Addressing Policy Barriers to Pre-Exposure Prophylaxis (PrEP) Uptake and Planning for Long-Acting Agents for Treatment and PrEP

The O’Neill Institute received a generous grant from amfAR, the Foundation for AIDS Research, to examine critical policy issues that impact access, availability and acceptability of pre-exposure prophylaxis (PrEP) and long-acting agents, which are innovative forms of PrEP and HIV treatment that are under development and do not require daily pill taking. The project will explore how to support uptake of effective HIV prevention and treatment modalities for adolescents and young adults, with a focus on young Black gay, bisexual, and other men who have sex with men.

Through a series of consultation meetings, the O’Neill Institute will bring together a diverse array of stakeholders to explore legal, ethical, and policy issues surrounding PrEP for adolescents and young adults, evaluate barriers and opportunities for increasing the engagement of adolescents and young adults in PrEP research and clinical practice, and initiate a policy dialogue for the future deployment of long-acting agents for both PrEP and HIV treatment. The first consultation meeting of this project was held on December 19, 2016 at Georgetown University Law Center, and additional meetings are scheduled for 2017. 

On July 16, 2018, amfAR, The Foundation for AIDS Research, released four reports, “Long-Acting HIV Treatment and Prevention Are Coming: Preparing for Potential Game Changers,” prepared by O’Neill Institute scholars Jeffrey S. Crowley and Sean E. Bland. The reports highlight the education and policy dialogues needed to prepare for innovative long-acting products under development to treat and prevent HIV infection. 

The four reports include: (1) an Overview, summarizing the need for and major policy issues related to extending access to new long-acting products for HIV treatment and prevention; (2) From Laboratory to Marketplace, discussing the Food and Drug Administration (FDA) review and approval process and special considerations for long-acting products; (3) Assessing the Payer Landscape, exploring the laws and policies that shape pharmaceutical access in public and private insurance; and (4) Defining the Intended Market for New Products, addressing issues such as adherence to non-daily products, consumer and provider acceptability, and cost-effectiveness. In addition to the reports, there is also a chart of long-acting agents in development for HIV treatment and prevention.

Briefing on Long-Acting HIV Treatment and Prevention

amfAR and the O’Neill Institute hosted a briefing on July 16, 2018 at Georgetown Law in connection with the release of the four reports, “Long-Acting HIV Treatment and Prevention Are Coming: Preparing for Potential Game Changers.”

Thematic Area: Infectious Diseases

Status: Active


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