Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12).

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

Details

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

Criteria

Inclusion Criteria:

• Infection with HCV genotype 2 or 3

• Had cirrhosis determination

• Prior treatment failure

• Screening laboratory values within defined thresholds

• Subject had not been treated with any investigational drug or device within 30 days of the screening visit

• Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

• Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase

• Pregnant or nursing female or male with pregnant female partner

• Current or prior history of clinical hepatic decompensation

• History of clinically significant illness or any other major medical disorder that may have interfered with subject treatment, assessment or compliance with the protocol

• Excessive alcohol ingestion or significant drug abuse