Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Na�ve and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

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.


Study Type: Interventional
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naïve and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection
Enrollment: 85
Study Start Date: March 2014
Study Completion Date: February 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Genotype 4: Treatment-naive
- Experimental: Genotype 4: Treatment-experienced
- Experimental: Genotype 5: Treatment-naive
- Experimental: Genotype 5: Treatment-experienced