Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).

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

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• Infection with HCV

• Must have participated in a prior Gilead HCV study

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

• Eligible patients include those in the following

• received placebo or Peg-IFN+RBV in a control arm

• previously participated in a Gilead-sponsored HCV study and did not attain sustained virologic response 24 weeks after discontinuation of therapy (SVR24) on a regimen containing:

• Sofosbuvir+RBV

• Peg-IFN and/or RBV in combination with one or more Gilead investigational direct-acting agents

Exclusion Criteria:

• Pregnant or nursing female or male with pregnant female partner

• Current or prior history of clinical hepatic decompensation

• Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

• Chronic use of systemically administered immunosuppressive agents

• Active drug abuse

• Use of any prohibited concomitant medications