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Free the PrEP - Over-the-Counter
Access to HIV Preexposure Prophylaxis
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List of authors.
• Douglas Krakower, M.D.,
• and Julia L. Marcus, Ph.D.
Several key barriers to PrEP access could be alleviated by making PrEP available over the counter. People would no longer need to disclose information about their behaviors to clinicians, which could facilitate access for all people, but particularly for populations that face stigma in health care settings, such as Black and Latino men who have sex with men. Adolescents and young adults, who have low rates of PrEP use, may prefer OTC PrEP if they are covered by their parents’ insurance plan and concerned about inadvertent disclosure of prescription PrEP use. For people facing challenges related to the complexity of PrEP financing or care, the convenience of OTC PrEP could facilitate both initiation and sustained use; studies have found that rates of continued use of oral contraception among people using OTC pills are equivalent to or higher than rates among those using pills obtained with a prescription.2 The juxtaposition of PrEP on shelves with other sexual health products, which will soon include oral contraception, could help normalize its use. Thoughtful marketing could increase demand and use in priority groups, including in populations - such as Black cisgender women - that have tended to perceive PrEP as being exclusively for men who have sex with men.3
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.
Although TDF-FTC for PrEP is well tolerated, there would be safety considerations related to OTC use. TDF-FTC for PrEP has been associated with decreased bone mineral density and renal function and isn’t recommended for people with osteoporosis or an estimated creatinine clearance of less than 60 ml per minute. TDF-FTC has antiviral activity against hepatitis B, and discontinuation can cause clinical relapse. For HIV treatment, TDF-FTC is insufficient to suppress viral replication, and use by people with undiagnosed HIV can select for resistance-associated mutations. FDA-approved labeling therefore advises testing for renal disease, hepatitis B, and HIV - and consideration of bone mineral density assessment in people with a history of pathologic fractures or risk factors for osteoporosis - before initiation of TDF-FTC for PrEP, as well as quarterly HIV testing and renal-function testing as clinically appropriate during use. Labeling also instructs clinicians to counsel patients on periodic screening for bacterial sexually transmitted infections (STIs), which are common among PrEP users.
OTC status for oral contraceptives was approved with the understanding that the small potential increase in risk associated with making the medication available without a prescription will most likely be outweighed by the benefits - and we believe the same conclusion could be reached for TDF-FTC for PrEP. Most people at heightened risk for HIV are in an age group in which osteoporosis and renal disease are uncommon; moreover, decreases in bone mineral density and renal function associated with TDF-FTC for PrEP are generally mild and reversible, and TDF-FTC for PrEP hasn’t been associated with a significantly increased risk of fractures or serious renal events in clinical trials.4 Hepatitis B prevalence is low in the United States, even in populations at risk for HIV, and serious hepatic inflammation or acute liver failure after discontinuing antiviral treatment is rare in the absence of cirrhosis. As in the case of widely used OTC pain medications that can affect the kidneys or liver, such as ibuprofen and acetaminophen, labels for OTC PrEP could warn people with potential contraindications to consult a clinician before use.
OTC HIV tests, which have been available for years in the United States, could be bundled with OTC PrEP; an example would be a 3-month PrEP package containing 90 pills and an HIV test. Although HIV self-tests designed for home use are less sensitive than laboratory-based tests, the CDC considers them an option for people using PrEP and recently launched a program to mail 1 million free self-tests to people who request them online. Even if people with undiagnosed HIV used TDF-FTC for PrEP and acquired drug-resistance mutations, first-line HIV treatment regimens would still probably lead to viral suppression. The World Health Organization strongly encourages but doesn’t require hepatitis B testing, considers renal-function testing optional for people younger than 50 years of age without kidney-related conditions, and supports HIV self-testing before use of TDF-FTC for PrEP (in addition to supporting HIV self-testing during ongoing use); U.S. guidelines could adopt similarly simplified approaches for implementing OTC PrEP.

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