Clinical trial NCT02487030: Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
Official title: A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus Infection
Keywords: HCV genotype 4 (GT-4)
HCV
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy
GS-7977
GS-5885
Ribavirin
Sofosbuvir
ledipasvir
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Virus Diseases
Antiviral Agents
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-07-01
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE)
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
timeFrame: Posttreatment Weeks 4 and 24
measure: Percentage of Participants With Overall Virologic Failure
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: Cairo
country: Egypt
city: Cairo
country: Egypt
city: Mansourah
country: Egypt
city: Shibin Al Kawm
country: Egypt
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Shiha G, Waked I, Soliman R, Abdelrazek W, Hassany M, Fouad R, et al. Ledipasvir/sofosbuvir for 8 or 12 weeks with or without ribavirin in HCV genotype 4 patients in Egypt. [Abstract OP158]. Asian Pacific Association for the Study of the Liver (APASL); 2017 15-19 February; Shanghai, China
citation: Shiha G, Esmat G, Hassany M, Soliman R, Elbasiony M, Fouad R, Elsharkawy A, Hammad R, Abdel-Razek W, Zakareya T, Kersey K, Massetto B, Osinusi A, Lu S, Brainard DM, McHutchison JG, Waked I, Doss W. 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. Gut. 2019 Apr;68(4):721-728. doi: 10.1136/gutjnl-2017-315906. Epub 2018 Apr 17.