ArticleThe Journal of infectious diseases2026
Potential Risks and Benefits of Low-Barrier Access and Monitoring for HIV Preexposure Prophylaxis: A Modeling Study.
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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Abstract
backgroundPrEP prevents HIV acquisition, but its population-level impact is limited by access barriers. Low-barrier delivery of daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), such as over-the-counter (OTC) availability, could improve access by eliminating clinic visits, though reduced monitoring may increase risks including drug resistance, renal toxicity, and hepatitis B virus (HBV) reactivation. We estimated the benefits and risks of OTC PrEP.
methodsUsing a stochastic network-based model of HIV/STI transmission among gay, bisexual, and other men who have sex with men (GBMSM) in Atlanta, we simulated two delivery pathways: clinic-based PrEP and OTC PrEP with simplified initiation and reduced monitoring. We modeled 10-50% increases in PrEP coverage over 10 years. Outcomes included HIV infections averted, STI incidence, contraindicated PrEP use (GFR < 60 mL/min/1.73 m2), HBV reactivations, and drug resistance.
resultsBy expanding coverage, OTC PrEP reduced HIV incidence across all scenarios. A 50% coverage increase averted 15.4% of HIV infections. However, clinical risks increased: renal impairment exposure rose from 2.5% to 4.8%; HBV reactivations reached 2.27 per 100 person-years; and TDF/FTC resistance rose from 0.68 to 8.40 events per 100 incident HIV infections. In sensitivity analyses, confirming HIV-negative status at initiation reduced resistance by >90% without reducing prevention benefits, and frequent renal monitoring reduced renal risk.
conclusionsOTC PrEP could produce population-level HIV prevention benefits if it expands coverage beyond clinic-based care. However, its net public health impact depends on implementation choices that preserve safety functions, particularly HIV testing at initiation and renal monitoring, without undermining access gains.
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