Overview

Ombitasvir/ Paritaprevir / Ritonavir Plus Ribavirin in Management HCV and End-stage Kidney Disease

Status:
Completed

Trial end date:
2018-09-30

Target enrollment:
0

Participant gender:
All

Summary

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. 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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Assiut University

Collaborators:

Sohag University
South Valley University

Treatments:

Ribavirin
Ritonavir

Criteria

Inclusion Criteria:

- patients were 18 years old or more,

- naive to HCV treatment,

- HCV genotype 4,

- compensated liver disease.

Exclusion Criteria:

- Patients with combined HCV/HBV co-infection

- hepatocellular carcinoma (HCC)

- decompensated liver cirrhosis (Child-Pugh score above 6)

- non-genotype 4