U.S. Approves Gilead's Twice-Yearly HIV Prevention Shot Lenacapavir

The U.S. has approved the world’s only twice-a-year shot to prevent HIV, marking a significant advancement in the fight against the virus. This approval is the first step in an anticipated global rollout that could protect millions of people. The drug, lenacapavir, developed by Gilead Sciences, has shown promising results in clinical trials, nearly eliminating new infections in studies involving people at high risk. This development is seen as a potential game-changer in HIV prevention, as it offers a longer-lasting option compared to daily preventive pills.

Lenacapavir, which will be sold under the brand name Yeztugo for prevention, is administered as two injections under the skin of the abdomen. This method leaves a small depot of medication to slowly absorb into the body, providing six months of protection. People must test negative for HIV before receiving their twice-a-year dose, and the drug only prevents HIV transmission, not other sexually transmitted diseases. Some researchers recommend using cold packs to counter injection-site pain.

Despite the promising prospects of lenacapavir, several challenges cloud its widespread adoption. Upheaval in U.S. healthcare, including cuts to public health agencies and Medicaid, along with reductions in American foreign aid to combat HIV, pose significant obstacles. Greg Millett, public policy director at amfAR, The Foundation for AIDS Research, highlighted that "gaping holes in the system" in the U.S. and globally will make it difficult to ensure that people receive the shot and return for their twice-a-year doses.

Global efforts to end the HIV pandemic by 2030 have stalled, with over 30,000 new infections in the U.S. each year and about 1.3 million worldwide. Only about 400,000 Americans currently use some form of PrEP, a fraction of those who could benefit. A recent study found that states with high use of PrEP saw a decrease in HIV infections, while rates continued to rise elsewhere. This underscores the importance of accessible and effective prevention methods like lenacapavir.

Lenacapavir has shown particular promise in protecting women, who often need prevention methods they can use without a partner’s knowledge or consent. A 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, who leads the Normal Anomaly Initiative, a nonprofit serving Black LGBTQ+ communities, participated in the lenacapavir study and continues with the twice-yearly shots. He noted that the convenience of the shot has made it easier for him to adhere to the prevention regimen. "Now I forget that I’m on PrEP because I don’t have to carry around a pill bottle," he said. "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 has set the U.S. list price for lenacapavir at $28,218 a year, which the company claims is similar to some other PrEP options. The company anticipates insurance coverage and has financial assistance programs in place. However, concerns remain about the affordability and accessibility of the drug. Winnie Byanyima, executive director of UNAIDS, stated that if the price is unaffordable, "it will change nothing."

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. However, HIV experts worry that the arrangements Gilead has made to reduce costs in some countries leave out middle-income countries like some in Latin America.

Despite these challenges, the approval of lenacapavir represents a significant step forward in the fight against HIV. With its long-lasting protection and potential to attract people wary of more frequent doctor visits or stigma from daily pills, lenacapavir could play a crucial role in reducing HIV transmission globally. However, ensuring widespread access and affordability will be key to realizing its full potential.