Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
Status and phase
Completed
Phase 3
Conditions
Hepatitis C Virus Infection
Treatments
Drug: LDV/SOF
Drug: RBV
Details and patient eligibility
About
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.
Enrollment
255 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion 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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
255 participants in 7 patient groups
LDV/SOF 8 wk TN (Cohort 1, Group 1)
Experimental group
Description:
LDV/SOF for 8 weeks (treatment-naive (TN))
Treatment:
Drug: LDV/SOF
LDV/SOF+RBV 8 wk TN (Cohort 1, Group 2)
Experimental group
Description:
LDV/SOF+RBV for 8 weeks (treatment-naive)
Treatment:
Drug: RBV
Drug: LDV/SOF
LDV/SOF 12 wk TN (Cohort 1, Group 3)
Experimental group
Description:
LDV/SOF for 12 weeks (treatment-naive)
Treatment:
Drug: LDV/SOF
LDV/SOF+RBV 12 wk TN (Cohort 1, Group 4)
Experimental group
Description:
LDV/SOF+RBV for 12 weeks (treatment-naive)
Treatment:
Drug: RBV
Drug: LDV/SOF
LDV/SOF+RBV 12 wk TE (Cohort 2)
Experimental group
Description:
Treatment-experienced (TE) participants who completed treatment in Gilead sponsored study GS-US-334-0138 or in Cohort 1 of this study and did not achieve SVR12 will receive LDV/SOF+RBV for 12 weeks.
Treatment:
Drug: RBV
Drug: LDV/SOF
LDV/SOF 12 wk TE (Cohort 3, Group 1)
Experimental group
Description:
LDV/SOF for 12 weeks (treatment-experienced)
Treatment:
Drug: LDV/SOF
LDV/SOF+RBV 12 wk TE (Cohort 3, Group 2)
Experimental group
Description:
LDV/SOF+RBV for 12 weeks (treatment-experienced)
Treatment:
Drug: RBV
Drug: LDV/SOF
Trial contacts and locations
4
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Data sourced from clinicaltrials.gov
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