The FDA has approved lenacapavir, a groundbreaking twice-yearly HIV prevention injection by Gilead Sciences, for adults and adolescents. Marketed as Yeztugo, this long-acting PrEP therapy showed 99.9% efficacy in clinical trials—offering a major advancement over daily pills and other existing HIV prevention options.
Superior Protection with Fewer Doses
Lenacapavir outperformed current daily oral and bi-monthly injectable PrEP options in the PURPOSE 1 and PURPOSE 2 trials, earning Science magazine’s “Breakthrough of the Year” in 2024. Side effects were minimal, mostly limited to injection-site reactions.
PrEP treatments have been used in the United States to prevent HIV since 2012. These therapies generally involve daily oral medication (Truvada) or injections every two months (Apretude).
Addressing Barriers to PrEP Access
Despite 2.5 million U.S. adults needing PrEP, only one-third currently use it due to cost, stigma, and adherence challenges. Experts believe Yeztugo’s twice-yearly dosing could improve accessibility, especially for marginalized communities disproportionately affected by HIV.
“Yeztugo could be the transformative PrEP option we’ve been waiting for — offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,” Carlos del Rio, MD, Distinguished Professor of Medicine in the Division of Infectious Diseases at Emory University School of Medicine and co-director of the Emory Center for AIDS Research in Atlanta, said in a news release.
“A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face. We also know that, in research, many people who need or want PrEP preferred less frequent dosing,” del Rio continued.
Dr. Carlos del Rio (Emory University) called it a “transformative PrEP option” that could boost adherence and help end the HIV epidemic.
Dr. Monica Gandhi (UCSF) highlighted its potential for low-income populations struggling with housing and substance use issues.
A Critical Step Amid Funding Cuts
The approval comes as federal HIV research funding faces cuts, making new prevention tools even more vital.
With over 100 daily HIV diagnoses in the U.S., Yeztugo provides hope for reducing infections through convenient, long-acting protection.
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