PMID- 30601818
OWN - NLM
STAT- MEDLINE
DCOM- 20190917
LR  - 20231005
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 14
IP  - 1
DP  - 2019
TI  - Safety and efficacy of glecaprevir/pibrentasvir for the treatment of chronic 
      hepatitis C in patients aged 65 years or older.
PG  - e0208506
LID - 10.1371/journal.pone.0208506 [doi]
LID - e0208506
AB  - Finding safe and effective treatments for chronic hepatitis C virus (HCV) 
      infection in the elderly is of clinical interest given the comorbidities and 
      associated polypharmacy in this population. However, the number of patients older 
      than age 65 years enrolled into clinical trials of anti-HCV medications generally 
      have been limited and thus reaching meaningful conclusions for this demographic 
      has been difficult. Glecaprevir/pibrentasvir is a once-daily, all-oral, 
      ribavirin-free, pangenotypic direct-acting antiviral (DAA) combination therapy 
      that has demonstrated high sustained virologic response rates at post-treatment 
      week 12 (SVR12) and a favorable safety profile in patients with chronic HCV 
      infection. This analysis evaluated the safety and efficacy of 
      glecaprevir/pibrentasvir in patients aged >/=65 years. Data were pooled for 
      treatment-naive and -experienced patients with chronic HCV genotype (GT) 1-6 
      infections who received glecaprevir/pibrentasvir for 8, 12, or 16 weeks in 9 
      Phase 2 and 3 trials. SVR12 and adverse events (AEs) were evaluated for patients 
      aged >/=65 versus <65 years. Of the 2369 patients enrolled, 328 (14%) were aged >/=65 
      years. Among patients aged >/=65 years, 42% and 34% had GT1 and GT2, respectively; 
      40% were treatment-experienced and 20% had compensated cirrhosis. 
      Glecaprevir/pibrentasvir treatment resulted in SVR12 rates of 97.9% (95% CI, 
      96.3-99.4; n/N = 321/328) for patients aged >/=65 years and 97.3% (95% CI, 
      96.6-98.0; n/N = 1986/2041) for patients aged <65 years. The rates were not 
      significantly different between the two age groups (P = 0.555). DAA-related AEs 
      leading to treatment discontinuation, or serious AEs were similarly rare (<0.5%) 
      for patients >/=65 and <65 years old. Glecaprevir/pibrentasvir is an efficacious 
      and well-tolerated treatment option for patients aged >/=65 years with chronic HCV 
      infection.
FAU - Foster, Graham R
AU  - Foster GR
AUID- ORCID: 0000-0002-3704-386X
AD  - Barts Liver Centre, Blizard Institute, Queen Mary University of London, London, 
      United Kingdom.
FAU - Asselah, Tarik
AU  - Asselah T
AD  - Hepatology Department, UMR1149, Physiopathology and Treatment of Viral Hepatitis, 
      Centre de Recherche sur l'Inflammation and Universite Denis Diderot Paris 7, 
      Beaujon Hospital, AP-HP, Clichy, France.
FAU - Kopecky-Bromberg, Sarah
AU  - Kopecky-Bromberg S
AD  - AbbVie Inc., North Chicago, Illinois, United States of America.
FAU - Lei, Yang
AU  - Lei Y
AD  - AbbVie Inc., North Chicago, Illinois, United States of America.
FAU - Asatryan, Armen
AU  - Asatryan A
AD  - AbbVie Inc., North Chicago, Illinois, United States of America.
FAU - Trinh, Roger
AU  - Trinh R
AD  - AbbVie Inc., North Chicago, Illinois, United States of America.
FAU - Zadeikis, Neddie
AU  - Zadeikis N
AD  - AbbVie Inc., North Chicago, Illinois, United States of America.
FAU - Mensa, Federico J
AU  - Mensa FJ
AUID- ORCID: 0000-0002-9421-1268
AD  - AbbVie Inc., North Chicago, Illinois, United States of America.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190102
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Aminoisobutyric Acids)
RN  - 0 (Benzimidazoles)
RN  - 0 (Cyclopropanes)
RN  - 0 (Lactams, Macrocyclic)
RN  - 0 (Pyrrolidines)
RN  - 0 (Quinoxalines)
RN  - 0 (Sulfonamides)
RN  - 2WU922TK3L (pibrentasvir)
RN  - 9DLQ4CIU6V (Proline)
RN  - GMW67QNF9C (Leucine)
RN  - K6BUU8J72P (glecaprevir)
SB  - IM
MH  - Aged
MH  - Aminoisobutyric Acids
MH  - Benzimidazoles/*adverse effects/*therapeutic use
MH  - Cyclopropanes
MH  - Drug Therapy, Combination
MH  - Female
MH  - Hepatitis C, Chronic/*drug therapy/virology
MH  - Humans
MH  - Kidney/pathology
MH  - Lactams, Macrocyclic
MH  - Leucine/analogs & derivatives
MH  - Male
MH  - Proline/analogs & derivatives
MH  - Pyrrolidines
MH  - Quinoxalines/*adverse effects/*therapeutic use
MH  - Sulfonamides/*adverse effects/*therapeutic use
MH  - Treatment Outcome
PMC - PMC6314565
COIS- Graham R Foster has received fees for serving as a speaker, consultant, and 
      advisory board member for Gilead, Janssen, AbbVie, Merck, and GSK. Tarik Asselah 
      has been a clinical investigator, speaker, and consultant for AbbVie, Boehringer 
      Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen Pharmaceuticals, Merck 
      Sharp & Dohme, and Roche. Sarah Kopecky-Bromberg, Yang Lei, Armen Asatryan, Roger 
      Trinh, Neddie Zadeikis, and Federico J Mensa are employees of AbbVie and may hold 
      stock or options. This does not alter our adherence to PLOS ONE policies on 
      sharing data and materials. Data will be made available to all interested 
      researchers upon request.
EDAT- 2019/01/03 06:00
MHDA- 2019/09/19 06:00
PMCR- 2019/01/02
CRDT- 2019/01/03 06:00
PHST- 2018/06/13 00:00 [received]
PHST- 2018/11/16 00:00 [accepted]
PHST- 2019/01/03 06:00 [entrez]
PHST- 2019/01/03 06:00 [pubmed]
PHST- 2019/09/19 06:00 [medline]
PHST- 2019/01/02 00:00 [pmc-release]
AID - PONE-D-18-17743 [pii]
AID - 10.1371/journal.pone.0208506 [doi]
PST - epublish
SO  - PLoS One. 2019 Jan 2;14(1):e0208506. doi: 10.1371/journal.pone.0208506. 
      eCollection 2019.