Informacja

Drogi użytkowniku, aplikacja do prawidłowego działania wymaga obsługi JavaScript. Proszę włącz obsługę JavaScript w Twojej przeglądarce.

Tytuł pozycji:

How Generalizable Are the Results From Trials of Direct Antiviral Agents to People Coinfected With HIV/HCV in the Real World?

Tytuł:
How Generalizable Are the Results From Trials of Direct Antiviral Agents to People Coinfected With HIV/HCV in the Real World?
Autorzy:
Saeed S; Department of Medicine, Division of Infectious Diseases/Chronic Viral Illness Service, McGill University Health Centre.; Department of Epidemiology & Biostatistics.
Strumpf EC; Department of Epidemiology & Biostatistics.; Department of Economics, McGill University, Montreal, Quebec.
Walmsley SL; Division of Infectious Diseases, Toronto Hospital, University Health Network, Ontario.; Canadian Institutes of Health Research, Canadian HIV Trials Network.
Rollet-Kurhajec K; Department of Medicine, Division of Infectious Diseases/Chronic Viral Illness Service, McGill University Health Centre.
Pick N; Division of Infectious Diseases, Oak Tree Clinic, BC Women's Hospital, Vancouver, British Columbia.
Martel-Laferrière V; Centre de Recherche du Centre Hospitalier de l'Université de Montréal, Quebec.
Hull M; Department of Infectious Disease, Centre for Excellence in HIV/AIDS, St. Paul's Hospital, Vancouver, British Columbia.
Gill MJ; Southern Alberta HIV Clinic, Calgary.
Cox J; Department of Epidemiology & Biostatistics.; Public Health Department, Montreal Health and Social Services Agency, Quebec.
Cooper C; Department of Medicine, University of Ottawa, Ontario, Canada.
Klein MB; Department of Medicine, Division of Infectious Diseases/Chronic Viral Illness Service, McGill University Health Centre.; Canadian Institutes of Health Research, Canadian HIV Trials Network.
Cohen J
Conway B
Cooper C
Côté P
Cox J
Gill J
Haider S
Harris M
Haase D
Hull M
Montaner J
Moodie E
Pick N
Rachlis A
Rouleau D
Sandre R
Tyndall JM
Vachon ML
Walmsley S
Wong D
Corporate Authors:
Canadian Co-Infection Cohort Study
Źródło:
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2016 Apr 01; Vol. 62 (7), pp. 919-926. Date of Electronic Publication: 2016 Jan 06.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
Język:
English
Imprint Name(s):
Publication: Jan. 2011- : Oxford : Oxford University Press
Original Publication: Chicago, IL : The University of Chicago Press, c1992-
MeSH Terms:
HIV Infections*/complications
HIV Infections*/drug therapy
Hepatitis C*/complications
Hepatitis C*/drug therapy
Antiviral Agents/*therapeutic use
Clinical Trials as Topic/*standards
Coinfection/*drug therapy
Adult ; Aged ; Cohort Studies ; Female ; Humans ; Male ; Middle Aged ; Young Adult
References:
JAMA. 2014 Jul 23-30;312(4):353-61. (PMID: 25038354)
Infect Dis Clin North Am. 2012 Dec;26(4):931-48. (PMID: 23083825)
N Engl J Med. 2014 May 22;370(21):1983-92. (PMID: 24795200)
JAMA. 2007 Jan 17;297(3):314-6. (PMID: 17227985)
N Engl J Med. 2013 May 16;368(20):1878-87. (PMID: 23607594)
Lancet. 2014 Aug 2;384(9941):403-13. (PMID: 24907225)
Lancet HIV. 2015 Aug;2(8):e319-27. (PMID: 26423374)
J Infect Dis. 2007 Sep 1;196(5):670-6. (PMID: 17674307)
Arch Intern Med. 2006 Aug 14-28;166(15):1632-41. (PMID: 16908797)
JAMA. 2012 Jul 25;308(4):370-8. (PMID: 22820790)
N Engl J Med. 2004 Jul 29;351(5):438-50. (PMID: 15282351)
Liver Transpl. 2016 Jan;22(1):24-33. (PMID: 26519873)
Lancet. 2014 Nov 1;384(9954):1597-605. (PMID: 25078304)
N Engl J Med. 2015 Aug 20;373(8):705-13. (PMID: 26196665)
Clin Infect Dis. 2009 Aug 15;49(4):561-73. (PMID: 19589081)
N Engl J Med. 2014 May 15;370(20):1889-98. (PMID: 24725239)
JAMA. 2015 Mar 24-31;313(12):1223-31. (PMID: 25706092)
Annu Rev Med. 2008;59:473-85. (PMID: 18186707)
PLoS One. 2013;8(2):e55373. (PMID: 23393570)
N Engl J Med. 2014 May 22;370(21):1973-82. (PMID: 24725237)
AIDS Rev. 2013 Jan-Mar;15(1):25-31. (PMID: 23449226)
N Engl J Med. 2015 Aug 20;373(8):714-25. (PMID: 26196502)
Int J Epidemiol. 2010 Oct;39(5):1162-9. (PMID: 19786463)
BMC Infect Dis. 2014;14:203. (PMID: 24731285)
AIDS Patient Care STDS. 2015 Jun;29(6):329-37. (PMID: 26020726)
Clin Infect Dis. 2014 Dec 1;59(11):1579-87. (PMID: 25192745)
Ann Intern Med. 2015 Aug 4;163(3):215-23. (PMID: 26120969)
CMAJ Open. 2013 Sep 24;1(3):E106-14. (PMID: 25077109)
J Hepatol. 2009 Apr;50(4):736-45. (PMID: 19231018)
HIV Med. 2013 Jan;14(1):10-20. (PMID: 22639840)
Lancet. 2015 Mar 21;385(9973):1098-106. (PMID: 25659285)
Grant Information:
CIHR MOP-79529 Canada Canadian Institutes of Health Research; CTN222 Canada Canadian Institutes of Health Research
Contributed Indexing:
Keywords: HIV–hepatitis C coinfection; clinical trials; direct-acting antivirals; generalizability; people who inject drugs
Molecular Sequence:
ClinicalTrials.gov NCT01479868; NCT01667731; NCT01939197; NCT02073656
Substance Nomenclature:
0 (Antiviral Agents)
Entry Date(s):
Date Created: 20160109 Date Completed: 20161213 Latest Revision: 20220408
Update Code:
20240104
PubMed Central ID:
PMC4787608
DOI:
10.1093/cid/civ1222
PMID:
26743093
Czasopismo naukowe
Background: Direct-acting antivirals (DAAs) against hepatitis C virus (HCV) have been described as revolutionary. However, it remains uncertain how effective these drugs will be for individuals coinfected with human immunodeficiency virus (HIV)-HCV. Bridging this gap between efficacy and effectiveness requires a focus on the generalizability of clinical trials.
Methods: Generalizability of DAA trials was assessed by applying the eligibility criteria from 5 efficacy trials: NCT01479868, PHOTON-1 (NCT01667731), TURQUOISE-I (NCT01939197), ION-4 (NCT02073656), and ALLY-2 (NCT02032888) that evaluated simeprevir; sofosbuvir; ombitasvir, paritaprevir/ritonavir/dasabuvir; sofosbuvir/ledipasvir; and daclatasvir/sofosbuvir, respectively, to the Canadian Coinfection Cohort, representing approximately 23% of the total coinfected population in care in Canada.
Results: Of 874 active participants, 70% had chronic HCV, of whom 410, 26, 94, and 11 had genotypes 1, 2, 3, and 4, respectively. After applying trial eligibility criteria, only 5.9% (24/410) would have been eligible for enrollment in the simeprevir trial, 9.8% (52/530) in PHOTON-1, 6.3% (26/410) in TURQUOISE-I, and 8.1% (34/421) in ION-4. The ALLY-2 study was more inclusive; 43% (233/541) of the cohort would have been eligible. The most exclusive eligibility criteria across all trials with the exception of ALLY-2 were restriction to specific antiretroviral therapies (63%-79%) and active illicit drug use (53%-55%).
Conclusions: DAA trial results may have limited generalizability, since the majority of coinfected individuals were not eligible to participate. Exclusions appeared to be related to improving treatment outcomes by not including those at higher risk of poor adherence and reinfection--individuals for whom real-world data are urgently needed.
(© The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.)
Comment in: Clin Infect Dis. 2016 Apr 1;62(7):927-8. (PMID: 26743092)
Comment in: Clin Infect Dis. 2016 Oct 1;63(7):994-5. (PMID: 27369322)
Comment in: AIDS. 2017 Mar 27;31(6):N11-N12. (PMID: 28252531)

Ta witryna wykorzystuje pliki cookies do przechowywania informacji na Twoim komputerze. Pliki cookies stosujemy w celu świadczenia usług na najwyższym poziomie, w tym w sposób dostosowany do indywidualnych potrzeb. Korzystanie z witryny bez zmiany ustawień dotyczących cookies oznacza, że będą one zamieszczane w Twoim komputerze. W każdym momencie możesz dokonać zmiany ustawień dotyczących cookies