A recent study featured in the New England Journal of Medicine reveals that biannual injections of Lenacapavir dramatically reduce the risk of HIV infection by 96%. The Phase III PURPOSE 2 trial, orchestrated by medical professionals at Emory University and Grady Health System, juxtaposed the safety and effectiveness of subcutaneous Lenacapavir administered twice yearly for pre-exposure prophylaxis (PrEP) with the daily oral regimen of Truvada.
While oral PrEP medications like Truvada play a crucial role in preventing HIV infection, their effectiveness is contingent upon daily adherence as prescribed. "The near-total efficacy observed with a biannual injection is remarkable," stated Colleen Kelley, a leading researcher and professor from Emory University's School of Medicine. She added, “This marks a substantial advancement in healthcare, particularly for individuals unable to maintain a daily medication schedule and for communities disproportionately affected by HIV."
Conducted in seven countries, the randomized, double-blind trial included participants from varied backgrounds. Of the 2,179 individuals in the Lenacapavir cohort, only two cases of HIV emerged. Kelley noted, "Approximately half of the individuals who commence daily oral PrEP cease within a year due to an array of factors."
The availability of a highly effective injection required only twice a year is transformative, especially for those facing challenges in accessing healthcare or maintaining the routine of a daily pill," Kelley added. Based on the promising outcomes from prior Phase 1 and 2 trials, researchers anticipate Lenacapavir could receive approval for commercial distribution by 2025.
"For those unable to adhere to daily oral PrEP, injectable alternatives present a groundbreaking approach to remaining HIV-negative," Kelley concluded.
