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

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ribavirin; Sofosbuvir

Criteria

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