Conditions: Chronic Genotype 4 HCV Chronic Genotype 5 HCV
Keywords: HCV GT 4 HCV GT 5
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 85
Healthy volunteers: no

Brief summary:
This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.

Detailed description:

Arms:
arm 1: LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 4 hepatitis C virus (HCV) infection arm 2: LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 5 hepatitis C virus (HCV) infection

Interventions: intervention 1: LDV/SOF
Intervention descriptions: intervention 1: LDV/SOF (90/400 mg) FDC tablet administered orally once daily

Protocol document: