Recent findings from a clinical trial reveal that administering Lenacapavir through an injection twice a year significantly lowers the risk of contracting HIV by 96%. This makes it far more effective than the traditional daily oral PrEP (pre-exposure prophylaxis).
To effectively prevent new HIV infections with oral medications, patients must take certain steps, including attending regular doctor appointments every three months and, most crucially, maintaining consistency in their medication routine.
Daily oral antiretroviral medications, commonly known as PrEP (pre-exposure prophylaxis), like Truvada®, are highly effective in preventing HIV, but they require daily adherence to be fully effective. If Truvada is taken inconsistently, its effectiveness is significantly reduced.
However, a recent clinical trial funded by Gilead, called Purpose-2, led by medical experts from Emory University and Grady Health System, has shown that a biannual injection of Lenacapavir offers a 96% reduction in HIV infection risk overall. This makes the injection vastly more effective than the daily oral PrEP. The results were published in the New England Journal of Medicine.
Dr. Colleen Kelley, lead author of the study and a professor at Emory University’s School of Medicine, remarked, “The high level of efficacy seen here — almost 100% — in a treatment given just every six months is remarkable. This represents a significant advancement in healthcare, especially for individuals who may struggle to take a daily pill and for groups that are disproportionately affected by HIV.”
The trial, which was randomized and double-blind, compared the effectiveness of both treatment options. Among the 2,179 participants in the Lenacapavir group, 99% did not contract HIV, with only two infections reported. Conversely, the Truvada group, consisting of 1,086 participants, recorded nine new HIV cases. High adherence to the injectable option was noted compared to the daily pill.
Dr. Kelley, who also serves as co-director of the Emory Center for AIDS Research and Associate Dean for Research at Grady, pointed out that despite PrEP’s high effectiveness, adherence challenges associated with taking daily oral medications contributed to the injection’s greater efficacy in the trial.
“Over time, we see that roughly half of individuals who start daily oral PrEP discontinue within a year due to a variety of reasons,” says Kelley, referring to healthcare inequalities. “The availability of an effective injectable that only needs to be taken twice a year is very important for those who have trouble accessing healthcare or sticking to a daily regimen.”
The trial’s participant diversity was significant as it included representatives from various racial, ethnic, and gender backgrounds, reflecting populations that are notably affected by HIV. Participants included cisgender men and gender-diverse individuals recruited from 88 sites across Peru, Brazil, Argentina, Mexico, South Africa, Thailand, and the U.S.
The study highlights that the same groups most affected by HIV often have limited access to PrEP or may struggle to take oral anti-HIV medications consistently, underlining the need for additional preventive options. It also notes that in 2022, over half of new HIV cases in the U.S. occurred among cisgender gay men, with 70% of those cases among Black or Hispanic individuals.
Dr. Valeria Cantos, an associate professor in Emory’s School of Medicine and the principal investigator at the Grady trial site, stressed the importance of including participants who truly represent the community served by Grady.
“At Grady, we prioritize representing underserved and vulnerable populations, recognizing the distrust that some community members may have towards research due to past neglect or misconduct by research institutions,” says Cantos. “Grady is a trusted research site dedicated to equity.”
At the Grady trial site, informational materials were provided in Spanish, and bilingual staff were actively involved in recruiting and enrolling participants who spoke Spanish. Cantos noted that the site successfully enrolled individuals who would benefit the most from Lenacapavir. Other participating sites included the Hope Clinic and Emory Midtown Hospital.
Dr. Kelley added, “We are not adequately reaching those most impacted by HIV and healthcare disparities with our current prevention strategies. For individuals unable to take daily oral medications, injectable options can offer incredible effectiveness and have the potential to dramatically reduce new HIV infections.”
With the Phase III clinical trial completed and submitted to the FDA for evaluation, Kelley is optimistic that Lenacapavir may receive approval for commercial use by 2025.
“The findings of this study expand our tools for HIV prevention. Long-acting antiretrovirals offer fresh hope for those who cannot adhere to oral medication,” comments Dr. Carlos del Rio, chair of the Department of Medicine at Emory University School of Medicine. “The key challenge remains in ensuring equitable access to these tools so we can see a significant reduction in new HIV infections both locally and globally,” adds del Rio, who is also a co-director of the Emory Center for AIDS Research.
