Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection
Trial ID or NCT#
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 hepatitis C virus (HCV) infection.
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection
- - Age > 18, with chronic genotype 1 HCV infection - HCV treatment-experienced, including patients who have previously failed a nonstructural protein (NS)3/4A protease inhibitor plus pegylated interferon (PEG)/RBV regimen - HCV RNA > 10,000 IU/mL at screening - Cirrhosis determination; a liver biopsy may be required - Screening laboratory values within defined thresholds - Use of two effective contraception methods if female of childbearing potential or sexually active male
- - Pregnant or nursing female or male with pregnant female partner - Coinfection with HIV or hepatitis B virus - Current or prior history of clinical hepatic decompensation - Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers) - Chronic use of systemic immunosuppressive agents - History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
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Mindie H. Nguyen, MD