickly it was absorbed and how much built up in the bloodstream), and what proportion of participants had very low or undetectable virus levels at set time points during treatment. The reported data shows that, for the primary outcome of virus level change during the first three days of taking the experimental drug alone, the ABT-450/r groups showed the largest average reductions from their starting levels — around −4.07 to −4.11 on a logarithmic scale (a scale where each whole number represents a tenfold difference) depending on dose. The ABT-072 and ABT-333 groups showed smaller average reductions, ranging from approximately −0.95 to −1.57, while the placebo group showed an average reduction of −0.36. For blood concentration of ABT-450/r, the reported data shows that higher doses were associated with substantially higher peak blood levels and greater overall drug exposure. At Week 4, the percentage of participants with virus levels below the detectable threshold ranged from 87.5% to 100% across the three ABT-450/r dose groups, compared with 12.5% to 50% across the ABT-072 and ABT-333 groups, and 9.1% in the placebo group. By Week 12, the proportion of participants whose virus levels had dropped by more than 100-fold from their starting point ranged from 87.5% to 100% in the ABT-450/r groups, 62.5% to 100% in the ABT-072 and ABT-333 groups, and 36.4% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00726882 · results posted 8 January 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT00726882) enrolled 35 people who had previously taken part in one of two earlier studies (known as M10-380 and M10-351) and had been treated with a medicine called ABT-333 for hepatitis C infection. The trial was a follow-up study designed to track whether certain virus changes — called resistance-associated variants — that appeared during the earlier treatment were still present over time, and whether the virus had become less responsive (shown by laboratory measurements) to ABT-333 after treatment had ended. Of the 35 people who started, only 13 completed the study, and 22 did not complete it. The reported data shows that, among the 22 participants who came from the M10-380 study, 4 were found to still carry virus variants at positions in the virus linked to resistance, and 2 showed a measurable reduction in the virus's laboratory response to ABT-333 (this is expressed as a "fold change in EC50," meaning the amount of the drug needed to affect the virus in a lab test had shifted compared to the starting point). Among the 6 participants from the M10-351 study, the reported data shows 0 participants had these resistance-associated variants persisting, and 0 showed reduced laboratory response to the drug. For the secondary outcome, the reported data shows that no participants (0 out of 35) experienced a serious adverse event — meaning a severe or significant medical problem — that was considered related to the study procedures, such as blood draws. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01833533 · results posted 6 January 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01833533) enrolled 305 adults with a hepatitis C virus (genotype 1a) infection who had not previously been treated. All participants received a combination of three antiviral medicines (ABT-450/r, ABT-267, and ABT-333). One group of 100 people also received ribavirin (a fourth medicine), while a larger group of 205 people received a placebo (dummy pill) instead of ribavirin. The trial's main goal was to measure how many participants had no detectable hepatitis C virus in their blood 12 weeks after finishing treatment — a result researchers call a "sustained virologic response," which simply means the virus could no longer be measured at that point in time. The reported data shows that, in the group who received the real ribavirin alongside the three antivirals, 97.0% of participants had undetectable virus levels at the 12-week follow-up. In the group who received the placebo ribavirin instead, 90.2% reached that same result. Regarding a secondary measure — the proportion of participants whose virus levels were detected again after treatment ended (called "virologic relapse") — the reported figures were 1.0% in the ribavirin group and 5.2% in the placebo ribavirin group. The trial also tracked a drop in haemoglobin (a protein in red blood cells) to below the normal range by the end of treatment: 42.0% of participants in the ribavirin group experienced this drop, compared with 3.9% in the placebo ribavirin group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01464827 · results posted 6 January 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01464827) enrolled a total of 580 participants across 14 different groups (labelled A through N), each receiving different combinations, doses, or durations of antiviral medicines for hepatitis C. The trial was primarily measuring two things: how many participants experienced unwanted medical events (called adverse events) during the study, and what percentage of participants had no detectable hepatitis C virus in their blood 24 weeks after finishing treatment — a result referred to as SVR24 (sustained virologic response at 24 weeks). The main comparison the trial was designed to make was between participants who took three antiviral medicines plus ribavirin for 8 weeks versus those who took the same combination for 12 weeks. The reported data shows that, for the primary SVR24 result, the percentage of participants with no detectable virus at 24 weeks after treatment ranged from around 82.9% to 97.4% depending on which group they were in. For the key head-to-head comparison (8 weeks versus 12 weeks of three medicines plus ribavirin), the reported figures were 87.5% for the 8-week group and 95.0% for the 12-week group. Results for groups receiving only two antiviral medicines plus ribavirin for 12 weeks were reported at 82.9% and 88.7%, while the group receiving three medicines without ribavirin showed 88.6%. When comparing participants who had never previously been treated for hepatitis C with those who had not responded to earlier treatment, the reported SVR24 figures were 93.7% and 94.3% respectively. Regarding unwanted medical events, the reported data shows the number of participants who experienced at least one adverse event ranged from 36 to 77 across the various groups, though the full breakdown across all groups was not completely reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00333710 · results posted 15 December 2014

According to the results reported on ClinicalTrials.gov, this trial involved 53 people in total, split across three groups: 19 received individual face-to-face contact, 18 received individual telephone contact, and 16 received the control condition (treatment as usual). The trial was measuring participants' knowledge about the Hepatitis C virus, using a 62-question quiz where higher scores mean greater knowledge of the virus. The reported data shows that knowledge scores were recorded at two points in time (a before and after measurement) for each group. Before the study, the face-to-face group scored an average of 37.88 out of 62, the telephone group scored 40.50, and the control group scored 35.80. Afterwards, the face-to-face group's average score rose to 45.38, the telephone group's average score moved to 42.36, and the control group's average score went to 34.73. It is worth noting that a notable number of participants did not complete the study — 11 out of 19 in the face-to-face group, 4 out of 18 in the telephone group, and 1 out of 16 in the control group. No other outcome measures were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01667731 · results posted 21 November 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 224 people in total across five groups, all of whom had hepatitis C (a liver infection caused by a virus). Participants were split based on which strain ("genotype") of the virus they had — genotype 1, 2, or 3 — and whether they had received previous treatment or were being treated for the first time. All groups received a combination of two medicines: sofosbuvir (SOF) and ribavirin (RBV), for either 12 or 24 weeks. The main things the trial was measuring were: the proportion of people whose virus levels dropped to an undetectable level 12 weeks after finishing treatment (known as SVR12, which researchers use as a marker when studying hepatitis C), and the proportion of people who stopped taking the study medicines early due to an unwanted reaction. The reported data shows that the share of participants reaching undetectable virus levels at 12 weeks after finishing treatment varied across the five groups. In the genotype 2 group who had not been treated before (12 weeks of treatment), the figure was 88.5%. For the genotype 3 group who had not been treated before (12 weeks), it was 66.7%. Among those who had been treated before, the genotype 2 group (24 weeks) reached 91.7%, the genotype 3 group (24 weeks) reached 94.1%, and the genotype 1 group who had not been treated before (24 weeks) reached 76.3%. Regarding early stopping due to unwanted reactions, the reported data shows this occurred in 4.4% of the combined genotype 2/3 first-time treatment group, 2.4% of the previously treated genotype 2/3 group, and 2.6% of the genotype 1 first-time treatment group. The secondary outcomes tracked virus levels at earlier time points (4 and 24 weeks after finishing treatment) as well as how much the virus level in the blood dropped after 1, 2, and 4 weeks of taking the medicines. The reported figures for virus level drops at week 1 ranged from around −4.42 to −4.78 (measured on a scientific scale), and by week 4 ranged from around −4.86 to −5.16 across all groups — indicating the measurements were being taken, though what these numbers mean clinically is a matter for medical professionals to interpret. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01468584 · results posted 3 November 2014

According to the results reported on ClinicalTrials.gov, this trial involved 10 participants, all of whom received the study drug, MP-424 (also known as telaprevir). All 10 participants completed the trial — none dropped out. The trial was measuring what is called a "Sustained Viral Response" (SVR) — this means whether the hepatitis C virus (HCV) became undetectable in the blood 24 weeks after finishing the course of medication. In other words, it was looking at how many participants had no detectable virus in their blood roughly six months after stopping treatment. The reported data shows that 50% of participants (that is, 5 out of the 10 people in the trial) had undetectable levels of the hepatitis C virus in their blood at the 24-week follow-up point. No secondary outcome measures were included in the structured results data submitted, so no further outcome figures are available to report. It is also worth noting that with only 10 participants, this was a very small study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01466192 · results posted 3 November 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 108 people, all of whom received a treatment called MP-424 (also known as telaprevir). The trial was measuring something called a "Sustained Viral Response" (SVR) — this means whether the hepatitis C virus became undetectable in a person's blood 24 weeks after they finished taking the study medication. Of the 108 people who started, 104 completed the study, and 4 did not finish. The reported data shows that 88% of participants had undetectable levels of the hepatitis C virus in their blood at the 24-week follow-up point after finishing treatment. No other outcome measures were included in the structured results data submitted to ClinicalTrials.gov for this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01479868 · results posted 29 October 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01479868) enrolled 106 participants, all of whom received the study treatment — TMC435 (simeprevir) at 150mg for 12 weeks, combined with two other medicines (pegylated interferon and ribavirin) for either 24 or 48 weeks in total. The trial was looking at how participants' hepatitis C virus (HCV) levels responded to this treatment combination. Of the 106 who started, 97 completed the study and 9 did not. The reported data shows that the main thing being measured was called "SVR12" — this stands for "sustained virologic response at 12 weeks," meaning that the hepatitis C virus was at an undetectable or very low level in the blood at the end of treatment and still at that level 12 weeks later. The reported figure for SVR12 was 73.6% of participants. A similar measure taken 24 weeks after the end of treatment (SVR24) was reported at 72.6%. The reported data also shows that 17% of participants were recorded as having "on-treatment failure" (meaning the virus was still detectable at the end of treatment), 11.4% experienced a "viral breakthrough" (where virus levels rose again during treatment after previously falling), and 10.3% experienced a "viral relapse" (where virus levels rose again after the end of treatment). The reported data also includes a series of measurements tracking how many participants had very low or undetectable virus levels at various points during and after treatment, with figures ranging from 65.7% to 100% across those different time points — though the specific time point labels for each figure were not included in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01405937 · results posted 13 October 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 51 people in total — 25 in a group that received vaniprevir (an antiviral medicine) for 12 weeks, and 26 in a group that received it for 24 weeks. All 51 participants completed the trial. The trial was measuring how many people had no detectable hepatitis C virus (HCV) in their blood at various points during and after treatment, as well as tracking certain pre-specified side effects of interest. The reported data shows that for the main goal — having undetectable HCV in the blood 24 weeks after finishing all treatment (called SVR24) — 92% of participants in the 12-week group and 96.2% in the 24-week group reached this point. For a similar measure taken at 12 weeks after treatment ended (SVR12), the figures were 88% and 92.3% respectively. By week 4 of treatment, 88% in both groups had undetectable virus levels. By week 12 of treatment, and again at the very end of treatment, 100% of participants in both groups had undetectable virus levels. The reported data also shows that the trial tracked five specific categories of unwanted events: serious rash, anaemia (low red blood cell levels), neutropenia (low white blood cell levels), raised bilirubin (a liver-related marker), and gut symptoms such as nausea, vomiting, and diarrhoea. Across both groups, the percentage of participants who experienced at least one of these events ranged from roughly 4% to 88% depending on the specific category and group — for example, gut-related symptoms were reported in 88% of the 12-week group and 84.6% of the 24-week group, while serious rash was reported in 8% and 3.8% respectively. These are the numbers as submitted; the data does not allow conclusions about whether these events were caused by the treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01682720 · results posted 9 October 2014

According to the results reported on ClinicalTrials.gov, this trial involved people with chronic hepatitis C (a liver infection caused by the hepatitis C virus) and looked at a medicine called sofosbuvir (SOF). In total, 421 people started the trial across four groups: 85 received a placebo (a dummy treatment) for 12 weeks, 74 had genotype 2 of the virus and received SOF for 12 weeks, 12 had genotype 3 and received SOF for 12 weeks, and 250 had genotype 3 and received SOF for 24 weeks. (Genotype simply refers to the particular strain of the hepatitis C virus a person has.) The trial was primarily measuring how many participants had no detectable virus in their blood 12 weeks after finishing treatment — a result called SVR12 — as well as how many people stopped treatment early due to a side effect. The reported data shows the following SVR12 figures (the percentage of people with no detectable virus 12 weeks after treatment ended): 93.2% in the genotype 2 group who took SOF for 12 weeks, 27.3% in the genotype 3 group who took SOF for 12 weeks, and 85.2% in the genotype 3 group who took SOF for 24 weeks. Regarding stopping treatment early due to an unwanted event, the reported data shows this occurred in 1.2% of placebo participants, 1.2% of the combined SOF 12-week group, and 0.4% of the SOF 24-week genotype 3 group. The reported data also shows results for two secondary measurements. For the percentage of people who experienced the virus becoming detectable again during treatment (called viral breakthrough), the figures were 0% across all three SOF groups. For viral relapse — where the virus became undetectable by the end of treatment but was detected again afterwards — the reported figures were 6.8% for the genotype 2 SOF 12-week group, 54.5% for the genotype 3 SOF 12-week group, and 14.0% for the genotype 3 SOF 24-week group. Results for the placebo group were not collected for these virus-related measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01700179 · results posted 3 October 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 8 people, all of whom received a combination of two treatments: an experimental medicine called ACH-0143102 together with ribavirin (an existing antiviral medicine). The trial was looking at how many participants had very low or undetectable levels of hepatitis C virus in their blood 12 weeks after finishing treatment — a measurement known as "sustained virologic response at 12 weeks" (SVR12). Of the 8 people who started, 6 completed the trial and 2 did not. The reported data shows that 50% of participants (which in a group of 8 would represent 4 people) had hepatitis C virus levels that were below the limit of what the test could reliably measure at the 12-week point after finishing treatment. No other outcome measures were included in the results submitted to ClinicalTrials.gov, so no further figures are available to describe. It is worth noting that this was a very small trial, and the results as reported cover only this single group of 8 participants. The reported data does not include a comparison group, and no safety or side-effect data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01425203 · results posted 18 August 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01425203) enrolled 238 adult participants across two main groups during the treatment phase: 159 people received a combination called RGT BOC + PR (which included the experimental drug boceprevir alongside two standard medicines), and 79 people received a control combination of PBO + PR (a placebo plus the same two standard medicines). A smaller crossover group of 27 people — who had not responded well in the control group — later received the boceprevir-containing combination in a separate phase. The trial's main goal was to measure how many participants had no detectable Hepatitis C virus in their blood 24 weeks after finishing treatment, a milestone researchers call a "sustained virologic response" (SVR24). The reported data shows that, for the primary outcome, 74.8% of participants in the boceprevir group had no detectable virus at the 24-week follow-up point, compared with 46.2% in the control group. A closely related secondary measure — looking only at those who received at least one dose of the experimental drug — reported figures of 76.3% and 46.8% respectively. The reported data also shows a secondary outcome measured at 8 weeks into treatment (called an "early virologic response"): 87.4% of the boceprevir group had undetectable virus at that earlier point, compared with 42.3% in the control group. No outcome figures were separately reported for the crossover arm in the data submitted. It is worth noting that not everyone completed the treatment phase — 27 people in the boceprevir group and 37 in the control group did not finish — which may be relevant context when reading these percentages. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00882908 · results posted 16 June 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 386 adults with Hepatitis C across five treatment groups. Participants received either the investigational drug TMC435 (at one of two doses — 75 mg or 150 mg — and for either 12 or 24 weeks) combined with a standard backbone treatment called PR (pegylated interferon and ribavirin), or a placebo combined with the same PR treatment. The main thing the trial was measuring was whether participants had no detectable Hepatitis C virus in their blood at the end of treatment and again at 72 weeks (roughly 18 months) after the study began — a result researchers called a "sustained virologic response." The reported data shows that, for the primary goal (no detectable virus at week 72), the percentages of participants who reached that point varied across groups. In the four TMC435 groups, the reported figures were: 80.8% (75 mg, 12-week TMC435 course), 70.7% (75 mg, 24-week course), 77.9% (150 mg, 12-week course), and 84.8% (150 mg, 24-week course). In the placebo group, the reported figure was 64.9%. For a related secondary measure — no detectable virus at 24 weeks after the planned end of treatment — the reported figures were 82.1%, 74.7%, 80.5%, and 86.1% across the four TMC435 groups respectively, compared with 64.9% in the placebo group. An early measure at week 4 (called a rapid virologic response) showed no detectable virus in 68.0%–75.6% of TMC435 participants, compared with 5.2% in the placebo group. Some secondary outcome data points were only partially reported in the submitted results, so complete figures across all groups at every time point were not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01290679 · results posted 13 June 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01290679) involved 391 people with Hepatitis C — 257 in the group receiving the investigational medicine TMC435 (also taken alongside two other standard medicines) and 134 in the group receiving a placebo (inactive treatment, also alongside the same standard medicines). The trial was primarily measuring what proportion of participants had no detectable Hepatitis C virus in their blood 12 weeks after their planned end of treatment — a point in time often used in Hepatitis C research to assess whether the virus remains undetectable after treatment has stopped. By the end of the study, 241 people in the TMC435 group and 113 in the placebo group had completed the trial. The reported data shows that 81.3% of participants in the TMC435 group had no detectable virus in their blood at 12 weeks after treatment ended, compared with 50.0% in the placebo group. The reported data also shows similar figures at other follow-up points: at 4 weeks after treatment ended, the figures were 84.8% (TMC435) versus 53.0% (placebo); at 24 weeks after treatment ended, 80.5% versus 50.0%; and at week 72 of the study overall, 78.6% versus 50.0%. These are the percentages of people in each group who had no detectable virus at those time points, as counted and reported by the trial investigators. The reported data also includes measurements of the actual amount of Hepatitis C virus detected in participants' blood at various points during and after treatment, showing changes over time in both groups — however, because these figures are recorded in a technical laboratory unit, a straightforward plain-English comparison is not possible without further context from the full study report. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01289782 · results posted 4 June 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01289782) enrolled 394 adults with Hepatitis C — 264 in the group receiving the investigational drug TMC435 (150mg) alongside standard antiviral treatment, and 130 in the group receiving a placebo alongside standard antiviral treatment. The trial was measuring whether the Hepatitis C virus became undetectable in participants' blood and stayed undetectable for a period of weeks to months after treatment finished. Of those who started the trial, 239 in the TMC435 group and 118 in the placebo group completed it. The reported data shows that for the main outcome — the proportion of participants whose virus was undetectable 12 weeks after the planned end of treatment — 79.5% of those in the TMC435 group reached this point, compared with 50% in the placebo group. For related measures checked at other time points, the reported figures were broadly similar: at 4 weeks after the end of treatment, 82.2% (TMC435) versus 56.2% (placebo); at 24 weeks after, 79.5% versus 49.2%; and at a later check around week 72, 78.4% versus 49.2%. The reported data also tracked how the level of Hepatitis C virus in participants' blood changed over time, measured on a scientific scale (log10 IU/mL — essentially a way of expressing very large or very small numbers in a compact form). These figures showed reductions in virus levels in both groups across various time points during and after treatment, with the TMC435 group generally showing larger reductions at the earlier time points during active treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01241760 · results posted 4 June 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 740 adults with hepatitis C — 371 in one group and 369 in the other. Both groups received a combination of three medicines: telaprevir (taken either every 8 hours or twice daily) together with two other hepatitis C drugs, peginterferon and ribavirin. The trial was primarily measuring what proportion of participants had undetectable levels of the hepatitis C virus in their blood 12 weeks after finishing their planned course of treatment — a result known as a "sustained virologic response" or SVR (meaning the virus was no longer measurable at that later check-up point). The reported data shows that for the primary measure — virus undetectable at 12 weeks after the planned end of treatment — 72.8% of participants in the every-8-hours group and 74.3% in the twice-daily group met that threshold. For a similar check at 24 weeks after planned treatment end, the figures were 72.8% and 74.8% respectively, and at 72 weeks from the start of treatment they were 69.0% and 70.2%. The reported data also shows that around 9.7% and 10.3% of participants in each group respectively had to stop all study drugs early because the virus remained detectable at levels that triggered a pre-set stopping rule. Separately, 7.2% and 7.7% of participants in each group were recorded as having relapsed — meaning the virus became detectable again during the follow-up period after it had previously been undetectable. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00606086 · results posted 3 June 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT00606086) involved 140 people in total — 72 in one group (Arm 1) and 68 in another (Arm 2). The trial was looking at a measure called Early Virologic Response, or EVR, which means how many participants showed a significant reduction in the amount of virus in their blood after 12 weeks of treatment. One group received a combination of Peg-IFN/Ribavirin plus an additional treatment called GI-5005, while the other group received Peg-IFN/Ribavirin (with or without GI-5005). By the end of the study, 60 people in Arm 1 and 53 people in Arm 2 had completed the trial, with 12 and 15 participants respectively not completing it. The reported data shows that for the primary outcome — Early Virologic Response at 12 weeks — 79.4% of participants in Arm 1 (the Peg-IFN/Ribavirin plus GI-5005 group) showed this reduction in virus levels. In Arm 2, the figure was 78.5%. No secondary outcome measures were included in the data submitted to ClinicalTrials.gov, so those results were not reported and cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01641640 · results posted 8 May 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 328 people, with 327 actually receiving treatment. All participants received a combination of three medicines: sofosbuvir, pegylated interferon, and ribavirin (often shortened to SOF+PEG+RBV). The trial was measuring how many participants cleared the hepatitis C virus from their blood — both during and after finishing treatment — and also tracking how many people stopped taking the study medicines early due to unwanted side effects. The reported data shows that the main goal of the trial was to measure what is called SVR12 — this means having an undetectable level of hepatitis C virus in the blood 12 weeks after finishing treatment. According to the results reported on ClinicalTrials.gov, 91% of participants reached this point. At 4 weeks after treatment (SVR4), the figure was reported as 92.4%, and at 24 weeks after treatment (SVR24), it was 90.5%. The reported data also shows that 0% of participants experienced what is called a "viral breakthrough" — meaning no participants whose virus became undetectable during treatment then had it return while still on treatment. However, 8.6% of participants were reported to have experienced a "viral relapse," meaning the virus became detectable again after treatment had ended. Regarding stopping treatment early due to unwanted effects, the reported data shows that 8 participants permanently discontinued the study medicines for this reason (with individual events accounting for 2, 1, 1, 1, 1, 1, and 1 participants respectively). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01604850 · results posted 1 May 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 103 people in one group (sofosbuvir + ribavirin + placebo, treated for 12 weeks) and 99 people in a second group (sofosbuvir + ribavirin, treated for 16 weeks). All participants had hepatitis C. The trial was primarily measuring what proportion of people had virus levels too low to detect in a standard test 12 weeks after finishing treatment — a result researchers call SVR12 — as well as whether any participants stopped treatment permanently due to unwanted side effects. Secondary measurements looked at similar virus-level checkpoints at 4 and 24 weeks after treatment ended, and tracked whether the virus rebounded during or after treatment. The reported data shows that, for the primary measure of SVR12, 51% of participants in the 12-week group and 72.6% in the 16-week group had virus levels below the detectable threshold at the 12-week post-treatment check. Regarding stopping treatment permanently due to adverse events (unwanted reactions), one participant in the 12-week group discontinued, while none did in the 16-week group. For the secondary measures, the reported data shows that 56% (12-week group) and 76.8% (16-week group) reached undetectable virus levels at 4 weeks after treatment, and 50% versus 71.6% at 24 weeks after treatment. No participants in either group experienced viral breakthrough (the virus returning while still on treatment). However, 47 participants in the 12-week group and 26 in the 16-week group had the virus return to detectable levels after finishing treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00919633 · results posted 30 April 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 106 people in total, split across four groups. Three groups received different doses of a medicine called Interferon Alfa-2b (25 people in Dose 1, 27 in Dose 2, and 26 in Dose 3), while a fourth group of 28 people received a related medicine called Peginterferon Alfa-2b. The trial was measuring how the virus levels in participants' blood changed over time, looking at three specific points: whether the virus became undetectable early in treatment (Rapid Virologic Response), at a set point during treatment (Early Virologic Response), and whether it stayed undetectable some time after treatment finished (Sustained Virologic Response, the primary goal). It is worth noting that a large number of participants did not complete the study — only 25 out of 106 people finished across all four groups. The reported data shows the following numbers for the main goal — how many participants in each group had no detectable virus some time after finishing treatment: 4 out of 28 in the Peginterferon group, 7 out of 25 in the Interferon Dose 1 group, 2 out of 27 in the Interferon Dose 2 group, and 4 out of 26 in the Interferon Dose 3 group. For the secondary measure of early virus disappearance during treatment, the reported numbers were: 2, 4, 7, and 11 participants respectively across the four groups. For the mid-treatment virus measure, the reported numbers were: 7, 15, 13, and 11 participants respectively. The reported data shows that across all groups, only a minority of participants reached each of these measured points, and the high number of people who did not complete the study makes the figures difficult to interpret without expert guidance. No conclusions about which treatment performed better should be drawn from these numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01281839 · results posted 23 April 2014

According to the results reported on ClinicalTrials.gov, this trial involved 393 people with Hepatitis C. Participants were split into two groups: 260 people received the study drug TMC435 (150mg) for 12 weeks alongside a standard background treatment (referred to as PR) for either 24 or 48 weeks, while 133 people received a placebo (a dummy pill with no active ingredient) alongside the same standard background treatment for 48 weeks. The trial was primarily measuring how many participants had no detectable Hepatitis C virus in their blood 12 weeks after their planned end of treatment — a result known as a "sustained virologic response" or SVR12. The reported data shows that, for the main outcome (SVR12), 79.2% of participants in the TMC435 group had no detectable virus at that 12-week follow-up point, compared with 36.1% in the placebo group. For the additional (secondary) outcomes, the reported figures at 4 weeks after end of treatment were 88.5% versus 48.1%; at 24 weeks after end of treatment, 77.3% versus 33.8%; and at week 72 of the overall study, 76.5% versus 33.8%. The trial also tracked the actual levels of Hepatitis C virus in participants' blood over time, with the reported data showing that virus levels in the TMC435 group fell more quickly from as early as week 4 onward compared with the placebo group. Overall, 250 people in the TMC435 group and 119 in the placebo group completed the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01497366 · results posted 2 April 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01497366) enrolled 263 people in the sofosbuvir plus ribavirin (Sofosbuvir+RBV) group and 264 people in the pegylated interferon plus ribavirin (PEG+RBV) group — 527 participants in total. The trial was measuring whether the hepatitis C virus became undetectable in participants' blood both during treatment and at set points after treatment finished, as well as tracking certain side effects and lab changes. The reported data shows that the main outcome — the proportion of participants whose hepatitis C virus was undetectable in the blood 12 weeks after stopping all study drugs (called SVR12) — was 67% in both the Sofosbuvir+RBV group and the PEG+RBV group. At 24 weeks after stopping treatment, the reported figures were very similar: 66.8% for Sofosbuvir+RBV and 65.4% for PEG+RBV. During treatment itself, the reported data shows that the proportion of participants with undetectable virus levels was higher in the Sofosbuvir+RBV group at earlier time points compared with the PEG+RBV group, though the two groups appeared closer together by later time points. The proportion of participants who experienced what the trial defined as "virologic failure" (the virus not responding or coming back) during treatment was reported as 0.4% in the Sofosbuvir+RBV group and 7.4% in the PEG+RBV group. Regarding side effects and lab abnormalities, the reported numbers varied across different categories; the full breakdown of those categories was not labelled in the data provided, so a detailed description cannot be given without risking misrepresentation. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01188772 · results posted 19 February 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 147 adults with hepatitis C (a liver infection caused by a virus). Participants were divided into four groups based on their virus "genotype" (a way of categorising different strains of the virus) and the dose of medicine they received: 48 people received sofosbuvir 200 mg with genotype 1, 48 received sofosbuvir 400 mg with genotype 1, 26 received a placebo (a dummy treatment with no active ingredient) with genotype 1, and 25 received sofosbuvir 400 mg with genotype 2 or 3. The trial's main focus was tracking how many participants experienced side effects during the treatment period, and it also measured how the level of hepatitis C virus in the blood changed over time. The reported data shows that the primary outcome — the proportion of people who experienced any side effect during the treatment period — was very high across all groups: around 97.9% in the sofosbuvir 200 mg genotype 1 group, 97.9% in the sofosbuvir 400 mg genotype 1 group, 100% in the placebo genotype 1 group, and 96.0% in the sofosbuvir 400 mg genotype 2/3 group. For the secondary outcomes, the reported data shows that by week 4, the proportion of participants whose virus dropped to an undetectable level in their blood was 97.9% (sofosbuvir 200 mg, genotype 1), 97.9% (sofosbuvir 400 mg, genotype 1), 19.2% (placebo, genotype 1), and 96.0% (sofosbuvir 400 mg, genotype 2/3). By the end of treatment, the proportions with undetectable virus levels were 93.8%, 100%, 61.5%, and 100% respectively across the four groups. The average reduction in the amount of virus in the blood from the start to week 12 was also reported, measured on a scientific scale, but a plain comparison of the specific numbers was not provided in a form that makes direct everyday interpretation straightforward. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00445315 · results posted 17 February 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 32 people in total. Six participants were assigned to each of four different dose groups of an investigational drug called PF-00868554 (tested at 100 mg twice daily, 300 mg twice daily, 300 mg three times daily, and 450 mg twice daily), while eight participants received a placebo (a dummy treatment with no active ingredient). All 32 participants completed the study. The trial was primarily measuring how the drug behaved in the body — specifically, how much of it got into the bloodstream and how quickly — across different doses over an 8-day period. The reported data shows the peak level of the drug detected in the blood (the highest concentration reached after a dose) on Day 1 and Day 8 for each dose group. On Day 1, the reported peak blood levels ranged from 3,467 units (ng/mL) in the lowest dose group up to 48,393 units in the highest dose group. By Day 8, those peak levels had increased slightly across all groups, ranging from 5,859 units in the lowest dose group up to 57,725 units in the highest. The reported data also shows that the drug reached its peak level in the blood relatively quickly — within about half an hour to one hour after a dose on both Day 1 and Day 8. Additionally, the total amount of drug the body was exposed to over each dosing period (a measure called "area under the curve") was also reported, and this figure was higher with larger doses and increased modestly from Day 1 to Day 8. No outcome data was reported for the placebo group for these measurements, as these measures relate specifically to how the active drug moves through the body. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01542788 · results posted 17 February 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 209 people in the active treatment group (receiving a combination of sofosbuvir and ribavirin, referred to here as SOF+RBV) and 71 people in a placebo group (receiving dummy treatment). The trial was measuring whether people with hepatitis C could reach a point where the hepatitis C virus became undetectable in their blood — first at 4 weeks, then at 12 weeks, and again at 24 weeks after finishing treatment. The trial also tracked whether the virus came back during or after treatment, and whether any participants had to permanently stop taking the study drug due to unwanted side effects. The reported data shows that among those who received SOF+RBV, 78% had undetectable levels of the hepatitis C virus in their blood 12 weeks after finishing treatment (the main goal of the trial), compared with 0% in the placebo group. At 4 weeks after treatment, the reported figure for the SOF+RBV group was 83.1%, and at 24 weeks it was 77.8% — again, 0% for the placebo group at both timepoints. The reported data shows that 0% of participants in either group experienced what is called "viral breakthrough" (the virus becoming detectable again while still on treatment). However, a viral relapse rate of 20.5% was reported for the SOF+RBV group, meaning roughly 1 in 5 people in that group who had undetectable virus at the end of treatment saw the virus return afterwards. Regarding permanent stops due to unwanted effects, the reported data shows 1 participant in the SOF+RBV group and 0 in the placebo group stopped for this reason (from the 202 and 68 participants respectively assessed for this measure). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00980330 · results posted 6 February 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 462 adults with Hepatitis C across seven groups. Each group received a different combination of an investigational drug called TMC435 (also known as simeprevir) alongside two existing medicines — pegylated interferon and ribavirin (together called "PR"). TMC435 was tested at two different doses (100 mg and 150 mg) and for different lengths of time (12, 24, or 48 weeks), always combined with 48 weeks of the background medicines. A seventh group received a dummy pill (placebo) alongside the same background medicines. The main thing the trial was measuring was a "sustained virologic response at 24 weeks after the end of treatment" — this means the Hepatitis C virus was undetectable in the blood both at the end of treatment and still 24 weeks later. The reported data shows that for the primary measure, the percentage of participants in whom the virus was undetectable at that 24-week follow-up point ranged from about 61% to 80% across the six TMC435 groups, compared with approximately 23% in the placebo group. Specifically, the reported figures were: 69.7% (100 mg, 12 weeks), 66.2% (100 mg, 24 weeks), 60.6% (100 mg, 48 weeks), 66.7% (150 mg, 12 weeks), 72.1% (150 mg, 24 weeks), and 80.0% (150 mg, 48 weeks), versus 22.7% for placebo. For the secondary measures, the reported data shows that after just 4 weeks of treatment, between roughly 53% and 68% of participants in the TMC435 groups had undetectable virus levels, compared with 1.5% in the placebo group. At 12 weeks, between about 85% and 92% of TMC435 group participants showed a meaningful reduction in virus levels (defined as a tenfold-squared, or 100-fold, drop from their starting level), compared with about 61% in the placebo group. Some secondary outcome data points were not fully reported for all groups in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01290731 · results posted 4 February 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 49 participants, with 48 completing the study and 1 not completing it. All participants received TMC435 (100 mg) for 12 weeks combined with two other medicines (referred to as PR — pegylated interferon and ribavirin) for either 24 or 48 weeks in total. The trial was measuring how many participants had undetectable levels of the Hepatitis C virus in their blood at various points during and after treatment, including 12 and 24 weeks after finishing all treatment. The reported data shows that the main outcome — having no detectable Hepatitis C virus in the blood 12 weeks after finishing treatment (called SVR12) — was recorded in 95.9% of participants. For the same measure taken 24 weeks after finishing treatment (SVR24), the reported figure was 89.8%. The reported data also shows that at various check-in points during and after treatment, between 81.6% and 100% of participants had either undetectable virus levels or a meaningful drop in virus levels from where they started. No participants were reported to have experienced what the trial called "viral breakthrough" — a significant rise in virus levels during treatment — while 4 participants were reported to have had a "viral relapse," meaning the virus became detectable again after being undetectable at the end of treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01498068 · results posted 30 December 2013

According to the results reported on ClinicalTrials.gov, this trial (NCT01498068) enrolled 36 people with hepatitis C — 16 who had never received treatment before ("treatment-naïve") and 20 who had been treated previously ("treatment-experienced"). One person from each group did not complete the study. The trial was measuring how well participants' hepatitis C virus (HCV) levels responded to treatment at various points in time, using blood tests that detect the amount of virus present. The reported data shows that for the main outcome — called an "extended rapid virologic response," meaning the virus was undetectable in the blood at both week 4 and week 12 of treatment — 13 out of 16 treatment-naïve participants and 18 out of 20 treatment-experienced participants met this measure. For a related measure at week 4 alone, 14 of the 16 treatment-naïve and 18 of the 20 treatment-experienced participants had undetectable virus levels. The reported data also shows that 1 treatment-naïve and 2 treatment-experienced participants met the definition of "virologic failure," meaning their virus levels rose above a certain threshold at a specified time point during treatment. Regarding longer-term outcomes, the reported data shows that 14 treatment-naïve and 16 treatment-experienced participants achieved what is called an "SVR12" — meaning the virus was undetectable 12 weeks after the last planned dose. No treatment-naïve participants relapsed after finishing treatment, compared to 1 treatment-experienced participant. The trial also tracked changes in the amount of virus in the blood over time, though the full breakdown of those numbers across all time points was not labelled by specific week in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01292239 · results posted 9 December 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 183 people with hepatitis C — 123 in the group that received an investigational medicine called TMC435 (also given alongside two standard medicines, referred to as PR) for 12 weeks followed by PR alone for up to a total of 24 or 48 weeks, and 60 in a comparison group that received a placebo (a dummy pill with no active ingredient) for 12 weeks alongside PR for a total of 48 weeks. The trial's main goal was to measure how many participants had no detectable hepatitis C virus in their blood both at the end of treatment and again 12 weeks later — a result researchers call SVR12. The reported data shows that for the primary measure (SVR12), 88.6% of participants in the TMC435 group and 61.7% in the placebo group had no detectable virus at that point. For a similar measure taken 24 weeks after finishing treatment (SVR24), the reported figures were 88.6% and 56.7% respectively. The reported data also shows that earlier in treatment — at week 4 — 83.7% of the TMC435 group had undetectable virus levels compared with 13.3% in the placebo group, with both figures generally rising over time. Regarding virus "breaking through" during treatment (meaning levels rose again after falling), 1 person in the TMC435 group and 2 in the placebo group experienced this. Viral relapse after finishing treatment (virus becoming detectable again after having been undetectable) was reported in 9 participants in the TMC435 group and 15 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00996216 · results posted 6 December 2013

According to the results reported on ClinicalTrials.gov, this trial involved 27 participants who were given a medicine called eltrombopag. The trial was run in two parts: a pre-antiviral phase (Part 1) and an antiviral treatment phase (Part 2). The trial was primarily measuring how many participants experienced unwanted medical events (called adverse events) and serious adverse events while taking the medicine. It also tracked changes in blood test results over time, including platelet counts — platelets are tiny blood cells that help with clotting. The reported data shows that in Part 1, no participants experienced a serious adverse event, while 9 out of 27 participants experienced at least one adverse event of any kind. In Part 2, the reported data shows that 25 out of the 25 participants who entered that phase experienced at least one adverse event, and 5 experienced a serious adverse event. Regarding platelet counts (measured in units called Gi/L, which represent billions of platelets per litre of blood), the reported figures across various time points during the trial ranged from around 53 to 133 Gi/L. Of the 27 participants who started Part 1, 25 went on to begin antiviral treatment in Part 2, while 2 did not proceed. The reported data also shows that varying small numbers of participants had noteworthy changes in other blood chemistry measurements across both parts of the trial, though the full breakdown by specific test was not described in plain terms in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00983853 · results posted 10 October 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 62 people in total across six groups. Participants had both HIV and hepatitis C (HCV) infections. The trial was divided into two parts: Part A looked at people not on HIV treatment, and Part B looked at people already taking one of two common HIV treatment regimens (known as HAART). Within each part, some participants received telaprevir (an hepatitis C medicine, labelled "T") alongside two standard hepatitis C drugs (referred to as "PR"), while others received a dummy (placebo) pill alongside the same two drugs. The main thing being measured was how many people had no detectable hepatitis C virus in their blood at week 12 of treatment. The reported data shows that at week 12, 6 out of 7 people in the Part A telaprevir group had undetectable HCV levels, compared with 2 out of 7 in the Part A placebo group. In Part B, among those on one type of HIV treatment (EFV-based), 14 out of 17 in the telaprevir group had undetectable HCV at week 12, versus 2 out of 8 in the placebo group. Among those on the other HIV treatment (ATV/r-based), 10 out of 15 in the telaprevir group had undetectable HCV at week 12, compared with 2 out of 8 in the placebo group. The trial also tracked undetectable HCV levels at weeks 4, 12, 24 weeks after finishing treatment (called SVR12 and SVR24 — meaning no detectable virus at those follow-up points). The reported SVR12 and SVR24 numbers were identical across all groups, suggesting the virus remained undetectable for those who had already reached that milestone. The trial also measured how the HIV medicines and telaprevir affected each other's levels in the blood; the reported ratios were generally close to 1.0, meaning blood levels were broadly similar whether the medicines were taken together or separately, though the full detail of what those specific figures mean clinically was not elaborated in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01853254 · results posted 4 September 2013

According to the results reported on ClinicalTrials.gov, this trial (NCT01853254) enrolled 272 participants, all of whom received either peginterferon alfa-2a on its own or combined with ribavirin (two antiviral medicines). Of the 272 people who started the trial, 168 completed it, while 104 did not finish — though the reasons for not completing were not reported in the data provided here. The trial's main focus was tracking how many participants experienced at least one adverse event (that is, any unwanted or unexpected health occurrence noted during the study). The reported data shows that the only primary outcome measure recorded was the proportion of participants who had at least one adverse event. According to the results reported on ClinicalTrials.gov, 38.2% of participants — roughly just over one in three people — experienced at least one adverse event during the study. No secondary outcome measures appear to have been included in the submitted results data, so no further figures on other aspects of the trial are available to describe here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01427504 · results posted 9 July 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 26 people across six groups. The study was looking at how two medications — boceprevir (a hepatitis C treatment) and etravirine (an HIV medication) — behave in the body, both on their own and when taken together. To do this, the trial measured drug levels in participants' blood at different points in time. Between 20 and 25 participants completed the study depending on which part they were in, with a small number not finishing for reasons not detailed in the reported data. The reported data shows the following blood-level measurements for each drug when taken alone. For boceprevir, the total amount of drug detected in the blood over time (a measure called "area under the curve," or AUC) was reported as 4,601 ng·hr/mL; the highest level reached in the blood (called Cmax) was 1,423 ng/mL; and the level remaining at the 8-hour mark was 106 ng/mL. For etravirine, the AUC was reported as 7,698 ng·hr/mL; the peak blood level (Cmax) was 900 ng/mL; and the lowest level recorded (Cmin) was 439 ng/mL. No outcome measurements for the combination phase were included in the data submitted to ClinicalTrials.gov, so those figures are not available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00623428 · results posted 24 June 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 188 people in total — 95 in a group that received a combination of two medicines (PEG-IFN Alfa-2a and Ribavirin) for 24 weeks, and 93 in a group that received the same combination for 48 weeks. The trial was measuring whether the hepatitis C virus became undetectable in participants' blood and stayed that way after treatment finished — a result researchers call a "sustained virological response," which simply means the virus could no longer be detected in a blood test taken well after the treatment course ended. The reported data shows that, for the main result measured 24 weeks after the scheduled end of treatment, 52% of people in the 24-week group and 57% of people in the 48-week group had undetectable virus levels. For a slightly different version of this same main measure — taken 24 weeks after each person's actual last dose (which could differ if someone stopped early) — the figures were 52% for the 24-week group and 61% for the 48-week group. When virus levels were checked at the moment treatment finished, 93% of the 24-week group and 90% of the 48-week group had undetectable virus at that point. However, among those who had undetectable virus at the end of treatment, a portion later showed the virus returning — this was reported as 41% of the 24-week group and 29% of the 48-week group. At 72 weeks after the start of treatment, 44% of the 24-week group and 57% of the 48-week group still had undetectable virus levels. Results at 12 weeks after the actual end of treatment were also reported, showing 52% and 61% respectively — the same figures as the 24-week post-treatment measurement. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00561015 · results posted 4 June 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 49 people in total across six treatment groups. Participants had hepatitis C virus (HCV) infection of either genotype 2 or genotype 3 — two common strains of the virus. The trial tested a drug called telaprevir (TVR) in different combinations and sequences with two other medicines (pegylated interferon alfa-2a and ribavirin), comparing these against a placebo-based combination. The study was measuring how the amount of hepatitis C virus in the blood changed over time, and also tracking how telaprevir moved through the body (for example, how quickly it was absorbed and how much built up in the bloodstream). The reported data shows that, by Day 15, the level of HCV in the blood (measured on a logarithmic scale — a way of expressing very large or very small numbers more simply) had fallen across all groups from their starting points. For genotype 2 participants, the reported reductions ranged from about 3.7 to 5.5 log₁₀ units depending on the treatment group. For genotype 3 participants, the reported reductions ranged from about 0.5 to 6.9 log₁₀ units. By the end of treatment (around weeks 24–26), the reported reductions in virus levels across all six groups ranged from approximately 5.5 to 6.2 log₁₀ units. The reported data also shows that telaprevir reached its peak concentration in the bloodstream within 3 to 4 hours of dosing on Day 1, with peak blood levels ranging from roughly 1,500 to 2,500 nanograms per millilitre depending on the group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01276756 · results posted 3 May 2013

According to the results reported on ClinicalTrials.gov, this trial (NCT01276756) enrolled 100 people in total — 50 in a "Standard of Care" group and 50 in a "Triple Therapy" group. The trial was looking at treatments for hepatitis C virus (HCV) infection. The main thing it set out to measure was whether, six months after finishing treatment, a blood test for the virus came back negative — a result researchers call a "sustained virologic response." It also tracked several other markers along the way, including how quickly the virus became undetectable at earlier time points during treatment. The reported data shows that for the main outcome (virus undetectable six months after treatment ended), 24 out of 50 people in the Standard of Care group and 25 out of 50 in the Triple Therapy group recorded a negative blood test at that point. For the secondary outcomes, the reported data shows that at four weeks into treatment, 30 people in the Standard of Care group and 25 in the Triple Therapy group had undetectable virus. At 90 days, 35 (Standard of Care) and 36 (Triple Therapy) had a completely negative test, while 5 and 0 respectively had a partial response (meaning the virus dropped significantly but was not fully gone), and 10 and 14 did not meet either of those criteria. At the end of the full treatment course, 31 (Standard of Care) and 29 (Triple Therapy) had a negative test. Regarding the count of participants who experienced adverse events (unwanted side effects that could reasonably be linked to the study drugs), the reported data shows 50 out of 50 in the Standard of Care group and 47 out of 50 in the Triple Therapy group recorded at least one such event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01054573 · results posted 19 April 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 90 people in total across four groups. Nine participants took part in an early Phase 1 group testing the study drug combination (telaprevir given every 8 hours, together with two other hepatitis C medicines). The remaining 81 participants were in Phase 3, split by how they had previously responded to hepatitis C treatment: 32 were "prior null responders" (those whose virus had not responded at all to earlier treatment), 22 were "prior partial responders" (those who had some earlier response but not enough), and 27 were "prior relapsers" (those whose virus had come back after earlier treatment). The trial was primarily measuring what proportion of participants had no detectable hepatitis C virus in their blood 24 weeks after finishing treatment — a result called a sustained virologic response (SVR24). The reported data shows the following SVR24 figures: among prior null responders, 34.4% reached this point; among prior partial responders, 72.7% did; and among prior relapsers, 81.5% did. In the smaller Phase 1 group, 44.4% reached SVR24. The reported data also shows that at Week 4 of treatment, the proportion with undetectable virus levels was 37.5% (null responders), 77.3% (partial responders), 85.2% (relapsers), and 33.3% (Phase 1 group). At Week 12, those figures rose to 56.3%, 86.4%, 92.6%, and 66.7% respectively. Regarding stopping rules — pre-set thresholds where the virus level was still too high and study drugs had to be stopped — the reported data shows that 28.1% of null responders met an early stopping rule at Week 4 or 8, compared with 4.5% of partial responders, 3.7% of relapsers, and 11.1% of the Phase 1 group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01378104 · results posted 8 March 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 178 people in total — 92 in a group receiving a full (100%) dose of a medicine called peginterferon alfa-2a, and 86 in a group receiving a slightly reduced (80%) dose. The trial was measuring something called a "sustained virologic response" (SVR) — this means whether the virus was undetectable in a person's blood at a set point after finishing treatment. Of those who started, 65 people in the full-dose group and 60 in the reduced-dose group completed the study. The reported data shows that in the full-dose group, 52 out of 92 participants achieved an SVR, while in the reduced-dose group, 44 out of 86 participants achieved an SVR. The trial was specifically looking at whether there was a meaningful difference between these two numbers. The reported data also includes a secondary measurement looking at a genetic marker called IL28B — a naturally occurring variation in a person's genes that may be related to how the body responds during the trial. Among participants with a so-called "favourable" version of this genetic marker, the reported SVR rate was 71.9%, compared to 33.3% among those with an "unfavourable" version. It is worth noting that these two genetic subgroups were not broken down further by dose group in the data as reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00582738 · results posted 6 September 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 43 people who had received a liver transplant and were being treated for hepatitis C. Participants were split into two groups: 21 received standard anti-rejection treatment (referred to as CsA-TAC, a combination of existing medicines) and 22 received a medicine called everolimus. The trial's main goal was to measure any change in liver scarring (called fibrosis) over 24 months, using a scoring system where a lower score means less scarring. Notably, far fewer participants in the everolimus group completed the study (4 out of 22) compared to the standard treatment group (12 out of 21). The reported data shows that, on the primary measure of liver scarring using the Ishak-Knodell scale (which runs from 0 to 6), the standard treatment group's average score decreased by 0.5 points from their starting score, while the everolimus group's average score showed no change (0.0). A secondary scarring measure (the Metavir score) showed similar patterns across both groups at 12 and 24 months, with scores remaining largely stable. For kidney function — measured as a filtration rate where higher numbers generally indicate better function — the reported data shows the standard treatment group recorded scores of approximately 62 and 66 at the two time points measured, while the everolimus group recorded approximately 66 and 72. Regarding serious events such as death or organ rejection, the reported data shows none occurred in the standard treatment group, while a small number of events were recorded in the everolimus group. It is worth noting that the small number of participants and the high proportion who did not complete the study — particularly in the everolimus group — are important limitations of this data that the reported figures alone cannot fully account for. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00781274 · results posted 20 August 2012

According to the results reported on ClinicalTrials.gov, this trial involved 32 people, all of whom received a treatment called MP-424 (also known as telaprevir). The trial was measuring what is called a "Sustained Viral Response" (SVR) — this means the researchers were checking whether the hepatitis C virus became undetectable in participants' blood 24 weeks after they finished taking the study drug. Thirty of the 32 participants completed the trial, while two did not finish. The reported data shows that 34.4% of participants achieved an undetectable level of the hepatitis C virus in their blood at the 24-week check after finishing treatment. No secondary outcome measure data was included in the results submitted to ClinicalTrials.gov, so no further figures are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00516321 · results posted 30 July 2012

According to the results reported on ClinicalTrials.gov, this trial involved people with hepatitis C who had low platelet counts (platelets are tiny blood cells that help with clotting). The trial had two stages. In the first, open stage, 715 people received the study drug eltrombopag to see if it could raise their platelet count high enough to start hepatitis C antiviral treatment. In the second, blinded stage — where neither participants nor their doctors knew who was receiving which treatment — 682 people who had completed the first stage were randomly assigned to receive either eltrombopag plus antiviral therapy (450 people) or a placebo (a dummy pill) plus antiviral therapy (232 people). The main thing being measured was whether participants' hepatitis C virus became undetectable and stayed that way for 24 weeks after finishing treatment — a result known as a "sustained virologic response." The reported data shows that, in the blinded phase, 104 out of 450 participants in the eltrombopag-plus-antiviral group and 33 out of 232 participants in the placebo-plus-antiviral group achieved this undetectable virus result at 24 weeks after treatment ended. Regarding platelet counts, the reported data shows that in the first open stage, 691 of the 715 participants had their platelet count rise from below 75 to at or above 90 (the threshold needed to start antiviral treatment). During the blinded stage, platelet counts in the placebo group dropped more steeply over time — falling to a midpoint (median) of around 40–43 at certain time points — compared to the eltrombopag group, where the midpoint count remained higher, around 86–90 at similar time points. The reported data also shows that during the blinded stage, 63 people in the placebo group had a minimum platelet count that fell below 25, compared to 12 in the eltrombopag group. Conversely, more people in the eltrombopag group (245) had a minimum count in the 50–90 range, compared to 19 in the placebo group. These figures describe what was counted and measured in the trial; they do not on their own tell us whether any outcome is better or worse for any individual. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00529568 · results posted 17 May 2012

According to the results reported on ClinicalTrials.gov, this trial looked at people with chronic Hepatitis C who had low platelet counts (platelets are tiny blood cells that help with clotting). Low platelet counts can make it difficult to start or continue standard antiviral treatment for Hepatitis C. The trial had two phases. First, 805 people received an open-label course of eltrombopag (meaning everyone knew what they were taking) to try to raise their platelet counts before starting antiviral therapy. Then, 759 of those participants moved into a double-blind phase (where neither participants nor doctors knew who was getting which treatment), with 253 people receiving a placebo (dummy treatment) alongside antiviral therapy and 506 receiving eltrombopag alongside antiviral therapy. The primary outcome the trial was measuring was how many people in the double-blind phase achieved what is called a "sustained virologic response" — meaning no detectable Hepatitis C virus in their blood at the end of treatment and for up to 24 weeks afterwards. The reported data shows that 32 out of 253 participants in the placebo group and 97 out of 506 in the eltrombopag group reached this outcome. Regarding platelet counts, the reported data shows that 773 out of 805 participants saw their platelet count rise to the target level during the open-label phase. During the double-blind phase, the reported median platelet counts (the middle value across all participants) were generally higher over time in the eltrombopag group compared with the placebo group, though the data was not reported in a way that links each number to a specific time point clearly enough to describe each individually. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00845065 · results posted 2 February 2012

According to the results reported on ClinicalTrials.gov, this trial (NCT00845065) enrolled 201 people in total — 67 in a group receiving a two-drug combination (pegylated interferon alfa-2a plus ribavirin, referred to here as PEG2a/Ribavirin) and 134 in a group receiving a three-drug combination that added boceprevir to those same two medicines. The trial was primarily measuring what is called a "sustained virologic response" (SVR) — meaning that the hepatitis C virus became undetectable in a person's blood and stayed that way after treatment ended. Not everyone finished the trial: 20 people in the two-drug group and 79 in the three-drug group completed it. The reported data shows that, looking at all participants who received at least one dose of their assigned medication, 20.9% of people in the two-drug group and 64.2% of people in the three-drug group had undetectable hepatitis C virus levels at the end of follow-up (the primary outcome). A secondary analysis that excluded people who dropped out very early produced similar figures — 20.9% and 66.2% respectively. The reported data also shows that at a specific 12-week follow-up check, 12 participants in the two-drug group and 87 in the three-drug group had undetectable virus levels. For a measure of how much the virus level dropped in the blood during the first four weeks of treatment, the reported average change was -2.44 (log units) in the two-drug group and -2.33 in the three-drug group — a "log unit" here is a way of expressing very large changes in virus levels on a compressed scale. Additional secondary results looked at how many people who showed an early response to treatment (undetectable virus at weeks 2, 4, 8, or 12) went on to achieve the longer-term SVR outcome. The reported data shows figures varied depending on when that early response was first recorded, but the data as submitted to ClinicalTrials.gov contained multiple sub-groupings for this measure and not all individual subgroup labels were fully specified in the dataset provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01340573 · results posted 30 January 2012

According to the results reported on ClinicalTrials.gov, this trial (NCT01340573) enrolled 3 participants in total, all placed in a single group. The trial was looking at two things: first, how many serious unexpected health events (called "serious adverse events") occurred in people with a specific strain of hepatitis C (genotype 1) compared to those with other strains, while they were taking a combination of two medications — pegylated interferon (PegIntron pen) and ribavirin. Second, it was measuring whether participants' hepatitis C virus became undetectable in the blood after treatment, which is referred to as a "sustained virologic response." The trial had planned to follow participants for up to 48 weeks of treatment plus a further 24-week check-up period. The reported data shows that none of the 3 participants completed the study — all 3 withdrew or were lost before the study finished. Because of this, no measurements were recorded for any of the primary or secondary outcomes. In other words, no numbers were reported for serious adverse events at any time point, and no data was reported on whether the virus became undetectable in any participant's blood. Because the trial ended without any participants completing it, the ClinicalTrials.gov record contains no outcome figures at all — the data was simply not collected. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00724464 · results posted 8 November 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 332 adults who were treated with a combination of pegylated interferon alpha-2b and ribavirin for hepatitis C. The trial was measuring how many participants achieved what is called a "sustained virological response" (SVR) — meaning the hepatitis C virus became undetectable in the blood and stayed undetectable for 24 weeks after finishing treatment. The trial also tracked how many participants experienced a "virological relapse," meaning the virus was undetectable at the end of treatment but then became detectable again during follow-up. Of the 332 who started, 309 completed the trial. The reported data shows that 286 out of 332 participants achieved a sustained virological response at the 24-week post-treatment check. The reported data also shows that 23 participants experienced a virological relapse. When broken down by virus type (genotype), the numbers reporting a sustained virological response were: 81 participants with genotype 1, 28 with genotype 2, 146 with genotype 3, 30 with genotype 4, and 1 with a combined genotype 2 & 3. Looking at participants grouped by the amount of virus in their blood at the start, 99 with a lower viral load and 155 with a higher viral load achieved a sustained virological response, with 32 where this information was not clearly categorised. Results broken down by liver scarring level and by a liver enzyme called ALT were also reported, though the data did not include the total number of participants in each subgroup, so direct comparisons between subgroups cannot be made from these figures alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00200343 · results posted 7 November 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 596 people across three groups, each receiving a different daily dose of the study treatment: 150 mg, 600 mg, or 900 mg per day (199, 200, and 197 participants respectively). The trial was measuring levels of certain liver enzymes in the blood — specifically alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transpeptidase (GGT). These are proteins that doctors monitor as indicators of liver activity. The main thing the trial was looking at was how much ALT levels changed after 24 weeks of treatment compared to where they started. The reported data shows that at the start of the trial, average ALT levels were similar across all three groups (around 106–111 units per litre). After 24 weeks, the reported percentage change in ALT from the starting point was a decrease of 15.3% in the 150 mg group, 29.2% in the 600 mg group, and 36.2% in the 900 mg group. For AST, the reported changes were decreases of 13.6%, 25.0%, and 29.8% respectively. For GGT, the reported changes were decreases of 22.4%, 41.0%, and 50.0% across the three dose groups. In all cases, the higher dose groups showed larger reported reductions in these enzyme levels compared to the lowest dose group. It is worth noting that this trial did not include a placebo (inactive treatment) comparison group in the reported data, so these numbers reflect changes within each dose group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00703118 · results posted 11 August 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 662 adults with hepatitis C across three groups. The largest two groups — 266 and 264 people respectively — received the antiviral drug telaprevir (in slightly different dosing schedules, referred to as T12/PR48 and T12(DS)/PR48) combined with two other standard medicines (peginterferon and ribavirin) for 48 weeks. A third, smaller group of 132 people received a placebo (dummy pill) instead of telaprevir, alongside the same two standard medicines. The trial's main goal was to measure how many people in each group had no detectable hepatitis C virus in their blood 24 weeks after finishing their planned course of treatment — a result researchers call a "sustained virologic response" (SVR24), meaning the virus was undetectable at that later check-up point. The reported data shows that for the primary measure (undetectable virus at 24 weeks after planned end of treatment), 171 out of 266 participants in the first telaprevir group and 175 out of 264 in the second telaprevir group reached this point, compared with 22 out of 132 in the placebo group. For the secondary measures: at week 4 of treatment, undetectable virus levels were reported in 152, 188, and 3 participants across the three groups respectively; at week 48 (the end of treatment), those numbers were 184, 191, and 49. Checking for undetectable virus at 12 weeks after planned end of treatment gave figures of 175, 178, and 22 across the three groups. During the follow-up period of up to 72 weeks, the virus was detected again (known as "viral relapse") in 26, 27, and 33 participants across the three groups. The reported data also shows that a pre-set "stopping rule" — triggered when the virus remained above a certain level during the early weeks of telaprevir treatment — applied to 16 participants in the first telaprevir group and 14 in the second at week 4, with smaller numbers meeting that threshold at weeks 6 and 8. This stopping rule did not apply to the placebo group, so no data was reported for them on that measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00372385 · results posted 21 July 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 323 people with hepatitis C (a liver infection caused by a virus). Participants were split into four groups, each receiving a different combination or length of treatment involving telaprevir (an antiviral medicine), pegylated interferon alfa-2a, ribavirin, or a placebo (a dummy treatment with no active medicine). The main thing the trial was measuring was the proportion of people in each group whose hepatitis C virus could not be detected in their blood 24 weeks after they finished taking their study medicines — sometimes called a "sustained virological response," which simply means the virus was undetectable at that follow-up point. The reported data shows that, for the primary measure at 24 weeks after finishing treatment, the percentage of participants with undetectable virus was: 46.3% in the placebo plus 48 weeks of the other two medicines group; 69.1% in the telaprevir plus 24-week combination group; 59.8% in the telaprevir plus 12-week combination group; and 35.9% in the telaprevir-plus-interferon-only 12-week group (that group did not receive ribavirin). The reported data also shows similar patterns at 12 weeks after finishing treatment and at the time treatment ended. For viral relapse — meaning the virus became detectable again during follow-up — the numbers reported were 10, 8, 19, and 22 participants across the four groups respectively. Regarding unwanted health events during the study, the reported data shows that virtually all participants in every group experienced at least one adverse event, and serious adverse events were recorded in 8, 16, 11, and 9 participants across the four groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00627926 · results posted 21 July 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,088 people with hepatitis C across three groups. One group of 361 people received a placebo (a dummy treatment) for 12 weeks alongside two standard antiviral medicines — pegylated interferon alfa-2a and ribavirin — for 48 weeks total. A second group of 364 people received the experimental drug telaprevir for 8 weeks (plus a placebo for 4 weeks) alongside the same two standard medicines, for either 24 or 48 weeks total depending on their response. A third group of 363 people received telaprevir for 12 weeks alongside the standard medicines, again for 24 or 48 weeks. The trial was measuring the level of hepatitis C virus in participants' blood at various points in time, with the main question being how many people had no detectable virus in their blood at different stages. The reported data shows the following numbers of participants who had no detectable hepatitis C virus in their blood at each measured point. At 4 weeks into treatment: 34 (placebo group), 242 (telaprevir 8-week group), and 246 (telaprevir 12-week group). At both 4 weeks and 12 weeks: 29, 207, and 212 respectively. At week 12: 146, 277, and 283. At the end of treatment: 229, 295, and 314. At 12 weeks after the last planned dose of treatment: 161, 255, and 275. At week 72 (the furthest follow-up point): 158, 243, and 265. Regarding completion of the study, 202 people in the placebo group, 260 in the telaprevir 8-week group, and 268 in the telaprevir 12-week group were recorded as having completed the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00857311 · results posted 7 July 2011

According to the results reported on ClinicalTrials.gov, this trial (NCT00857311) enrolled a small number of participants to look at an experimental HIV vaccine called MRKAd5 HIV-1 Gag. Nine people were assigned to receive the lower dose of the vaccine (1×10⁹ vp/dose) and eight people received a placebo (an inactive substance). The two higher-dose vaccine group and the tetanus/diphtheria comparison group each had zero participants enrolled, so no data was collected for those groups. The trial's main focus was on recording any unwanted health changes — called adverse events — that investigators judged to be related to receiving the vaccine or placebo. Importantly, the reported data notes that a separate, larger study using the same vaccine had already found it was not efficacious (did not achieve its intended purpose), so no immune response testing was carried out in this trial. The reported data shows that, for the primary outcome — adverse events considered by the investigators to be possibly, probably, or definitely linked to the vaccine — 5 out of 9 participants in the vaccine group had at least one such event, compared with 1 out of 8 in the placebo group. For the secondary outcome looking at all adverse events (not just those judged to be vaccine-related), 8 out of 9 vaccine-group participants and 6 out of 8 placebo-group participants had at least one recorded adverse event of any kind. The data also reports smaller subsets of participants with specific categories of adverse events across both groups, though the breakdown by category is limited given the very small numbers involved. Because the linked earlier study had already concluded the vaccine was not efficacious, the immune response measurements that were originally planned as a secondary outcome were never analysed, and no immune response data was reported for this trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00423670 · results posted 15 June 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 631 adults across eight treatment groups. It was testing different combinations and durations of three medicines — pegylated interferon (PEG), ribavirin (RBV), and a then-newer antiviral called boceprevir (BOC) — for the treatment of hepatitis C. One group received only PEG and RBV as a comparison, while the others received all three medicines for varying lengths of time and with slightly different starting points. The main thing the trial was measuring was whether the hepatitis C virus became undetectable in participants' blood 24 weeks after finishing treatment — a result called a "sustained virologic response" or SVR. The reported data shows that, for the primary outcome of SVR, the numbers of participants who reached that result in each group were: 39 out of 104 in the PEG+RBV-only group (Arm 1); 58 out of 107 in the 28-week boceprevir group (Arm 2); 58 out of 103 in the group that started boceprevir at week 4 for 24 weeks (Arm 3); 69 out of 103 in the 48-week boceprevir group (Arm 4); 77 out of 103 in the group that started boceprevir at week 4 for 44 weeks (Arm 5); 8 out of 16 in one smaller Part II group (Arm 6); and 21 out of 59 in the low-dose ribavirin Part II group (Arm 7). The reported secondary results showed broadly similar patterns — for example, when pooling the groups that had a 4-week lead-in period before boceprevir, 135 participants achieved SVR, compared with 127 in the groups without a lead-in. When grouping by total duration of boceprevir treatment, 146 participants achieved SVR in the longer (48-week) boceprevir groups compared with 116 in the shorter (28-week) groups. Data on undetectable virus at other time points (12 weeks after finishing treatment, and 72 weeks after starting) were also reported and followed a similar pattern, though some participants had missing data at those time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00493805 · results posted 9 February 2011

According to the results reported on ClinicalTrials.gov, a total of 59 people took part in this clinical trial — 17 in a non-interventional group (those without insulin resistance, based on a score called HOMA-IR of 2 or below) and 42 in an interventional group (those with insulin resistance, based on a HOMA-IR score above 2). Insulin resistance is a condition where the body doesn't respond normally to insulin, a hormone that controls blood sugar. The trial was measuring how people with the hepatitis C virus (HCV) and different levels of insulin resistance responded to treatment, by looking at virus levels in the blood at specific points in time. All 59 participants who started the trial completed it. The reported data shows that the main thing being measured was called an "Early Virological Response" — meaning whether the amount of hepatitis C virus in a person's blood had either disappeared or dropped to very low levels by week 12 of treatment. According to the results reported on ClinicalTrials.gov, 10 out of 17 participants in the non-insulin-resistant group and 24 out of 42 in the insulin-resistant group met this measure at week 12. The trial also tracked a "Sustained Virological Response" — meaning whether the virus was still undetectable in the blood 24 weeks after finishing treatment. The reported data shows that 1 out of 17 participants in the non-insulin-resistant group and 3 out of 42 in the insulin-resistant group had undetectable virus at that later point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00087633 · results posted 24 January 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 115 people who had received a liver transplant and had hepatitis C (HCV). They were split into two groups: 55 people in the "Prophylaxis Arm" (who received a preventive treatment) and 60 people in the "Observation Arm" (who were monitored without that treatment). The trial's main goal was to measure how many people in each group developed a confirmed return of hepatitis C liver damage after their transplant, defined by specific tissue-sample scores for inflammation and scarring. The reported data shows that, among those who had tissue samples assessed, 61.8% of participants in the Prophylaxis Arm and 65.0% in the Observation Arm met the criteria for confirmed hepatitis C recurrence. For the secondary measures — which tracked the virus levels in the blood at various points during and after treatment — the Prophylaxis Arm reported more participants with undetectable virus at each time point compared to the Observation Arm. For example, 27 participants in the Prophylaxis Arm versus 7 in the Observation Arm showed an early virus response by week 12, and 18 versus 3 participants respectively had undetectable virus at 48 weeks. Not all participants completed the study — 24 in the Prophylaxis Arm and 17 in the Observation Arm did not finish — and the data does not report reasons for this in the figures provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00724854 · results posted 10 January 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,082 people in total — 1,010 who had hepatitis C (HCV) alone, and 72 who had both hepatitis C and HIV at the same time. The trial was measuring how many participants showed no detectable hepatitis C virus in their blood after four weeks of treatment (called a "rapid virologic response"), and then whether that virus remained undetectable 24 weeks after finishing treatment (called a "sustained virologic response"). Not everyone completed the trial — 607 of the HCV-only group and 41 of the HCV-and-HIV group finished the full study period. The reported data shows that after four weeks of treatment, 551 out of 1,010 participants in the HCV-only group, and 32 out of 72 in the HCV-and-HIV group, had no detectable hepatitis C virus in their blood. Looking further along, 375 people in the HCV-only group and 24 in the HCV-and-HIV group still had no detectable virus 24 weeks after completing treatment. Of those who had no detectable virus at the four-week mark, the reported data shows that 300 (HCV-only group) and 19 (HCV-and-HIV group) also went on to have no detectable virus 24 or more weeks after treatment ended. The reported data also includes a breakdown looking at specific virus types (genotypes), where 251 participants in the HCV-only group and 13 in the HCV-and-HIV group who had shown no virus at four weeks were also recorded as having no detectable virus at a later check point specific to their genotype. Some baseline characteristics such as age, gender, and genotype among those who achieved a sustained response were also recorded, though the full breakdown of those figures is complex and was not reported in a way that allows straightforward plain-language summary here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00491179 · results posted 13 November 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people in total who had hepatitis C. Twenty-five participants had a type of hepatitis C called genotype 1 and were treated with a combination of pegylated interferon and ribavirin (two antiviral medicines) for 48 weeks. The remaining 10 participants had genotype 2 and received the same medicines for 24 weeks. The trial was measuring two main things: how many people had no detectable hepatitis C virus in their blood six months after finishing treatment (called a sustained virologic response, or SVR), and how many people stopped the treatment early because of unwanted side effects. A liver tissue examination (biopsy) was also used to look at changes in liver health before and after treatment. The reported data shows that, among the 25 genotype 1 participants, 13 had no detectable virus in their blood six months after finishing treatment, and 7 stopped the treatment early due to side effects. Among the 10 genotype 2 participants, 8 had no detectable virus at that six-month point, and 2 left the study early due to side effects. For the liver biopsy results, the reported data shows that 11 out of the genotype 1 group and 6 out of the genotype 2 group showed an improvement of at least 2 points on a liver health scoring scale compared to their starting score. It is worth noting that not everyone who started the trial completed it — 7 genotype 1 participants and 2 genotype 2 participants did not finish the study overall. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00081770 · results posted 30 October 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 3,070 adults with hepatitis C, split across three treatment groups: one group received a higher dose of PegIntron plus Rebetol (1,019 people), another received a lower dose of PegIntron plus Rebetol (1,016 people), and a third received Pegasys plus Copegus (1,035 people). The trial was measuring whether the hepatitis C virus became undetectable in participants' blood after completing treatment and a further 24 weeks of follow-up — a result called a "sustained virologic response." It also tracked how much the amount of virus in the blood changed during treatment at weeks 2 and 4, and how many people had no detectable virus at week 12. The reported data shows that, for the main outcome — no detectable virus 24 weeks after finishing treatment — 39.8% of participants in the higher-dose PegIntron plus Rebetol group reached this point, compared with 38.0% in the lower-dose PegIntron plus Rebetol group and 40.9% in the Pegasys plus Copegus group. For the secondary outcomes, the reported data shows that at week 12, undetectable virus levels were recorded in 39.9%, 36.0%, and 45.0% of participants in those same three groups respectively. The trial also measured changes in the amount of virus in the blood at weeks 2 and 4 using a technical scale; the reported data shows reductions across all three groups at both time points, with the Pegasys plus Copegus group showing slightly larger average reductions than the two PegIntron groups. It is also worth noting that a sizeable proportion of participants did not complete the study — roughly half in the two PegIntron groups and about 44% in the Pegasys plus Copegus group — though the reasons for this are not detailed in the reported data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00728494 · results posted 19 August 2009

According to the results reported on ClinicalTrials.gov, this trial looked at people being treated for hepatitis C with a combination of two medicines (PegIntron and Rebetol). A total of 99 people took part — 60 in a group that received the medicines along with a patient assistance program (extra support alongside their treatment), and 39 in a group that received the medicines alone without that extra support. The trial was measuring several things: how many people finished their full course of treatment, whether the hepatitis C virus became undetectable in their blood six months after finishing treatment, and whether the virus came back after treatment ended. The reported data shows that, of the 60 people in the group with the patient assistance program, 51 completed treatment, compared with 32 out of 39 in the treatment-alone group. For the question of whether the virus was undetectable six months after finishing treatment (called a "sustained virologic response" — meaning no detectable virus at the end of treatment and still none six months later), the reported numbers were 29 out of 60 participants in the assistance program group, and 7 out of 39 in the treatment-alone group. The reported data also shows that 17 people in the assistance program group and 4 people in the treatment-alone group were recorded as having relapsed — meaning the virus had become undetectable by the end of treatment but was detectable again six months later. Regarding the doses of medicine received, the reported data shows both groups received very similar average amounts of each medicine. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00441584 · results posted 4 August 2009

According to the results reported on ClinicalTrials.gov, this trial enrolled 117 people who were given a combination treatment of PegIntron plus Rebetol (two medicines used in hepatitis C treatment). The trial was measuring how many participants achieved what is called a "Sustained Virological Response" (SVR) — this means having a very low, essentially undetectable level of the hepatitis C virus in the blood at 24 weeks after finishing treatment. Only 12 of the 117 people who started the trial completed it, while 105 did not complete it. The reasons for not completing were not detailed in the reported data. The reported data shows that, for the primary outcome — the number of participants who achieved that very low virus level in the blood at 24 weeks after treatment ended — only 1 out of 117 participants reached this result. No secondary outcome measures appear to have been reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.