Retrospective Cohort Study
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 14, 2015; 21(18): 5496-5504
Published online May 14, 2015. doi: 10.3748/wjg.v21.i18.5496
Relevance of low viral load in haemodialysed patients with chronic hepatitis C virus infection
Jan Sperl, Sona Frankova, Renata Senkerikova, Magdalena Neroldova, Vaclav Hejda, Miroslava Volfova, Dusan Merta, Ondrej Viklicky, Julius Spicak, Milan Jirsa
Jan Sperl, Sona Frankova, Renata Senkerikova, Julius Spicak, Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, 14021 Prague, Czech Republic
Magdalena Neroldova, Milan Jirsa, Laboratory of Experimental Hepatology, Institute for Clinical and Experimental Medicine, 14021 Prague, Czech Republic
Vaclav Hejda, Department of Internal Medicine, Division of Gastroenterology and Hepatology, Charles University Medical School and Teaching Hospital, 30460 Plzen, Czech Republic
Miroslava Volfova, Hepato-gastroenterology, 50012 Hradec Kralove, Czech Republic
Dusan Merta, Department of Anesthesiology, Resuscitation and Intensive Care, Institute for Clinical and Experimental Medicine, 14021 Prague, Czech Republic
Ondrej Viklicky, Department of Nephrology, Institute for Clinical and Experimental Medicine, 14021 Prague, Czech Republic
Author contributions: Sperl J and Jirsa M designed the study. Frankova S, Hejda V and Volfova M provided clinical and laboratory data; Senkerikova R and Neroldova M genotyped the DNA samples; Sperl J, Frankova S and Senkerikova R analysed the data; Merta D performed the statistical analysis; Sperl J and Frankova S wrote the manuscript; Viklicky O, Jirsa M and Spicak J revised the manuscript.
Supported by The Internal Grant Agency of Ministry of Health of the Czech Republic, No. NT/11235-5.
Ethics approval: The study was reviewed and approved by Institute for Clinical and Experimental Medicine and Thomayer Hospital Institutional Review Board.
Informed consent: All study participants provided written consent with retrospective personal data collection, and DNA sampling and analysis.
Conflict-of-interest: All the authors declare that they do not have anything to disclose regarding funding or conflict of interests with respect to this manuscript.
Data sharing: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Jan Sperl, MD, PhD, Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Videnska 1958/9, 14021 Praha 4, Czech Republic. jan.sperl@ikem.cz
Telephone: +420-26-1364003 Fax: +420-26-1362602
Received: November 21, 2014
Peer-review started: November 21, 2014
First decision: December 26, 2014
Revised: January 19, 2015
Accepted: February 11, 2015
Article in press: February 11, 2015
Published online: May 14, 2015
Processing time: 178 Days and 12.1 Hours
Abstract

AIM: To identify predictors of sustained virological response in hemodialysed patients treated by PEGinterferon α for chronic hepatitis C, genotype 1.

METHODS: The sustained virological response (SVR) rate, IL28B genotype, IFNL4 genotype, initial viral load (IVL) and other pretreatment variables in 39 end-stage renal disease patients (ESRD) on maintenance haemodialysis (HD) infected with hepatitis C virus (HCV), genotype 1b, were compared with a control group of 109 patients with normal kidney function treated within the same period. All the patients were treatment naïve and had well compensated liver disease. The ESRD patients received 135 μg of PEGylated interferon α-2a (PegIFN-α) weekly and a reduced dose of ribavirin (RBV) was administered to 23/39 patients with an initial haemoglobin level > 10 g/dL. Control group patients were given standard doses of PegIFN-α and RBV. SVR was assessed as HCV RNA negativity 24 wk post-treatment. A t-test or ANOVA were used for comparisons of the means and a χ2 test compared the frequencies. Logistic regression was used to determine significant predictors of SVR. Cutoff values for continuous variables were obtained from Receiver Operating Characteristic analysis.

RESULTS: The distribution of IL28B rs12979860 CC, CT and TT genotypes in the ESRD group was 28.2%, 64.1% and 7.7%, respectively, and 19.3%, 62.4% and 18.3% in the controls. The IFNL4 genotype was in almost absolute linkage disequlibrium with IL28B. The proportion of patients with a low IVL (< 600000 IU/mL) was significantly higher in the ESRD group than in the controls (28/39, 71.8% vs 51/109, 46.8%, P = 0.009), as was the proportion of patients with low IVL in IL28B CC carriers compared with non-CC carriers in the ESRD group (10/11, 90.9% vs 18/28, 64.3%, P = 0.0035). This difference was not found in the controls (7/22, 31.8% vs 44/87, 50.6%, P = 0.9). The overall SVR rate was 64.1% (25/39) in the ESRD group and 50.5% (55/109) in the control group (P = 0.19). 11/11 (100%) and 19/22 (86.4%) IL28B CC patients achieved SVR in the ESRD and control groups, respectively. A statistically significant association between SVR and IL28B and IFNL4 variants was found in both groups. The ESRD patients who achieved SVR showed the lowest IVL [median 21000, interquartile range (IQR): 6000-23000 IU/mL], compared with ESRD individuals without SVR (1680000, IQR: 481000-6880000, P = 0.001), controls with SVR (387000, IQR: 111000-1253000) and controls without SVR (905000, IQR: 451000-3020000). In ESRD, an IVL < 600000 IU/mL was strongly associated with SVR: 24/28 (85.7%) patients who achieved SVR had viraemia below this threshold.

CONCLUSION: Haemodialysis decreases the viral load, especially in IL28B CC genotype carriers. A low IVL was the strongest predictor of SVR in ESRD patients identified in multivariate analysis.

Keywords: End-stage renal disease; Hepatitis C virus genotype 1; Interferon alpha; IFNL4; Ribavirin

Core tip: The proportion of haemodialysed patients infected with chronic hepatitis C virus (HCV) receiving antiviral treatment remains unsatisfactory and should increase. Patients should be selected with high probability of successful treatment. Therefore, this study evaluated predictors of sustained virological response (SVR) in haemodialysed patients treated with PEGylated interferon α for HCV, genotype 1. The results of the study indicated that there was a high number of individuals with a low initial viral load (< 600000 IU/mL) among haemodialysed patients, especially in IL28B CC genotype carriers. A low initial viral load was the strongest predictor of SVR in haemodialysed patients.