The U.S. Food and Drug Administration (FDA) has approved the first twice-yearly injection to reduce the risk of HIV infection. The drug, lenacapavir (brand name Yeztugo), offers a new way to protect against the virus, which affects over a million Americans and has no cure. Originally approved in 2012, the shot is designed for use before potential exposure to HIV.
HIV spreads through unprotected sex and shared needles, including those used for tattoos or piercings. The virus attacks the immune system, and without treatment, it can progress to AIDS, leaving the body unable to fight infections. Despite available prevention methods, only about a third of eligible Americans use them. Uptake is especially low among women, Black/African American and Hispanic communities, and Southern residents, due to stigma, lack of awareness, and challenges with daily pills or frequent shots.
Dr. Carlos del Rio, a leading infectious disease expert at Emory University, believes the twice-yearly shot could improve adherence.
“Yeztugo could be the transformative PrEP option we’ve been waiting for,” said del Rio, co-director of the Emory Center for AIDS Research. “It could boost prevention efforts and help end the HIV epidemic.”
Proven Effectiveness in Clinical Trials
The FDA approved Yeztugo based on two major studies showing it outperformed daily PrEP pills, with a near 100% success rate. In one trial, none of the 2,134 women who took Yeztugo contracted HIV. In another, only two out of 2,179 participants became infected. The drug was well-tolerated, with no major safety concerns, earning it Science magazine’s 2024 “Breakthrough of the Year.”
How Yeztugo Works
Unlike most HIV drugs, which target one stage of the virus’s life cycle, Yeztugo attacks multiple points, including a protective shell HIV needs to survive. It remains effective even when other treatments fail.
Who Can Use It?
- Only for HIV-negative individuals.
- Requires HIV testing before starting and before each shot to prevent drug resistance.
- Starts with two injections and oral tablets, followed by six-monthly shots.
If a dose is delayed by over two weeks, patients can switch to a weekly pill for up to six months. After 28 weeks without treatment, a restart may be needed. If someone contracts HIV while on Yeztugo, they’ll require full HIV treatment, as the shot alone is not enough.
Side Effects & Precautions
Common side effects include headaches, nausea, and injection-site reactions. Experts stress that Yeztugo should be used alongside safe sex practices, like condoms, for maximum protection.
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