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. 2024 Oct 3;391(13):1253-1256.
doi: 10.1056/NEJMc2402088. Epub 2024 Jul 24.

Features of HIV Infection in the Context of Long-Acting Cabotegravir Preexposure Prophylaxis

Raphael J Landovitz  1 , Sinead Delany-Moretlwe  2 , Jessica M Fogel  3 , Mark A Marzinke  3 , Estelle Piwowar-Manning  3 , Paul Richardson  3 , Elias K Halvas  4 , John W Mellors  4 , Deborah Persaud  3 , Ryan Kofron  5 , Marybeth McCauley  6 , Scott Rose  6 , Alex R Rinehart  7 , James F Rooney  8 , Adeola Adeyeye  9 , Myron S Cohen  10 , Deborah Donnell  11 , Mina C Hosseinipour  10 , Beatriz Grinsztejn  12 , Susan H Eshleman  3 ; HPTN 083 and 084 Study Teams
Collaborators, Affiliations

Features of HIV Infection in the Context of Long-Acting Cabotegravir Preexposure Prophylaxis

Raphael J Landovitz et al. N Engl J Med. .
No abstract available

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Figures

Figure:
Figure:. Key features of early HIV infection with long-acting early viral inhibition compared to classical acute/primary HIV infection.
Key features of classical acute/primary HIV infection (AHI, left) and long-acting early viral inhibition (LEVI, right) are illustrated in the figure. Panel A: Abbreviations: AHI: acute HIV infection; Ab: antibody; Ag: antigen; CAB-LA: long-acting injectable cabotegravir; LEVI: long-acting early viral inhibition; POC: point-of-care; PrEP: pre-exposure prophylaxis. Panel B: HIV RNA levels are shown with purple lines; HIV antibody levels are shown with blue lines. In the absence of antiretroviral drugs, AHI usually exhibits unconstrained, explosive viral replication following infection with peak viremia 7–14 days after infection. AHI can be detected in the first days of infection using an RNA assay. Ag/Ab assays usually become reactive 12–15 days after infection. Antibody-based confirmatory/discriminatory assays usually become positive around one month after infection. Antibody expression is associated with a rapid decline in viral load followed by establishment of a viral load set point. In LEVI, HIV acquisition may occur before or after PrEP initiation. HIV drug resistance often emerges early when viral loads are low; additional resistance associated mutations may emerge over time before viral breakthrough occurs. Viral breakthrough can occur with on-time drug administration and expected drug levels (left dashed lines) or after drug administration stops and drug levels decline (right dashed lines). In some cases, viral breakthrough was not observed even after drug concentrations dropped below detectable levels (right dotted lines). Antibody-based confirmatory/discriminatory assays often remain negative or indeterminate for long periods and may still not be positive even one year after HIV infection.
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References

    1. Landovitz RJ, Donnell D, Clement ME, et al. Cabotegravir for HIV prevention in cisgender men and transgender women. N Engl J Med 2021;385:595–608. - PMC - PubMed
    1. Delany-Moretlwe S, Hughes JP, Bock P, et al. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. Lancet 2022;399:1779–89. - PMC - PubMed
    1. Eshleman SH, Fogel JM, Halvas EK, et al. HIV RNA screening reduces integrase strand transfer inhibitor resistance risk in persons receiving long-acting cabotegravir for HIV prevention. J Infect Dis 2022;226:2170–80. - PMC - PubMed
    1. Marzinke MA, Fogel JM, Wang Z, et al. Extended characterization of HIV infection in cisgender men and transgender women who have sex with men receiving injectable cabotegravir for HIV prevention: HPTN 083. Antimicrob Agents Chemotherapy 2023;67:e0005323. - PMC - PubMed
    1. Eshleman SH, Fogel JM, Piwowar-Manning E, et al. The LEVI Syndrome: characteristics of early HIV infection with cabotegravir for PrEP. 30th Conf on Retroviruses and Opportunistic Infections. Feb 18–22, 2023. Seattle, WA. Abstract #160.

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