Retrospective Study
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Feb 21, 2018; 24(7): 852-861
Published online Feb 21, 2018. doi: 10.3748/wjg.v24.i7.852
Predictors of functional benefit of hepatitis C therapy in a ‘real-life’ cohort
Niels Steinebrunner, Kerstin Stein, Catharina Sandig, Thomas Bruckner, Wolfgang Stremmel, Anita Pathil
Niels Steinebrunner, Catharina Sandig, Wolfgang Stremmel, Anita Pathil, Department of Internal Medicine IV, University Hospital Heidelberg, Heidelberg 69120, Germany
Kerstin Stein, Department of Gastroenterology, Hepatology and Infectious Diseases, University Hospital of Magdeburg, Magdeburg 39120, Germany
Thomas Bruckner, Department of Medical Biometry, Institute of Medical Biometry and Informatics (IMBI), Heidelberg 69120, Germany
Author contributions: Steinebrunner N, Stein K, Sandig C and Pathil A drafted the original manuscript, contributed to the study design, interpreted the results and collected the data; Bruckner T performed the statistical analyses; Stremmel W critically revised the manuscript. All authors read and approved the final manuscript.
Institutional review board statement: The institutional Ethics Committee (Ethikkommission der Medizinischen Fakultät Heidelberg) approved the protocol.
Informed consent statement: Informed consent to participate in the study was obtained from each subject.
Conflict-of-interest statement: Steinebrunner N received travel support from BMS and Gilead; Stein K received lecturer fees from Roche and Gilead; and Pathil A received travel support from AbbVie and BMS and lecturer fees from AbbVie, BMS and Gilead.
Data sharing statement: Statistical code and datasets analysed during the current study are available from the corresponding author on reasonable request via e-mail (anita.pathil-warth@med.uni-heidelberg.de); Consent for data sharing was not obtained but the presented data are anonymized and risk of identification is low.
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: Anita Pathil, MD, Doctor, Department of Internal Medicine IV, Gastroenterology and Hepatology, University of Heidelberg, Im Neuenheimer Feld 410, Heidelberg 69120, Germany. anita.pathil-warth@med.uni-heidelberg.de
Telephone: +49-6221-5638102 Fax: +49-6221-565697
Received: October 22, 2017
Peer-review started: October 25, 2017
First decision: November 22, 2017
Revised: December 31, 2017
Accepted: January 15, 2018
Article in press: January 15, 2018
Published online: February 21, 2018
Processing time: 109 Days and 10 Hours
Abstract
AIM

To define predictors of functional benefit of direct-acting antivirals (DAAs) in patients with chronic hepatitis C virus (HCV) infection and liver cirrhosis.

METHODS

We analysed a cohort of 199 patients with chronic HCV genotype 1, 2, 3 and 4 infection involving previously treated and untreated patients with compensated (76%) and decompensated (24%) liver cirrhosis at two tertiary centres in Germany. Patients were included with treatment initiation between February 2014 and August 2016. All patients received a combination regimen of one or more DAAs for either 12 or 24 wk. Predictors of functional benefit were assessed in a univariable as well as multivariable model by binary logistic regression analysis.

RESULTS

Viral clearance was achieved in 88% (175/199) of patients. Sustained virological response (SVR) 12 rates were as follows: among 156 patients with genotype 1 infection the SVR 12 rate was 90% (n = 141); among 7 patients with genotype 2 infection the SVR 12 rate was 57% (n = 4); among 30 patients with genotype 3 infection the SVR 12 rate was 87% (n = 26); and among 6 patients with genotype 4 infection the SVR 12 rate was 67% (n = 4). Follow-up MELD scores were available for 179 patients. A MELD score improvement was observed in 37% (65/179) of patients, no change of MELD score in 41% (74/179) of patients, and an aggravation was observed in 22% (40/179) of patients. We analysed predictors of functional benefit from antiviral therapy in our patients beyond viral eradication. We identified the Child-Pugh score, the MELD score, the number of platelets and the levels of albumin and bilirubin as significant factors for functional benefit.

CONCLUSION

Our data may contribute to the discussion of potential risks and benefits of antiviral therapy with individual patients infected with HCV and with advanced liver disease.

Keywords: Functional benefit; Direct acting antiviral; Hepatitis C; Cirrhosis; Real-life data

Core tip: Therapeutic regimens for patients with chronic hepatitis C virus (HCV) infection have substantially improved over the last few years. However real-life data in patients with cirrhosis are still limited, and predictors of functional benefit of direct-acting antivirals are not well defined. We analysed data from patients with HCV infection and liver cirrhosis to evaluate predictors of functional benefit for identifying patients profiting most from antiviral therapy beyond HCV eradication.