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1981. Real-World Data on Safety and Effectiveness of Glecaprevir/Pibrentasvir for the Treatment of Patients With Chronic Hepatitis C Virus Infection on Opioid Substitution Therapy: Latest Results from the German Hepatitis C-Registry
BACKGROUND: The coformulated direct-acting antivirals glecaprevir/pibrentasvir (G/P) are approved to treat chronic hepatitis C virus (HCV) genotype 1–6 infection. In clinical trials, G/P demonstrated high efficacy, but real-world data in patients on opioid substitution therapy (OST), a population fo...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6254652/ http://dx.doi.org/10.1093/ofid/ofy210.1637 |
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author | Reimer, Jens Stoehr, Albrecht Naumann, Uwe Teuber, Gerlinde Zamani, Carsten Mauss, Stefan Qurishi, Nazifa Lohmann, Kristina Kleine, Henning Pangerl, Andreas Christensen, Stefan |
author_facet | Reimer, Jens Stoehr, Albrecht Naumann, Uwe Teuber, Gerlinde Zamani, Carsten Mauss, Stefan Qurishi, Nazifa Lohmann, Kristina Kleine, Henning Pangerl, Andreas Christensen, Stefan |
author_sort | Reimer, Jens |
collection | PubMed |
description | BACKGROUND: The coformulated direct-acting antivirals glecaprevir/pibrentasvir (G/P) are approved to treat chronic hepatitis C virus (HCV) genotype 1–6 infection. In clinical trials, G/P demonstrated high efficacy, but real-world data in patients on opioid substitution therapy (OST), a population for which antiviral treatment is critical for HCV elimination, are limited. Here we report the first real-world data on the effectiveness and safety of G/P for OST patients within the German Hepatitis C-Registry (DHC-R). METHODS: The DHC-R is an ongoing, noninterventional, multicenter, prospective, monitored registry study. Data were collected between July 28, 2017 and February 9, 2018 from 104 sites in Germany. The analysis included adult HCV-infected patients who were treated with G/P according to the European Medicines Agency label. The primary endpoint was sustained virologic response at post-treatment week 12 (SVR12). Safety and tolerability were assessed in patients that completed treatment. RESULTS: As of February 9, 2018, 638 patients had initiated on-label treatment with G/P and are included in the baseline analysis. Patients on OST comprised 26% (168/638) of the baseline population, of which most patients were treatment-naive, without cirrhosis and had HCV genotype 1a or 3. Among patients with available SVR12 data, 96% (27/28) of OST patients and 97% (66/68) of non-OST patients achieved SVR12. There were no virologic failures: of three early discontinuations, one OST patient was lost to follow-up and two non-OST patients discontinued treatment due to adverse events (AE). In the modified intention-to-treat population which excluded non-virologic failures, SVR12 was 100% for both OST and non-OST patients. The safety population included 321 patients in total. Among OST patients, 2% (2/84) experienced serious AEs (SAE) without any treatment discontinuations due to AE/SAE. CONCLUSION: In this real-world analysis, G/P treatment yielded favorable effectiveness and safety results in patients on OST. Updated data and SVR12 results will be presented. DISCLOSURES: J. Reimer, AbbVie, Bristol-Myers Squibb, Gilead, Janssen-Cilag, MSD: Board Member and Scientific Advisor, Educational grant and Speaker honorarium. A. Stoehr, AbbVie, Gilead, Janssen, MSD, ViiV: Consultant and Scientific Advisor, Consulting fee and Speaker honorarium. U. Naumann, AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, Mundipharma, MSD, Roche, ViiV: Board Member, Scientific Advisor and Speaker’s Bureau, Consulting fee and Speaker honorarium. G. Teuber,: AbbVie, BMS, Janssen, Gilead, MSD: Consultant and Scientific Advisor, Consulting fee and Speaker honorarium. C. Zamani, AbbVie Inc.: Board Member and Scientific Advisor, Consulting fee. S. Mauss, AbbVie, Gilead, Falk, Janssen, MSD: Scientific Advisor and Speaker’s Bureau, Consulting fee and Speaker honorarium. N. Qurishi, AbbVie, Gilead, Janssen, MSD, ViiV, Mundipharma, Hexal: Consultant and Scientific Advisor, Consulting fee and Speaker honorarium. K. Lohmann, AbbVie Inc.: Employee and Shareholder, Salary and Stock and/or options. H. Kleine, AbbVie Inc.: Employee and Shareholder, Salary and Stock and/or options. A. Pangerl, AbbVie Inc.: Employee and Shareholder, Salary and Stock and/or options. S. Christensen, AbbVie, Gilead, Indivior, Janssen-Cilag, MSD, ViiV: Consultant and Scientific Advisor, Consulting fee and Speaker honorarium. |
format | Online Article Text |
id | pubmed-6254652 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-62546522018-11-28 1981. Real-World Data on Safety and Effectiveness of Glecaprevir/Pibrentasvir for the Treatment of Patients With Chronic Hepatitis C Virus Infection on Opioid Substitution Therapy: Latest Results from the German Hepatitis C-Registry Reimer, Jens Stoehr, Albrecht Naumann, Uwe Teuber, Gerlinde Zamani, Carsten Mauss, Stefan Qurishi, Nazifa Lohmann, Kristina Kleine, Henning Pangerl, Andreas Christensen, Stefan Open Forum Infect Dis Abstracts BACKGROUND: The coformulated direct-acting antivirals glecaprevir/pibrentasvir (G/P) are approved to treat chronic hepatitis C virus (HCV) genotype 1–6 infection. In clinical trials, G/P demonstrated high efficacy, but real-world data in patients on opioid substitution therapy (OST), a population for which antiviral treatment is critical for HCV elimination, are limited. Here we report the first real-world data on the effectiveness and safety of G/P for OST patients within the German Hepatitis C-Registry (DHC-R). METHODS: The DHC-R is an ongoing, noninterventional, multicenter, prospective, monitored registry study. Data were collected between July 28, 2017 and February 9, 2018 from 104 sites in Germany. The analysis included adult HCV-infected patients who were treated with G/P according to the European Medicines Agency label. The primary endpoint was sustained virologic response at post-treatment week 12 (SVR12). Safety and tolerability were assessed in patients that completed treatment. RESULTS: As of February 9, 2018, 638 patients had initiated on-label treatment with G/P and are included in the baseline analysis. Patients on OST comprised 26% (168/638) of the baseline population, of which most patients were treatment-naive, without cirrhosis and had HCV genotype 1a or 3. Among patients with available SVR12 data, 96% (27/28) of OST patients and 97% (66/68) of non-OST patients achieved SVR12. There were no virologic failures: of three early discontinuations, one OST patient was lost to follow-up and two non-OST patients discontinued treatment due to adverse events (AE). In the modified intention-to-treat population which excluded non-virologic failures, SVR12 was 100% for both OST and non-OST patients. The safety population included 321 patients in total. Among OST patients, 2% (2/84) experienced serious AEs (SAE) without any treatment discontinuations due to AE/SAE. CONCLUSION: In this real-world analysis, G/P treatment yielded favorable effectiveness and safety results in patients on OST. Updated data and SVR12 results will be presented. DISCLOSURES: J. Reimer, AbbVie, Bristol-Myers Squibb, Gilead, Janssen-Cilag, MSD: Board Member and Scientific Advisor, Educational grant and Speaker honorarium. A. Stoehr, AbbVie, Gilead, Janssen, MSD, ViiV: Consultant and Scientific Advisor, Consulting fee and Speaker honorarium. U. Naumann, AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, Mundipharma, MSD, Roche, ViiV: Board Member, Scientific Advisor and Speaker’s Bureau, Consulting fee and Speaker honorarium. G. Teuber,: AbbVie, BMS, Janssen, Gilead, MSD: Consultant and Scientific Advisor, Consulting fee and Speaker honorarium. C. Zamani, AbbVie Inc.: Board Member and Scientific Advisor, Consulting fee. S. Mauss, AbbVie, Gilead, Falk, Janssen, MSD: Scientific Advisor and Speaker’s Bureau, Consulting fee and Speaker honorarium. N. Qurishi, AbbVie, Gilead, Janssen, MSD, ViiV, Mundipharma, Hexal: Consultant and Scientific Advisor, Consulting fee and Speaker honorarium. K. Lohmann, AbbVie Inc.: Employee and Shareholder, Salary and Stock and/or options. H. Kleine, AbbVie Inc.: Employee and Shareholder, Salary and Stock and/or options. A. Pangerl, AbbVie Inc.: Employee and Shareholder, Salary and Stock and/or options. S. Christensen, AbbVie, Gilead, Indivior, Janssen-Cilag, MSD, ViiV: Consultant and Scientific Advisor, Consulting fee and Speaker honorarium. Oxford University Press 2018-11-26 /pmc/articles/PMC6254652/ http://dx.doi.org/10.1093/ofid/ofy210.1637 Text en © The Author(s) 2018. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Abstracts Reimer, Jens Stoehr, Albrecht Naumann, Uwe Teuber, Gerlinde Zamani, Carsten Mauss, Stefan Qurishi, Nazifa Lohmann, Kristina Kleine, Henning Pangerl, Andreas Christensen, Stefan 1981. Real-World Data on Safety and Effectiveness of Glecaprevir/Pibrentasvir for the Treatment of Patients With Chronic Hepatitis C Virus Infection on Opioid Substitution Therapy: Latest Results from the German Hepatitis C-Registry |
title | 1981. Real-World Data on Safety and Effectiveness of Glecaprevir/Pibrentasvir for the Treatment of Patients With Chronic Hepatitis C Virus Infection on Opioid Substitution Therapy: Latest Results from the German Hepatitis C-Registry |
title_full | 1981. Real-World Data on Safety and Effectiveness of Glecaprevir/Pibrentasvir for the Treatment of Patients With Chronic Hepatitis C Virus Infection on Opioid Substitution Therapy: Latest Results from the German Hepatitis C-Registry |
title_fullStr | 1981. Real-World Data on Safety and Effectiveness of Glecaprevir/Pibrentasvir for the Treatment of Patients With Chronic Hepatitis C Virus Infection on Opioid Substitution Therapy: Latest Results from the German Hepatitis C-Registry |
title_full_unstemmed | 1981. Real-World Data on Safety and Effectiveness of Glecaprevir/Pibrentasvir for the Treatment of Patients With Chronic Hepatitis C Virus Infection on Opioid Substitution Therapy: Latest Results from the German Hepatitis C-Registry |
title_short | 1981. Real-World Data on Safety and Effectiveness of Glecaprevir/Pibrentasvir for the Treatment of Patients With Chronic Hepatitis C Virus Infection on Opioid Substitution Therapy: Latest Results from the German Hepatitis C-Registry |
title_sort | 1981. real-world data on safety and effectiveness of glecaprevir/pibrentasvir for the treatment of patients with chronic hepatitis c virus infection on opioid substitution therapy: latest results from the german hepatitis c-registry |
topic | Abstracts |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6254652/ http://dx.doi.org/10.1093/ofid/ofy210.1637 |
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