Trevor A Crowell1,2, Justin Ritz3, Robert W Coombs4, Lu Zheng3, Joseph J Eron5, John W Mellors6, Joan Dragavon4, Gert U van Zyl7, Javier R Lama8, Kiat Ruxrungtham9,10, Beatriz Grinsztejn11, Roberto C Arduino12, Lawrence Fox13, Jintanat Ananworanich1,2,14, Eric S Daar15. 1. US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA. 2. Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, Maryland, USA. 3. Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA. 4. Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA. 5. Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. 6. Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA. 7. Department of Pathology, Stellenbosch University, Cape Town, South Africa. 8. Asociación Civil Impacta Salud y Educación, Lima, Peru. 9. Thai Red Cross AIDS Research Centre, Bangkok, Thailand. 10. Department of Medicine, Chulalongkorn University, Bangkok, Thailand. 11. Institute de Pesquisa Clinica Evandro Chagas, Rio de Janeiro, Brazil. 12. Department of Internal Medicine, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA. 13. Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland, USA. 14. Department of Global Health, University of Amsterdam, Amsterdam, The Netherlands. 15. Lundquist Institute at Harbor-University of California-Los Angeles Medical Center, Torrance, California, USA.
Abstract
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.
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.
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