Novel Criteria for Diagnosing Acute and Early Human Immunodeficiency Virus Infection in a Multinational Study of Early Antiretroviral Therapy Initiation.
acute HIV infection
antigen/antibody assays
antiretroviral agents
same-day therapy
signal-to-cutoff ratio
Journal
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213
Informations de publication
Date de publication:
02 08 2021
02 08 2021
Historique:
received:
10
09
2020
pubmed:
1
1
2021
medline:
7
8
2021
entrez:
31
12
2020
Statut:
ppublish
Résumé
Antiretroviral therapy (ART) initiation during acute and early human immunodeficiency virus infection (AEHI) limits HIV reservoir formation and may facilitate post-ART control but is logistically challenging. We evaluated the performance of AEHI diagnostic criteria from a prospective study of early ART initiation. AIDS Clinical Trials Group A 5354 enrolled adults at 30 sites in the Americas, Africa, and Asia who met any 1 of 6 criteria based on combinations of results of HIV RNA, HIV antibody, Western blot or Geenius assay, and/or the signal-to-cutoff (S/CO) ratio of the ARCHITECT HIV Ag/Ab Combo or GS HIV Combo Ag/Ab EIA. HIV status and Fiebig stage were confirmed by centralized testing. From 2017 through 2019, 195 participants were enrolled with median age of 27 years (interquartile range, 23-39). Thirty (15.4%) were female. ART was started by 171 (87.7%) on the day of enrollment and 24 (12.3%) the next day. AEHI was confirmed in 188 (96.4%) participants after centralized testing, 4 (2.0%) participants were found to have chronic infection, and 3 (1.5%) found not to have HIV discontinued ART and were withdrawn. Retrospectively, a nonreactive or indeterminate HIV antibody on the Geenius assay combined with ARCHITECT S/CO ≥10 correctly identified 99 of 122 (81.2%) Fiebig II-IV AEHI cases with no false-positive results. Novel AEHI criteria that incorporate ARCHITECT S/CO facilitated rapid and efficient ART initiation without waiting for an HIV RNA result. These criteria may facilitate AEHI diagnosis, staging, and immediate ART initiation in future research studies and clinical practice. NCT02859558.
Sections du résumé
BACKGROUND
Antiretroviral therapy (ART) initiation during acute and early human immunodeficiency virus infection (AEHI) limits HIV reservoir formation and may facilitate post-ART control but is logistically challenging. We evaluated the performance of AEHI diagnostic criteria from a prospective study of early ART initiation.
METHODS
AIDS Clinical Trials Group A 5354 enrolled adults at 30 sites in the Americas, Africa, and Asia who met any 1 of 6 criteria based on combinations of results of HIV RNA, HIV antibody, Western blot or Geenius assay, and/or the signal-to-cutoff (S/CO) ratio of the ARCHITECT HIV Ag/Ab Combo or GS HIV Combo Ag/Ab EIA. HIV status and Fiebig stage were confirmed by centralized testing.
RESULTS
From 2017 through 2019, 195 participants were enrolled with median age of 27 years (interquartile range, 23-39). Thirty (15.4%) were female. ART was started by 171 (87.7%) on the day of enrollment and 24 (12.3%) the next day. AEHI was confirmed in 188 (96.4%) participants after centralized testing, 4 (2.0%) participants were found to have chronic infection, and 3 (1.5%) found not to have HIV discontinued ART and were withdrawn. Retrospectively, a nonreactive or indeterminate HIV antibody on the Geenius assay combined with ARCHITECT S/CO ≥10 correctly identified 99 of 122 (81.2%) Fiebig II-IV AEHI cases with no false-positive results.
CONCLUSIONS
Novel AEHI criteria that incorporate ARCHITECT S/CO facilitated rapid and efficient ART initiation without waiting for an HIV RNA result. These criteria may facilitate AEHI diagnosis, staging, and immediate ART initiation in future research studies and clinical practice.
CLINICAL TRIALS REGISTRATION
NCT02859558.
Identifiants
pubmed: 33382405
pii: 6056473
doi: 10.1093/cid/ciaa1893
pmc: PMC8326583
doi:
Banques de données
ClinicalTrials.gov
['NCT02859558']
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
e643-e651Subventions
Organisme : NIAID NIH HHS
ID : UM1 AI069494
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI069476
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI069470
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069481
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068618
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069399
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068613
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069476
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069424
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069470
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068634
Pays : United States
Organisme : NIAID NIH HHS
ID : P30 AI027757
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI106701
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068636
Pays : United States
Organisme : NIAID NIH HHS
ID : P30 AI050410
Pays : United States
Investigateurs
Oladapo Alli
(O)
Deborah Anisman-Posner
(D)
LuAnn Borowski
(L)
Benjamin Chi
(B)
Susan E Cohn
(SE)
Ann Collier
(A)
Morgan Gapara
(M)
Sonya Heath
(S)
Tydie Higgins
(T)
Brenda Hoagland
(B)
Andrew Kaytes
(A)
Dimas Kliemann
(D)
Eugène Kroon
(E)
Gonasagrie Nair
(G)
Deborah Persaud
(D)
Sharon Riddler
(S)
James Rooney
(J)
Scott Sieg
(S)
Magdalena Sobieszczyk
(M)
Jennifer Tiu
(J)
Kyle Whitson
(K)
Informations de copyright
© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.
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