Phase 3
Completed N=127
Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection
Source: ClinicalTrials.gov NCT01896193 ↗Enrolled (actual)
127
Serious AEs
1.6%
Results posted
Apr 2015
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) — 50.0; 76.5; 86.7; 90.3 percentage of participants
Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1 (GT1) or genotype 3 (GT3) hepatitis C virus (HCV) infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) |
50.0; 76.5; 86.7; 90.3 | — |
| PRIMARY Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
53.1; 76.5; 90.0; 90.3; 46.9; 76.5 | — |
| SECONDARY Percentage of Participants Experiencing On-treatment Virologic Failure |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Experiencing Virologic Relapse |
50.0; 23.5; 13.3; 9.7 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed chronic genotype 1 or 3 HCV infection
- HCV treatment-naive
- Individuals will have cirrhosis status assessment; liver biopsy may be required.
- Screening laboratory values within predefined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria
- Pregnant or nursing female or male with pregnant female partner
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Contraindication to ribavirin therapy
- Excessive alcohol ingestion as defined by protocol
- History of solid organ transplantation
- Current or prior history of clinical hepatic decompensation
- History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment, or compliance with the protocol
Data sourced from ClinicalTrials.gov (NCT01896193). 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.