FDA approves new twice-yearly HIV prevention shot. Here's how it works
FILE-A lab technician checks an HIV test at a medical facility. (Photo by Anton Raharjo/Anadolu Agency/Getty Images)
The Food and Drug Administration approved the world’s only twice-a-year shot to prevent HIV, but it’s unknown how many people in the U.S. and globally will have access to it.
Here’s what you need to know about this new shot.
What is lenacapavir?
Why you should care:
Lenacapavir, a new drug manufactured by U.S. pharmaceutical company Gilead Sciences, nearly eliminated new infections in two studies of people at elevated risk of HIV at a rate better than daily preventative pills, the Associated Press reported.
Gilead’s drug is already sold to treat HIV under the brand name Sunlenca. The AP noted that it will be sold under the brand name Yeztugo.
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The shot is given as two injections under the skin of the abdomen, leaving a small "depot" of medication to absorb into the body.
According to the AP, individuals must test negative for HIV before getting their twice-a-year dose, Gilead explained to the AP. It only prevents HIV transmission — it doesn't block other sexually transmitted diseases. Some researchers who helped test the shot advise cold packs to counter injection-site pain.
Gilead told the AP that the U.S. list price for the shot, meaning before insurance, is $28,218 a year, which the company called like some other PrEP options. Gilead officials noted that it expected insurance coverage but also has some financial assistance programs.
Gilead also has applications pending for the twice-yearly shot in other countries. In 2024, the company signed agreements with six generic drug manufacturers to produce low-cost versions of the shot for 120 countries mostly in Africa, Southeast Asia, and the Caribbean.
The company told the Associated Press that it intends to make enough shots to supply 2 million people in those countries, at no profit, until the generic versions are available, company senior vice president Dr. Jared Baeten told the AP.
HIV infections data
By the numbers:
The Associated Press noted there are still over 30,000 new HIV infections in the U.S. each year and about 1.3 million worldwide.
Only about 400,000 Americans already use some form of PrEP, which is pre-exposure prophylaxis, a medication that helps prevent HIV infection in people who are HIV-negative.
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Roughly 400,000 Americans use some form of PrEP. Citing a recent study, the Associated Press noted that states with high use of PrEP experienced a decrease in HIV infections, while rates continued to rise in other places.
Meanwhile, half of new infections are in women, who often need protection they can use without a partner's knowledge or consent. The AP reported that another study in South Africa and Uganda compared over 5,300 sexually active young women and teen girls given twice-yearly lenacapavir or the daily pills.
There were no HIV infections in those patients receiving the shot, while roughly 2% in the comparison group caught HIV from infected sex partners.
Another study found the twice-yearly shot was nearly as effective in gay men and gender-nonconforming individuals in the U.S. and in several other countries impacted the most by HIV.
The Source: Information for this story was provided by the Associated Press, which received comments from Gilead Sciences about the new shot and also cites data on HIV infections. This story was reported from Washington, D.C.