WASHINGTON (AP) 鈥 The U.S. has approved the world鈥檚 only twice-a-year shot to prevent HIV, the first step in an anticipated global rollout that could protect millions 鈥 although it's unclear how many in the U.S. and abroad will get access to the powerful new option.
While a vaccine to prevent HIV still is needed, some experts say the shot made by Gilead Sciences 鈥 a drug called lenacapavir 鈥 could be the next best thing. It nearly in two groundbreaking studies of people , better than daily preventive pills they can forget to take.
鈥淭his really has the possibility of ending HIV transmission,鈥 said Greg Millett, public policy director at amfAR, The Foundation for AIDS Research.
Condoms help guard against HIV infection if used properly but what's called PrEP 鈥 regularly using preventive medicines such as the daily pills or a different shot given every two months 鈥 is increasingly important. Lenacapavir's six-month protection makes it the longest-lasting type, an option that could attract people wary of more frequent doctor visits or stigma from daily pills.
But upheaval in U.S. healthcare 鈥 agencies and 鈥 and slashing of American are clouding the prospects.
Millett said 鈥済aping holes in the system" in the U.S. and globally "are going to make it difficult for us to make sure we not only get lenacapavir into people鈥檚 bodies but make sure they come back鈥 twice a year to keep up their protection.
Gilead鈥檚 drug already is sold to treat HIV under the brand name Sunlenca. The prevention dose will be sold under a different name, Yeztugo. It鈥檚 given as two injections under the skin of the abdomen, leaving a small 鈥渄epot鈥 of medication to slowly absorb into the body. People must test negative for HIV before getting their twice-a-year dose, Gilead warned. It only prevents HIV transmission 鈥 it doesn't block other sexually transmitted diseases. Some researchers who helped test the shot advise cold packs to counter injection-site pain.
Global efforts at ending the HIV pandemic by 2030 have stalled. There still are more than 30,000 new infections in the U.S. each year and about 1.3 million worldwide.
Only about 400,000 Americans already use some form of PrEP, a fraction of those estimated to benefit. A recent study found states with high use of PrEP saw a decrease in HIV infections, while rates continued rising elsewhere.
About half of new infections are in women, who often need protection they can use without a partner's knowledge or consent. One rigorous study in South Africa and Uganda compared more than 5,300 sexually active young women and teen girls given twice-yearly lenacapavir or the daily pills. There were no HIV infections in those receiving the shot while about 2% in the comparison group caught HIV from infected sex partners.
A second study found the twice-yearly shot nearly as effective in gay men and gender-nonconforming people in the U.S. and in several other countries hard-hit by HIV.
Ian Haddock of Houston had tried PrEP off and on since 2015 but he jumped at the chance to participate in the lenacapavir study and continues with the twice-yearly shots as part of the research follow-up.
鈥淣ow I forget that I鈥檓 on PrEP because I don鈥檛 have to carry around a pill bottle,鈥 said Haddock, who leads the Normal Anomaly Initiative, a nonprofit serving Black LGBTQ+ communities.
鈥淢en, women, gay, straight 鈥 it really just kinds of expands the opportunity for prevention,鈥 he added. Just remembering a clinic visit every six months 鈥渋s a powerful tool versus constantly having to talk about, like, condoms, constantly making sure you鈥檙e taking your pill every day.鈥
Gilead said the U.S. list price, meaning before insurance, is $28,218 a year, which it called similar to some other PrEP options. The company said it anticipated insurance coverage but also has some financial assistance programs.
Most private insurers are supposed to cover PrEP options without a co-pay although the Supreme Court is considering a case that could overturn that requirement. Congress also is considering huge cuts to Medicaid. And while community health centers still are an option, the Trump administration has largely dismantled HIV prevention work at the Centers for Disease Control and Prevention that would normally get the message to vulnerable populations who'd qualify for the shot, said Carl Schmid of the nonprofit HIV+Hepatitis Policy Institute.
Schmid worries the shot won't meet its potential because 鈥渨e鈥檙e basically pulling the rug out of HIV prevention and testing and outreach programs.鈥
Gilead also has applications pending for the twice-yearly shot in other countries. Last fall, the company signed agreements with six generic drug makers to produce low-cost versions of the shot for 120 poor countries mostly in Africa, Southeast Asia and the Caribbean. Gilead plans to make enough shots to supply 2 million people in those countries, at no profit, until the generics are available, said company senior vice president Dr. Jared Baeten.
Winnie Byanyima, executive director of UNAIDS, said in a statement the price is still too high. If it's unaffordable, she said, 鈥渋t will change nothing.鈥
And HIV experts worry the arrangements Gilead has made to reduce costs in some countries leave out middle-income countries like some in Latin America.
鈥淓veryone in every country who鈥檚 at risk of HIV needs access to PrEP,鈥 said Dr. Gordon Crofoot of Houston, who helped lead the study in men. 鈥淲e need to get easier access to PrEP that鈥檚 highly effective like this is.鈥
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute鈥檚 Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
