Conditions: Hepatitis C Virus Infection
Keywords: hepatitis C Gilead GS-9451
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 47
Healthy volunteers: no

Brief summary:
This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV) ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1 hepatitis C virus (HCV) infection and cirrhosis.

Detailed description:

Arms:
arm 1: Participants will receive LDV/SOF+VDV for 8 weeks. arm 2: Participants will receive LDV/SOF+VDV+RBV for 8 weeks.

Interventions: intervention 1: LDV/SOF intervention 2: VDV intervention 3: RBV
Intervention descriptions: intervention 1: LDV/SOF (90/400 mg) FDC tablet administered orally once daily intervention 2: VDV 80 mg tablet administered orally once daily intervention 3: 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: