Conditions: Hepatitis C Virus Infection
Keywords: HCV genotype 3 (GT-3) HCV Sustained Virologic Response Direct Acting Antiviral GS-7977 GS-5885 Ribavirin Sofosbuvir Ledipasvir Hepatitis C Hepatitis C, Chronic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 111
Healthy volunteers: no

Brief summary:
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.

Detailed description:

Arms:
arm 1: LDV/SOF FDC plus RBV for 12 weeks

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