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 (NCT01940471) compared two antiviral tablets — TAF 25 mg and TDF 300 mg — in people with chronic hepatitis B (a long-term liver infection). In the first, blinded phase (where neither participants nor doctors knew which tablet was being taken), 582 people were assigned to TAF and 293 to TDF. After 48 weeks, most participants moved into an open-label extension phase where everyone took TAF. The trial's main goal was to measure how many people had very low levels of the hepatitis B virus in their blood at the 48-week mark. The reported data shows that at 48 weeks, 63.9% of participants in the TAF group and 66.8% in the TDF group had hepatitis B virus levels below the threshold the trial was measuring (less than 29 IU/mL, a very low level). For a secondary measure looking at a specific immune response — where the body stopped reacting to a particular virus protein and developed a counter-response — the reported figures were 10.3% in the TAF group and 8.1% in the TDF group. The trial also measured changes in bone density in the hip and spine. The reported data shows the TAF group had a hip bone density change of −0.10% and spine change of −0.42% from their starting point, while the TDF group had changes of −1.72% (hip) and −2.29% (spine). A kidney marker called serum creatinine (a substance in the blood that can indicate how the kidneys are working) changed by +0.009 mg/dL in the TAF group and +0.026 mg/dL in the TDF group from baseline. The reported data also includes a measure of protein detected in urine (which can sometimes signal kidney stress). At the mild level, 23.9% of the TAF group and 17.8% of the TDF group had a treatment-related finding; at the moderate level, those figures were 3.5% and 4.5% respectively; and at the severe level, 0% and 0.3%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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 must be able to understand and sign a consent form before any study procedures begin.
- You must be an adult male, or a female who is not pregnant or breastfeeding.
- You must have a confirmed, long-term (chronic) hepatitis B virus (HBV) infection.
- Your hepatitis B must be the type that tests positive for a protein called "HBeAg," with a high enough level of the virus in your blood and liver enzyme levels within a specific range at the time of screening.
- You are either new to treatment (having taken antiviral tablets for less than 12 weeks total) or you have previously been treated (having taken antiviral tablets for 12 weeks or more), as long as you still meet the blood test requirements.
- If you have previously been treated with interferon (a type of injection-based therapy), that treatment must have ended at least 6 months before the study starts.
- Your kidneys must be functioning well enough as shown by blood tests.
- You must have a normal heart tracing (ECG) result.
Who may not be able to join:
- Women who are currently breastfeeding.
- Men or women who could potentially have children but are unwilling to use an effective method of contraception specified by the study throughout the trial.
- People who also have hepatitis C, HIV, or hepatitis D infection.
- People who have liver cancer or show signs of it.
- People who have ever had, or currently show signs of, serious liver failure.
- People with certain abnormal blood or chemistry test results, including very high levels of a specific liver enzyme (AST).
- People who have had a solid organ (such as a kidney or liver) or bone marrow transplant.
- People who have had cancer in the past 5 years, with limited exceptions for cancers fully removed by surgery; people currently being checked for possible cancer are also not eligible.
- People currently taking certain medicines, including immune-suppressing drugs (such as steroids), experimental treatments, or drugs that can affect the kidneys.
- People taking medications that should not be combined with the study drugs, or people known to be allergic to any of the study drugs or their ingredients.
- People with current alcohol or drug misuse that the study doctor believes could affect their ability to follow the study rules.
- Anyone the study doctor believes would not be suitable for the study or unable to follow the treatment schedule for any other reason.
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
11 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 at Week 48
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.