Conditions: Hepatitis C Virus Infection
Keywords: Sickle Cell Disease Gilead Hepatitis C
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 10
Healthy volunteers: no

Brief summary:
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle cell disease (SCD).

Detailed description:

Arms:
arm 1: Treatment-naive or treatment-experienced participants without cirrhosis will receive LDV/SOF for 12 weeks. arm 2: Treatment-experienced participants with cirrhosis will receive LDV/SOF for 24 weeks.

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

Protocol document: