Conditions: Chronic HCV Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 341
Healthy volunteers: no

Brief summary:
This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or treatment-experienced Japanese participants with chronic genotype 1 HCV infection. Participants receive 12 weeks of treatment and continue assessments during a 24-week posttreatment follow-up period.

Detailed description:

Arms:
arm 1: Treatment-naive participants will receive LDV/SOF for 12 weeks. arm 2: Treatment-naive participants will receive LDV/SOF plus RBV for 12 weeks. arm 3: Treatment-experienced participants will receive LDV/SOF for 12 weeks. arm 4: Treatment-experienced participants will receive LDV/SOF plus RBV for 12 weeks.

Interventions: intervention 1: LDV/SOF intervention 2: RBV
Intervention descriptions: intervention 1: LDV/SOF 90/400 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 (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)

Protocol document: