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 Treatment-Naïve Protease Inhibitors PI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Treatment-naive (TN) participants will be randomized to receive LDV/SOF for 8 weeks. arm 2: Treatment-naive participants will be randomized to receive LDV/SOF plus RBV for 8 weeks. arm 3: Treatment-naive participants will be randomized to receive LDV/SOF for 12 weeks. arm 4: Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor \[PI\]+pegylated interferon \[PEG\]+RBV regimen) will be randomized to receive LDV/SOF for 12 weeks. arm 5: Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) will be randomized to receive LDV/SOF plus RBV for 12 weeks.

Interventions: intervention 1: LDV/SOF intervention 2: RBV
Intervention descriptions: intervention 1: LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily intervention 2: 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: