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J Infect Dis ; 229(4): 1131-1140, 2024 Apr 12.
Artículo en Inglés | MEDLINE | ID: mdl-38019657

RESUMEN

BACKGROUND: Despite highly effective HIV preexposure prophylaxis (PrEP) options, no options provide on-demand, nonsystemic, behaviorally congruent PrEP that many desire. A tenofovir-medicated rectal douche before receptive anal intercourse may provide this option. METHODS: Three tenofovir rectal douches-220 mg iso-osmolar product A, 660 mg iso-osmolar product B, and 660 mg hypo-osmolar product C-were studied in 21 HIV-negative men who have sex with men. We sampled blood and colorectal tissue to assess safety, acceptability, pharmacokinetics, and pharmacodynamics. RESULTS: The douches had high acceptability without toxicity. Median plasma tenofovir peak concentrations for all products were several-fold below trough concentrations associated with oral tenofovir disoproxil fumarate (TDF). Median colon tissue mucosal mononuclear cell (MMC) tenofovir-diphosphate concentrations exceeded target concentrations from 1 hour through 3 to 7 days after dosing. For 6-7 days after a single product C dose, MMC tenofovir-diphosphate exceeded concentrations expected with steady-state oral TDF 300 mg on-demand 2-1-1 dosing. Compared to predrug baseline, HIV replication after ex vivo colon tissue HIV challenge demonstrated a concentration-response relationship with 1.9 log10 maximal effect. CONCLUSIONS: All 3 tenofovir douches achieved tissue tenofovir-diphosphate concentrations and colorectal antiviral effect exceeding oral TDF and with lower systemic tenofovir. Tenofovir douches may provide a single-dose, on-demand, behaviorally congruent PrEP option, and warrant continued development. Clinical Trials Registration . NCT02750540.


Asunto(s)
Adenina/análogos & derivados , Fármacos Anti-VIH , Neoplasias Colorrectales , Infecciones por VIH , Organofosfatos , Profilaxis Pre-Exposición , Minorías Sexuales y de Género , Masculino , Humanos , Tenofovir , Infecciones por VIH/prevención & control , Infecciones por VIH/tratamiento farmacológico , Emtricitabina , Homosexualidad Masculina , Difosfatos/uso terapéutico , Neoplasias Colorrectales/tratamiento farmacológico
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