Phase 3
Completed N=255
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
Source: ClinicalTrials.gov NCT02487030 ↗Enrolled (actual)
255
Serious AEs
1.2%
Results posted
Dec 2017
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 95.3; 90.5; 97.7; 97.6 percentage of participants
◆ Published Evidence
Established
49citations · ~7 / year
Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt.
Summary
The primary objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.
Linked Publications
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Ledipasvir/sofosbuvir with or without ribavirin for 8 or 12 weeks for the treatment of HCV genotype 4 infection: results from a randomised phase III study in Egypt.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) |
95.3; 90.5; 97.7; 97.6; 94.4; 100.0 | — |
| PRIMARY Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE) |
0; 0; 0; 1.1 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
95.3; 95.2; 97.7; 97.6; 100.0; 100.0 | — |
| SECONDARY Percentage of Participants With Overall Virologic Failure |
4.7; 9.5; 2.3; 0.0; 2.8; 0.0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Willing and able to provide written informed consent
- Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
- HCV genotype 4 at screening
- HCV treatment naive or prior participation in this study or study GS-US-334-0138 (Cohorts 1 and 2 only)
- Cohort 3 only: HCV treatment-experienced (previously received therapy for HCV infection with an interferon (IFN)-containing regimen, with or without RBV and/or an HCV NS3/NS4A protease inhibitor (PI)
- Body mass index (BMI) ≥ 18 kg/m^2
- Screening laboratory values within defined thresholds
- Use of effective protocol-approved contraception methods
Key Exclusion Criteria
- History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Pregnant or nursing females or male with pregnant female partner
- Clinically-relevant drug or alcohol abuse within 12 months of screening
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02487030) and the linked publication. 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.