Phase 3
Completed N=328
Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
Source: ClinicalTrials.gov NCT01641640 ↗Enrolled (actual)
328
Serious AEs
1.2%
Results posted
May 2014
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virologic Response (SVR)12 — 91 percentage of participants — p=< 0.001
Summary
This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virologic Response (SVR)12 |
91 | < 0.001 sig |
| PRIMARY Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug |
2; 1; 1; 1; 1; 1 | — |
| SECONDARY Percentage of Participants Achieving SVR4 |
92.4 | — |
| SECONDARY Percentage of Participants Achieving SVR24 |
90.5 | — |
| SECONDARY Percentage of Participants With Viral Breakthrough |
0.0 | — |
| SECONDARY Percentage of Participants With Viral Relapse |
8.6 | — |
Eligibility Criteria
Inclusion Criteria
- Infection with HCV genotype 1, 4, 5, or 6
- Cirrhosis determination
- Subject met the following classifications:
- Treatment-naive
- Screening laboratory values within defined thresholds
- Not treated with any investigational drug or device within 30 days of screening
- 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 (NCT01641640). 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.