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

Gilead Sciences

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C

Treatments: Drug: Peg-IFN; Drug: SOF; Drug: RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT01625338

GS-US-334-0109

2012-000571-16 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 534 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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534 participants in 3 patient groups

SOF+RBV 12 Weeks

Experimental group

Description:

SOF+RBV for 12 weeks

Treatment:

Drug: SOF

Drug: RBV

SOF+RBV 24 Weeks

Experimental group

Description:

SOF+RBV for 24 weeks

Treatment:

Drug: SOF

Drug: RBV

SOF+RBV+Peg-IFN 12 Weeks

Experimental group

Description:

SOF+RBV+Peg-IFN for 12 weeks

Treatment:

Drug: SOF

Drug: RBV

Drug: Peg-IFN