Study the Response of Qurevo (Ombitasvir, Paritaprevir and Ritonavir) in End Stage Renal Disease Patients with Hepatitis C Virus

Abstract

Background: The prevalence of HCV infection in patients with ESRD, on haemodialysis ranges from 6% to 60% in different parts of the world (In Egypt 50.8%). Treatment of HCV compensated cirrhosis with the new DAA therapy Qurevo "ombitasvir/paritapre-vir/ritonavir" with ribavirin in ESRD was approved in many countries. The aim: is to evaluate the efficacy and safety of Qurevo/Ribavirin in ESRD patients infected by hepatitis C on regular hae-modialysis. Patients and Methods: A prospective cohort study enrolled 50 ESRD patients, on regular haemodialysis with HCV at the virology clinic at Ain Shams University hospital over a period of 15 months (from December 2016 to February 2018). Treatment with daily fixed-dose combination of 2 tabs Qurevo "paritaprevir (75 mg, NS3/4A protease inhibitor)/ritonavir (50 mg)/ombitasvir (12.5 mg, NS5A inhibitor)" with meal + 200 mg ribavirin daily for 12 weeks. Result(s): the mean age of patients 51.4 years. The SVR12 rate was 96% (48/50); 2 patients had virologic failure. The most frequent adverse events were fatigue/asthenia in 44 patients (88%) and worsening anaemia (Hb dropped to < 10 g/dl) in 42 patients (84%). GIT upset occurred in 10 patients (20%), sleep disorders in 8 patients (16%), decreased appetite in 8 patients (16%), respiratory distress in 6 patients (12%), headache, dizziness in 6 patients (12%). Muscle spasms in 4 patients (8%). Itching(pruritis) occurred in 3 patients (6%). Death occurred in 4 patients (8%), no hepatic decompensation, hypersensitivity (angioedema), teratogenicity and drug interactions did not occur in any patient (0%). Other events occurred in 11 patients (22%). They were parenchymal liver changes in ultrasound at the end of therapy after being normal before therapy (in 3 patients), thrombocytopenia, increased alkaline phosphatase, hiccough, deterioration of hypertension, urinary tract infection, lower limb cellulitis, vaginal bleeding, chest infection (in 1 patient each). SVR12 was achieved in 100% of patients who had to stop or modify ribavirin dose; this means that Ribavirin absence didn't affect the sustained viral response in these patients. Conclusion(s): Our results confirm the efficacy of Qurevo "ombitasvir/paritaprevir/ritonavir" with Ribavirin combination therapy in ESRD patients (on regular haemodialysis) with HCV infection with anaemia as the most frequent adverse event.