A new once-monthly oral HIV prevention drug, MK-8527, has shown a favorable safety profile and promising pharmacokinetics, according to interim results from a phase 2 study presented on July 14 at the IAS 2025 conference in Kigali (Abstract 6515).
In the randomized, double-blind, multicenter trial involving 350 participants—over half of them women—MK-8527 was well tolerated across three dosage levels (3, 6, and 12 mg), with adverse event rates similar to those seen in the placebo group. No significant laboratory abnormalities were observed, including in total lymphocyte and CD4 T-cell counts.
MK-8527 is a novel nucleoside reverse transcriptase translocation inhibitor (NRTTI) designed to be taken once a month. Study investigators from sites in the U.S., South Africa, and Israel found that drug levels in plasma and its active metabolite in cells were dose-proportional and supported continued development of the compound for HIV pre-exposure prophylaxis (PrEP).
While the trial enrolled only people at low risk of HIV infection, the findings are an encouraging step toward diversifying long-acting HIV prevention options, especially for those who may prefer oral alternatives to injectables.
Further studies in higher-risk populations will be required before the drug can be considered for wider use.
