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Pan-Genotypic Direct-Acting Antiviral Agents for Undetermined or Mixed-Genotype Hepatitis C Infection: A Real-World Multi-Center Effectiveness Analysis

Although the pan-genotypic direct-acting antiviral regimen was approved for treating chronic hepatitis C infection regardless of the hepatitis C virus (HCV) genotype, real-world data on its effectiveness against mixed-genotype or genotype-undetermined HCV infection are scarce. We evaluated the real-...

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Autores principales: Yen, Hsu-Heng, Chen, Yang-Yuan, Lai, Jun-Hung, Chen, Hung-Ming, Yao, Chih-Ta, Huang, Siou-Ping, Liu, I-Ling, Zeng, Ya-Huei, Yang, Fang-Chi, Siao, Fu-Yuan, Chen, Mei-Wen, Su, Pei-Yuan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8999637/
https://www.ncbi.nlm.nih.gov/pubmed/35407462
http://dx.doi.org/10.3390/jcm11071853
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author Yen, Hsu-Heng
Chen, Yang-Yuan
Lai, Jun-Hung
Chen, Hung-Ming
Yao, Chih-Ta
Huang, Siou-Ping
Liu, I-Ling
Zeng, Ya-Huei
Yang, Fang-Chi
Siao, Fu-Yuan
Chen, Mei-Wen
Su, Pei-Yuan
author_facet Yen, Hsu-Heng
Chen, Yang-Yuan
Lai, Jun-Hung
Chen, Hung-Ming
Yao, Chih-Ta
Huang, Siou-Ping
Liu, I-Ling
Zeng, Ya-Huei
Yang, Fang-Chi
Siao, Fu-Yuan
Chen, Mei-Wen
Su, Pei-Yuan
author_sort Yen, Hsu-Heng
collection PubMed
description Although the pan-genotypic direct-acting antiviral regimen was approved for treating chronic hepatitis C infection regardless of the hepatitis C virus (HCV) genotype, real-world data on its effectiveness against mixed-genotype or genotype-undetermined HCV infection are scarce. We evaluated the real-world safety and efficacy of two pan-genotypic regimens (Glecaprevir/Pibrentasvir and Sofosbuvir/Velpatasvir) for HCV-infected patients with mixed or undetermined HCV genotypes from the five hospitals in the Changhua Christian Care System that commenced treatment between August 2018 and December 2020. This retrospective study evaluated the efficacy and safety of pan-genotypic direct-acting antiviral (DAA) treatment in adults with HCV infection. The primary endpoint was the sustained virological response (SVR) observed 12 weeks after completing the treatment. Altogether, 2446 HCV-infected patients received the pan-genotypic DAA regimen, 37 (1.5%) patients had mixed-genotype HCV infections and 110 (4.5%) patients had undetermined HCV genotypes. The mean age was 63 years and 55.8% of our participants were males. Nine (6.1%) patients had end-stage renal disease and three (2%) had co-existing hepatomas. We lost one patient to follow-up during treatment and one more patient after treatment. A total of four patients died. However, none of these losses were due to treatment-related side effects. The rates of SVR12 for mixed-genotype and genotype-undetermined infections were 97.1% and 96.2%, respectively, by per-protocol analyses, and 91.9% and 92.7% respectively, by intention-to-treat population analyses. Laboratory adverse events with grades ≥3 included anemia (2.5%), thrombocytopenia (2.5%), and jaundice (0.7%). Pan-genotypic DAAs are effective and well-tolerated for mixed-genotype or genotype-undetermined HCV infection real-world settings.
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spelling pubmed-89996372022-04-12 Pan-Genotypic Direct-Acting Antiviral Agents for Undetermined or Mixed-Genotype Hepatitis C Infection: A Real-World Multi-Center Effectiveness Analysis Yen, Hsu-Heng Chen, Yang-Yuan Lai, Jun-Hung Chen, Hung-Ming Yao, Chih-Ta Huang, Siou-Ping Liu, I-Ling Zeng, Ya-Huei Yang, Fang-Chi Siao, Fu-Yuan Chen, Mei-Wen Su, Pei-Yuan J Clin Med Article Although the pan-genotypic direct-acting antiviral regimen was approved for treating chronic hepatitis C infection regardless of the hepatitis C virus (HCV) genotype, real-world data on its effectiveness against mixed-genotype or genotype-undetermined HCV infection are scarce. We evaluated the real-world safety and efficacy of two pan-genotypic regimens (Glecaprevir/Pibrentasvir and Sofosbuvir/Velpatasvir) for HCV-infected patients with mixed or undetermined HCV genotypes from the five hospitals in the Changhua Christian Care System that commenced treatment between August 2018 and December 2020. This retrospective study evaluated the efficacy and safety of pan-genotypic direct-acting antiviral (DAA) treatment in adults with HCV infection. The primary endpoint was the sustained virological response (SVR) observed 12 weeks after completing the treatment. Altogether, 2446 HCV-infected patients received the pan-genotypic DAA regimen, 37 (1.5%) patients had mixed-genotype HCV infections and 110 (4.5%) patients had undetermined HCV genotypes. The mean age was 63 years and 55.8% of our participants were males. Nine (6.1%) patients had end-stage renal disease and three (2%) had co-existing hepatomas. We lost one patient to follow-up during treatment and one more patient after treatment. A total of four patients died. However, none of these losses were due to treatment-related side effects. The rates of SVR12 for mixed-genotype and genotype-undetermined infections were 97.1% and 96.2%, respectively, by per-protocol analyses, and 91.9% and 92.7% respectively, by intention-to-treat population analyses. Laboratory adverse events with grades ≥3 included anemia (2.5%), thrombocytopenia (2.5%), and jaundice (0.7%). Pan-genotypic DAAs are effective and well-tolerated for mixed-genotype or genotype-undetermined HCV infection real-world settings. MDPI 2022-03-27 /pmc/articles/PMC8999637/ /pubmed/35407462 http://dx.doi.org/10.3390/jcm11071853 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Yen, Hsu-Heng
Chen, Yang-Yuan
Lai, Jun-Hung
Chen, Hung-Ming
Yao, Chih-Ta
Huang, Siou-Ping
Liu, I-Ling
Zeng, Ya-Huei
Yang, Fang-Chi
Siao, Fu-Yuan
Chen, Mei-Wen
Su, Pei-Yuan
Pan-Genotypic Direct-Acting Antiviral Agents for Undetermined or Mixed-Genotype Hepatitis C Infection: A Real-World Multi-Center Effectiveness Analysis
title Pan-Genotypic Direct-Acting Antiviral Agents for Undetermined or Mixed-Genotype Hepatitis C Infection: A Real-World Multi-Center Effectiveness Analysis
title_full Pan-Genotypic Direct-Acting Antiviral Agents for Undetermined or Mixed-Genotype Hepatitis C Infection: A Real-World Multi-Center Effectiveness Analysis
title_fullStr Pan-Genotypic Direct-Acting Antiviral Agents for Undetermined or Mixed-Genotype Hepatitis C Infection: A Real-World Multi-Center Effectiveness Analysis
title_full_unstemmed Pan-Genotypic Direct-Acting Antiviral Agents for Undetermined or Mixed-Genotype Hepatitis C Infection: A Real-World Multi-Center Effectiveness Analysis
title_short Pan-Genotypic Direct-Acting Antiviral Agents for Undetermined or Mixed-Genotype Hepatitis C Infection: A Real-World Multi-Center Effectiveness Analysis
title_sort pan-genotypic direct-acting antiviral agents for undetermined or mixed-genotype hepatitis c infection: a real-world multi-center effectiveness analysis
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8999637/
https://www.ncbi.nlm.nih.gov/pubmed/35407462
http://dx.doi.org/10.3390/jcm11071853
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