On June 18, the US Food and Drug Administration (FDA) approved the use of Gilead’s anti-HIV medication, Lenacapravir (trade name: Yeztugo) as a twice-yearly subcutaneous injection for pre-exposure prophylaxis (PrEP) for HIV prevention. In the 2 major studies, PURPOSE-1 and PURPOSE-2 that led to the FDA approval, the medication was found to be superior to daily oral PrEP with a protection rate of over 99.9%.
Read Gilead’s press release here.
Fenway Health was the only New England site that enrolled participants in PURPOSE-2, one of the 2 landmark studies leading to FDA approval. The BioMedical Team at The Fenway Institute is currently enrolling participants in the HPTN 102/PURPOSE-3 study that is focused on evaluating Lenacapravir use in cisgender US women, and again, is the only site enrolling participants in New England.
“The FDA approval of Lenacapravir is a major advance for HIV prevention, since it only requires twice yearly injections and is nearly 100% effective,” said Kenneth Mayer, MD, Medical Research Director at Fenway Health and Co-Director of The Fenway Institute. “We anticipate that this will allow us to reach the majority of people who could benefit from PrEP, but who have not accessed it because of concerns about pill use and/or frequency of medical visits. We look forward to making it available at our clinic in the weeks ahead.”
Lenacapravir is a major improvement over daily PrEP pills, offering better adherence with only two injections per year and is considered a potential game-changer in curbing the HIV epidemic. Gilead is working to make it available globally through strategic partnerships and licensing.
“Lenacapravir has amazing promise as an HIV prevention tool. Unfortunately, recent dramatic cuts to federal support of HIV research and prevention could negatively impact medical and public health organizations’ ability to fully leverage it to curb the epidemic,” said Mayer, referring to the recent elimination of funding for HIV and LGBTQIA+ health research and the closing of the CDC HIV prevention division.
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.