Developed by Gilead Sciences, Yeztugo (generic name: lenacapavir) is the first and only pre-exposure prophylaxis (PrEP) option administered just twice per year, offering a highly effective and potentially transformative tool in curbing HIV transmission.

The approval follows remarkable results from two Phase 3 clinical trials, PURPOSE 1 and PURPOSE 2, in which Yeztugo demonstrated near-complete protection against HIV.

In the PURPOSE 1 study among cisgender women in sub-Saharan Africa, not a single participant who received Yeztugo contracted HIV. In the PURPOSE 2 trial, which enrolled cisgender men and gender-diverse individuals, 99.9% of those given Yeztugo remained HIV negative, with only two infections reported among over 2,100 participants.

“This is the single best opportunity in 44 years of HIV prevention,” said Mitchell Warren, executive director of the HIV advocacy nonprofit AVAC.

Gilead’s CEO, Daniel O’Day, called the approval “historic,” emphasising that Yeztugo could help “end the HIV epidemic once and for all.”

Yeztugo works by blocking HIV’s ability to infect and replicate inside immune cells. Its long-acting formula only requires administration twice a year, solving one of the most persistent barriers to effective PrEP use: daily adherence.

Older PrEP medications, such as Truvada and Descovy, both oral pills taken daily, have shown over 99% effectiveness when used consistently, but real-world adherence has been uneven, particularly among at-risk populations.

The new drug arrives at a pivotal moment. According to the Centers for Disease Control and Prevention (CDC), only about one-third of eligible individuals in the U.S. are currently prescribed any form of PrEP.

Usage is especially low among Black, Latino, and Southern populations, groups disproportionately impacted by HIV. Experts believe Yeztugo’s simplified dosing schedule may help reduce these disparities if access is widespread.

However, challenges remain. At a list price of $14,109 per injection, affordability and insurance coverage will be critical. While Gilead has committed to offering co-pay assistance for insured patients and free medication for eligible uninsured individuals, barriers like high out-of-pocket costs and complex insurance authorisations could restrict uptake.

Adding to concerns is the political climate. The Trump administration’s proposed 2026 budget seeks to slash domestic HIV funding by 35%, including eliminating the CDC’s HIV-prevention division. Experts warn that such cuts could undermine the infrastructure needed to deliver Yeztugo to the populations who need it most.

Dr. Carlos del Rio of Emory University said Yeztugo “could greatly address key barriers like adherence and stigma,” but emphasised the importance of equitable access. “We must ensure it reaches those most vulnerable to HIV.”

Gilead has submitted applications for approval in other countries, including South Africa, Brazil, and EU member states, with the goal of global rollout.

While there is still no cure for HIV or AIDS, the FDA’s approval of Yeztugo brings the U.S. one step closer to controlling the epidemic, with science, strategy, and equitable implementation all playing vital roles.

The U.S. Food and Drug Administration has approved Yeztugo, a groundbreaking twice-yearly injectable medication for HIV prevention, marking a major milestone in the decades-long fight against the virus.