Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in Portugal
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 prosp...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Ordem dos Médicos
2024-02-01
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| Series: | Acta Médica Portuguesa |
| Subjects: | |
| Online Access: | https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/19178 |
| _version_ | 1827356370872041472 |
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| author | José Vera André Gomes Diana Póvoas Diana Seixas Fernando Maltez Isabel Pedroto Luís Maia Margarida Mota Maria João Vieira Maria José Manata Paula Ferreira Sara Lino Tiago Pereira Guedes Vânia Barradas Nuno Marques |
| author_facet | José Vera André Gomes Diana Póvoas Diana Seixas Fernando Maltez Isabel Pedroto Luís Maia Margarida Mota Maria João Vieira Maria José Manata Paula Ferreira Sara Lino Tiago Pereira Guedes Vânia Barradas Nuno Marques |
| author_sort | José Vera |
| collection | DOAJ |
| 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).
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| first_indexed | 2024-03-08T04:59:46Z |
| format | Article |
| id | doaj.art-c6949422f29c4c0cb3dfbb11673ce691 |
| institution | Directory Open Access Journal |
| issn | 0870-399X 1646-0758 |
| language | English |
| last_indexed | 2024-03-08T04:59:46Z |
| publishDate | 2024-02-01 |
| publisher | Ordem dos Médicos |
| record_format | Article |
| series | Acta Médica Portuguesa |
| spelling | doaj.art-c6949422f29c4c0cb3dfbb11673ce6912024-02-07T14:34:50ZengOrdem dos MédicosActa Médica Portuguesa0870-399X1646-07582024-02-0110.20344/amp.19178Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in PortugalJosé Vera0André Gomes1Diana Póvoas2Diana Seixas3Fernando Maltez4Isabel Pedroto5Luís Maia6Margarida Mota7Maria João Vieira8Maria José Manata9Paula Ferreira10Sara Lino11Tiago Pereira Guedes12Vânia Barradas13Nuno Marques14Centro Hospitalar Barreiro-Montijo. Barreiro. Hospital Garcia de Orta. Almada. Centro Hospitalar Lisboa Central. Lisboa.Centro Hospitalar Lisboa Central. Lisboa.Centro Hospitalar Lisboa Central. Lisboa. Centro Hospitalar Universitário Porto. Porto.Centro Hospitalar Universitário Porto. Porto.Centro Hospitalar Vila Nova de Gaia/Espinho. Vila Nova de Gaia.Centro Hospitalar Barreiro-Montijo. Barreiro.Centro Hospitalar Lisboa Central. Lisboa.Centro Hospitalar Lisboa Norte. Lisboa. Centro Hospitalar Lisboa Central. Lisboa.Centro Hospitalar Universitário Porto. Porto. Centro Hospitalar Barreiro-Montijo. Barreiro. Hospital Garcia de Orta. Almada. 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). https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/19178GenotypeGlecaprevirHepatitis C, Chronic/drug therapyPibrentasvirPortugalTreatment Outcome |
| spellingShingle | José Vera André Gomes Diana Póvoas Diana Seixas Fernando Maltez Isabel Pedroto Luís Maia Margarida Mota Maria João Vieira Maria José Manata Paula Ferreira Sara Lino Tiago Pereira Guedes Vânia Barradas Nuno Marques Real-World Effectiveness and Safety of Glecaprevir/Pibrentasvir for the Treatment of Chronic Hepatitis C: A Prospective Cohort Study in Portugal Acta Médica Portuguesa Genotype Glecaprevir Hepatitis C, Chronic/drug therapy Pibrentasvir Portugal Treatment Outcome |
| title | 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_short | 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 |
| topic | Genotype Glecaprevir Hepatitis C, Chronic/drug therapy Pibrentasvir Portugal Treatment Outcome |
| url | https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/19178 |
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