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

Authors

• Raphael J. Landovitz, University of California Los Angeles, Los Angeles, CA
• Jessica M. Fogel, Johns Hopkins University School of Medicine, Baltimore, MA
• Fei Gao, Fred Hutchinson Cancer Center, Seattle, WA
• Brett Hanscom, Fred Hutchinson Cancer Center, Seattle, WA
• Estelle Piwowar-Manning, Johns Hopkins University School of Medicine, Baltimore, MA
• Amber Moser, Johns Hopkins University School of Medicine, Baltimore, MA
• Mark A. Marzinke, Johns Hopkins University School of Medicine, Baltimore, MA
• Joshua Cyktor, University of Pittsburgh, Pittsburgh, PA
• Michael Seisa, Monogram Biosciences, South San Francisco, CA
• Elias K. Halvas, University of Pittsburgh, Pittsburgh, PA
• Ryan Kofron, University of California Los Angeles, Los Angeles, CA
• Andrea Jennings, FHI 360, Durham, NC
• Meredith Clement, LSU Health Sciences Center - New Orleans
• Ha Viet Tran, The University of North Carolina - Vietnam, Hanoi City, Vietnam
• Aditya Gaur, St. Jude Children's Research Hospital, Memphis, TN
• Carl J. Fichtenbaum, University of Cincinnati, Cincinnati, OH
• Aida Asmelash, FHI 360, Durham, NC
• Lydia Soto-Torres, National Institute of Allergy and Infectious Diseases, Rockville, MD
• James F. Rooney, Gilead Sciences, Foster City, CA
• Alex R. Rinehart, ViiV Healthcare, Research Triangle Park, NC
• Myron S. Cohen, University of North Carolina, Chapel Hill, NC
• Beatriz Grinsztejn, Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil
• Susan H. Eshleman, Johns Hopkins University School of Medicine, Baltimore, MD

Document Type

Article

Publication Date

4-27-2026

Publication Title

Clinical Infectious Diseases

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.

PubMed ID

42044061

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-No Derivative Works 4.0 International License.

Recommended Citation

Landovitz, Raphael J.; Fogel, Jessica M.; Gao, Fei; Hanscom, Brett; Piwowar-Manning, Estelle; Moser, Amber; Marzinke, Mark A.; Cyktor, Joshua; Seisa, Michael; Halvas, Elias K.; Kofron, Ryan; Jennings, Andrea; Clement, Meredith; Viet Tran, Ha; Gaur, Aditya; Fichtenbaum, Carl J.; Asmelash, Aida; Soto-Torres, Lydia; Rooney, James F.; Rinehart, Alex R.; Cohen, Myron S.; Grinsztejn, Beatriz; and Eshleman, Susan H., "Prospective HIV RNA screening with long-acting cabotegravir pre-exposure prophylaxis in HPTN 083" (2026). School of Medicine Faculty Publications. 4731.
https://digitalscholar.lsuhsc.edu/som_facpubs/4731
10.1093/cid/ciag285