Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in Portugal
Autor(a) principal: | |
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Data de Publicação: | 2024 |
Outros Autores: | , , , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/19178 |
Resumo: | Introduction: Information about pan-genotypic treatments for hepatitis in Portugal is scarce. We aimed to evaluate the effectiveness and safety of glecaprevir plus pibrentasvir (GLE/PIB) treatment for hepatitis C virus (HCV) infection in real-world clinical practice.Methods: An observational prospective study was implemented in six hospitals with 121 adult HCV patients who initiated treatment with GLE/PIB between October 2018 and April 2019, according to clinical practice. Eligible patients had confirmed HCV infection genotype (GT) 1 to 6 and were either treatment-naïve or had experience with interferon-, ribavirin- or sofosbuvir-based regimens, with or without compensated cirrhosis. Baseline sociodemographic and safety data are described for the total population (N = 115). Effectiveness [sustained virologic response 12 weeks after treatment (SVR12)] and patient-reported outcomes are presented for the core population with sufficient follow-up data (n = 97).Results: Most patients were male (83.5%), aged < 65 years (94.8%), with current or former alcohol consumption (77.3%), illicit drug use (72.6%), and HCV acquisition through intravenous drug use (62.0%). HIV co-infection occurred in 22.6% of patients. The prevalence of each GT was: GT1 51.3%, GT2 1.7%, GT3 30.4%, GT4 16.5%, and GT5.6 0%. Most patients were non-cirrhotic (80.9%) and treatment-naïve (93.8%). The SVR12 rates were 97.9% (95% CI: 92.8 - 99.4), and > 95% across cirrhosis status, GT, illicit drug use, alcohol consumption, and HCV treatment experience. The adverse event rate was 2.6%, and no patient discontinued treatment due to adverse events related to GLE/PIB.Conclusion: Consistent with other real-world studies and clinical trials, treatment with GLE/PIB showed high effectiveness and tolerability overall and in difficult-to-treat subgroups (ClinicalTrials.gov: NCT03303599). |
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Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in PortugalEfetividade e Segurança de Glecaprevir/Pibrentasvir para Tratamento de Hepatite C Crónica: Um Estudo de Coorte Prospetiva em PortugalGenotypeGlecaprevirHepatitis C, Chronic/drug therapyPibrentasvirPortugalTreatment OutcomeGenótipoGlecaprevirHepatite C Crónica/tratamento farmacológicoPibrentasvirPortugalResultado do TratamentoIntroduction: Information about pan-genotypic treatments for hepatitis in Portugal is scarce. We aimed to evaluate the effectiveness and safety of glecaprevir plus pibrentasvir (GLE/PIB) treatment for hepatitis C virus (HCV) infection in real-world clinical practice.Methods: An observational prospective study was implemented in six hospitals with 121 adult HCV patients who initiated treatment with GLE/PIB between October 2018 and April 2019, according to clinical practice. Eligible patients had confirmed HCV infection genotype (GT) 1 to 6 and were either treatment-naïve or had experience with interferon-, ribavirin- or sofosbuvir-based regimens, with or without compensated cirrhosis. Baseline sociodemographic and safety data are described for the total population (N = 115). Effectiveness [sustained virologic response 12 weeks after treatment (SVR12)] and patient-reported outcomes are presented for the core population with sufficient follow-up data (n = 97).Results: Most patients were male (83.5%), aged < 65 years (94.8%), with current or former alcohol consumption (77.3%), illicit drug use (72.6%), and HCV acquisition through intravenous drug use (62.0%). HIV co-infection occurred in 22.6% of patients. The prevalence of each GT was: GT1 51.3%, GT2 1.7%, GT3 30.4%, GT4 16.5%, and GT5.6 0%. Most patients were non-cirrhotic (80.9%) and treatment-naïve (93.8%). The SVR12 rates were 97.9% (95% CI: 92.8 - 99.4), and > 95% across cirrhosis status, GT, illicit drug use, alcohol consumption, and HCV treatment experience. The adverse event rate was 2.6%, and no patient discontinued treatment due to adverse events related to GLE/PIB.Conclusion: Consistent with other real-world studies and clinical trials, treatment with GLE/PIB showed high effectiveness and tolerability overall and in difficult-to-treat subgroups (ClinicalTrials.gov: NCT03303599).Introdução: A informação sobre os tratamentos pan-genotípicos da hepatite em Portugal é escassa. Pretendeu-se avaliar a efetividade e segurança do glecaprevir+pibrentasvir (GLE/PIB) para tratamento da infeção por vírus da hepatite C (VHC), na prática clínica habitual em Portugal.Métodos: Estudo prospetivo observacional em seis hospitais, com 121 adultos com hepatite C que iniciaram GLE/PIB entre outubro 2018 e abril 2019, conforme a prática clínica habitual. Os doentes elegíveis tinham infeção por VHC de genótipo (GT) 1 a 6, independentemente de ter ou não cirrose compensada e tratamento prévio. Os dados sociodemográficos e de segurança foram descritos para a população total (N = 115). As taxas de resposta virológica sustentada às 12 semanas (RVS12) foram apresentadas para a população com seguimento completo (n = 97).Resultados: A maioria dos doentes eram homens (83,5%), < 65 anos (94,8%), consumo atual ou anterior de álcool (77,3%) e de substâncias ilícitas (72,6%), e infeção VHC adquirida por agulha contaminada/uso de substâncias intravenosas (62,0%); 22,6% era co-infetado com VIH. A prevalência de GT1 foi de 51,3%, GT2 1,7%, GT3 30,4%, GT4 16,5% e GT5,6 0%. A maioria não tinha cirrose (80,9%) nem tratamento prévio (93,8%). As taxas de RVS12 foram de 97,9% (IC de 95%: 92,8 - 99,4) no geral e > 95% nos subgrupos com cirrose, GT3, uso de substâncias ilícitas, alcoolismo e tratamento prévio. A taxa de eventos adversos foi de 2,6% e nenhum doente interrompeu o tratamento devido a eventos adversos. A qualidade de vida, produtividade e fadiga melhoraram após tratamento.Conclusão: Em linha com outros estudos, o tratamento com GLE/PIB mostrou alta eficácia e tolerabilidade, no geral e por subgrupos de doentes de difícil tratamento (ClinicalTrials.gov: NCT03303599).Ordem dos Médicos2024-02-07info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfapplication/pdfhttps://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/19178Acta Médica Portuguesa; In PressActa Médica Portuguesa; In Press1646-07580870-399Xreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAPenghttps://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/19178https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/19178/15303https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/19178/15304Direitos de Autor (c) 2024 Acta Médica Portuguesainfo:eu-repo/semantics/openAccessVera, JoséGomes, AndréPóvoas, DianaSeixas, DianaMaltez, FernandoPedroto, IsabelMaia, LuísMota, MargaridaVieira, Maria JoãoManata, Maria JoséFerreira, PaulaLino, SaraPereira Guedes, TiagoBarradas, VâniaMarques, Nuno2024-03-03T03:00:57Zoai:ojs.www.actamedicaportuguesa.com:article/19178Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T02:37:44.388230Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in Portugal Efetividade e Segurança de Glecaprevir/Pibrentasvir para Tratamento de Hepatite C Crónica: Um Estudo de Coorte Prospetiva em Portugal |
title |
Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in Portugal |
spellingShingle |
Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in Portugal Vera, José Genotype Glecaprevir Hepatitis C, Chronic/drug therapy Pibrentasvir Portugal Treatment Outcome Genótipo Glecaprevir Hepatite C Crónica/tratamento farmacológico Pibrentasvir Portugal Resultado do Tratamento |
title_short |
Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in Portugal |
title_full |
Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in Portugal |
title_fullStr |
Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in Portugal |
title_full_unstemmed |
Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in Portugal |
title_sort |
Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in Portugal |
author |
Vera, José |
author_facet |
Vera, José Gomes, André Póvoas, Diana Seixas, Diana Maltez, Fernando Pedroto, Isabel Maia, Luís Mota, Margarida Vieira, Maria João Manata, Maria José Ferreira, Paula Lino, Sara Pereira Guedes, Tiago Barradas, Vânia Marques, Nuno |
author_role |
author |
author2 |
Gomes, André Póvoas, Diana Seixas, Diana Maltez, Fernando Pedroto, Isabel Maia, Luís Mota, Margarida Vieira, Maria João Manata, Maria José Ferreira, Paula Lino, Sara Pereira Guedes, Tiago Barradas, Vânia Marques, Nuno |
author2_role |
author author author author author author author author author author author author author author |
dc.contributor.author.fl_str_mv |
Vera, José Gomes, André Póvoas, Diana Seixas, Diana Maltez, Fernando Pedroto, Isabel Maia, Luís Mota, Margarida Vieira, Maria João Manata, Maria José Ferreira, Paula Lino, Sara Pereira Guedes, Tiago Barradas, Vânia Marques, Nuno |
dc.subject.por.fl_str_mv |
Genotype Glecaprevir Hepatitis C, Chronic/drug therapy Pibrentasvir Portugal Treatment Outcome Genótipo Glecaprevir Hepatite C Crónica/tratamento farmacológico Pibrentasvir Portugal Resultado do Tratamento |
topic |
Genotype Glecaprevir Hepatitis C, Chronic/drug therapy Pibrentasvir Portugal Treatment Outcome Genótipo Glecaprevir Hepatite C Crónica/tratamento farmacológico Pibrentasvir Portugal Resultado do Tratamento |
description |
Introduction: Information about pan-genotypic treatments for hepatitis in Portugal is scarce. We aimed to evaluate the effectiveness and safety of glecaprevir plus pibrentasvir (GLE/PIB) treatment for hepatitis C virus (HCV) infection in real-world clinical practice.Methods: An observational prospective study was implemented in six hospitals with 121 adult HCV patients who initiated treatment with GLE/PIB between October 2018 and April 2019, according to clinical practice. Eligible patients had confirmed HCV infection genotype (GT) 1 to 6 and were either treatment-naïve or had experience with interferon-, ribavirin- or sofosbuvir-based regimens, with or without compensated cirrhosis. Baseline sociodemographic and safety data are described for the total population (N = 115). Effectiveness [sustained virologic response 12 weeks after treatment (SVR12)] and patient-reported outcomes are presented for the core population with sufficient follow-up data (n = 97).Results: Most patients were male (83.5%), aged < 65 years (94.8%), with current or former alcohol consumption (77.3%), illicit drug use (72.6%), and HCV acquisition through intravenous drug use (62.0%). HIV co-infection occurred in 22.6% of patients. The prevalence of each GT was: GT1 51.3%, GT2 1.7%, GT3 30.4%, GT4 16.5%, and GT5.6 0%. Most patients were non-cirrhotic (80.9%) and treatment-naïve (93.8%). The SVR12 rates were 97.9% (95% CI: 92.8 - 99.4), and > 95% across cirrhosis status, GT, illicit drug use, alcohol consumption, and HCV treatment experience. The adverse event rate was 2.6%, and no patient discontinued treatment due to adverse events related to GLE/PIB.Conclusion: Consistent with other real-world studies and clinical trials, treatment with GLE/PIB showed high effectiveness and tolerability overall and in difficult-to-treat subgroups (ClinicalTrials.gov: NCT03303599). |
publishDate |
2024 |
dc.date.none.fl_str_mv |
2024-02-07 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/19178 |
url |
https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/19178 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/19178 https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/19178/15303 https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/19178/15304 |
dc.rights.driver.fl_str_mv |
Direitos de Autor (c) 2024 Acta Médica Portuguesa info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Direitos de Autor (c) 2024 Acta Médica Portuguesa |
eu_rights_str_mv |
openAccess |
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application/pdf application/pdf |
dc.publisher.none.fl_str_mv |
Ordem dos Médicos |
publisher.none.fl_str_mv |
Ordem dos Médicos |
dc.source.none.fl_str_mv |
Acta Médica Portuguesa; In Press Acta Médica Portuguesa; In Press 1646-0758 0870-399X reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
instacron_str |
RCAAP |
institution |
RCAAP |
reponame_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
collection |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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1799137428428029952 |