The U.S. Food and Drug Administration has approved lenacapavir, the world’s first twice-a-year injection to prevent HIV infection. This new option could protect millions by offering a powerful alternative to daily pills, which many people find hard to take consistently.
Lenacapavir, developed by Gilead Sciences and sold under the brand name Yeztugo for prevention, works by interfering with the HIV virus’s ability to multiply.
It is given as two injections under the skin of the abdomen every six months, providing long-lasting protection. Clinical trials showed the shot nearly eliminated new HIV infections in high-risk groups, outperforming daily preventive pills.
Experts say this shot could be a breakthrough in ending HIV transmission. Greg Millett of amfAR called it a potential game-changer, especially for people who struggle with daily medication or fear stigma. It also offers a discreet option for women who need protection without their partner’s knowledge.
However, challenges remain. The high cost—about $28,000 a year before insurance—and cuts to public health funding and Medicaid threaten access in the U.S.
Globally, many countries still lack affordable options, and middle-income nations may be left out of current pricing deals. Experts warn that without better healthcare support and outreach, the shot’s full benefits might not be realized.
Gilead has agreements with generic manufacturers to supply low-cost versions to 120 poorer countries, mainly in Africa, Southeast Asia, and the Caribbean. Still, UNAIDS and other health leaders stress that the price must come down further to make a real difference worldwide.
With over 30,000 new HIV infections annually in the U.S. and 1.3 million globally, the approval of lenacapavir marks a hopeful step. But ensuring people can get and continue using this twice-yearly shot will be key to its success in preventing HIV.
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