Prospective HIV RNA screening with long-acting cabotegravir pre-exposure prophylaxis in HPTN 083

BACKGROUND: Pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention. However, breakthrough infections can occur, even with optimal adherence. We evaluated the performance of prospective HIV RNA screening in cisgender men and transgender women who have sex with men using long-acting injectable cabotegravir (CAB-LA) pre-exposure prophylaxis (PrEP) in HPTN 083. METHODS: In the Open Label Extension of HPTN 083, sites performed HIV rapid, antigen/antibody (Ag/Ab) and RNA testing at each visit. Results from site testing and retrospective HIV testing were used to determine final HIV status and identify the first HIV positive visit. RESULTS: HIV RNA screening was associated with fewer diagnostic delays (7% vs. 47% of cases, p=0.02) and earlier treatment initiation (median 15 vs. 62 days, p=0.02). Drug resistance was less frequent with RNA screening (15% vs. 31% of cases, p=0.22). Five cases were first detected with RNA testing only. Sensitivity and specificity of RNA testing were 93% (95% CI: 76, 99) and 99.92% (95% CI: 99.88, 99.95), respectively. However, positive predictive value (PPV) was low overall (55%; 95% CI: 40, 69) and was lower if CAB-LA was administered <6 months earlier (29%; 95% CI: 13, 49). Some false positive RNA test results led to delay or discontinuation of CAB-LA injections. CONCLUSIONS: HIV RNA screening improved clinical outcomes in the setting of CAB-LA PrEP, but the PPV for RNA screening was low which could compromise patient care.

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Journal
Clinical Infectious Diseases
Published
2026-04-24
DOI
https://doi.org/10.1093/cid/ciag285
Primary Topic
HIV/AIDS drug development and treatment
Type
article
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article

Prospective HIV RNA screening with long-acting cabotegravir pre-exposure prophylaxis in HPTN 083

Carl J. Fichtenbaum, Meredith E. Clement, Jessica M. Fogel, Amber Moser et al.
Clinical Infectious Diseases
HIV/AIDS drug development and treatment
article

Prospective HIV RNA screening with long-acting cabotegravir pre-exposure prophylaxis in HPTN 083

Carl J. Fichtenbaum, Meredith E. Clement, Jessica M. Fogel, Amber Moser, Andrea Jennings, Myron S. Cohen, Fei Gao, Michael Seisa, Raphael J. Landovitz, Elias K. Halvas, Joshua C. Cyktor, Susan H. Eshleman, Ryan Kofron, Brett Hanscom, Alex R. Rinehart, Aida Asmelash, Aditya Gaur, Lydia Soto-Torres, Ha Viet Tran, Beatriz Grinsztejn, Estelle Piwowar-Manning, Mark A Marzinke, James F Rooney
article en

Abstract

BACKGROUND: Pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention. However, breakthrough infections can occur, even with optimal adherence. We evaluated the performance of prospective HIV RNA screening in cisgender men and transgender women who have sex with men using long-acting injectable cabotegravir (CAB-LA) pre-exposure prophylaxis (PrEP) in HPTN 083. METHODS: In the Open Label Extension of HPTN 083, sites performed HIV rapid, antigen/antibody (Ag/Ab) and RNA testing at each visit. Results from site testing and retrospective HIV testing were used to determine final HIV status and identify the first HIV positive visit. RESULTS: HIV RNA screening was associated with fewer diagnostic delays (7% vs. 47% of cases, p=0.02) and earlier treatment initiation (median 15 vs. 62 days, p=0.02). Drug resistance was less frequent with RNA screening (15% vs. 31% of cases, p=0.22). Five cases were first detected with RNA testing only. Sensitivity and specificity of RNA testing were 93% (95% CI: 76, 99) and 99.92% (95% CI: 99.88, 99.95), respectively. However, positive predictive value (PPV) was low overall (55%; 95% CI: 40, 69) and was lower if CAB-LA was administered <6 months earlier (29%; 95% CI: 13, 49). Some false positive RNA test results led to delay or discontinuation of CAB-LA injections. CONCLUSIONS: HIV RNA screening improved clinical outcomes in the setting of CAB-LA PrEP, but the PPV for RNA screening was low which could compromise patient care.

Clinical Infectious Diseases
University of North Carolina at Chapel Hill (US), Family Health International 360 (US), St. Jude Children's Research Hospital (US), APLA Health (US), Johns Hopkins University (US), University of Pittsburgh (US), Johns Hopkins Medicine (US), Fred Hutch Cancer Center (US), Ideaya Biosciences (United States) (US), National Institute of Allergy and Infectious Diseases (US), Gilead Sciences (United States) (US), Instituto Evandro Chagas (BR), University of Cincinnati (US), Hanoi University (VN), Louisiana State University Health Sciences Center New Orleans (US)
Good health and well-being
Openalex Percentile: Top 9%
HIV/AIDS drug development and treatment
DOISourceOpenAlex
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