Phase 3
Completed N=103
Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
Source: ClinicalTrials.gov NCT01838590 ↗Enrolled (actual)
103
Serious AEs
1.9%
Results posted
May 2015
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) — 84.0; 70.4; 91.7; 88.9 percentage of participants
Summary
This study is to to evaluate the safety, tolerability, and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) in Egyptian adults with 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) |
84.0; 70.4; 91.7; 88.9 | — |
| PRIMARY Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event |
0; 0 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
88.0; 74.1; 91.7; 88.9; 84.0; 70.4 | — |
| SECONDARY Percentage of Participants Experiencing On-treatment Virologic Failure |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Experiencing Virologic Relapse |
16.0; 29.6; 4.2; 11.1 | — |
Eligibility Criteria
Inclusion Criteria
- Treatment experienced and naïve subjects
- Chronic genotype 4 HCV-infection
- Not co-infected with HIV
- Screening laboratory values within defined thresholds
- Use of highly effective contraception methods
- Subject 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 subject treatment, assessment or compliance with the protocol
- Excessive alcohol ingestion or significant drug abuse
Data sourced from ClinicalTrials.gov (NCT01838590). 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.