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J Acquir Immune Defic Syndr. 2017 Aug 1;75(4):426-430. doi: 10.1097/QAI.0000000000001421.

Brief Report: Impact of Early Antiretroviral Therapy on the Performance of HIV Rapid Tests and HIV Incidence Assays.

Author information

1
Departments of *Pathology; and †Medicine, Johns Hopkins University, School of Medicine, Baltimore, MD; ‡Laboratory of Immunoregulation, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Baltimore, MD; §Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA; ‖Science Facilitation Department, FHI 360, Washington, DC; ¶Science Facilitation Department, FHI 360, Durham, NC; #UNC Project Laboratory, Tidziwe Centre, Kamuzu Central Hospital, Lilongwe, Malawi; **College of Medicine-Johns Hopkins Project, Blantyre, Malawi; ††Division of Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC; ‡‡UNC Project-Malawi, Institute for Global Health and Infectious Diseases, Lilongwe, Malawi; §§Vaccine and Infectious Disease Division and Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA; and ‖‖Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.

Abstract

BACKGROUND:

Antiretroviral therapy (ART) can downregulate antibody responses to HIV infection. We evaluated the impact of early vs. delayed ART on the performance of HIV diagnostic and incidence assays.

METHODS:

Samples were obtained from 207 participants in the HPTN 052 trial, who were stably suppressed on ART for ≥4 years [Malawi sites; pre-ART CD4 cell count 350-550 cells/mm (early ART arm, N = 180) or <250 cells/mm or an AIDS-defining illness (delayed ART arm, N = 27)]. Samples were tested with 2 HIV rapid tests and 2 HIV incidence assays; selected samples were also tested with two fourth-generation immunoassays and a Western blot (WB) assay. A pre-ART sample was analyzed if the follow-up sample had a false-negative or weakly-reactive rapid test result, or had an incidence assay result indicative of recent infection (false-recent result).

RESULTS:

Ten (4.8%) samples had a nonreactive or weakly-reactive rapid test result (7/180 early ART arm, 3/27 delayed ART arm, P = 0.13); one sample had nonreactive fourth-generation assay results and 3 had indeterminate WBs. Forty (18.9%) samples had a false-recent incidence assay result; 16 (7.8%) had false-recent results with both incidence assays. Baseline samples had stronger rapid test and WB bands, higher fourth-generation assay signal-to-cutoff values, and fewer HIV incidence assay results indicative of recent infection.

CONCLUSIONS:

False-negative/weakly-reactive HIV rapid tests and false-recent HIV incidence assay results were observed in virally-suppressed individuals, regardless of pre-ART CD4 cell count. Downregulation of the antibody response to HIV infection in the setting of ART may impact population-level surveys of HIV prevalence and incidence.

PMID:
28471839
PMCID:
PMC5499248
DOI:
10.1097/QAI.0000000000001421
[Indexed for MEDLINE]
Free PMC Article

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