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Safety and effectiveness of 8 weeks of Glecaprevir/Pibrentasvir in challenging HCV patients: Italian data from the CREST study

INTRODUCTION: Glecaprevir/pibrentasvir (G/P) has demonstrated high rates (>95%) of sustained virologic response at posttreatment Week 12 (SVR12) in treatment-naïve (TN) patients with hepatitis C virus (HCV) infection and compensated cirrhosis (CC). Here, in a key real-world subset of TN Italian p...

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Autores principales: Aghemo, Alessio, Persico, Marcello, D’Ambrosio, Roberta, Andreoni, Massimo, Villa, Erica, Bhagat, Abhi, Gallinaro, Valentina, Gualberti, Giuliana, Merolla, Rocco Cosimo Damiano, Gasbarrini, Antonio
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9894491/
https://www.ncbi.nlm.nih.gov/pubmed/36730135
http://dx.doi.org/10.1371/journal.pone.0280165
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author Aghemo, Alessio
Persico, Marcello
D’Ambrosio, Roberta
Andreoni, Massimo
Villa, Erica
Bhagat, Abhi
Gallinaro, Valentina
Gualberti, Giuliana
Merolla, Rocco Cosimo Damiano
Gasbarrini, Antonio
author_facet Aghemo, Alessio
Persico, Marcello
D’Ambrosio, Roberta
Andreoni, Massimo
Villa, Erica
Bhagat, Abhi
Gallinaro, Valentina
Gualberti, Giuliana
Merolla, Rocco Cosimo Damiano
Gasbarrini, Antonio
author_sort Aghemo, Alessio
collection PubMed
description INTRODUCTION: Glecaprevir/pibrentasvir (G/P) has demonstrated high rates (>95%) of sustained virologic response at posttreatment Week 12 (SVR12) in treatment-naïve (TN) patients with hepatitis C virus (HCV) infection and compensated cirrhosis (CC). Here, in a key real-world subset of TN Italian patients with CC, we evaluated the effectiveness and safety of 8-week G/P treatment, including subgroups of interest such as those with genotype 3 (GT3) infection, elderly patients, and those with more advanced liver disease. METHODS: Subanalysis of Italian patients enrolled in the CREST study. The full analysis set (FAS) included all patients enrolled in the study; the modified analysis set (MAS) excluded patients who discontinued G/P for nonvirologic failure or who had missing SVR12 results. Primary and secondary endpoints included SVR12 and safety, respectively. RESULTS: Of 42 patients included in the FAS, 1 discontinued for unknown reasons, and 2 had missing SVR12 data, leaving 39 patients included in the MAS. At treatment initiation, 74% of patients had ≥1 comorbidity, and 62% were receiving concomitant medications, including some that may potentially interact with G/P. SVR12 was achieved in 100% of patients in the MAS, and in 95% in the FAS. In subgroups of interest, the proportion of patients achieving SVR12 in the MAS (and FAS) was: 100% (94%) for patients ≥65 years, 100% (86%) for GT3, and 100% (100%) for patients with platelet count <150 × 10(9)/L and FibroScan(®) >20 kPa. Overall, 2 (5%) patients had an adverse event and neither were serious. CONCLUSION: Results from this real-world Italian cohort demonstrated the safety and effectiveness of 8-week G/P, with SVR12 rate >95%, even in elderly patients. These findings further support real-world evidence of the use of short-course G/P treatment in all patients with CC, including those with GT3, and those with advanced liver disease.
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spelling pubmed-98944912023-02-03 Safety and effectiveness of 8 weeks of Glecaprevir/Pibrentasvir in challenging HCV patients: Italian data from the CREST study Aghemo, Alessio Persico, Marcello D’Ambrosio, Roberta Andreoni, Massimo Villa, Erica Bhagat, Abhi Gallinaro, Valentina Gualberti, Giuliana Merolla, Rocco Cosimo Damiano Gasbarrini, Antonio PLoS One Research Article INTRODUCTION: Glecaprevir/pibrentasvir (G/P) has demonstrated high rates (>95%) of sustained virologic response at posttreatment Week 12 (SVR12) in treatment-naïve (TN) patients with hepatitis C virus (HCV) infection and compensated cirrhosis (CC). Here, in a key real-world subset of TN Italian patients with CC, we evaluated the effectiveness and safety of 8-week G/P treatment, including subgroups of interest such as those with genotype 3 (GT3) infection, elderly patients, and those with more advanced liver disease. METHODS: Subanalysis of Italian patients enrolled in the CREST study. The full analysis set (FAS) included all patients enrolled in the study; the modified analysis set (MAS) excluded patients who discontinued G/P for nonvirologic failure or who had missing SVR12 results. Primary and secondary endpoints included SVR12 and safety, respectively. RESULTS: Of 42 patients included in the FAS, 1 discontinued for unknown reasons, and 2 had missing SVR12 data, leaving 39 patients included in the MAS. At treatment initiation, 74% of patients had ≥1 comorbidity, and 62% were receiving concomitant medications, including some that may potentially interact with G/P. SVR12 was achieved in 100% of patients in the MAS, and in 95% in the FAS. In subgroups of interest, the proportion of patients achieving SVR12 in the MAS (and FAS) was: 100% (94%) for patients ≥65 years, 100% (86%) for GT3, and 100% (100%) for patients with platelet count <150 × 10(9)/L and FibroScan(®) >20 kPa. Overall, 2 (5%) patients had an adverse event and neither were serious. CONCLUSION: Results from this real-world Italian cohort demonstrated the safety and effectiveness of 8-week G/P, with SVR12 rate >95%, even in elderly patients. These findings further support real-world evidence of the use of short-course G/P treatment in all patients with CC, including those with GT3, and those with advanced liver disease. Public Library of Science 2023-02-02 /pmc/articles/PMC9894491/ /pubmed/36730135 http://dx.doi.org/10.1371/journal.pone.0280165 Text en © 2023 Aghemo et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Aghemo, Alessio
Persico, Marcello
D’Ambrosio, Roberta
Andreoni, Massimo
Villa, Erica
Bhagat, Abhi
Gallinaro, Valentina
Gualberti, Giuliana
Merolla, Rocco Cosimo Damiano
Gasbarrini, Antonio
Safety and effectiveness of 8 weeks of Glecaprevir/Pibrentasvir in challenging HCV patients: Italian data from the CREST study
title Safety and effectiveness of 8 weeks of Glecaprevir/Pibrentasvir in challenging HCV patients: Italian data from the CREST study
title_full Safety and effectiveness of 8 weeks of Glecaprevir/Pibrentasvir in challenging HCV patients: Italian data from the CREST study
title_fullStr Safety and effectiveness of 8 weeks of Glecaprevir/Pibrentasvir in challenging HCV patients: Italian data from the CREST study
title_full_unstemmed Safety and effectiveness of 8 weeks of Glecaprevir/Pibrentasvir in challenging HCV patients: Italian data from the CREST study
title_short Safety and effectiveness of 8 weeks of Glecaprevir/Pibrentasvir in challenging HCV patients: Italian data from the CREST study
title_sort safety and effectiveness of 8 weeks of glecaprevir/pibrentasvir in challenging hcv patients: italian data from the crest study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9894491/
https://www.ncbi.nlm.nih.gov/pubmed/36730135
http://dx.doi.org/10.1371/journal.pone.0280165
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