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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
875
25 mg tablet administered orally once daily
300 mg tablet administered orally once daily
Tablet administered orally once daily
Percentage of Participants With Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48
Time frame: Week 48
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Seroconversion to Antibody Against Hepatitis B e Antigen (Anti-HBe) at Week 48
Time frame: Week 48
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
Time frame: Baseline, Week 48
Percent Change From Baseline in Spine BMD at Week 48
Time frame: Baseline, Week 48
Change From Baseline at Week 48 in Serum Creatinine
Time frame: Baseline, Week 48
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Tablet administered orally once daily
Coalition of Inclusive Medicine
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