Conditions: Hepatitis C Virus Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

Brief summary:
The primary objectives of this study are to evaluate the effect of sustained virologic response (SVR) on cerebral metabolism as determined by magnetic resonance spectroscopy (MRS) and on neurocognition as measured by neurocognitive tests. This study will also evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 weeks in treatment-naive or treatment-experienced adults.

During the blinded treatment phase, participants will be randomized 2:1 to receive LDV/SOF FDC or placebo for 12 weeks. After the unblinding at the Posttreatment Week 4 visit, participants in the placebo group will be offered open-label treatment of LDV/SOF FDC for 12 weeks.

Detailed description:

Arms:
arm 1: Participants will receive LDV/SOF FDC for 12 weeks. arm 2: Participants will receive LDV/SOF placebo for 12 weeks. arm 3: Following Posttreatment Week 4, participants in the placebo group will be offered open-label treatment with LDV/SOF FDC for 12 weeks.

Interventions: intervention 1: LDV/SOF intervention 2: Placebo
Intervention descriptions: intervention 1: 90/400 mg FDC tablet administered orally once daily intervention 2: Tablet administered orally once daily

Protocol document: