Abstract
Background: The ongoing standard treatment for patients with chronic hepatitis C virus (HCV) is a mixture of direct-acting antiviral agents (DAAs). Aim of work: the aim of this study is to analyse the efficacy and safety of oral interferon-free regimen of ombitasvir, and paritaprevir with ritonavir, given with or without ribavirin (OBV/PTV/R) for chronic hepatitis C GT4 patients with or without compensated cirrhosis and experiencing long-term hemodialysis. Patients and Methods: The study was a prospective, cohort, open label trial. Fifty patients were recruited and only 47 patients completed the study. All patients were given ombitsavir 25 mg, paritaprevir 150 mg, and ritonavir 100 mg(2X50mg hard gelatin capsules) in combination with 200 mg of ribavirin daily for 12 weeks. Primary endpoints were SVR12 (HCV-RNA Results: Out of the fifty patients who contributed in the study, only forty-four (88%) patients achieved SVR12. Three patients (6%) discontinued the Qurevo; one experienced interaction with valsartan, one suffered fatigue, severe HTN, dyspnea and severe anemia and the last was infected with pneumonia. Quervo resistance rate after therapy was (6%). On the other hand, the withdrawal rate of ribavirin was 31.5% among patients who received Quervo ribavirin combination. Conclusion: A 12-week administration of OBV/PTV/R with or without RBV is highly effective with appropriate safety profile amongst GT4 hepatitis C with or without compensated cirrhosis patients with haemodialysis.
Highlights
About 71 million individuals worldwide are affected with chronic hepatitis C virus (HCV) infection as it is a wide-ranging health problem; in Egypt, approximately 6-8 million individuals are chronically infected with HCV GT4 and at risk of advanced complications [1, 2]
After the last dose of the study drug, high SVR12 rates were achieved in HCV GT4-infected patients without cirrhosis or with compensated cirrhosis treated with Q plus RBV for 12 weeks duration, in the phase 2b/3 PEARL-I 10 and AGATE-I [8, 15] studies
OBV, PTV, DSV, and R are all hepatically metabolized with minimal renal clearance, the pharmacokinetics of these direct-acting antiviral agents (DAAs) were evaluated in HCV seronegative persons with mild, moderate, and severe renal impairment and the plasma exposures observed supports use of this regimen in HCV-infected patients with renal impairment with no need for dose adjustments [24]
Summary
About 71 million individuals worldwide are affected with chronic HCV infection as it is a wide-ranging health problem; in Egypt, approximately 6-8 million individuals are chronically infected with HCV GT4 and at risk of advanced complications (cirrhosis, progression to liver failure, and hepatocellular carcinoma) [1, 2]. The aim of HCV treatment is HCV-RNA clearance from serum, which reduces the risk of the serious complications of the disease and explains an effective virological therapy for all patients [3]. After the last dose of the study drug, high SVR12 rates were achieved in HCV GT4-infected patients without cirrhosis or with compensated cirrhosis treated with Q plus RBV for 12 weeks duration, in the phase 2b/3 PEARL-I 10 and AGATE-I [8, 15] studies. The relation between HCV infection and kidney disease is well detected [16]
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