CLINICAL RESEARCH UPDATE

by Carolyn Chu, MD, MSc, AAHIVS, AAHIVM Chief Medical Officer

July 15, 2025


Featured Literature:

Preexposure Prophylaxis for HIV: Updated Recommendations from the 2024 International Antiviral Society-USA Panel. Available at: https://www.iasusa.org/2025/06/27/updated-recommendations-from-the-2024-international-antiviral-society-usa-panel/.

Interim Guideline on the Use of Twice-Yearly Lenacapavir for HIV Prevention: New York State Department of Health AIDS Institute Clinical Guidelines Program. Available at: https://www.hivguidelines.org/guideline/hiv-prep-len/?mycollection=pep-prep.

BASHH/BHIVA Guidelines on the Use of HIV Pre-exposure Prophylaxis (PrEP), 2025. Available at: https://bhiva.org/clinical-guideline/PrEP-guidelines/.

Guidelines on Lenacapavir for HIV Prevention and Testing Strategies for Long-acting Injectable Pre-exposure Prophylaxis (PrEP).  Geneva: World Health Organization (WHO); 2025.  Available at: https://www.who.int/publications/i/item/9789240111608.

Several groups (e.g., International Antiviral Society-USA, NYSDOH AIDS Institute, British Association for Sexual Health and HIV/British HIV Association, and World Health Organization) recently released updated PrEP recommendations.  Although many of these were developed in response to the recent approval of lenacapavir, some also include newer data regarding oral PrEP.  Of note, most groups recommend lab-based HIV antigen/antibody testing for lenacapavir initiation and continuation monitoring; WHO supports use of rapid diagnostic tests.  HIV RNA (viral load) is not required but is recommended under certain circumstances such as likely HIV exposure within the past 21 days, or concern for acute HIV in people not already taking and adherent to PrEP.  Drug interaction potential should be carefully considered, since lenacapavir is a substrate and moderate inhibitor of CYP3A4 and a substrate of P-gp.  For people interested in oral PrEP options, IAS-USA now recommends TAF/FTC for prevention of HIV acquisition from vaginal exposures for people in whom TDF/FTC is contraindicated or undesirable.  The BASHH/BHIVA updates outline several oral PrEP initiation and dosing strategies across multiple exposure types based on various PK/PD analyses and increasing confidence in recognizing PBMC drug levels as the relevant marker of protection. They also include sections on what to do in the event of missed doses, renal function assessment flowcharts, and suggestions for managing renal function changes while on PrEP.

Author’s Commentary:

PrEP continues to be vastly underutilized in most communities—new products and innovative dosing strategies are greatly needed, and these updated guidelines will hopefully help address some outstanding questions and increase provider confidence and uptake across varied settings to increase PrEP access.  Many clinical practices and HIV programs are likely adjusting their operations in anticipation of resource constraints, making simplification, integration and task-shifting imperative as new PrEP options are implemented.

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