September 13, 2024

Please see below for a statement from experts at the O’Neill Institute for National and Global Health Law’s on the findings of the PURPOSE 2 HIV prevention study.

Kirk Grisham is the program manager of the Longer-Acting HIV Treatment and Prevention Policy Project in the Infectious Diseases Initiative. Jeffrey S. Crowley is the director of the Infectious Diseases Initiative. The Longer-Acting Policy Project is supported by grants from Gilead Sciences, Merck, and ViiV Healthcare. The project is conducted independently of its funders.

Yesterday Gilead Sciences announced interim results from its PURPOSE 2 trial that evaluated the efficacy of lenacapavir administered as a once every six-month injectable form of pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM), transgender, and nonbinary individuals. 

These results found that 99.9% of trial participants did not acquire HIV in the study period (two HIV diagnoses occurred out of 2,180 study participants). This study builds on the earlier results of the PURPOSE 1 study in cisgender women in sub-Saharan Africa, which showed no new HIV infections among women receiving lenacapavir in that study. New products such as injectable lenacaprivir are exciting for expanding the range of HIV prevention options which can help us to further reduce new HIV cases. Innovative products, however, will mean little if we cannot deliver them to communities who need them most. In the United States, this includes Black and Latinx MSM, transgender women, and Black cisgender women. 

To maximize the benefits of injectable lenacapavir and other longer-acting products, we must focus on ensuring equitable access. We must demand delivery system reforms to ensure that clinics and other settings can administer these products to all who can benefit from them, and we must tackle pricing, financing, and insurance barriers among private health plans, Medicaid, and Medicare that cannot be permitted to deny coverage for these critical prevention tools.

If you are interested in interviews with the experts, please contact Heena Patel, O’Neill Institute director of strategic communications, at hp498@georgetown.edu.