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
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 255
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: LDV/SOF for 8 weeks (treatment-naive (TN)) arm 2: LDV/SOF+RBV for 8 weeks (treatment-naive) arm 3: LDV/SOF for 12 weeks (treatment-naive) arm 4: LDV/SOF+RBV for 12 weeks (treatment-naive) arm 5: 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. arm 6: LDV/SOF for 12 weeks (treatment-experienced) arm 7: LDV/SOF+RBV for 12 weeks (treatment-experienced)

Interventions: intervention 1: LDV/SOF intervention 2: RBV
Intervention descriptions: intervention 1: 90/400 mg FDC tablet administered orally once daily intervention 2: Tablets administered orally in a divided daily dose based on weight (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol document: