Observational Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Apr 7, 2023; 29(13): 2015-2033
Published online Apr 7, 2023. doi: 10.3748/wjg.v29.i13.2015
Changes in characteristics of patients with hepatitis C virus-related cirrhosis from the beginning of the interferon-free era
Michał Brzdęk, Dorota Zarębska-Michaluk, Piotr Rzymski, Beata Lorenc, Adam Kazek, Magdalena Tudrujek-Zdunek, Justyna Janocha-Litwin, Włodzimierz Mazur, Dorota Dybowska, Hanna Berak, Anna Parfieniuk-Kowerda, Jakub Klapaczyński, Marek Sitko, Barbara Sobala-Szczygieł, Anna Piekarska, Robert Flisiak
Michał Brzdęk, Dorota Zarębska-Michaluk, Department of Infectious Diseases, Jan Kochanowski University, Kielce 25-317, Poland
Piotr Rzymski, Department of Environmental Medicine, Poznan University of Medical Sciences, Poznań 60-806, Poland
Piotr Rzymski, Integrated Science Association, Universal Scientific Education and Research Network, Poznań 60-806, Poland
Beata Lorenc, Pomeranian Center of Infectious Diseases, Medical University Gdańsk, Gdańsk 80-214, Poland
Adam Kazek, ID Clinic, Mysłowice 41-400, Poland
Magdalena Tudrujek-Zdunek, Department of Infectious Diseases, Medical University of Lublin, Lublin 20-059, Poland
Justyna Janocha-Litwin, Department of Infectious Diseases and Hepatology, Medical University Wrocław, Wrocław 50-367, Poland
Włodzimierz Mazur, Clinical Department of Infectious Diseases, Clinical University of Silesia in Katowice, Chorzów 41-500, Poland
Dorota Dybowska, Department of Infectious Diseases and Hepatology, Faculty of Medicine, Nicolaus Copernicus University, Bydgoszcz 85-030, Poland
Hanna Berak, Daily Department, Hospital for Infectious Diseases in Warsaw, Warszawa 01-201, Poland
Anna Parfieniuk-Kowerda, Robert Flisiak, Department of Infectious Diseases and Hepatology, Medical University of Białystok, Białystok 15-089, Poland
Jakub Klapaczyński, Department of Internal Medicine and Hepatology, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warszawa 00-241, Poland
Marek Sitko, Department of Infectious and Tropical Diseases, Jagiellonian University, Kraków 31-088, Poland
Barbara Sobala-Szczygieł, Department of Infectious Diseases, Medical University of Silesia in Katowice, Bytom 41-902, Poland
Anna Piekarska, Department of Infectious Diseases and Hepatology, Medical University of Łódź, Łódź 90-419, Poland
Author contributions: Brzdęk M, Zarębska-Michaluk D, and Flisiak R conceived the study design, and analyzed and interpreted the data; Brzdęk M and Flisiak R prepared the figures; Brzdęk M prepared the tables; Brzdęk M, Zarębska-Michaluk D, and Flisiak R drafted the manuscript; Rzymski P performed the statistical analysis; Lorenc B, Kazek A, Tudrujek-Zdunek M, Janocha-Litwin J, Mazur W, Dybowska D, Berak H, Parfieniuk-Kowerda A, Klapaczyński J, Sitko M, Sobala-Szczygieł B, and Piekarska A acquired the data; Brzdęk M, Zarębska-Michaluk D, Rzymski P, and Flisiak R prepared a revised version of the manuscript; Brzdęk M and Zarębska-Michaluk D prepared the manuscript for the submission; and all authors approved the final version of the manuscript.
Institutional review board statement: According to local law (Pharmaceutical Law of 6th September 2001, art. 37al), non-interventional studies do not require ethics committee approval.
Informed consent statement: All study participants provided informed consent for treatment and processing of personal data.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: Dataset available upon reasonable request to the corresponding author at dorota1010@tlen.pl.
STROBE statement: The authors have read the STROBE Statement-a checklist of items, and the manuscript was prepared and revised according to the STROBE Statement-a checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Dorota Zarębska-Michaluk, PhD, Assistant Professor, Professor, Department of Infectious Diseases, Jan Kochanowski University, Radiowa 7, Kielce 25-317, Poland. dorota1010@tlen.pl
Received: November 21, 2022
Peer-review started: November 21, 2022
First decision: January 11, 2023
Revised: January 16, 2023
Accepted: March 20, 2023
Article in press: March 20, 2023
Published online: April 7, 2023
Processing time: 136 Days and 15.8 Hours
Abstract
BACKGROUND

Nearly 290000 patients with chronic hepatitis C die annually from the most severe complications of the disease. One of them is liver cirrhosis, which occurs in about 20% of patients chronically infected with the hepatitis C virus (HCV). Direct-acting antivirals (DAAs), which replaced interferon (IFN)-based regimens, significantly improved the prognosis of this group of patients, increasing HCV eradication rates and tolerability of therapy. Our study is the first to assess changes in patient profile, effectiveness, and safety in the HCV-infected cirrhotic population in the IFN-free era.

AIM

To document changes in patient characteristics and treatment regimens along with their effectiveness and safety profile over the years.

METHODS

The studied patients were selected from 14801 chronically HCV-infected individuals who started IFN-free therapy between July 2015 and December 2021 in 22 Polish hepatology centers. The retrospective analysis was conducted in real-world clinical practice based on the EpiTer-2 multicenter database. The measure of treatment effectiveness was the percentage of sustained virologic response (SVR) calculated after excluding patients lost to follow-up. Safety data collected during therapy and the 12-wk post-treatment period included information on adverse events, including serious ones, deaths, and treatment course.

RESULTS

The studied population (n = 3577) was balanced in terms of gender in 2015-2017, while the following years showed the dominance of men. The decline in the median age from 60 in 2015-2016 to 57 years in 2021 was accompanied by a decrease in the percentage of patients with comorbidities and comedications. Treatment-experienced patients dominated in 2015-2016, while treatment-naive individuals gained an advantage in 2017 and reached 93.2% in 2021. Genotype (GT)-specific options were more prevalent in treatment in 2015-2018 and were supplanted by pangenotypic combinations in subsequent years. The effectiveness of the therapy was comparable regardless of the period analyzed, and patients achieved an overall response rate of 95%, with an SVR range of 72.9%-100% for the different therapeutic regimens. Male gender, GT3 infection, and prior treatment failure were identified as independent negative predictors of therapeutic success.

CONCLUSION

We have documented changes in the profile of HCV-infected cirrhotic patients over the years of accessibility to changing DAA regimens, confirming the high effectiveness of IFN-free therapy in all analyzed periods.

Keywords: Hepatitis C, Liver cirrhosis, Direct-acting antivirals, Pangenotypic, Genotype-specific, Epidemiology

Core Tip: Patients with cirrhosis in the course of chronic infection with the hepatitis C virus, in whom the risk of death due to advanced liver disease is the highest, seem to be the greatest beneficiaries of the introduction of therapies with direct-acting antiviral drugs. Our analysis tracking changes in the profile of these patients documents the very high effectiveness and good safety profile from the beginning of the interferon-free era to the present.