Phase 3
Completed N=202
Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT01604850 ↗
Enrolled (actual)
202
Serious AEs
4.0%
Results posted
May 2014
Primary outcomePrimary: Percentage of Participants Achieving SVR12 — 51.0; 72.6 percentage of participants — p=< 0.001
Summary
This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving SVR12 |
51.0; 72.6 | < 0.001 sig |
| PRIMARY Adverse Events Leading to Permanent Discontinuation of Study Drug |
1; 0 | — |
| SECONDARY Percentage of Participants Achieving SVR4 |
56.0; 76.8 | — |
| SECONDARY Percentage of Participants Achieving SVR24 |
50.0; 71.6 | — |
| SECONDARY Percentage of Participants With Viral Breakthrough |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Viral Relapse |
47; 26 | — |
Eligibility Criteria
Inclusion Criteria
- Infection with HCV genotype 2 or 3
- Had cirrhosis determination
- Prior treatment failure
- Screening laboratory values within defined thresholds
- Subject had 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 an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B 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 have interfered with subject treatment, assessment or compliance with the protocol
- Excessive alcohol ingestion or significant drug abuse
Data sourced from ClinicalTrials.gov (NCT01604850). 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.