Phase 2
Completed N=47
Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
Source: ClinicalTrials.gov NCT01808248 ↗Enrolled (actual)
47
Serious AEs
8.5%
Results posted
Sep 2014
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) — 95.7; 83.3 percentage of participants
Summary
This study is to evaluate the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who have previously failed prior treatment with an interferon-based regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) |
95.7; 83.3 | — |
| PRIMARY Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
8.5 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
95.7; 87.5; 95.7; 83.3 | — |
| SECONDARY Percentage of Participants Experiencing On-treatment Virologic Failure |
0; 0 | — |
| SECONDARY Percentage of Participants Experiencing Viral Relapse |
0; 8.7 | — |
Eligibility Criteria
Inclusion Criteria
- Infection with genotype 2 or 3 HCV infection
- Cirrhosis determination
- Individual is treatment-experienced
- Screening laboratory values within defined thresholds
- Individual has not been treated with any investigational drug or device within 30 days of the Screening visit
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria
- Prior exposure to a direct-acting antiviral drug targeting the HCV NS5B polymerase
- Pregnant or nursing female or male with pregnant female partner
- Current or prior history of clinical hepatic decompensation
- History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the study protocol
- Excessive alcohol ingestion or significant drug abuse
Data sourced from ClinicalTrials.gov (NCT01808248). 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.