Trial 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
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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 26575258) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Hepatitis C Trial, Completed
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- You are willing and able to sign a written consent form agreeing to take part
- Your blood test shows a certain level of the hepatitis C virus (HCV) in your body (confirm with trial site for exact level)
- You have been diagnosed with a specific type of hepatitis C called "genotype 3"
- You have had hepatitis C for at least 6 months (known as a chronic infection)
- If you are a woman who could become pregnant, you must have a negative pregnancy test before joining
- If you are a man or woman who could become pregnant and are sexually active with a partner of the opposite sex, you must agree to use specific birth control methods required by the trial
Who may not be able to join:
- You have, or have previously had, a serious health condition (other than hepatitis C) that could affect your treatment or ability to follow the trial's requirements
- Your heart trace test (ECG) showed important abnormalities during screening
- Your blood or other lab test results fell outside of acceptable ranges at your screening appointment
- You are currently pregnant, breastfeeding, or are a man whose female partner is pregnant
- You have a long-term liver disease caused by something other than hepatitis C, such as certain inherited or inflammatory liver conditions (confirm with trial site)
- You are also infected with hepatitis B virus (HBV) or HIV
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: John McNally, PhD, Gilead Sciences
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
8 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12); Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.