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Given the alarming upward trend in HIV infection rates and the downward trend in condom usage, we need a new approach to HIV prevention in the United States. One such approach, HIV Pre-Exposure Prophylaxis (commonly known as “PrEP”), has the potential to significantly reduce HIV incidence. The FDA recently approved a daily dose of Truvada® — an antiretroviral drug that suppresses the virus in HIV-positive individuals — for daily use by high-risk HIV-negative individuals to prevent infection. Despite an effectiveness above ninety percent and significant regulatory momentum, this pharmacological prevention modality has proven difficult to implement. In this Article, I address the social, legal, and policy challenges that will shape future implementation of this potentially game-changing HIV prevention modality. I develop a framework for understanding these challenges by dividing them into two dimensions: acceptability and accessibility. I argue that self-imposed, individual, and institutional stigma affects PrEP acceptability among high-risk groups and among healthcare providers. In addition, I discuss the accessibility barriers of cost, prior authorization, and policy exclusions. One solution to overcoming these challenges is mandating benefits for, and eliminating accessibility hurdles to, PrEP under The Patient Protection and Affordable Care Act, as well as mandating PrEP coverage through state action. Health content regulation, although controversial particularly after the U.S. Supreme Court’s decision in Burwell v. Hobby Lobby, will be necessary both to ensure that PrEP treatment reaches the populations most at risk of spreading the virus and to overcome antiquated assumptions about HIV prevention.


Originally published by the San Diego Law Review in 2015.