Evaluation of Efficacy and Safety of Ombitasvir, Paritaprevir, and Ritonavir plus Ribavirin Based Therapy for Chronic Hepatitis C with or without Compensated Cirrhosis in Haemodialysis Patients

Abstract

This study was a prospective, cohort, open-label trial for 9 months (3 months therapy + 6 months follow up after therapy); to evaluate the efficacy and safety of ombitasvir, paritaprevir and ritonavir plus RBV based therapy for chronic hepatitis C with or without compensated cirrhosis in HCV treatment naïve patients receiving long-term haemodialysis. A total of 50 HCV treatment naïve patients with or without compensated cirrhosis on regular hemodialysis enrolled in the study. They received 25 mg ombitasvir, 150 mg paritaprevir, and 100 mg ritonavir (2 capsules Qurevo®) plus ribavirin 200 mg daily for 12 weeks. Qurevo was given once daily (on the day of dialysis, it was given after dialysis session);. In contrast, Ribavirin was given once daily (on the day of dialysis, it was given 4 hrs before dialysis session). After treatment, patients were followed-up for up to 24 weeks. The cases involved in the study recruited from Al-Maadi armed forces hospital. Medical and drug history was taken; along with baseline laboratory assessment (including CBC, liver, renal functions, AFP, HCV RNA and FibroTest score). Patients were followed up at the nephrology and Hepatology departments for the whole study period and subjected to assessment of (Quantitative PCR for HCV RNA testing every month during therapy, and at 3 and 6 months after the end of treatment) and (Anti-HCV antibody every three months during therapy and at 3 and 6 months after the end of treatment). During the study, 3 patients were withdrawn due to suffering nondrug related complications & drug interactions complication leaving 47 patients who completed the study period.