Phase 2
Completed N=60
Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
Source: ClinicalTrials.gov NCT01713283 ↗Enrolled (actual)
60
Serious AEs
5.0%
Results posted
Nov 2014
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) — 78.6; 58.8; 100.0; 86.7 percentage of participants
Summary
This study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 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) |
78.6; 58.8; 100.0; 86.7 | — |
| PRIMARY Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
0; 3.4 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
78.6; 58.8; 100.0; 93.3; 78.6; 58.8 | — |
| SECONDARY Percentage of Participants Experiencing On-treatment Virologic Failure |
7.1; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Experiencing Viral Relapse |
15.4; 41.2; 0; 13.3 | — |
Eligibility Criteria
Inclusion Criteria
- First generation Egyptian; must have been born in Egypt and can trace both maternal and paternal Egyptian ancestry
- Treatment-experienced or treatment-naive
- Chronic genotype 4 HCV infection
- Not co-infected with HIV
- Screening laboratory values within defined thresholds
- Use of highly effective contraception methods
- Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
Exclusion Criteria
- History of any other clinically significant chronic liver disease
- Pregnant or nursing female or male with pregnant female partner
- History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol
- Excessive alcohol ingestion or significant drug abuse
Data sourced from ClinicalTrials.gov (NCT01713283). 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.