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...

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Main Authors: Steven Flamm MD, Cheng-Yuan Peng MD, Oren Shibolet MD, Ronald Nahass MD, Peggy Hwang PhD, Eliav Barr MD, Michael N. Robertson MD, Barbara A. Haber MD
Format: Article
Language:English
Published: SAGE Publishing 2019-01-01
Series:Gerontology and Geriatric Medicine
Online Access:https://doi.org/10.1177/2333721418817398
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spelling doaj-485010ee6c754ad7a4fce1c12c0cc8712020-11-25T03:24:48ZengSAGE PublishingGerontology and Geriatric Medicine2333-72142019-01-01510.1177/2333721418817398Efficacy and Safety of Elbasvir/Grazoprevir in Hepatitis C Virus GT1- and GT4-Infected People Aged 65 Years or OlderSteven Flamm MD0Cheng-Yuan Peng MD1Oren Shibolet MD2Ronald Nahass MD3Peggy Hwang PhD4Eliav Barr MD5Michael N. Robertson MD6Barbara A. Haber MD7Northwestern University Feinberg School of Medicine, Chicago, IL, USAChina Medical University Hospital, Taichung CityTel-Aviv Medical Center, Tel-Aviv, IsraelID Care, Hillsborough, NJ, USAMerck & Co., Inc., Kenilworth, NJ, USAMerck & Co., Inc., Kenilworth, NJ, USAMerck & Co., Inc., Kenilworth, NJ, USAMerck & Co., Inc., Kenilworth, NJ, USABackground: 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.https://doi.org/10.1177/2333721418817398
collection DOAJ
language English
format Article
sources DOAJ
author Steven Flamm MD
Cheng-Yuan Peng MD
Oren Shibolet MD
Ronald Nahass MD
Peggy Hwang PhD
Eliav Barr MD
Michael N. Robertson MD
Barbara A. Haber MD
spellingShingle Steven Flamm MD
Cheng-Yuan Peng MD
Oren Shibolet MD
Ronald Nahass MD
Peggy Hwang PhD
Eliav Barr MD
Michael N. Robertson MD
Barbara A. Haber MD
Efficacy and Safety of Elbasvir/Grazoprevir in Hepatitis C Virus GT1- and GT4-Infected People Aged 65 Years or Older
Gerontology and Geriatric Medicine
author_facet Steven Flamm MD
Cheng-Yuan Peng MD
Oren Shibolet MD
Ronald Nahass MD
Peggy Hwang PhD
Eliav Barr MD
Michael N. Robertson MD
Barbara A. Haber MD
author_sort Steven Flamm MD
title 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_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_sort efficacy and safety of elbasvir/grazoprevir in hepatitis c virus gt1- and gt4-infected people aged 65 years or older
publisher SAGE Publishing
series Gerontology and Geriatric Medicine
issn 2333-7214
publishDate 2019-01-01
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.
url https://doi.org/10.1177/2333721418817398
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