“A Quiet Revolution: How Two Injections a Year Could Change HIV Prevention”

Lenacapavir, developed by Gilead Sciences under the brand name Yeztugo, has emerged as a transformative tool: an HIV-1 capsid inhibitor that, when injected twice a year, offers sustained protection. The U.S. Food and Drug Administration has approved it for pre-exposure prophylaxis (PrEP) in adults and adolescents weighing at least 35 kg.

The clinical evidence backing Yeztugo is striking. In Gilead’s Phase 3 trials — PURPOSE 1 and PURPOSE 2 — more than 99.9% of participants who received the twice-yearly injections remained HIV negative. According to Gilead, this outcome is rare among prevention tools and speaks to both the drug’s potency and its potential to reduce the daily burden many PrEP users face.

Global health institutions have taken note. The World Health Organization issued new guidelines in July 2025 recommending injectable lenacapavir every six months as an additional PrEP option. Importantly, WHO’s updated testing guidance simplifies the path to access: fewer complex tests, more community-based delivery via clinics, pharmacies, and telehealth.

What gives this rollout its “unprecedented” character is the scale of access planning. Gilead has struck a no-profit deal with the Global Fund to supply enough lenacapavir to reach up to two million people in low- and lower-middle-income countries. At the same time, through a partnership with PEPFAR (the U.S. global AIDS relief program), doses will be distributed in high-incidence regions.

On the manufacturing side, Gilead has signed royalty-free, voluntary licensing agreements with six generic drugmakers to produce lenacapavir for 120 high-incidence, resource-limited countries. This is one of the broadest licensing strategies yet for an anti-HIV agent, signaling real commitment to global equity.

Nevertheless, challenges remain. Distributing a biannual injectable means building or adapting health systems: training, cold chain, patient follow-up. Even with generous licensing, regulatory approvals in many countries are still pending. There is also the question of prioritization — ensuring that the populations most at risk can access this innovation first.

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Sources WHO Gilead Sciences press statements Gilead-Global Fund partnership news Gilead-PEPFAR partnership Gilead voluntary licensing agreements