FDA approves first-ever twice-yearly vaccine to prevent HIV

In a landmark move that could transform HIV prevention in the United States, the US Food and Drug Administration (FDA) has approved Yeztugo – a brand name for lenacapavir – a revolutionary injectable medication that only needs to be administered twice a year to prevent HIV infection.

Developed by Gilead Sciences, the vaccine is the first and only biannual injectable pre-exposure prophylaxis (PrEP) option approved in the US for adults and adolescents weighing at least 35 kg. It works by targeting the HIV-1 capsid, blocking the virus's ability to replicate in the body.

 What makes Yeztugo a breakthrough?

The approval of Yeztugo marks a significant advancement in the decades-long fight against HIV, offering a more convenient and discreet alternative to daily oral PrEP options. The twice-yearly dosing could overcome key barriers such as low adherence, stigma, and lack of awareness, as per the statement by Gilead University.

According to the Centers for Disease Control and Prevention (CDC), only 36% of eligible individuals in the US were using PrEP as of 2022, with the lowest rates seen among women, Black and Latino communities, and residents in the US South.

In contrast, Yeztugo’s simplified schedule may make prevention more accessible and acceptable, especially for populations disproportionately affected by the virus.

The FDA’s decision follows results from Gilead’s PURPOSE 1 and PURPOSE 2 Phase 3 trials, which demonstrated 99.9% effectiveness in preventing HIV among over 4,300 participants across diverse demographics.

In PURPOSE 1, none of the 2,134 cisgender women in sub-Saharan Africa who received Yeztugo contracted HIV.

In PURPOSE 2, only 2 of 2,179 participants mostly cisgender men and gender-diverse individuals contracted the virus.

The injectable was also shown to be superior to once-daily Truvada in preventing new infections and was well-tolerated, with no major safety concerns reported.

In recognition of its potential impact, Science magazine named lenacapavir the ‘Breakthrough of the Year’ in 2024. The drug had earlier received Breakthrough Therapy Designation and Priority Review status from the FDA, expediting its approval process.