Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
NCT ID: NCT02487030
Last Updated: 2018-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
255 participants
INTERVENTIONAL
2015-09-07
2017-02-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LDV/SOF 8 wk TN (Cohort 1, Group 1)
LDV/SOF for 8 weeks (treatment-naive (TN))
LDV/SOF
90/400 mg FDC tablet administered orally once daily
LDV/SOF+RBV 8 wk TN (Cohort 1, Group 2)
LDV/SOF+RBV for 8 weeks (treatment-naive)
LDV/SOF
90/400 mg FDC tablet administered orally once daily
RBV
Tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
LDV/SOF 12 wk TN (Cohort 1, Group 3)
LDV/SOF for 12 weeks (treatment-naive)
LDV/SOF
90/400 mg FDC tablet administered orally once daily
LDV/SOF+RBV 12 wk TN (Cohort 1, Group 4)
LDV/SOF+RBV for 12 weeks (treatment-naive)
LDV/SOF
90/400 mg FDC tablet administered orally once daily
RBV
Tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
LDV/SOF+RBV 12 wk TE (Cohort 2)
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.
LDV/SOF
90/400 mg FDC tablet administered orally once daily
RBV
Tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
LDV/SOF 12 wk TE (Cohort 3, Group 1)
LDV/SOF for 12 weeks (treatment-experienced)
LDV/SOF
90/400 mg FDC tablet administered orally once daily
LDV/SOF+RBV 12 wk TE (Cohort 3, Group 2)
LDV/SOF+RBV for 12 weeks (treatment-experienced)
LDV/SOF
90/400 mg FDC tablet administered orally once daily
RBV
Tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Interventions
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LDV/SOF
90/400 mg FDC tablet administered orally once daily
RBV
Tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Al Mansurah, , Egypt
Cairo, , Egypt
Cairo, , Egypt
Shibīn al Kawm, , Egypt
Countries
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References
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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
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.
Other Identifiers
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GS-US-337-1643
Identifier Type: -
Identifier Source: org_study_id
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