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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

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