Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection

A Phase 3b, Multi-Center, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Chronic Genotype 1 or 3 Hepatitis C Virus Infection

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + ribavirin (RBV) in treatment-naive adults with chronic genotype 1 or 3 hepatitis C virus (HCV) infection.

Inclusion Criteria:

• HCV RNA ≥10^4 IU/mL at screening
• Confirmed chronic HCV genotype 1 or 3 infection
• HCV treatment naive
• Approximately 30% of individuals may have compensated cirrhosis at screening

Exclusion Criteria:

• Any other chronic liver disease
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Current or prior history of clinical hepatic de-compensation
• Contraindication to RBV therapy, e.g., history of clinically significant hemoglobinopathy (sickle cell disease, thalassemia).
• Chronic use of systemically administered immunosuppressive agents
• History of solid organ transplantation