Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection

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

Summary

This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over 12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit (sustained virologic response [SVR]) versus risk (safety and resistance).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Collaborator: Quintiles, Inc.
• Treatments: Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• Chronic HCV-infection

• Naive to all HCV antiviral treatment

• Otherwise healthy patients

Exclusion Criteria:

• Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab

• History of any other clinically significant chronic liver disease

• Medical history which the investigator considers the patient unsuitable for the study