Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection

A Phase 3b, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 1 HCV Infection

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.

Inclusion Criteria:

• Body weight ≥ 40 kg
• HCV RNA ≥ 10^5 IU/mL at screening

Exclusion Criteria:

• Current or prior history of any clinically-significant illness (other than HCV)
• Pregnant or nursing female or male with pregnant female partner
• Chronic liver disease of a non-HCV etiology
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)