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Gerontol Geriatr Med. 2019 Jan 22;5:2333721418817398. doi: 10.1177/2333721418817398. eCollection 2019 Jan-Dec.

Efficacy and Safety of Elbasvir/Grazoprevir in Hepatitis C Virus GT1- and GT4-Infected People Aged 65 Years or Older.

Author information

1
Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
2
China Medical University Hospital, Taichung City.
3
Tel-Aviv Medical Center, Tel-Aviv, Israel.
4
ID Care, Hillsborough, NJ, USA.
5
Merck & Co., Inc., Kenilworth, NJ, USA.

Abstract

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.

KEYWORDS:

mortality; quality of life; therapy; veterans

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: S.F. is a consultant for and has served on speakers’ bureaus for AbbVie, Gilead, and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. R.N. received fees from Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., for the conduct of this study and has received fees from Gilead and Janssen for the conduct of clinical trials. C-Y.P. has served as an advisory committee member for AbbVie, BMS, Gilead, and MSD. O.S. has received grants from Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., and AbbVie and has received personal fees from Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., AbbVie, Gilead, and Neopharm. P.H., B.H., M.N.R., and E.B. are employees of and hold stock in Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

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