Gilead's Twice-Yearly Lenacapavir Reduces HIV Infection Risk

Gilead Sciences

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(RTTNews) - According to a study published in the New England Journal of Medicine, twice-yearly injection of Lenacapavir offers a 96 percent reduced risk of HIV infection overall.

The Phase III PURPOSE 2 trial, led by physicians at Emory University and Grady Health System, compared the safety and efficacy of twice-yearly subcutaneous lenacapavir for pre-exposure prophylaxis or PrEP to the once-daily oral Truvada.

Daily oral antiretrovirals, also known as PrEP, like Truvada are significant for preventing the infection of HIV. However, Truvada is only effective if it is taken daily as directed by doctors.

"Seeing these high levels of efficacy—at almost 100 percent—in an injectable that people only have to take every six months is incredible," said lead author Colleen Kelley, professor in the School of Medicine at Emory University.

"This is a considerable and profound advancement in medicine, especially for people whose circumstances don't allow them to take a daily oral medication, and for those among populations disproportionately impacted by HIV."

The randomized, double-blind trial was conducted across seven countries, ensuring involvement of participants from diverse backgrounds. Notably, among 2,179 participants in the lenacapavir group, only two cases of HIV were reported.

"What we see over time is that about half of people who start taking daily oral PrEP stop within a year due to various factors," Kelley continued.

"Having an effective injectable that is only needed twice annually is very significant for people who have trouble accessing health care or staying adherent to daily, oral pills."

Along with the findings from Phase 1 and 2 trials, the researchers expect that Lenacapavir might be approved for commercial use by 2025.

"For people that are unable to take the daily oral pills, the injectable agents can really give incredible efficacy and be a game changer in helping them stay HIV negative," Kelley said.