Phase 3
Completed N=534
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
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT01625338 ↗
Enrolled (actual)
534
Serious AEs
3.6%
Results posted
Nov 2015
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) — 71.9; 77.5; 82.6 percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) |
71.9; 77.5; 82.6 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
0.9; 1.0; 3.7 | — |
| SECONDARY Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
73.7; 81.5; 87.2; 71.9; 76.0; 82.6 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
0.9; 0.5; 0 | — |
| SECONDARY Percentage of Participants With Viral Relapse |
25.7; 20.6; 16.4 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01625338). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.