Analysis examines biomedical prevention technology to be reviewed by U.S. Food and Drug Administration by June 15, 2012

Pre-exposure chemoprophylaxis (PrEP)—taking antiretroviral medications to prevent HIV transmission—could be a “game changer” for HIV prevention. PrEP has demonstrated partial efficacy with men who have sex with men (MSM), transgender women, and heterosexuals in several recent studies. Recent modeling of PrEP implementation coupled with scaled up treatment predicts that PrEP could significantly reduce HIV incidence and prevalence. And if PrEP is accompanied by sustained care, behavioral interventions, and safety monitoring, PrEP need not lead to increased sexual risk behavior or drug resistance.

The latest Policy Focus from The Fenway Insitute summarizes the state of PrEP and microbicides research as of January 2012, looks at willingness to use PrEP among various populations, addresses concerns about PrEP that could present obstacles to implementation, offers strategies for effective implementation, and examines policy issues related to cost and how to make PrEP accessible to those most vulnerable to HIV.

The Fenway Institute’s analysis found that the most effective prevention interventions will be those that combine behavioral interventions, structural interventions, and emerging biomedical technologies, such as PrEP and microbicides. The analysis concludes with recommendations for implementation of PrEP, including:

• If the U.S. Food and Drug Administration (FDA), which is considering approving FTC-TDF for use as PrEP, feels that research on PrEP’s efficacy among heterosexuals is inconclusive, it should consider approving PrEP for MSM now separately and consider heterosexuals, IDUs and other populations in the near future as the science advances;
• The World Health Organization (WHO) should issue guidance on PrEP that takes into account the promising results of the iPrEx study, Partners PrEP, and the Botswana CDC study;
• Following the release of the Bangkok injection drug user (IDU) trial results, if appropriate the U.S. Centers for Disease Control and Prevention, the U.S. Public Health Service, and the WHO should issue guidance for PrEP with IDUs.;
• States should provide access to PrEP as a critical prevention service and prescription medication under the Essential Health Benefits provision of the Affordable Care Act;
• State Medicaid programs should also cover PrEP as a cost-saving measure that will improve public health and ultimately save money in health care costs;
• Provision of PrEP to MSM and transgender women should occur in a broader context of ensuring clinically competent health care to gay, lesbian, bisexual and transgender people.

You can also read past Policy Focuses on asking about sexual orientation and gender identity in clinical settings. 

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