Cargando…

Real-World Safety, Effectiveness, and Patient-Reported Outcomes in Patients with Chronic Hepatitis C Virus Infection Treated with Glecaprevir/Pibrentasvir: Updated Data from the German Hepatitis C-Registry (DHC-R)

Using data from the German Hepatitis C-Registry (Deutsche Hepatitis C-Register, DHC-R), we report the real-world safety and effectiveness of glecaprevir/pibrentasvir (GLE/PIB) treatment and its impact on patient-reported outcomes (PROs) in underserved populations who are not typically included in cl...

Descripción completa

Detalles Bibliográficos
Autores principales: Cornberg, Markus, Stoehr, Albrecht, Naumann, Uwe, Teuber, Gerlinde, Klinker, Hartwig, Lutz, Thomas, Möller, Hjördis, Hidde, Dennis, Lohmann, Kristina, Simon, Karl-Georg
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9318383/
https://www.ncbi.nlm.nih.gov/pubmed/35891520
http://dx.doi.org/10.3390/v14071541
_version_ 1784755277161037824
author Cornberg, Markus
Stoehr, Albrecht
Naumann, Uwe
Teuber, Gerlinde
Klinker, Hartwig
Lutz, Thomas
Möller, Hjördis
Hidde, Dennis
Lohmann, Kristina
Simon, Karl-Georg
author_facet Cornberg, Markus
Stoehr, Albrecht
Naumann, Uwe
Teuber, Gerlinde
Klinker, Hartwig
Lutz, Thomas
Möller, Hjördis
Hidde, Dennis
Lohmann, Kristina
Simon, Karl-Georg
author_sort Cornberg, Markus
collection PubMed
description Using data from the German Hepatitis C-Registry (Deutsche Hepatitis C-Register, DHC-R), we report the real-world safety and effectiveness of glecaprevir/pibrentasvir (GLE/PIB) treatment and its impact on patient-reported outcomes (PROs) in underserved populations who are not typically included in clinical trials, yet who will be crucial for achieving hepatitis C virus (HCV) elimination. The DHC-R is an ongoing, non-interventional, multicenter, prospective, observational cohort study on patients treated for chronic HCV infection in Germany. The data cutoff was 17 January 2021. The primary effectiveness endpoint was sustained virologic response at post-treatment Week 12 (SVR12). Safety outcomes were assessed in all patients receiving GLE/PIB. PROs were assessed using the SF-36 survey. Of 2354 patients, 1964 had valid SVR12 data (intention-to-treat analysis). Of these, 1905 (97.0%) achieved SVR12 with rates similar across the comorbidities analyzed, except for people who actively use drugs (PWUD (active)) (86.4%). Excluding those who discontinued treatment and did not achieve SVR12, or were reinfected with HCV, the rate was 99.3%, with similar results regardless of comorbidity. PWUD (active) and those with psychiatric disorders had the most meaningful improvements in PROs. Adverse events (AEs) occurred in 631/2354 patients (26.8%), and serious AEs in 44 patients (1.9%). GLE/PIB was highly effective and well tolerated in this real-world study of patient groups key to HCV elimination.
format Online
Article
Text
id pubmed-9318383
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-93183832022-07-27 Real-World Safety, Effectiveness, and Patient-Reported Outcomes in Patients with Chronic Hepatitis C Virus Infection Treated with Glecaprevir/Pibrentasvir: Updated Data from the German Hepatitis C-Registry (DHC-R) Cornberg, Markus Stoehr, Albrecht Naumann, Uwe Teuber, Gerlinde Klinker, Hartwig Lutz, Thomas Möller, Hjördis Hidde, Dennis Lohmann, Kristina Simon, Karl-Georg Viruses Article Using data from the German Hepatitis C-Registry (Deutsche Hepatitis C-Register, DHC-R), we report the real-world safety and effectiveness of glecaprevir/pibrentasvir (GLE/PIB) treatment and its impact on patient-reported outcomes (PROs) in underserved populations who are not typically included in clinical trials, yet who will be crucial for achieving hepatitis C virus (HCV) elimination. The DHC-R is an ongoing, non-interventional, multicenter, prospective, observational cohort study on patients treated for chronic HCV infection in Germany. The data cutoff was 17 January 2021. The primary effectiveness endpoint was sustained virologic response at post-treatment Week 12 (SVR12). Safety outcomes were assessed in all patients receiving GLE/PIB. PROs were assessed using the SF-36 survey. Of 2354 patients, 1964 had valid SVR12 data (intention-to-treat analysis). Of these, 1905 (97.0%) achieved SVR12 with rates similar across the comorbidities analyzed, except for people who actively use drugs (PWUD (active)) (86.4%). Excluding those who discontinued treatment and did not achieve SVR12, or were reinfected with HCV, the rate was 99.3%, with similar results regardless of comorbidity. PWUD (active) and those with psychiatric disorders had the most meaningful improvements in PROs. Adverse events (AEs) occurred in 631/2354 patients (26.8%), and serious AEs in 44 patients (1.9%). GLE/PIB was highly effective and well tolerated in this real-world study of patient groups key to HCV elimination. MDPI 2022-07-14 /pmc/articles/PMC9318383/ /pubmed/35891520 http://dx.doi.org/10.3390/v14071541 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Cornberg, Markus
Stoehr, Albrecht
Naumann, Uwe
Teuber, Gerlinde
Klinker, Hartwig
Lutz, Thomas
Möller, Hjördis
Hidde, Dennis
Lohmann, Kristina
Simon, Karl-Georg
Real-World Safety, Effectiveness, and Patient-Reported Outcomes in Patients with Chronic Hepatitis C Virus Infection Treated with Glecaprevir/Pibrentasvir: Updated Data from the German Hepatitis C-Registry (DHC-R)
title Real-World Safety, Effectiveness, and Patient-Reported Outcomes in Patients with Chronic Hepatitis C Virus Infection Treated with Glecaprevir/Pibrentasvir: Updated Data from the German Hepatitis C-Registry (DHC-R)
title_full Real-World Safety, Effectiveness, and Patient-Reported Outcomes in Patients with Chronic Hepatitis C Virus Infection Treated with Glecaprevir/Pibrentasvir: Updated Data from the German Hepatitis C-Registry (DHC-R)
title_fullStr Real-World Safety, Effectiveness, and Patient-Reported Outcomes in Patients with Chronic Hepatitis C Virus Infection Treated with Glecaprevir/Pibrentasvir: Updated Data from the German Hepatitis C-Registry (DHC-R)
title_full_unstemmed Real-World Safety, Effectiveness, and Patient-Reported Outcomes in Patients with Chronic Hepatitis C Virus Infection Treated with Glecaprevir/Pibrentasvir: Updated Data from the German Hepatitis C-Registry (DHC-R)
title_short Real-World Safety, Effectiveness, and Patient-Reported Outcomes in Patients with Chronic Hepatitis C Virus Infection Treated with Glecaprevir/Pibrentasvir: Updated Data from the German Hepatitis C-Registry (DHC-R)
title_sort real-world safety, effectiveness, and patient-reported outcomes in patients with chronic hepatitis c virus infection treated with glecaprevir/pibrentasvir: updated data from the german hepatitis c-registry (dhc-r)
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9318383/
https://www.ncbi.nlm.nih.gov/pubmed/35891520
http://dx.doi.org/10.3390/v14071541
work_keys_str_mv AT cornbergmarkus realworldsafetyeffectivenessandpatientreportedoutcomesinpatientswithchronichepatitiscvirusinfectiontreatedwithglecaprevirpibrentasvirupdateddatafromthegermanhepatitiscregistrydhcr
AT stoehralbrecht realworldsafetyeffectivenessandpatientreportedoutcomesinpatientswithchronichepatitiscvirusinfectiontreatedwithglecaprevirpibrentasvirupdateddatafromthegermanhepatitiscregistrydhcr
AT naumannuwe realworldsafetyeffectivenessandpatientreportedoutcomesinpatientswithchronichepatitiscvirusinfectiontreatedwithglecaprevirpibrentasvirupdateddatafromthegermanhepatitiscregistrydhcr
AT teubergerlinde realworldsafetyeffectivenessandpatientreportedoutcomesinpatientswithchronichepatitiscvirusinfectiontreatedwithglecaprevirpibrentasvirupdateddatafromthegermanhepatitiscregistrydhcr
AT klinkerhartwig realworldsafetyeffectivenessandpatientreportedoutcomesinpatientswithchronichepatitiscvirusinfectiontreatedwithglecaprevirpibrentasvirupdateddatafromthegermanhepatitiscregistrydhcr
AT lutzthomas realworldsafetyeffectivenessandpatientreportedoutcomesinpatientswithchronichepatitiscvirusinfectiontreatedwithglecaprevirpibrentasvirupdateddatafromthegermanhepatitiscregistrydhcr
AT mollerhjordis realworldsafetyeffectivenessandpatientreportedoutcomesinpatientswithchronichepatitiscvirusinfectiontreatedwithglecaprevirpibrentasvirupdateddatafromthegermanhepatitiscregistrydhcr
AT hiddedennis realworldsafetyeffectivenessandpatientreportedoutcomesinpatientswithchronichepatitiscvirusinfectiontreatedwithglecaprevirpibrentasvirupdateddatafromthegermanhepatitiscregistrydhcr
AT lohmannkristina realworldsafetyeffectivenessandpatientreportedoutcomesinpatientswithchronichepatitiscvirusinfectiontreatedwithglecaprevirpibrentasvirupdateddatafromthegermanhepatitiscregistrydhcr
AT simonkarlgeorg realworldsafetyeffectivenessandpatientreportedoutcomesinpatientswithchronichepatitiscvirusinfectiontreatedwithglecaprevirpibrentasvirupdateddatafromthegermanhepatitiscregistrydhcr