Conditions: Chronic HCV Infection
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 122
Healthy volunteers: no

Brief summary:
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF) plus ribavirin (RBV) in participants with genotypes 2 and 3 HCV infection. Participants with an inherited bleeding disorder and chronic HCV infection (either monoinfected or HIV-1/HCV coinfected) will be enrolled.

Detailed description:

Arms:
arm 1: Participants with chronic genotypes (GT) 1 or 4 HCV infection will receive LDV/SOF for 12 or 24 weeks. Treatment-experienced cirrhotic participants with genotype 1 HCV infection will receive LDV/SOF for 24 weeks. arm 2: Participants with chronic genotype 2 HCV infection will receive SOF+RBV for 12 weeks. arm 3: Participants with chronic genotype 3 HCV infection will receive SOF+RBV for 24 weeks.

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