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Safety analysis of glecaprevir/pibrentasvir in patients with markers of advanced liver disease in clinical and real‐world cohorts

Chronic hepatitis C virus (HCV) infection has the greatest health impact in patients with advanced liver disease. The direct‐acting antiviral (DAA) regimen glecaprevir/pibrentasvir (G/P) is approved for treatment of HCV‐infected patients without cirrhosis and with compensated cirrhosis. However, eve...

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Autores principales: Feld, Jordan J., Forns, Xavier, Dylla, Douglas E., Kumada, Hiromitsu, de Ledinghen, Victor, Wei, Lai, Brown, Robert S., Flisiak, Robert, Lampertico, Pietro, Thabut, Dominique, Bondin, Mark, Tatsch, Fernando, Burroughs, Margaret, Marcinak, John, Zhang, Zhenzhen, Emmett, Amanda, Jacobson, Ira M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9827821/
https://www.ncbi.nlm.nih.gov/pubmed/36036117
http://dx.doi.org/10.1111/jvh.13738
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author Feld, Jordan J.
Forns, Xavier
Dylla, Douglas E.
Kumada, Hiromitsu
de Ledinghen, Victor
Wei, Lai
Brown, Robert S.
Flisiak, Robert
Lampertico, Pietro
Thabut, Dominique
Bondin, Mark
Tatsch, Fernando
Burroughs, Margaret
Marcinak, John
Zhang, Zhenzhen
Emmett, Amanda
Jacobson, Ira M.
author_facet Feld, Jordan J.
Forns, Xavier
Dylla, Douglas E.
Kumada, Hiromitsu
de Ledinghen, Victor
Wei, Lai
Brown, Robert S.
Flisiak, Robert
Lampertico, Pietro
Thabut, Dominique
Bondin, Mark
Tatsch, Fernando
Burroughs, Margaret
Marcinak, John
Zhang, Zhenzhen
Emmett, Amanda
Jacobson, Ira M.
author_sort Feld, Jordan J.
collection PubMed
description Chronic hepatitis C virus (HCV) infection has the greatest health impact in patients with advanced liver disease. The direct‐acting antiviral (DAA) regimen glecaprevir/pibrentasvir (G/P) is approved for treatment of HCV‐infected patients without cirrhosis and with compensated cirrhosis. However, events of liver decompensation/failure have been reported in patients treated with protease‐inhibitor–containing DAA regimens, often in patients with advanced liver disease. This study examines the safety of on‐label G/P treatment in patients with compensated cirrhosis (F4 at baseline) with markers of advanced liver disease. Patients with cirrhosis were categorized into 4 subgroups, based on different noninvasive markers of advanced liver disease identified using laboratory measures: platelet count < or ≥ 100 × 10(9)/L, and Child‐Pugh score 5 or 6. Separate analyses were performed using pooled data from clinical trials and from real‐world post‐marketing observational studies. G/P was well tolerated in patients with platelet count ≥100 × 10(9)/L (n = 800), platelet count <100 × 10(9)/L (n = 215), a Child‐Pugh score of 5 (n = 915) and a Child‐Pugh score of 6 (n = 95). In the clinical trial and real‐world cohorts two patients and no patients experienced a serious adverse event (AE) possibly related to study drug, respectively; three patients and no patients experienced an AE of special interest for hepatic decompensation and hepatic failure. This analysis reaffirms G/P's safety profile in indicated patients with compensated cirrhosis, including those with markers of more advanced liver disease. Increasing the number of patients treated with short‐duration G/P therapy may contribute to meeting HCV elimination targets.
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spelling pubmed-98278212023-01-10 Safety analysis of glecaprevir/pibrentasvir in patients with markers of advanced liver disease in clinical and real‐world cohorts Feld, Jordan J. Forns, Xavier Dylla, Douglas E. Kumada, Hiromitsu de Ledinghen, Victor Wei, Lai Brown, Robert S. Flisiak, Robert Lampertico, Pietro Thabut, Dominique Bondin, Mark Tatsch, Fernando Burroughs, Margaret Marcinak, John Zhang, Zhenzhen Emmett, Amanda Jacobson, Ira M. J Viral Hepat Original Articles Chronic hepatitis C virus (HCV) infection has the greatest health impact in patients with advanced liver disease. The direct‐acting antiviral (DAA) regimen glecaprevir/pibrentasvir (G/P) is approved for treatment of HCV‐infected patients without cirrhosis and with compensated cirrhosis. However, events of liver decompensation/failure have been reported in patients treated with protease‐inhibitor–containing DAA regimens, often in patients with advanced liver disease. This study examines the safety of on‐label G/P treatment in patients with compensated cirrhosis (F4 at baseline) with markers of advanced liver disease. Patients with cirrhosis were categorized into 4 subgroups, based on different noninvasive markers of advanced liver disease identified using laboratory measures: platelet count < or ≥ 100 × 10(9)/L, and Child‐Pugh score 5 or 6. Separate analyses were performed using pooled data from clinical trials and from real‐world post‐marketing observational studies. G/P was well tolerated in patients with platelet count ≥100 × 10(9)/L (n = 800), platelet count <100 × 10(9)/L (n = 215), a Child‐Pugh score of 5 (n = 915) and a Child‐Pugh score of 6 (n = 95). In the clinical trial and real‐world cohorts two patients and no patients experienced a serious adverse event (AE) possibly related to study drug, respectively; three patients and no patients experienced an AE of special interest for hepatic decompensation and hepatic failure. This analysis reaffirms G/P's safety profile in indicated patients with compensated cirrhosis, including those with markers of more advanced liver disease. Increasing the number of patients treated with short‐duration G/P therapy may contribute to meeting HCV elimination targets. John Wiley and Sons Inc. 2022-10-06 2022-12 /pmc/articles/PMC9827821/ /pubmed/36036117 http://dx.doi.org/10.1111/jvh.13738 Text en © 2022 The Authors. Journal of Viral Hepatitis published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Articles
Feld, Jordan J.
Forns, Xavier
Dylla, Douglas E.
Kumada, Hiromitsu
de Ledinghen, Victor
Wei, Lai
Brown, Robert S.
Flisiak, Robert
Lampertico, Pietro
Thabut, Dominique
Bondin, Mark
Tatsch, Fernando
Burroughs, Margaret
Marcinak, John
Zhang, Zhenzhen
Emmett, Amanda
Jacobson, Ira M.
Safety analysis of glecaprevir/pibrentasvir in patients with markers of advanced liver disease in clinical and real‐world cohorts
title Safety analysis of glecaprevir/pibrentasvir in patients with markers of advanced liver disease in clinical and real‐world cohorts
title_full Safety analysis of glecaprevir/pibrentasvir in patients with markers of advanced liver disease in clinical and real‐world cohorts
title_fullStr Safety analysis of glecaprevir/pibrentasvir in patients with markers of advanced liver disease in clinical and real‐world cohorts
title_full_unstemmed Safety analysis of glecaprevir/pibrentasvir in patients with markers of advanced liver disease in clinical and real‐world cohorts
title_short Safety analysis of glecaprevir/pibrentasvir in patients with markers of advanced liver disease in clinical and real‐world cohorts
title_sort safety analysis of glecaprevir/pibrentasvir in patients with markers of advanced liver disease in clinical and real‐world cohorts
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9827821/
https://www.ncbi.nlm.nih.gov/pubmed/36036117
http://dx.doi.org/10.1111/jvh.13738
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