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Efficacy and Safety of Elbasvir/Grazoprevir in Hepatitis C Virus GT1- and GT4-Infected People Aged 65 Years or Older
Background: In elderly individuals aged ≥65 years with hepatitis C virus (HCV) infection, efficacious and safe HCV therapy is complicated by frequent comorbidities and concomitant medications. The aim of this analysis was to evaluate the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) in peopl...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6415929/ https://www.ncbi.nlm.nih.gov/pubmed/30891470 http://dx.doi.org/10.1177/2333721418817398 |
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author | Flamm, Steven Peng, Cheng-Yuan Shibolet, Oren Nahass, Ronald Hwang, Peggy Barr, Eliav Robertson, Michael N. Haber, Barbara A. |
author_facet | Flamm, Steven Peng, Cheng-Yuan Shibolet, Oren Nahass, Ronald Hwang, Peggy Barr, Eliav Robertson, Michael N. Haber, Barbara A. |
author_sort | Flamm, Steven |
collection | PubMed |
description | Background: In elderly individuals aged ≥65 years with hepatitis C virus (HCV) infection, efficacious and safe HCV therapy is complicated by frequent comorbidities and concomitant medications. The aim of this analysis was to evaluate the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) in people aged ≥65 years. Methods: This is an integrated retrospective analysis of EBR/GZR administered for 12 weeks in participants with HCV genotype 1 or 4 infection enrolled in 12 Phase 2/3 clinical trials. The primary end point was sustained virologic response 12 weeks after completing therapy (SVR12; HCV RNA below the lower limit of quantification). Results: Most participants aged ≥65 years were receiving ≥1 concomitant medication (322/339; 95.0%) and had ≥1 comorbidity (334/339; 99%). SVR12 rates were 95.3% (323/339) in participants aged ≥65 years and 95.4% (2,041/2,139) in those aged <65 years. Rates of adverse events, drug-related adverse events, serious adverse events, and discontinuations were similar in participants aged ≥65 years and those aged <65 years. In participants aged ≥65 years, median estimated glomerular filtration rate was similar at baseline and at the end of treatment. Conclusion: The efficacy and safety of EBR/GZR were similar in participants with HCV infection aged ≥65 years and those aged <65 years. |
format | Online Article Text |
id | pubmed-6415929 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-64159292019-03-19 Efficacy and Safety of Elbasvir/Grazoprevir in Hepatitis C Virus GT1- and GT4-Infected People Aged 65 Years or Older Flamm, Steven Peng, Cheng-Yuan Shibolet, Oren Nahass, Ronald Hwang, Peggy Barr, Eliav Robertson, Michael N. Haber, Barbara A. Gerontol Geriatr Med Article Background: In elderly individuals aged ≥65 years with hepatitis C virus (HCV) infection, efficacious and safe HCV therapy is complicated by frequent comorbidities and concomitant medications. The aim of this analysis was to evaluate the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) in people aged ≥65 years. Methods: This is an integrated retrospective analysis of EBR/GZR administered for 12 weeks in participants with HCV genotype 1 or 4 infection enrolled in 12 Phase 2/3 clinical trials. The primary end point was sustained virologic response 12 weeks after completing therapy (SVR12; HCV RNA below the lower limit of quantification). Results: Most participants aged ≥65 years were receiving ≥1 concomitant medication (322/339; 95.0%) and had ≥1 comorbidity (334/339; 99%). SVR12 rates were 95.3% (323/339) in participants aged ≥65 years and 95.4% (2,041/2,139) in those aged <65 years. Rates of adverse events, drug-related adverse events, serious adverse events, and discontinuations were similar in participants aged ≥65 years and those aged <65 years. In participants aged ≥65 years, median estimated glomerular filtration rate was similar at baseline and at the end of treatment. Conclusion: The efficacy and safety of EBR/GZR were similar in participants with HCV infection aged ≥65 years and those aged <65 years. SAGE Publications 2019-01-22 /pmc/articles/PMC6415929/ /pubmed/30891470 http://dx.doi.org/10.1177/2333721418817398 Text en © The Author(s) 2019 http://www.creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | Article Flamm, Steven Peng, Cheng-Yuan Shibolet, Oren Nahass, Ronald Hwang, Peggy Barr, Eliav Robertson, Michael N. Haber, Barbara A. Efficacy and Safety of Elbasvir/Grazoprevir in Hepatitis C Virus GT1- and GT4-Infected People Aged 65 Years or Older |
title | Efficacy and Safety of Elbasvir/Grazoprevir in Hepatitis C Virus GT1-
and GT4-Infected People Aged 65 Years or Older |
title_full | Efficacy and Safety of Elbasvir/Grazoprevir in Hepatitis C Virus GT1-
and GT4-Infected People Aged 65 Years or Older |
title_fullStr | Efficacy and Safety of Elbasvir/Grazoprevir in Hepatitis C Virus GT1-
and GT4-Infected People Aged 65 Years or Older |
title_full_unstemmed | Efficacy and Safety of Elbasvir/Grazoprevir in Hepatitis C Virus GT1-
and GT4-Infected People Aged 65 Years or Older |
title_short | Efficacy and Safety of Elbasvir/Grazoprevir in Hepatitis C Virus GT1-
and GT4-Infected People Aged 65 Years or Older |
title_sort | efficacy and safety of elbasvir/grazoprevir in hepatitis c virus gt1-
and gt4-infected people aged 65 years or older |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6415929/ https://www.ncbi.nlm.nih.gov/pubmed/30891470 http://dx.doi.org/10.1177/2333721418817398 |
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