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Published on: March 30, 2014
Potential Risks and Benefits of Low-Barrier Access and Monitoring for HIV Preexposure Prophylaxis: A Modeling Study
Adrien V Le Guillou1,2, Julia L Marcus3, Douglas S Krakower3,4
1Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA.
The Journal of Infectious Diseases
|July 17, 2026
Summary
Over-the-counter (OTC) PrEP can significantly reduce HIV infections by increasing access. However, careful implementation is crucial to manage risks like drug resistance and renal toxicity.
Area of Science:
- Public Health
- Infectious Disease Epidemiology
- Pharmacology
Background:
- HIV pre-exposure prophylaxis (PrEP) is effective but faces access barriers.
- Over-the-counter (OTC) PrEP delivery models could improve access by removing clinic visit requirements.
- Reduced monitoring in OTC PrEP may increase risks such as drug resistance, renal toxicity, and hepatitis B virus (HBV) reactivation.
Purpose of the Study:
- To estimate the benefits and risks associated with over-the-counter (OTC) PrEP.
- To model the impact of increased PrEP coverage on HIV/STI transmission among men who have sex with men (MSM).
Main Methods:
- A stochastic network-based model simulating HIV/STI transmission in Atlanta among MSM.
- Comparison of clinic-based PrEP delivery versus OTC PrEP with simplified initiation and reduced monitoring.
- Modeling of 10-50% increases in PrEP coverage over 10 years, assessing outcomes like HIV infections averted, STI incidence, contraindicated PrEP use, HBV reactivations, and drug resistance.
Main Results:
- Increased PrEP coverage, particularly OTC, significantly reduced HIV incidence, averting 15.4% of infections with a 50% coverage increase.
- OTC PrEP led to increased clinical risks: renal impairment exposure rose to 4.8%, HBV reactivations reached 2.27 per 100 person-years, and TDF/FTC resistance increased to 8.40 events per 100 incident HIV infections.
- Sensitivity analyses showed confirming HIV-negative status at initiation reduced resistance by over 90%, and renal monitoring mitigated renal risks.
Conclusions:
- OTC PrEP offers potential population-level HIV prevention benefits by expanding coverage beyond traditional clinic-based models.
- The net public health impact of OTC PrEP hinges on implementation strategies that maintain safety measures like HIV testing at initiation and renal monitoring.
- Balancing improved access with essential safety functions is key to maximizing the benefits of OTC PrEP.
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