Breakthrough HIV Prevention Study Shows Promise of new Injectable

A new, twice-yearly injection could transform HIV prevention for people in the United States and around the world. And Grady played a vital role. 

A recently completed clinical trial that took place at Grady and other sites has revealed that a simple twice-yearly injection of Lenacapavir was 96% effective in preventing HIV infection. This groundbreaking advancement could eliminate the need for daily pills that many patients struggle to take consistently. 

"Seeing these high levels of efficacy – at almost 100% — in an injectable that people only have to take every six months is incredible," said Dr. Colleen Kelley, who served as the lead author of the study published in the prestigious New England Journal of Medicine. "This is a considerable and profound advancement in medicine, especially for people whose circumstances don't allow them to take a daily oral medication." 

Grady's longstanding commitment to health equity made it an ideal partner in the trial. To ensure broad accessibility, the Grady team provided materials in Spanish and employed bilingual staff to work with Spanish-speaking participants. "At Grady, our focus is on increased representation of underserved and vulnerable populations," explained Dr. Valeria Cantos, principal investigator for the clinical trial at Grady. 

The completion of the Phase III clinical trial has allowed Gilead Sciences, which funded the clinical trial, to submit the results to the FDA for consideration. Dr. Kelley is hopeful that the injection may be approved as soon as 2025, launching a momentous opportunity to revolutionize HIV prevention while advancing Grady's mission of providing quality, comprehensive health care to all.