The U.S. Food and Drug Administration this week approved Gilead Sciences’ twice-a-year shot, lenacapvir, to prevent HIV, Gilead announced on Wednesday, June 18. It is the first and only long-acting injectable approved for pre-exposure prophylaxis at this time.
The approval is “the first step in an anticipated global rollout that could protect millions,” according to The Edge Media Network. But it remains unclear how many people in the U.S. and abroad will have access to the treatment.
The FDA’s decision is backed by data from the PURPOSE 2 trials, in which Ian L. Haddock, founder and executive director of the Houston-based Normal Anomaly Initiative, participated as a trial subject. Haddock called lenacapvir’s approval “a breakthrough in reshaping HIV prevention.”
“Being a part of the PURPOSE 2 trial was about more than just my own health, it was about opening a door for others like me,” Haddock said in a written statement.
“In a region where stigma and systemic health inequities too often limit access to care, this injectable PrEP has the potential to transform how people protect themselves and reclaim agency over their sexual health,” he added. “I’m honored to be part of this journey, and even more excited to help our communities navigate what comes next.”
Shavonne Jaquess-Smith, senior program manager at The Normal Anomaly Initiative, which also has offices in Dallas, said, “The approval of lenacapavir for all genders, including women, is a game-changer. Women, especially Black and brown women, have too often been an afterthought in HIV prevention efforts. Now, with a twice-a-year injectable, we have a tool that can truly meet people where they are, remove the mental load for women that comes with the daily pills, and provide more discretion, ultimately increasing their safety.”
Haddock called for access to and education about the new treatment to happen quickly, saying his organization will “continue to work with partners to equip their network with the knowledge and tools to make informed choices and build trust in this new era of prevention.”
“This isn’t just a medical win, it’s a movement,” Haddock said. “And we’re here to make sure our communities are informed, empowered, and centered every step of the way.”
— Tammye Nash