Hepatitis C Virus,Thalassemia Major,Transfusion Dependent Thalassemia,Genotype 1,Genotype 4,sofosbuvir/Velpatasvir
Safety and/or Efficacy Study
N/A: Single arm study
N/A: Not Applicable
Eligibility and IRB
This is an open label prospective observational randomized controlled trial taking place at the American University of Beirut Medical Center aimed at assessing the efficacy of Sofosbuvir/Velpatasvir in transfusion-dependent thalassemia patients suffering from HCV Genotype 1-6.
Sustained Viral Response following 12 weeks of therapy (primary objective)
Assessment of transfusion requirements (secondary objective)
Adverse events (secondary objective)
Efficacy in treatment naiive vs relapsers vs null responders (secondary objective)
Efficacy in patients with advanced fibrosis/cirrhosis vs F1, F2 by elastography (secondary objective)
10 adult patients suffering from transfusion dependent thalassemia major from the American University of Beirut Medical Center will be enrolled in this open label trial. Patients will be enrolled at the private clinics or endoscopy unit of the AUBMC
Patients who have both HCV genotype 1 or 4 and transfusion dependent thalassemia major will be enrolled in this study. Consecutive patients will be introduced to the study, consented, and supplied with 3 months worth of Sofosbuvir/Ledipasvir.