Efficacy and Safety of Ombitasvir/ Paritaprevir / Ritonavir Plus Ribavirin in Management HCV Genotype 4 and End-stage Kidney Disease With or Without Hemodialysis (An Open Label- Multicenter Prospective Study)

Introduction Management of patients with hepatitis C virus (HCV) related liver disease with concomitant co-morbidity was challenging, especially in the period before the era of new direct-acting antiviral (DAA) agents. With the introduction of DAAs protocols, the therapeutic options were expanded to endorse many patients that were previously assigned as difficult-to-treat population [ ]. Different situations were encountered with co-infection with HCV such as chronic kidney disease (CKD) with its spectrum from mild forms to the end-stage kidney disease (ESKD), patients on hemodialysis (HD), and in post-renal transplant settings [ , ]. Till now, pooled data about the safety and efficacy of different DAAs regimens in different renal situations are still under evaluation [ ], especially in Egypt, where HCV genotype 4 the most dominating genotype [ ]. In Egypt, there were two adopted protocols for patients with HCV and CKD; the sofosbuvir-based combinations and the ombitasvir, paritaprevir, and ritonavir plus ribavirin-based combination [5, ]. Sofosbuvir was proved to be contraindicated in patients with end-stage renal diseases as its elimination based mainly on renal route that may affect its bioavailability [ ]. On the other hand, ombitasvir, paritaprevir, and ritonavir plus ribavirin regimen was proved to be a well-tolerated protocol in non-cirrhotic patients with CKD [6, ].

Aim Therefore, we herein, tried to evaluate a real-life practice to evaluate the efficacy and safety of ombitasvir, paritaprevir, and ritonavir plus ribavirin regimen in patients with ESKD, with or without hemodialysis in Egyptian based multicenter cohort.

Patients and Methods

Patients' recruitment:

Starting from July 2017, a prospective multicenter cohort study was designed to enroll all consecutive patients presented at the Viral Hepatitis Management Outpatient Clinic at Assiut University Hospital, South Valley University Hospital, Sohag University Hospital, Egypt, with proven CHC genotype 4 and concomitant ESKD with or without hemodialysis.