Gilead announced today that the PURPOSE 2 study of twice yearly lenacapavir injections as pre-exposure prophylaxis (PrEP) reduced HIV infections by 96% among cisgender gay, bisexual and other men who have sex with men (MSM) and transgender and non-binary individuals who have sex with men. There were 2 incident HIV infections among 2,180 participants who received twice yearly lenacapravir injections, corresponding to 99.9% of participants not acquiring HIV infection in the lenacapavir group. This follows the results of the PURPOSE 1 study which was unblinded earlier this year after it showed lenacapivir’s strong efficacy among cisgender women in sub-saharan Africa. You can read Gilead’s press release here.
The Fenway Institute at Fenway Health was one of the US trial sites for PURPOSE 2 and the only site in New England recruiting MSM, transgender and non-binary participants for the study.
“As researchers based ,at Fenway Health, the largest provider of PrEP in New England, we are excited by the results of the PURPOSE 2 study, in which we participated, which enrolled men who have sex with men and transgender people. The findings that lenacapravir provided very high efficacy and superiority compared to a daily oral PrEP regimen are stunning, since they complement the impressive results from the PURPOSE-1 study in cisgender African women,” said Kenneth Mayer, MD, Medical Research Director at Fenway Health and Co-chair of The Fenway Institute. “
“Lenacapravir is a major advance, since it provides a highly effective PrEP option that can be delivered subcutaneously twice a year. Prior work suggests that the more PrEP options we can provide, the more effectively we will be in protecting the largest number of people against HIV. We hope that with data from a second well-conducted trial in a different population than the original trial, that the FDA will be able to move expeditiously for product approval.”
Fenway is currently enrolling participants in PURPOSE 3, which will help to understand if lenacapavir, can be used by cisgender women in the US to help prevent acquiring HIV through sex. Learn more and see if you qualify here.
Founded in 1971, Fenway Health advocates for and delivers innovative, equitable, accessible health care, supportive services, and transformative research and education. We center LGBTQIA+ people, BIPOC individuals, and other underserved communities to enable our local, national, and global neighbors to flourish. The Fenway Institute at Fenway Health is an interdisciplinary center for research, training, education and policy development focusing on national and international health issues.