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Abstract

Advances in Complementary & Alternative medicine

Real-World Safety and Efficacy of Ribavirin – Free Regimen of Ombitasvir/Paritaprevir/ Ritonavir in HCV Dialysis Patients

Submission: January 19, 2019; Published: January 28, 2019

DOI: 10.31031/ACAM.2019.03.000576

ISSN: 2637-7802
Volume4 Issue1

Abstract

Introduction: HCV prevalence in hemodialysis patients in Qatar is 8.4% (predominantly Genotype 4). Since the launch of the Qatar plan for “HCV control by 2020”, the treatment of HCV in hemodialysis patient has been a challenge. The approval of ombitasvir, paritaprevir, and ritonavir (Viekirax) has been accepted as a treatment option in this group of patients. We aim to explore the effectiveness and safety of this regimen in a Genotype 4 predominant population without using ribavirin, known to cause anemia.

Method: Non-Interventional, single-center cohort study, including retrospective collection of real -world data on 40 hemodialysis patients infected with HCV, 19 of them completed the 12 weeks with ribavirin-free Viekirax regimen (plus dasabuvir for G1) and 12 weeks follow up period. The proportion of patients achieving SVR12 presented and the confidence intervals of SVR rates were calculated using exact binomial methods and repeated-measures analysis of variance (ANOVA) was applied to assess differences in various laboratories and biochemical parameters measured over different time points.

Results: The mean age of patients was 57.04±16.79 years. Most of patients had genotype 4 (n=14, 73.7%), then genotype 1 (n=3, 15.8%). One patient had genotype 1 & 4 and one had genotype 4 &6. Overall SVR 12 was 94.7% (18/19) (95% CI, 75.4 to 99.1). 26.7% were Child A cirrhosis. There was no difference in SVR 12 between low grade fibrosis (stage≤2) (14/14;100%(95%CI 78.5to100%) and highgrade fibrosis (stage≥3) (4/5; 80% (95% CI 37.6 to 94.4%); P=0.263. Repeated measure analysis of variance (ANOVA) showed mean Hb levels decreased significantly from Week 0 (mean Hb 11.3±2.4) to week 24 (mean ALT 10.4±1.1); P=0.015. Mean platelet counts showed an insignificant increasing trend from Week 0 to week 12, (P=0.890). Both mean AST and ALT levels observed to decrease with linear trend from week 0 to week 12, (P>0.05). Bilirubin showed a transient increase by 4. Regarding safety, no patient discontinued treatment because of an adverse event, 2 patient required blood transfusions.

Conclusion: Ombitasvir/Paritaprevir/Ritonavir combination therapy without Ribavirin, is effective and safe, with low rates of anemia and treatment discontinuation in patients undergoing dialysis due to ESRD.

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