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 426 adults with chronic hepatitis B (a liver infection caused by the hepatitis B virus). Participants were randomly assigned to take one of two antiviral tablets daily — either TAF 25 mg (285 people) or TDF 300 mg (141 people) — for an initial 48-week blinded phase, where neither participants nor researchers knew who was taking which medicine. Those who completed that phase then moved into an open-label extension where everyone took TAF. The trial was primarily measuring how many people had hepatitis B virus levels in their blood fall below a very low threshold (29 IU/mL, a standard cut-off used to indicate the virus is being suppressed) after 48 weeks. It also tracked changes in bone density and kidney markers. The reported data shows that at the 48-week mark, 94.0% of participants in the TAF group and 92.9% in the TDF group had hepatitis B virus levels below that threshold. For bone mineral density (a measure of bone strength), the TAF group showed an average change of −0.288% at the hip and −0.876% at the spine, while the TDF group showed average changes of −2.156% at the hip and −2.514% at the spine — meaning both groups showed some reduction, with the TDF group showing larger reductions on average. A kidney marker called serum creatinine changed by an average of +0.01 mg/dL in the TAF group and +0.02 mg/dL in the TDF group, both very small changes. Regarding protein detected in urine (a kidney monitoring measure), mild levels were reported in 18.1% of TAF participants and 16.4% of TDF participants; moderate levels in 1.1% and 2.1% respectively; and severe levels in 0% of 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 39327857) ↗
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 B 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 able to understand and agree to the study terms by signing a consent form before anything begins.
- You are an adult male, or a female who is not pregnant or breastfeeding.
- You have been diagnosed with a long-term (chronic) hepatitis B virus (HBV) infection.
- Your hepatitis B blood tests show a specific pattern: a protein called "HBeAg" is absent, while the related antibody "HBeAb" is present in your blood.
- Your hepatitis B virus levels in the blood are at or above a certain amount (confirm with trial site for exact number).
- Your liver enzyme levels (ALT) are mildly to moderately elevated — above a low threshold but not extremely high.
- You have either never been treated with antiviral tablets for hepatitis B (or had fewer than 12 weeks of treatment), OR you have previously had at least 12 weeks of antiviral tablet treatment and still meet the blood test requirements.
- If you previously received interferon treatment (a type of injection therapy for hepatitis B), it must have ended at least 6 months ago.
- Your kidneys are working well enough as shown by blood tests.
- Your heart tracing (ECG) shows a normal result.
Who may not be able to join:
- You are currently breastfeeding.
- You are able to have children but are unwilling to use an approved method of contraception during the study.
- You are also infected with hepatitis C, HIV, or hepatitis D.
- There is any sign of liver cancer.
- You have had, or currently have, signs that your liver has stopped working properly (liver failure).
- Certain blood or body chemistry test results are too abnormal, including a liver enzyme called AST being very highly elevated.
- You have previously received a transplant of a solid organ (such as a kidney or liver) or bone marrow.
- You have had any cancer in the past 5 years (with some exceptions for cancers fully removed by surgery), or you are currently being checked for a possible cancer.
- You are currently taking certain medications, including steroids, experimental drugs, drugs that can harm the kidneys, or drugs that affect how the kidneys filter medicines.
- You are taking any medication that is not recommended for use alongside the study drugs, or you have a known allergy to the study drugs or their ingredients.
- You currently have an alcohol or drug use problem that the study doctor believes could affect your ability to follow the study rules.
- You have any other health condition or past treatment that, in the study doctor's opinion, makes you unsuitable for the trial.
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: Gilead Study Director, 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
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.