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EVALUATION OF XPERT POINT-OF-CARE ASSAYS FOR DETECTION OF HIV INFECTION IN PERSONS USING LONG-ACTING CABOTEGRAVIR FOR PREEXPOSURE PROPHYLAXIS
Long-acting cabotegravir
HPTN 083
Pre-exposure prophylaxis
Point-of-care
RNA
Author
Fogel, Jessica M.
Piwowar-Manning, Estelle
Moser, Amber
Hill, Tinia
Ahmed, Shahnaz
Cummings, Vanessa
Mostafa, Heba H.
Wang, Zhe
Jennings, Andrea
Gallardo-Cartagena, Jorge A.
Figueroa, María Inés
St Clair, Marty
Rinehart, Alex R.
Adeyeye, Adeola
Rooney, James F.
Cohen, Myron S.
Grinsztejn, Beatriz
Landovitz, Raphael J.
Eshleman, Susan H.
Piwowar-Manning, Estelle
Moser, Amber
Hill, Tinia
Ahmed, Shahnaz
Cummings, Vanessa
Mostafa, Heba H.
Wang, Zhe
Jennings, Andrea
Gallardo-Cartagena, Jorge A.
Figueroa, María Inés
St Clair, Marty
Rinehart, Alex R.
Adeyeye, Adeola
Rooney, James F.
Cohen, Myron S.
Grinsztejn, Beatriz
Landovitz, Raphael J.
Eshleman, Susan H.
Affilliation
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Fred Hutchinson Cancer Center. Seattle, Washington, USA.
FHI 360. Durham, North Carolina, USA.
Universidad Nacional Mayor de San Marcos. Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales. Lima, Peru.
Fundación Huésped. Clinical Research Department. Buenos Aires, Argentina.
ViiV Healthcare. Research Triangle Park. North Carolina, USA.
ViiV Healthcare. Research Triangle Park. North Carolina, USA.
Prevention Science Program. Division of AIDS. National Institute of Allergy and Infectious Diseases. National Institutes of Health. Rockville, Maryland, USA.
Gilead Sciences. Foster City, California, USA.
University of Carolina. Department of Medicine. Chapel Hill, North Carolina, USA.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST e AIDS. Rio de Janeiro, RJ, Brasil.
University of California. Center for Clinical AIDS Research & Education. Los Angeles, California, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Fred Hutchinson Cancer Center. Seattle, Washington, USA.
FHI 360. Durham, North Carolina, USA.
Universidad Nacional Mayor de San Marcos. Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales. Lima, Peru.
Fundación Huésped. Clinical Research Department. Buenos Aires, Argentina.
ViiV Healthcare. Research Triangle Park. North Carolina, USA.
ViiV Healthcare. Research Triangle Park. North Carolina, USA.
Prevention Science Program. Division of AIDS. National Institute of Allergy and Infectious Diseases. National Institutes of Health. Rockville, Maryland, USA.
Gilead Sciences. Foster City, California, USA.
University of Carolina. Department of Medicine. Chapel Hill, North Carolina, USA.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST e AIDS. Rio de Janeiro, RJ, Brasil.
University of California. Center for Clinical AIDS Research & Education. Los Angeles, California, USA.
Johns Hopkins University School of Medicine. Department of Pathology. Baltimore, Maryland, USA.
Abstract
Detection of HIV infection may be challenging in persons using long-acting cabotegravir (CAB-LA) pre-exposure prophylaxis (PrEP) due to viral suppression and reduced/delayed antibody production. We evaluated two point-of-care tests for detecting HIV infection in persons who received CAB-LA in the HPTN 083 trial. Samples were obtained from 12 participants who received CAB-LA and had delayed detection of HIV infection using HIV rapid tests and an antigen/antibody test (52 plasma samples; 18 dried blood spot [DBS] samples). Plasma samples were tested with the Xpert HIV-1 Viral Load XC test (Xpert VL-XC); DBS samples were tested with the total nucleic acid Xpert HIV-1 Qual XC test (Xpert Qual-XC). Results from these assays were compared to results from three reference, laboratory-based, plasma RNA assays (Aptima HIV-1 Qualitative assay [Aptima Qual]; Aptima HIV-1 Quant DX Assay [Aptima Quant]; cobas HIV-1/HIV-2 Qualitative Test [cobas]). HIV RNA was detected with all four plasma assays for all samples with viral loads (VLs) ≥ 200 copies/mL; the number of samples with VLs < 200 copies/mL with HIV RNA detected was: Xpert VL-XC: 19/26 (73.1%); Aptima Qual: 17/26 (65.4%); Aptima Quant: 17/26 (65.4%); and cobas: 12/21 (57.1%). The Xpert Qual-XC assay was positive for all DBS samples with VLs ≥ 200 copies/mL and 1/10 DBS with VLs < 200 copies/mL. The performance of the Xpert VL-XC assay was comparable to the reference assays for detecting HIV infection in these cases. The Xpert Qual-XC assay was less sensitive than plasma-based HIV RNA assays for detecting HIV in the setting of CAB-LA PrEP. Importance: HIV RNA assays can detect HIV infections earlier than HIV rapid tests or Ag/Ab tests in persons using CAB-LA PrEP. Earlier HIV diagnosis could allow for earlier treatment initiation and reduced risk of INSTI resistance. POC tests may help detect HIV infection before CAB-LA administration and may be more accessible than laboratory-based assays in some settings. In this study, the POC Xpert VL-XC assay detected HIV RNA in most samples from individuals who received CAB-LA PrEP and had delayed detection of HIV infection with HIV rapid tests and an Ag/Ab test. The performance of this assay was similar to laboratory-based HIV RNA assays in this cohort. The POC Xpert Qual-XC assay detects both HIV RNA and DNA, with a higher viral load cutoff for RNA detection. This assay was negative for most lower viral load samples and did not offer an advantage for HIV screening in persons using CAB-LA PrEP.
Keywords
HIV preventionLong-acting cabotegravir
HPTN 083
Pre-exposure prophylaxis
Point-of-care
RNA
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