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Over-the-Counter Access to HIV Preexposure Prophylaxis

Advocating over-the-counter (OTC) availability for preexposure prophylaxis (PrEP) for HIV, Perspective authors reflect on the recent approval of an OTC oral contraceptive product: “It has taken 63 years since initial approval to free the Pill from prescription-only status. We can’t wait that long for PrEP: the federal Ending the HIV Epidemic in the U.S. initiative aims to reduce national HIV incidence by 90% by 2030. Building on lessons learned from contraception, we believe it’s incumbent on the HIV-prevention community — including health professionals, advocates, and manufacturers — to lay the groundwork for a collaborative movement to ‘free the PrEP.’”

The authors support a particular formulation for OTC consideration: “Of currently available oral and injectable PrEP formulations, the logical initial choice for OTC access would be a daily fixed-dose combination tablet containing tenofovir disoproxil fumarate and emtricitabine (TDF–FTC). This formulation is approved for use in all populations at risk for HIV, including people of all genders, and for all modes of HIV exposure (i.e., sexual contact and injection-drug use) and is the only PrEP formulation for which a generic option is available.”

Source: New England Journal of Medicine