A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Negative, Chronic Hepatitis B

GS-US-320-0108 (China)

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)-negative chronic hepatitis B virus (HBV) infection in China.

2015-06-19

2017-02-24

2023-09-18

Completed

Early phase I

155

Key Inclusion Criteria: * Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * Adult males and non-pregnant, non-lactating females * Documented evidence of chronic HBV infection * Hepatitis e antigen (HBeAg)-negative, chronic hepatitis B with all of the following: * HBeAg-negative and hepatitis B e antibody (HBeAb) positive at screening * Screening HBV DNA ≥ 2 x 10\^4 IU/mL * Screening serum alanine aminotransferase (ALT) level \> 60 U/L (males) or \> 38 U/L (females) and ≤ 10 x the upper limit of the normal range (ULN) * Treatment-naive participants (defined as \< 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue), OR treatment-experienced participants (defined as participants meeting all entry criteria \[including HBV DNA and serum ALT criteria\] and with ≥ 12 weeks of previous treatment with any nucleoside or nucleotide analogue) * Previous treatment with interferon (pegylated or non-pegylated) must have ended at least 6 months prior to the baseline visit. * Adequate renal function * Normal ECG Key Exclusion Criteria: * Females who are breastfeeding * Males and females of reproductive potential who are unwilling to use an "effective", protocol-specified method(s) of contraception during the study * Co-infection with hepatitis C virus, HIV, or hepatitis D virus * Evidence of hepatocellular carcinoma * Any history of, or current evidence of, clinical hepatic decompensation * Abnormal hematological and biochemical parameters, including aspartate aminotransferase (AST) \> 10 x ULN * Received solid organ or bone marrow transplant * History of malignancy within the past 5 years, with the exception of specific cancers that are cured by surgical resection; individuals under evaluation for possible malignancy are not eligible * Currently receiving therapy with immunomodulators (eg, corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion * Individuals receiving ongoing therapy with drugs not to be used with tenofovir alafenamide or tenofovir disoproxil fumarate or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients * Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance * Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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2023-11-01