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      Efficacy and safety of ombitasvir/paritaprevir/ritonavir/ribavirin in management of Egyptian chronic hepatitis C virus patients with chronic kidney disease : A real-life experience

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          Abstract

          Treatment of hepatitis C virus (HCV) infection in patients with chronic kidney disease was difficult in the past because of the use of interferon (IFN). It was associated with high risk IFN-related adverse reactions due to reduced renal clearance of IFN. This study aimed to evaluate the antiviral efficacy, safety, and tolerability of ombitasvir/paritaprevir/ritonavir/ribavirin in chronic kidney disease patients infected with chronic HCV.

          This observational, open-label prospective study was carried out on 103 patients infected chronic HCV with different grades of renal impairment. Paritaprevir/ritonavir and ombitasvir (75/50/12.5 mg) twice daily plus ribavirin were given to the patients for 12 weeks. Dose adjustment of ribavirin was done according to degree of renal impairment.

          Sustained virological response (12 weeks after the end of treatment) occurred in 101 patients (98.1%). Anemia occurred in 48 patients. No serious adverse events were observed in any patient.

          Paritaprevir/ritonavir and ombitasvir plus ribavirin for 12 weeks was considered to be safe and effective in the treatment of chronic HCV infected patients with varying degrees of renal impairment.

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          Most cited references28

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          A new equation to estimate glomerular filtration rate.

          Andrew Levey, Lesley Stevens, Christopher H Schmid … (2009)
          Equations to estimate glomerular filtration rate (GFR) are routinely used to assess kidney function. Current equations have limited precision and systematically underestimate measured GFR at higher values. To develop a new estimating equation for GFR: the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. Cross-sectional analysis with separate pooled data sets for equation development and validation and a representative sample of the U.S. population for prevalence estimates. Research studies and clinical populations ("studies") with measured GFR and NHANES (National Health and Nutrition Examination Survey), 1999 to 2006. 8254 participants in 10 studies (equation development data set) and 3896 participants in 16 studies (validation data set). Prevalence estimates were based on 16,032 participants in NHANES. GFR, measured as the clearance of exogenous filtration markers (iothalamate in the development data set; iothalamate and other markers in the validation data set), and linear regression to estimate the logarithm of measured GFR from standardized creatinine levels, sex, race, and age. In the validation data set, the CKD-EPI equation performed better than the Modification of Diet in Renal Disease Study equation, especially at higher GFR (P < 0.001 for all subsequent comparisons), with less bias (median difference between measured and estimated GFR, 2.5 vs. 5.5 mL/min per 1.73 m(2)), improved precision (interquartile range [IQR] of the differences, 16.6 vs. 18.3 mL/min per 1.73 m(2)), and greater accuracy (percentage of estimated GFR within 30% of measured GFR, 84.1% vs. 80.6%). In NHANES, the median estimated GFR was 94.5 mL/min per 1.73 m(2) (IQR, 79.7 to 108.1) vs. 85.0 (IQR, 72.9 to 98.5) mL/min per 1.73 m(2), and the prevalence of chronic kidney disease was 11.5% (95% CI, 10.6% to 12.4%) versus 13.1% (CI, 12.1% to 14.0%). The sample contained a limited number of elderly people and racial and ethnic minorities with measured GFR. The CKD-EPI creatinine equation is more accurate than the Modification of Diet in Renal Disease Study equation and could replace it for routine clinical use. National Institute of Diabetes and Digestive and Kidney Diseases.
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            K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification.

            (2002)
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              Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study

              Sarah Blach, Stefan Zeuzem, Michael Manns … (2017)
              The 69th World Health Assembly approved the Global Health Sector Strategy to eliminate hepatitis C virus (HCV) infection by 2030, which can become a reality with the recent launch of direct acting antiviral therapies. Reliable disease burden estimates are required for national strategies. This analysis estimates the global prevalence of viraemic HCV at the end of 2015, an update of-and expansion on-the 2014 analysis, which reported 80 million (95% CI 64-103) viraemic infections in 2013.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Medicine (Baltimore)
                Journal ID (iso-abbrev): Medicine (Baltimore)
                Journal ID (publisher-id): MEDI
                Title: Medicine
                Publisher: Lippincott Williams & Wilkins (Hagerstown, MD )
                ISSN (Print): 0025-7974
                ISSN (Electronic): 1536-5964
                Publication date Collection: 16 October 2020
                Publication date (Electronic): 16 October 2020
                Volume: 99
                Issue: 42
                Electronic Location Identifier: e21972
                Affiliations
                [a ]Department of Tropical Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt
                [b ]Hepatology, Gastroenterology and Infectious Diseases Department, Mahala Hepatology Teaching Hospital, Gharbia
                [c ]National Hepatology and Tropical Medicine Research Institute in Cairo, Cairo, Egypt
                [d ]Internal Medicine Department, Tanta University, Tanta
                [e ]Department of Public health and Community medicine, Menofia University, Menofia, Egypt
                [f ]College of Dental Medicine, Basic & Clinical Oral Sciences, Umm al-qura University, Saudia Arabia.
                Author notes
                [∗ ]Correspondence: Sherief Abd-Elsalam, Tropical Medicine Department, Tropical Medicine Department, Tanta University, Tanta, Egypt, 35127 (e-mail: sherif_tropical@ 123456yahoo.com ).
                Author information
                http://orcid.org/0000-0003-4366-2218
                Article
                Publisher ID: MD-D-19-09887 Accession ID: 21972
                DOI: 10.1097/MD.0000000000021972
                PMC ID: 7572016
                PubMed ID: 33080669
                SO-VID: f6975537-4278-4b35-b5ab-1d3cf91237e6
                Copyright © Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc.
                License:

                This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc/4.0

                History
                Date received : 13 December 2019
                Date revision received : 2 July 2020
                Date accepted : 26 July 2020
                Categories
                Subject: 4900
                Subject: Research Article
                Subject: Observational Study
                Custom metadata
                OPEN-ACCESS TRUE

                Keywords: egypt.,end-stage renal disease,hepatitis c virus,renal impairment,sustained virological response
                Data availability:
                Keywords: egypt., end-stage renal disease, hepatitis c virus, renal impairment, sustained virological response

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