A study conducted at 88 locations worldwide with the participation of 3,265 individuals recorded only two cases of HIV infection in the group receiving the medication, compared to nine cases in the group that took the previous generation drug daily. The rate of HIV infection in the lenacapavir group was remarkably low at 0.10 per 100 person-years, in contrast to 0.93 in the F/TDF group and 2.37 in the broader surveyed group, reports Science Blog.
The research, led by Dr. Collin Kelly, a professor at Emory University, indicates significant progress for individuals struggling with adherence to daily oral regimens. Kelly, who also serves as co-director of the Emory University AIDS Research Center, emphasized the nearly 100 percent efficacy rate and its potential to transform HIV prevention strategies.
A key aspect of this study was addressing the issue of medication adherence. Current prevention methods face challenges due to the necessity of daily medication intake, leading many to abandon treatment within a year. The two-year injectable form of lenacapavir is seen as a breakthrough that could enhance effectiveness by eliminating a major barrier in HIV prevention.
The trial also placed special emphasis on diversity and inclusivity, reflecting the demographic characteristics of populations most affected by HIV. Under the guidance of Dr. Valeria Cantos from the Emory University Grady Research Center, participants were recruited from countries such as South Africa, Brazil, and Mexico, ensuring multilingual support and representation for underserved communities. These efforts are particularly crucial as over 50% of new HIV cases in the U.S. in 2022 were among cisgender gay men, significantly impacting Black and Latino populations.
The safety assessment during the study showed that lenacapavir was well tolerated, although a small percentage of participants (1.2%) experienced reactions at the injection site. Dr. Carlos del Rio, chair of the Emory Department of Medicine, highlighted that despite the promising results, ensuring equitable access to this prevention method remains a critical challenge.
Lenacapavir, expected to be FDA approved by 2025, has the potential to revolutionize HIV prevention by reducing the number of doctor visits from quarterly to biannual, significantly improving access for vulnerable populations. This change could particularly benefit communities facing systemic barriers to healthcare access, addressing a long-standing gap in effective HIV prevention strategies.