Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.

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

Details

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

Criteria

Inclusion Criteria:

• Infection with HCV genotype 2 or 3

• Cirrhosis determination

• Subject meets one of the following classifications:

1. IFN unwilling

2. IFN ineligible

3. IFN intolerant

• Screening laboratory values within defined thresholds

• Subject has 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 interfere with subject treatment, assessment or compliance with the protocol

• Excessive alcohol ingestion or significant drug abuse