Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
Trial ID or NCT#
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.
A Phase 2, Randomized, Open-Label Study of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin in Subjects With Chronic Genotype 1 HCV Infection
- - Age ≥ 18 years, with chronic genotype 1 HCV infection - HCV RNA equal to or greater than 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 - Current or prior history of clinical hepatic decompensation - Hepatocellular carcinoma (HCC) 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