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

A Phase 3b, Multicenter, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naïve Adults With Genotype 1 and 3 Chronic HCV Infection.

This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1 (GT1) or genotype 3 (GT3) hepatitis C virus (HCV) infection.

Inclusion Criteria:

• Confirmed chronic genotype 1 or 3 HCV infection
• HCV treatment-naive
• Individuals will have cirrhosis status assessment; liver biopsy may be required.
• Screening laboratory values within predefined thresholds
• Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

• Pregnant or nursing female or male with pregnant female partner
• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Contraindication to ribavirin therapy
• Excessive alcohol ingestion as defined by protocol
• History of solid organ transplantation
• Current or prior history of clinical hepatic decompensation
• History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol