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