Phase 3
Completed N=280
Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon
Source: ClinicalTrials.gov NCT01542788 ↗Enrolled (actual)
280
Serious AEs
4.7%
Results posted
Feb 2014
Primary outcomePrimary: Percentage of Participants Achieving SVR12 — 78; 0 percentage of participants — p=< 0.001
Summary
This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving SVR12 |
78; 0 | < 0.001 sig |
| PRIMARY Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug |
202; 68; 1; 0; 0; 1 | — |
| SECONDARY Percentage of Participants Achieving SVR4 |
83.1; 0.0 | — |
| SECONDARY Percentage of Participants Achieving SVR24 |
77.8; 0.0 | < 0.001 sig |
| SECONDARY Percentage of Participants Experiencing Viral Breakthrough |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants Experiencing Viral Relapse |
20.5 | — |
Eligibility Criteria
Inclusion Criteria
- Infection with HCV genotype 2 or 3
- Cirrhosis determination
- Subject meets one of the following classifications:
- IFN unwilling
- IFN ineligible
- IFN intolerant
- Screening laboratory values within defined thresholds
- Subject 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 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 interfere with subject treatment, assessment or compliance with the protocol
- Excessive alcohol ingestion or significant drug abuse
Data sourced from ClinicalTrials.gov (NCT01542788). 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.