Cargando…

Real-World Clinical Practice Use of 8-Week Glecaprevir/Pibrentasvir in Treatment-Naïve Patients with Compensated Cirrhosis

INTRODUCTION: More than 70 million people are estimated to be infected with hepatitis C virus globally. Glecaprevir/pibrentasvir is a widely used treatment and has recently been approved for an 8-week regimen for treatment-naïve patients with compensated cirrhosis in Europe and the USA, who would pr...

Descripción completa

Detalles Bibliográficos
Autores principales: Lampertico, Pietro, Mauss, Stefan, Persico, Marcello, Barclay, Stephen T., Marx, Steven, Lohmann, Kristina, Bondin, Mark, Zhang, ZhenZhen, Marra, Fiona, Belperio, Pamela S., Wedemeyer, Heiner, Flamm, Steven
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7444399/
https://www.ncbi.nlm.nih.gov/pubmed/32754824
http://dx.doi.org/10.1007/s12325-020-01449-0
_version_ 1783573798875824128
author Lampertico, Pietro
Mauss, Stefan
Persico, Marcello
Barclay, Stephen T.
Marx, Steven
Lohmann, Kristina
Bondin, Mark
Zhang, ZhenZhen
Marra, Fiona
Belperio, Pamela S.
Wedemeyer, Heiner
Flamm, Steven
author_facet Lampertico, Pietro
Mauss, Stefan
Persico, Marcello
Barclay, Stephen T.
Marx, Steven
Lohmann, Kristina
Bondin, Mark
Zhang, ZhenZhen
Marra, Fiona
Belperio, Pamela S.
Wedemeyer, Heiner
Flamm, Steven
author_sort Lampertico, Pietro
collection PubMed
description INTRODUCTION: More than 70 million people are estimated to be infected with hepatitis C virus globally. Glecaprevir/pibrentasvir is a widely used treatment and has recently been approved for an 8-week regimen for treatment-naïve patients with compensated cirrhosis in Europe and the USA, who would previously have received glecaprevir/pibrentasvir for 12 weeks. This label update was based on the EXPEDITION-8 study, which included 343 treatment-naïve patients with compensated cirrhosis. However, there is currently a lack of similarly large-scale real-world studies of the 8-week glecaprevir/pibrentasvir regimen in this population. METHODS: This summary of seven separate smaller real-world studies aims to validate the results seen in EXPEDITION-8 and provide an up-to-date real-world reference for clinicians making treatment decisions for patients with compensated cirrhosis (Child–Pugh A) who may benefit from a shorter-duration therapy with glecaprevir/pibrentasvir. The newly emerging real-world effectiveness data on treatment-naïve patients with compensated cirrhosis treated with 8 weeks of glecaprevir/pibrentasvir help to understand where further research is needed to support patients with hepatitis C virus. RESULTS: Across all seven studies, glecaprevir/pibrentasvir showed high effectiveness with an average sustained virologic response rate of 98.1%, similar to that found in a clinical trial setting (99.7%). Only one patient (0.5%) experienced virologic failure and treatment was well tolerated. CONCLUSION: Expanding the number of patients eligible for the shortened treatment duration will potentially increase treatment initiation and completion, particularly in underserved populations, contributing to the elimination of hepatitis C virus.
format Online
Article
Text
id pubmed-7444399
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher Springer Healthcare
record_format MEDLINE/PubMed
spelling pubmed-74443992020-08-31 Real-World Clinical Practice Use of 8-Week Glecaprevir/Pibrentasvir in Treatment-Naïve Patients with Compensated Cirrhosis Lampertico, Pietro Mauss, Stefan Persico, Marcello Barclay, Stephen T. Marx, Steven Lohmann, Kristina Bondin, Mark Zhang, ZhenZhen Marra, Fiona Belperio, Pamela S. Wedemeyer, Heiner Flamm, Steven Adv Ther Brief Report INTRODUCTION: More than 70 million people are estimated to be infected with hepatitis C virus globally. Glecaprevir/pibrentasvir is a widely used treatment and has recently been approved for an 8-week regimen for treatment-naïve patients with compensated cirrhosis in Europe and the USA, who would previously have received glecaprevir/pibrentasvir for 12 weeks. This label update was based on the EXPEDITION-8 study, which included 343 treatment-naïve patients with compensated cirrhosis. However, there is currently a lack of similarly large-scale real-world studies of the 8-week glecaprevir/pibrentasvir regimen in this population. METHODS: This summary of seven separate smaller real-world studies aims to validate the results seen in EXPEDITION-8 and provide an up-to-date real-world reference for clinicians making treatment decisions for patients with compensated cirrhosis (Child–Pugh A) who may benefit from a shorter-duration therapy with glecaprevir/pibrentasvir. The newly emerging real-world effectiveness data on treatment-naïve patients with compensated cirrhosis treated with 8 weeks of glecaprevir/pibrentasvir help to understand where further research is needed to support patients with hepatitis C virus. RESULTS: Across all seven studies, glecaprevir/pibrentasvir showed high effectiveness with an average sustained virologic response rate of 98.1%, similar to that found in a clinical trial setting (99.7%). Only one patient (0.5%) experienced virologic failure and treatment was well tolerated. CONCLUSION: Expanding the number of patients eligible for the shortened treatment duration will potentially increase treatment initiation and completion, particularly in underserved populations, contributing to the elimination of hepatitis C virus. Springer Healthcare 2020-08-04 2020 /pmc/articles/PMC7444399/ /pubmed/32754824 http://dx.doi.org/10.1007/s12325-020-01449-0 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Brief Report
Lampertico, Pietro
Mauss, Stefan
Persico, Marcello
Barclay, Stephen T.
Marx, Steven
Lohmann, Kristina
Bondin, Mark
Zhang, ZhenZhen
Marra, Fiona
Belperio, Pamela S.
Wedemeyer, Heiner
Flamm, Steven
Real-World Clinical Practice Use of 8-Week Glecaprevir/Pibrentasvir in Treatment-Naïve Patients with Compensated Cirrhosis
title Real-World Clinical Practice Use of 8-Week Glecaprevir/Pibrentasvir in Treatment-Naïve Patients with Compensated Cirrhosis
title_full Real-World Clinical Practice Use of 8-Week Glecaprevir/Pibrentasvir in Treatment-Naïve Patients with Compensated Cirrhosis
title_fullStr Real-World Clinical Practice Use of 8-Week Glecaprevir/Pibrentasvir in Treatment-Naïve Patients with Compensated Cirrhosis
title_full_unstemmed Real-World Clinical Practice Use of 8-Week Glecaprevir/Pibrentasvir in Treatment-Naïve Patients with Compensated Cirrhosis
title_short Real-World Clinical Practice Use of 8-Week Glecaprevir/Pibrentasvir in Treatment-Naïve Patients with Compensated Cirrhosis
title_sort real-world clinical practice use of 8-week glecaprevir/pibrentasvir in treatment-naïve patients with compensated cirrhosis
topic Brief Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7444399/
https://www.ncbi.nlm.nih.gov/pubmed/32754824
http://dx.doi.org/10.1007/s12325-020-01449-0
work_keys_str_mv AT lamperticopietro realworldclinicalpracticeuseof8weekglecaprevirpibrentasvirintreatmentnaivepatientswithcompensatedcirrhosis
AT maussstefan realworldclinicalpracticeuseof8weekglecaprevirpibrentasvirintreatmentnaivepatientswithcompensatedcirrhosis
AT persicomarcello realworldclinicalpracticeuseof8weekglecaprevirpibrentasvirintreatmentnaivepatientswithcompensatedcirrhosis
AT barclaystephent realworldclinicalpracticeuseof8weekglecaprevirpibrentasvirintreatmentnaivepatientswithcompensatedcirrhosis
AT marxsteven realworldclinicalpracticeuseof8weekglecaprevirpibrentasvirintreatmentnaivepatientswithcompensatedcirrhosis
AT lohmannkristina realworldclinicalpracticeuseof8weekglecaprevirpibrentasvirintreatmentnaivepatientswithcompensatedcirrhosis
AT bondinmark realworldclinicalpracticeuseof8weekglecaprevirpibrentasvirintreatmentnaivepatientswithcompensatedcirrhosis
AT zhangzhenzhen realworldclinicalpracticeuseof8weekglecaprevirpibrentasvirintreatmentnaivepatientswithcompensatedcirrhosis
AT marrafiona realworldclinicalpracticeuseof8weekglecaprevirpibrentasvirintreatmentnaivepatientswithcompensatedcirrhosis
AT belperiopamelas realworldclinicalpracticeuseof8weekglecaprevirpibrentasvirintreatmentnaivepatientswithcompensatedcirrhosis
AT wedemeyerheiner realworldclinicalpracticeuseof8weekglecaprevirpibrentasvirintreatmentnaivepatientswithcompensatedcirrhosis
AT flammsteven realworldclinicalpracticeuseof8weekglecaprevirpibrentasvirintreatmentnaivepatientswithcompensatedcirrhosis