ArticleThe Journal of infectious diseases2026
Weekly Oral Prophylaxis With MK-8527 Protects Rhesus Macaques From Intrarectal Challenge With Simian-Human Immunodeficiency Virus.
Article in The Journal of infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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15 authors.
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Abstract
backgroundMK-8527 is a novel nucleoside reverse transcriptase translocation inhibitor being evaluated for prevention of HIV-1 acquisition. MK-8527 is phosphorylated intracellularly to its active form, MK-8527-triphosphate, which inhibits HIV-1 replication. This study evaluated the efficacy of oral MK-8527 as pre-exposure prophylaxis in rhesus macaques challenged intrarectally with simian-human immunodeficiency virus (SHIV).
methodsTwo groups of male macaques (n = 8 per group) received weekly oral doses of MK-8527 for 12 weeks. Starting 1 week after treatment initiation, the macaques received weekly intrarectal challenge with SHIV162P3 for 10 weeks. Each group was treated in 3 dosing panels: Group 1 received MK-8527 6, 1, and 0 mg/kg (vehicle only), whereas Group 2 received MK-8527 2, 0.3, and 0.1 mg/kg. A washout period of ≥4 weeks followed each dosing panel. A control group (n = 8) was challenged without receiving MK-8527. Plasma viral loads were monitored weekly, with infection confirmed by 2 consecutive measurements of SHIV RNA >100 copies/mL. Concentrations of MK-8527 phosphorylated forms were quantified using liquid chromatography-tandem mass spectrometry.
resultsOnce-weekly doses of MK-8527 ≥ 0.1 mg/kg for 12 weeks conferred complete protection against intrarectal SHIV acquisition, and 7/8 untreated control macaques and 5/8 vehicle-only macaques became infected. The rate of infection for macaques receiving MK-8527 was at least 11.1-fold (P = .009) lower compared with the control or vehicle group. MK-8527-triphosphate trough concentrations at 0.1 mg/kg resulted in a mean inhibitory quotient of 2.2.
conclusionsProphylaxis with MK-8527 completely protected macaques from SHIV infection, supporting its further clinical development for prevention of HIV-1 acquisition.
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