Conditions: HBeAg-positive Chronic Hepatitis B
Keywords: Hepatitis Tenofovir Viread
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 875
Healthy volunteers: no

Brief summary:
The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B virus (HBV) infection.

Detailed description:
This study GS-US-320-0110 is a multi-center clinical trial planned to enroll participants in multiple countries, including China. However, due to the review timeline difference in China, full enrollment was reached in the main study before China was able to participate. Therefore, details for the China cohort are registered separately (NCT02836249) on ClinicalTrials.gov as this cohort will not be part of the main study analysis.

Arms:
arm 1: TAF + TDF placebo for 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3). arm 2: TDF + TAF placebo for 96 weeks (per amendment 1 \& 2) or 144 weeks (per amendment 3). arm 3: All participants who complete the double-blind period (96 weeks or 144 weeks) will be eligible to receive open-label TAF until Week 384 of the study.

After the end of study treatment, participants can either switch to commercially available anti-HBV treatments in their country or will be followed every 4 weeks, for up to 24 weeks off treatment (treatment-free follow-up (TFFU)) for safety assessment.

Interventions: intervention 1: TAF intervention 2: TDF intervention 3: TAF Placebo intervention 4: TDF Placebo
Intervention descriptions: intervention 1: 25 mg tablet administered orally once daily intervention 2: 300 mg tablet administered orally once daily intervention 3: Tablet administered orally once daily intervention 4: Tablet administered orally once daily

Protocol document: