Conditions: Chronic Hepatitis C Virus
Keywords: HCV genotype 1 (GT-1) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy GS-7977 GS-5885 Ribavirin Open Label Sofosbuvir Additional relevant MeSH terms: Hepatitis Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 441
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants will receive LDV/SOF FDC for 12 weeks. arm 2: Participants will receive LDV/SOF FDC plus RBV for 12 weeks. arm 3: Participants will receive LDV/SOF FDC for 24 weeks. arm 4: Participants will receive LDV/SOF FDC plus RBV for 24 weeks.

Interventions: intervention 1: LDV/SOF intervention 2: RBV
Intervention descriptions: intervention 1: Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily intervention 2: Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol document: