The world's only twice-a-year shot to prevent HIV could stop transmission — if people can get it
WASHINGTON (AP) — The U.S. has approved the world's only twice-a-year shot to prevent HIV, the first step in an anticipated global rollout that could protect millions – 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 — a drug called lenacapavir — could be the next best thing. It nearly eliminated new infections in two groundbreaking studies of people at high risk, better than daily preventive pills they can forget to take.
'This really has the possibility of ending HIV transmission,' 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 — regularly using preventive medicines such as the daily pills or a different shot given every two months — 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 — including cuts to public health agencies and Medicaid — and slashing of American foreign aid to fight HIV are clouding the prospects.
Millett said 'gaping 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's bodies but make sure they come back' twice a year to keep up their protection.
Gilead's drug already is sold to treat HIV under the brand name Sunlenca. The prevention dose will be sold under a different name, Yeztugo. It's given as two injections under the skin of the abdomen, leaving a small 'depot' 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 — 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.
'Now I forget that I'm on PrEP because I don't have to carry around a pill bottle,' said Haddock, who leads the Normal Anomaly Initiative, a nonprofit serving Black LGBTQ+ communities.
'Men, women, gay, straight – it really just kinds of expands the opportunity for prevention,' he added. Just remembering a clinic visit every six months 'is a powerful tool versus constantly having to talk about, like, condoms, constantly making sure you're taking your pill every day.'
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 'we're basically pulling the rug out of HIV prevention and testing and outreach programs.'
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, 'it will change nothing.'
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.
'Everyone in every country who's at risk of HIV needs access to PrEP,' said Dr. Gordon Crofoot of Houston, who helped lead the study in men. 'We need to get easier access to PrEP that's highly effective like this is.'
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Medscape
33 minutes ago
- Medscape
Key Abstracts in Early-Stage NSCLC From ASCO 2025
Dr Jonathan Goldman of the University of California, Los Angeles, highlights key abstracts in early-stage NSCLC from ASCO 2025. Dr Goldman begins with updated results from CheckMate 816, comparing neoadjuvant chemotherapy (chemo) vs chemo + nivolumab. Median overall survival (OS) in the nivolumab arm remains unreached vs 73.7 months with chemo alone. Event-free survival (EFS) is durable at 59.6 vs 21.1 months, as evidenced by 5-year EFS of 49% in the combination arm. Next, he reviews the NeoADAURA trial evaluating neoadjuvant osimertinib ± chemo in resectable EGFR-mutated stage II-IIIB NSCLC. Major pathologic response was higher in osimertinib-containing arms (26% and 25%) vs 2% in the chemo arm, although long-term outcomes remain pending. Dr Goldman also discusses the SWOG/NRG S1914 trial of perioperative stereotactic body radiotherapy ± atezolizumab, which did not show improvements in OS or progression-free survival (PFS). He then highlights a prospective, low-dose CT screening study of the Mississippi Delta cohort, which showed a 4.7% lung cancer detection rate overall and 4.5% in patients with incidental pulmonary nodules — underscoring the utility of low-dose CT as a modality in early detection. In closing, he reports on two studies in small cell lung cancer. The IMforte study showed that lurbinectedin + atezolizumab in 1L maintenance improved PFS (HR, 0.54). In the DeLLphi-304 study, second-line tarlatamab improved OS compared to chemo (HR, 0.6), which is a potentially practice-changing update.
Wall Street Journal
37 minutes ago
- Wall Street Journal
Health Insurers to Promise Changes to Preapproval Process That Drew Backlash
Following the backlash that hit health insurers after the killing of a top executive last year, the industry will pledge steps meant to smooth the controversial preapproval process that can deny or delay access to care. The initiative is set to be unveiled early next week, according to people familiar with the matter.
CBS News
43 minutes ago
- CBS News
Chicago officials detail preparation efforts, offer tips ahead of this weekend's extreme heat
With the extreme heat approaching, pools and waterparks will be busy, but according to city officials, taking a dip will not be the only precaution people will need this weekend. Scorching temperatures and high humidity are a bad combo, especially when that's the forecast for three days in a row, making heat stroke a real possibility. On Friday, city officials, including Mayor Brandon Johnson and the Office of Emergency Management and Communications, discussed the measures they're taking ahead of and during the first heat wave of the year. The city said it plans to operate cooling centers, but beware that many of them are only open on weekdays. In that case, libraries, park district buildings, and police stations are some spots where people can find some relief over the weekend. Officials also shared some alarming numbers showing how dangerous a heat wave can be. "Over the last three years, we have recorded 485 heat-related deaths in Chicago and more than 700 heat-related emergency department visits," Chicago Department of Public Health Commissioner Dr. Olusimbo Ige said. She added that men are more likely to experience a heat-related emergency than women. OEMC executive director Francisco Velez said they are monitoring the heat closely. "OEMC is working directly with the National Weather Center 24/7 to monitor the weather events and will alert residents if conditions worsen. OEMC is coordinating with city departments and sister agencies to ensure services and resources are available in response to the heat," he said. Mayor Johnson also stressed the importance of staying informed and checking on those with health conditions. "Over the next few days, make sure that we check in on our loved ones and neighbors, especially our seniors and those with health conditions, individuals with disabilities. We do have cooling locations all over the city, we have street outreach workers who are available as well to connect the unhoused Chicagoans with those resources," Johnson said. Doctors said seniors and anyone who takes beta blockers, diuretics, and sedatives are the most at risk. If you are worried about someone who lives in Chicago and can't make contact with them, you're encouraged to call 311 and request a well-being check.
