Ombitasvir/ Paritaprevir / Ritonavir Plus Ribavirin in Management HCV and End-stage Kidney Disease
Status:
Completed
Trial end date:
2018-09-30
Target enrollment:
Participant gender:
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.