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Changes in characteristics of patients with hepatitis C virus-related cirrhosis from the beginning of the interferon-free era

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 int...

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Autores principales: Brzdęk, Michał, Zarębska-Michaluk, Dorota, Rzymski, Piotr, Lorenc, Beata, Kazek, Adam, Tudrujek-Zdunek, Magdalena, Janocha-Litwin, Justyna, Mazur, Włodzimierz, Dybowska, Dorota, Berak, Hanna, Parfieniuk-Kowerda, Anna, Klapaczyński, Jakub, Sitko, Marek, Sobala-Szczygieł, Barbara, Piekarska, Anna, Flisiak, Robert
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Baishideng Publishing Group Inc 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10122793/
https://www.ncbi.nlm.nih.gov/pubmed/37155527
http://dx.doi.org/10.3748/wjg.v29.i13.2015
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author Brzdęk, Michał
Zarębska-Michaluk, Dorota
Rzymski, Piotr
Lorenc, Beata
Kazek, Adam
Tudrujek-Zdunek, Magdalena
Janocha-Litwin, Justyna
Mazur, Włodzimierz
Dybowska, Dorota
Berak, Hanna
Parfieniuk-Kowerda, Anna
Klapaczyński, Jakub
Sitko, Marek
Sobala-Szczygieł, Barbara
Piekarska, Anna
Flisiak, Robert
author_facet Brzdęk, Michał
Zarębska-Michaluk, Dorota
Rzymski, Piotr
Lorenc, Beata
Kazek, Adam
Tudrujek-Zdunek, Magdalena
Janocha-Litwin, Justyna
Mazur, Włodzimierz
Dybowska, Dorota
Berak, Hanna
Parfieniuk-Kowerda, Anna
Klapaczyński, Jakub
Sitko, Marek
Sobala-Szczygieł, Barbara
Piekarska, Anna
Flisiak, Robert
author_sort Brzdęk, Michał
collection PubMed
description 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.
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spelling pubmed-101227932023-04-24 Changes in characteristics of patients with hepatitis C virus-related cirrhosis from the beginning of the interferon-free era Brzdęk, Michał Zarębska-Michaluk, Dorota Rzymski, Piotr Lorenc, Beata Kazek, Adam Tudrujek-Zdunek, Magdalena Janocha-Litwin, Justyna Mazur, Włodzimierz Dybowska, Dorota Berak, Hanna Parfieniuk-Kowerda, Anna Klapaczyński, Jakub Sitko, Marek Sobala-Szczygieł, Barbara Piekarska, Anna Flisiak, Robert World J Gastroenterol Observational Study 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. Baishideng Publishing Group Inc 2023-04-07 2023-04-07 /pmc/articles/PMC10122793/ /pubmed/37155527 http://dx.doi.org/10.3748/wjg.v29.i13.2015 Text en ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved. https://creativecommons.org/licenses/by-nc/4.0/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/
spellingShingle Observational Study
Brzdęk, Michał
Zarębska-Michaluk, Dorota
Rzymski, Piotr
Lorenc, Beata
Kazek, Adam
Tudrujek-Zdunek, Magdalena
Janocha-Litwin, Justyna
Mazur, Włodzimierz
Dybowska, Dorota
Berak, Hanna
Parfieniuk-Kowerda, Anna
Klapaczyński, Jakub
Sitko, Marek
Sobala-Szczygieł, Barbara
Piekarska, Anna
Flisiak, Robert
Changes in characteristics of patients with hepatitis C virus-related cirrhosis from the beginning of the interferon-free era
title Changes in characteristics of patients with hepatitis C virus-related cirrhosis from the beginning of the interferon-free era
title_full Changes in characteristics of patients with hepatitis C virus-related cirrhosis from the beginning of the interferon-free era
title_fullStr Changes in characteristics of patients with hepatitis C virus-related cirrhosis from the beginning of the interferon-free era
title_full_unstemmed Changes in characteristics of patients with hepatitis C virus-related cirrhosis from the beginning of the interferon-free era
title_short Changes in characteristics of patients with hepatitis C virus-related cirrhosis from the beginning of the interferon-free era
title_sort changes in characteristics of patients with hepatitis c virus-related cirrhosis from the beginning of the interferon-free era
topic Observational Study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10122793/
https://www.ncbi.nlm.nih.gov/pubmed/37155527
http://dx.doi.org/10.3748/wjg.v29.i13.2015
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