Treatment of Patients With Hepatitis C Virus infection (Genotype 4) With Ledipasvir-Sofosbuvir in the Liver Transplant Setting.

Background: Hepatitis C virus infection is a major cause of liver cirrhosis and hepatocellular carcinoma and the leading indication for liver transplantation. In the Middle East, genotype 4 HCV infection is the most common genotype. However, limited data exists on the treatment of genotype-4 in the liver transplant setting. We evaluated the safety and efficacy of ledipasvir-sofosbuvir (LDV/SOF) in treating HCV genotype-4 infected patients with cirrhosis or postliver transplantation. Methods: This prospective, single-arm, observational study includes cohort of patients with cirrhosis before liver transplantation (Cohort A) and a cohort of postliver transplantation patients (Cohort B). Patients received LDV/SOF (90 mg-400 mg) once daily for 12-24 weeks with or without ribavirin (RBV). Patients with creatinine clearance below 30 were excluded. Results: A total of 111 patients (61 cirrhotic; 50 postliver transplants) with HCV genotype 4 were treated in KFSH&RC; 55% cohort A and 44% cohort B received ribavirin. Sustained virological response SVR12 was 91.8% and 86% of cohorts A and B, respectively. There were no treatment-related mortality or serious adverse effects. RBV dose reduction occurred in 25% without any treatment discontinuation. SVR12 rates in cohort A were significantly higher in patients with a viral load below 800 000 (100% vs 83.9%, p value=0.022). Viral load did not impact SVR rates in cohort B. The use of RBV did not increase SVR12 and was associated with anemia. Conclusions: Ledipasvir-sofosbuvir without ribavirin is an effective and safe treatment option for patients with HCV genotype 4 infection in pre and postliver transplant setting. Copyright (C) 2017 Wolters Kluwer Health, Inc. All rights reserved.

http://ift.tt/2uvE2cl