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

Abstract Background According to the WHO there are 185 million people infected with HCV in the world.Egypt has the highest prevalence of hepatitis C virus (HCV) in the world reaching 13% equating to an estimated 12 million Egyptians . HCV is one of the main causes of liver cirrhosis and hepatocellular carcinoma.HCV can develop kidney disease because of extrahepatic manifestations of HCV or as a disease process independent of the HCV infection.In addition, hemodialysis has been a risk factor for acquiring HCV infection. The prevalence of HCV infection is high in patients with ESRD, on hemodialysis ranges from 6% to 60% in different parts of the world. Several studies show that patients on hemodialysis have an increased overall mortality risk if they have chronic HCV when compared with those on dialysis who do not have HCV. Antiviral treatment in CKD patients can be complicated because many of the agents used for anti-HCV therapy can accumulate to toxic levels in the setting of renal impairment. Treatment of HCV compensated cirrhosis with the new DAA therapy Qurevo “ombitasvir/paritaprevir/ritonavir” with ribavirin in ESRD was approved in many countries. Aim of the study To evaluate the efficacy and safety of Qurevo/Ribavirin regimen in ESRD Egyptian patients who are infected with hepatitis C virus (HCV) . Patients and Methods A prospective cohort study evaluated the outcome of 12-week ombitasvir (NS5A inhibitor)/paritaprevir (NS3/4A protease inhibitor)/ritonavir with ribavirin combination therapy for 50 ESRD patients with HCV at the hepatic virology clinic at Ain Shams University hospital over a period of 15 months (from December 2016 to February 2018). The primary endpoint was sustained virologic response 12 weeks after therapy (SVR12). Results 50 ESRD patients with a mean age of 51.4 years, range from 23-77 years were enrolled.The SVR12 rate was 96% (48/50); 2 patients had virologic failure. As regards adverse events, the most frequent was fatigue/asthenia in 44 patients (88%) and worsening anemia (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%).2 patients (4%) were non-responders to treatment and another 2 (4%) were relapsers.Death occurred in 4 patients (8%) due to myocardial infarction, pulmonary edema, severe hypotension on hemodialysis sessions, shock due to blood loss in retroperitoneal hematoma following peritoneal dialysis. Hepatic decompensation, hypersenisitivity (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 Our results confirm the efficacy of Qurevo “ombitasvir/paritaprevir/ritonavir” with Ribavirin combination therapy in ESRD patients with HCV infection, with anemia as the most frequent adverse event.