Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection

A Phase 3b Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 2 Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Coinfection

The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan.

Key Inclusion Criteria:

• Individuals ≥ 40 kg in weight with chronic genotype 1 or 2 HCV and HBV coinfection
• Individuals must not be taking or requiring treatment with HBV antiviral therapy at screening. For participants that are HBV treatment experienced, the most recent treatment must have been completed at least 6 months prior to Day 1.
• Cirrhosis determination by Fibroscan
• Screening laboratory values within defined thresholds
• Use of two effective contraception methods if female or male is of childbearing potential

Key Exclusion Criteria:

• Current or prior history of clinically-significant illness or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
• Pregnant or nursing female
• Infection with human immunodeficiency virus (HIV) or hepatitis delta virus (HDV)
• Hepatocellular carcinoma (HCC) or other malignancy
• Current or prior history of clinical hepatic decompensation

Note: Other protocol defined Inclusion/Exclusion criteria may apply.