Experience of a Portuguese Center: Effectiveness of Direct-Acting Antiviral Therapy for Hepatitis C

Detalhes bibliográficos
Autor(a) principal: Falcão, Fátima
Data de Publicação: 2019
Outros Autores: Lopes, Carla, Viegas, Erica, Perez, Rita, Aldir, Isabel, Farinha, Helena, Carvalho, António, Mirco, Ana, Marques, Susana, Bana e Costa, Tiago, Miranda, Ana Cláudia, Lebre, Luís, Peixe, Paula, Chagas, Cristina, Mansinho, Kamal, Correia, José Manuel
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/10655
Resumo: Introduction: In late 2014, Portugal implemented a national program for the treatment of patients with chronic hepatitis C with directacting antiviral agents. This program has made Portugal one of the first European countries to implement a structured measure of treatment to eliminate this serious public health problem. The aim of this study was to assess the effectiveness of direct-acting antiviral therapy in the treatment of patients with chronic hepatitis C virus infection.Material and Methods: A retrospective observational study was conducted at Centro Hospitalar de Lisboa Ocidental on the national online platform from December 2014 until February 2017 and included patients with hepatitis C virus infection who underwent treatment. The primary endpoint was sustained virologic response at least 12 weeks post treatment. Data was analyzed with the SPSS 17.0 program.Results: During the study period, 820 patients completed therapy and achieved sufficient follow-up time to assess sustained virologic response with an overall response rate of 97.2% (n = 797) and a response rate of 98.0%, 99.5%, 90.9%, 95.1% and 94.2% for genotypes 1a, 1b, 2, 3 and 4, respectively. Data suggested that advanced fibrosis (F3/F4), human immunodeficiency virus co-infection and treatment failure with interferon and ribavirin were not negatively related with sustained virologic response in our population. Most patients (80.1%) completed treatment with ledipasvir/sofosbuvir ± ribavirin. The most common adverse events were fatigue and insomnia followed by headache and weight loss.Discussion: Patients predominantly had genotype 1 infection which correlates with HCV distribution in Europe, but we found a major proportion in genotype 4 which can be explained by immigration from African countries. Our patients’ ages ranging from 22 to 90 years, reflected a new approach with no upper age limit. Direct-acting antivirals regimens resulted in remarkably high SVR rates compared to interferon-based regimens, which were consistent with clinical trials data.Conclusion: Our data showed that direct-acting antiviral-based regimens are safe and have a high success rate in the treatment of patients with hepatitis C virus infection in a real-world setting.
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spelling Experience of a Portuguese Center: Effectiveness of Direct-Acting Antiviral Therapy for Hepatitis CExperiência de um Centro Português: Eficácia dos Antivirais de Acção Directa no Tratamento da Hepatite CAntiviral Agents/therapeutic useHepacivirus/drug effectsHepatitis C/drug therapyPortugalAntivirais/uso terapêutticoHepatite C Crónica/tratamentoPortugalVírus da Hepatite C/efeitos dos fármacosIntroduction: In late 2014, Portugal implemented a national program for the treatment of patients with chronic hepatitis C with directacting antiviral agents. This program has made Portugal one of the first European countries to implement a structured measure of treatment to eliminate this serious public health problem. The aim of this study was to assess the effectiveness of direct-acting antiviral therapy in the treatment of patients with chronic hepatitis C virus infection.Material and Methods: A retrospective observational study was conducted at Centro Hospitalar de Lisboa Ocidental on the national online platform from December 2014 until February 2017 and included patients with hepatitis C virus infection who underwent treatment. The primary endpoint was sustained virologic response at least 12 weeks post treatment. Data was analyzed with the SPSS 17.0 program.Results: During the study period, 820 patients completed therapy and achieved sufficient follow-up time to assess sustained virologic response with an overall response rate of 97.2% (n = 797) and a response rate of 98.0%, 99.5%, 90.9%, 95.1% and 94.2% for genotypes 1a, 1b, 2, 3 and 4, respectively. Data suggested that advanced fibrosis (F3/F4), human immunodeficiency virus co-infection and treatment failure with interferon and ribavirin were not negatively related with sustained virologic response in our population. Most patients (80.1%) completed treatment with ledipasvir/sofosbuvir ± ribavirin. The most common adverse events were fatigue and insomnia followed by headache and weight loss.Discussion: Patients predominantly had genotype 1 infection which correlates with HCV distribution in Europe, but we found a major proportion in genotype 4 which can be explained by immigration from African countries. Our patients’ ages ranging from 22 to 90 years, reflected a new approach with no upper age limit. Direct-acting antivirals regimens resulted in remarkably high SVR rates compared to interferon-based regimens, which were consistent with clinical trials data.Conclusion: Our data showed that direct-acting antiviral-based regimens are safe and have a high success rate in the treatment of patients with hepatitis C virus infection in a real-world setting.Introdução: No final de 2014 foi implementado em Portugal um programa nacional para o tratamento de doentes com infecção crónica por vírus da hepatite C com recurso a antivíricos de acção directa. Este programa fez com que Portugal fosse um dos primeiros países europeus a implementar uma medida estruturante para a eliminação da hepatite C. Este estudo tem como objectivo a avaliação da efectividade dos antivíricos de acção directa no tratamento da hepatite C crónica.Material e Métodos: Estudo retrospectivo observacional dos doentes seguidos no Centro Hospitalar de Lisboa Ocidental, entre dezembro de 2014 e fevereiro de 2017. O objectivo primário do estudo é avaliar a resposta virológica sustentada a partir das 12 semanas pós tratamento. Analisámos os dados com o programa SPSS 17.0.Resultados: Durante o período do estudo 820 doentes completaram o tratamento e o tempo necessário para avaliação da resposta virológica sustentada. A resposta virológica sustentada global foi de 97.2% (n = 797), com taxas de resposta de 97,2%, 98,5%, 90,9%, 95,1% e 94,2% para os genótipos 1a, 1b, 2, 3 e 4, respectivamente. Os dados sugerem não haver relação entre a fibrose avançada (F3 / F4), a coinfecção pelo vírus da imunodeficiência humana e a falência do tratamento com interferão e ribavirina e uma menor resposta ao tratamento. A maioria dos doentes (80,1%) concluiu o tratamento com ledipasvir/sofosbuvir ± ribavirina. Os eventos adversos mais frequentes foram a fadiga e a insónia, seguida de dor de cabeça e perda de peso.Discussão: A população em estudo apresentou maior prevalência de infecção pelo genótipo 1, à semelhança dos restantes países Europeus, contudo a prevalência do genótipo 4 foi superior, reflectindo a imigração africana. A faixa etária (22 - 90 anos) dos doentes tratados reflecte uma nova abordagem sem limite superior de idade. A taxa de RVS obtida, muito superior à obtida com regimes baseados em interferão, foi consistente com os dados dos ensaios clínicos.Conclusão: Os dados encontrados demonstram que os regimes baseados em antivirais de acção directa, em contexto de vida real, são seguros e eficazes no tratamento de doentes com infecção por vírus da hepatite C.Ordem dos Médicos2019-03-29info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfimage/pngimage/pngapplication/mswordapplication/mswordapplication/pdfapplication/pdfapplication/pdfapplication/pdfhttps://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655oai:ojs.www.actamedicaportuguesa.com:article/10655Acta Médica Portuguesa; Vol. 32 No. 3 (2019): March; 189-194Acta Médica Portuguesa; Vol. 32 N.º 3 (2019): Março; 189-1941646-07580870-399Xreponame: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/10655https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655/5637https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655/10323https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655/10324https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655/10325https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655/10326https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655/10349https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655/10350https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655/10458https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655/10774Direitos de Autor (c) 2019 Acta Médica Portuguesainfo:eu-repo/semantics/openAccessFalcão, FátimaLopes, CarlaViegas, EricaPerez, RitaAldir, IsabelFarinha, HelenaCarvalho, AntónioMirco, AnaMarques, SusanaBana e Costa, TiagoMiranda, Ana CláudiaLebre, LuísPeixe, PaulaChagas, CristinaMansinho, KamalCorreia, José Manuel2022-12-20T11:06:02Zoai:ojs.www.actamedicaportuguesa.com:article/10655Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T16:19:55.245404Repositório 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 Experience of a Portuguese Center: Effectiveness of Direct-Acting Antiviral Therapy for Hepatitis C
Experiência de um Centro Português: Eficácia dos Antivirais de Acção Directa no Tratamento da Hepatite C
title Experience of a Portuguese Center: Effectiveness of Direct-Acting Antiviral Therapy for Hepatitis C
spellingShingle Experience of a Portuguese Center: Effectiveness of Direct-Acting Antiviral Therapy for Hepatitis C
Falcão, Fátima
Antiviral Agents/therapeutic use
Hepacivirus/drug effects
Hepatitis C/drug therapy
Portugal
Antivirais/uso terapêuttico
Hepatite C Crónica/tratamento
Portugal
Vírus da Hepatite C/efeitos dos fármacos
title_short Experience of a Portuguese Center: Effectiveness of Direct-Acting Antiviral Therapy for Hepatitis C
title_full Experience of a Portuguese Center: Effectiveness of Direct-Acting Antiviral Therapy for Hepatitis C
title_fullStr Experience of a Portuguese Center: Effectiveness of Direct-Acting Antiviral Therapy for Hepatitis C
title_full_unstemmed Experience of a Portuguese Center: Effectiveness of Direct-Acting Antiviral Therapy for Hepatitis C
title_sort Experience of a Portuguese Center: Effectiveness of Direct-Acting Antiviral Therapy for Hepatitis C
author Falcão, Fátima
author_facet Falcão, Fátima
Lopes, Carla
Viegas, Erica
Perez, Rita
Aldir, Isabel
Farinha, Helena
Carvalho, António
Mirco, Ana
Marques, Susana
Bana e Costa, Tiago
Miranda, Ana Cláudia
Lebre, Luís
Peixe, Paula
Chagas, Cristina
Mansinho, Kamal
Correia, José Manuel
author_role author
author2 Lopes, Carla
Viegas, Erica
Perez, Rita
Aldir, Isabel
Farinha, Helena
Carvalho, António
Mirco, Ana
Marques, Susana
Bana e Costa, Tiago
Miranda, Ana Cláudia
Lebre, Luís
Peixe, Paula
Chagas, Cristina
Mansinho, Kamal
Correia, José Manuel
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Falcão, Fátima
Lopes, Carla
Viegas, Erica
Perez, Rita
Aldir, Isabel
Farinha, Helena
Carvalho, António
Mirco, Ana
Marques, Susana
Bana e Costa, Tiago
Miranda, Ana Cláudia
Lebre, Luís
Peixe, Paula
Chagas, Cristina
Mansinho, Kamal
Correia, José Manuel
dc.subject.por.fl_str_mv Antiviral Agents/therapeutic use
Hepacivirus/drug effects
Hepatitis C/drug therapy
Portugal
Antivirais/uso terapêuttico
Hepatite C Crónica/tratamento
Portugal
Vírus da Hepatite C/efeitos dos fármacos
topic Antiviral Agents/therapeutic use
Hepacivirus/drug effects
Hepatitis C/drug therapy
Portugal
Antivirais/uso terapêuttico
Hepatite C Crónica/tratamento
Portugal
Vírus da Hepatite C/efeitos dos fármacos
description Introduction: In late 2014, Portugal implemented a national program for the treatment of patients with chronic hepatitis C with directacting antiviral agents. This program has made Portugal one of the first European countries to implement a structured measure of treatment to eliminate this serious public health problem. The aim of this study was to assess the effectiveness of direct-acting antiviral therapy in the treatment of patients with chronic hepatitis C virus infection.Material and Methods: A retrospective observational study was conducted at Centro Hospitalar de Lisboa Ocidental on the national online platform from December 2014 until February 2017 and included patients with hepatitis C virus infection who underwent treatment. The primary endpoint was sustained virologic response at least 12 weeks post treatment. Data was analyzed with the SPSS 17.0 program.Results: During the study period, 820 patients completed therapy and achieved sufficient follow-up time to assess sustained virologic response with an overall response rate of 97.2% (n = 797) and a response rate of 98.0%, 99.5%, 90.9%, 95.1% and 94.2% for genotypes 1a, 1b, 2, 3 and 4, respectively. Data suggested that advanced fibrosis (F3/F4), human immunodeficiency virus co-infection and treatment failure with interferon and ribavirin were not negatively related with sustained virologic response in our population. Most patients (80.1%) completed treatment with ledipasvir/sofosbuvir ± ribavirin. The most common adverse events were fatigue and insomnia followed by headache and weight loss.Discussion: Patients predominantly had genotype 1 infection which correlates with HCV distribution in Europe, but we found a major proportion in genotype 4 which can be explained by immigration from African countries. Our patients’ ages ranging from 22 to 90 years, reflected a new approach with no upper age limit. Direct-acting antivirals regimens resulted in remarkably high SVR rates compared to interferon-based regimens, which were consistent with clinical trials data.Conclusion: Our data showed that direct-acting antiviral-based regimens are safe and have a high success rate in the treatment of patients with hepatitis C virus infection in a real-world setting.
publishDate 2019
dc.date.none.fl_str_mv 2019-03-29
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https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655/10323
https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655/10324
https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655/10325
https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655/10326
https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655/10349
https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655/10350
https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655/10458
https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/10655/10774
dc.rights.driver.fl_str_mv Direitos de Autor (c) 2019 Acta Médica Portuguesa
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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; Vol. 32 No. 3 (2019): March; 189-194
Acta Médica Portuguesa; Vol. 32 N.º 3 (2019): Março; 189-194
1646-0758
0870-399X
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