Conditions: Chronic HCV Infection
Keywords: HCV genotype 1 HCV Sustained Virologic Response Direct-Acting Antiviral Combination Therapy GS-7977 GS-5885 Ribavirin Open Label Sofosbuvir Treatment-Naive Protease Inhibitors PI Treatment experienced Cirrhotic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 101
Healthy volunteers: no

Brief summary:
This study will evaluate the antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) or LDV/SOF plus GS-9669 in treatment-naive or treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection. A total of 90 participants are planned to be enrolled in the study for 8 weeks of treatment, approximately 60 having had prior treatment with a regimen containing pegylated interferon (PEG) and RBV for ≥ 12 weeks. Randomization will be stratified by treatment-naive versus treatment-experienced and by HCV genotype (1a versus 1b).

Detailed description:

Arms:
arm 1: Participants will receive LDV/SOF plus RBV for 8 weeks. arm 2: Participants will receive LDV/SOF plus GS-9669 250 mg for 8 weeks. arm 3: Participants will receive LDV/SOF plus GS-9669 500 mg (2 x 250 mg) for 8 weeks.

Interventions: intervention 1: LDV/SOF intervention 2: RBV intervention 3: GS-9669
Intervention descriptions: intervention 1: Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg 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) intervention 3: GS-9669 tablet(s) administered orally once daily

Protocol document: