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
ARTICLE HIGHLIGHTS
Research background

To improve patient care by assisting health care professionals in the decision-making process for treatment of patients infected with hepatitis C virus (HCV).

Research motivation

Direct-acting antivirals (DAAs) have recently opened up promising new therapeutic options for patients with chronic HCV infection. Nevertheless, in order to study the efficacy of these regimens, especially in difficult-to-treat patient populations, such as patients with liver cirrhosis, real-life data is needed.

Research objectives

We investigated patients in our real-life cohort from two tertiary referral centres in Germany. We analysed data from patients with HCV infection and liver cirrhosis to evaluate predictors of functional benefit for identifying patients profiting most of antiviral therapy beyond HCV eradication.

Research methods

Predictors of functional benefit were determined in a univariable as well as multivariable model assessed by binary logistic regression analysis. For reasons of validity of the logistic regression analysis (relative to the number of outcome events), a maximum of 7 clinically relevant variables was selected.

Research results

Our results indicate that the Child-Pugh score, the MELD score, the number of platelets and the levels of albumin and bilirubin may be predictors of functional benefit from DAA-based therapy, so that these variables may serve as another tool to guide antiviral therapy in affected patients.

Research conclusions

With the introduction of DAAs, the indication for therapy for patients with HCV infection and with liver cirrhosis has dramatically expanded with vast improvements of SVR. However, it remains unclear, which patients profit most from antiviral therapy. Therefore, a simple and feasible clinical index may be beneficial to evaluate the presumed effect of antiviral therapy before treatment initiation. Based on the parameters studied, we suggest the MELD score as part of such an evaluation system.

Research perspectives

The ultimate goal of antiviral therapy in patients with HCV infection is to avoid hepatic complications such as the development of hepatocellular carcinoma or hepatic decompensation. Further research with large patient groups and longer observation periods is warranted to define and confirm predictive markers to identify patients, which profit clinically most from antiviral therapy beyond viral eradication