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
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
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).
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