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A groundbreaking clinical trial has revealed that a new twice-yearly injection, Lenacapavir, offers 96% HIV prevention efficacy, making it significantly more effective than traditional daily oral PrEP medications like Truvada. This promising development was showcased in the recent Purpose-2 study, a Gilead-funded trial conducted by researchers at Emory University and Grady Health System. The findings, published in the New England Journal of Medicine, mark a major leap forward in HIV prevention, particularly for individuals facing challenges in maintaining daily medication regimens.
The trial’s results indicate that Lenacapavir’s injection administered every six months dramatically reduces the risk of HIV infection, with 99% of participants in the injection group remaining HIV-negative. Out of 2,179 participants, only two contracted HIV, compared to nine infections in the 1,086 participants who took Truvada daily. The findings suggest that the injectable medication’s adherence rates surpass those of daily oral PrEP, which relies on strict daily use to be effective.
Colleen Kelley, MD, the study’s lead author and professor at Emory University, noted, “This is a considerable and profound advancement in medicine, especially for people whose circumstances don’t allow them to take a daily oral medication.” Dr. Kelley emphasized that consistent use of oral PrEP can be a significant challenge, as approximately half of individuals who start daily PrEP discontinue its use within a year due to various personal, social, or logistical barriers.
The Purpose-2 trial also stands out for its inclusion of racially, ethnically, and gender-diverse participants, ensuring that the results reflect populations that are disproportionately impacted by HIV. The study highlighted that many of the communities most affected by HIV also face obstacles in accessing or adhering to current HIV prevention methods. Notably, more than half of new HIV infections in 2022 occurred among cisgender gay men, with 70% of these individuals identifying as Black or Hispanic.
In response to these disparities, Valeria Cantos, MD, principal investigator at Grady Memorial Hospital, emphasized the importance of conducting research that is inclusive and representative of the populations most in need. At Grady, trial materials were available in Spanish, and bilingual staff were crucial in recruiting participants who may otherwise face language or healthcare barriers.
The promise of Lenacapavir is not just in its efficacy, but also in its potential to transform HIV prevention for those with limited access to daily medications. “For people unable to take daily oral pills, this injectable can be a game changer,” said Dr. Kelley.
As the FDA considers the data for approval, there is hope that Lenacapavir could become available for commercial use by 2025, offering a new, accessible option for HIV prevention. The challenge now, according to Carlos del Rio, MD, chair of the Department of Medicine at Emory, will be ensuring these tools are rolled out equitably across populations that need them most.
This new advancement in HIV prevention is seen as a pivotal moment in the fight against HIV, providing hope for reducing new infections locally and globally. With ongoing commitment to equity, the healthcare community aims to make these breakthroughs accessible to all, especially to underserved populations.
