HIV Prevention Shot Approved: U.S. OKs Twice-Yearly PrEP
A Game-Changer in HIV Prevention
Imagine saying goodbye to daily pills and hello to just two shots a year—for HIV protection. That fantasy is now a reality in the United States, as health officials have approved the world’s first twice-a-year shot to prevent HIV transmission. This groundbreaking option, called lenacapavir (brand name Yeztugo for prevention), could revolutionize how we fight HIV—but only if people can get it.
How Effective Is the New Shot?
Lenacapavir, developed by Gilead Sciences, isn’t just another drug—it’s a potential game-changer. In two major studies, the shot nearly eliminated new HIV infections among high-risk people, outperforming daily preventive pills that can be forgotten or skipped. In a South Africa and Uganda study with over 5,300 young women and teen girls, not a single person who received lenacapavir got HIV, while about 2% in the comparison group did. Similarly, the shot proved almost as effective in gay men and gender-nonconforming people across several countries.
Why Does This Matter?
For years, PrEP (pre-exposure prophylaxis) has meant daily pills or bi-monthly shots—options that can be hard to stick with due to stigma, forgetfulness, or frequent doctor visits. Lenacapavir’s six-month protection makes it the longest-lasting PrEP yet, and it could attract people who want an easier, more discreet way to stay safe. “Men, women, gay, straight—it really just expands the opportunity for prevention,” says Ian Haddock, a participant in the lenacapavir study and leader of a nonprofit serving Black LGBTQ+ communities.
How Does the Shot Work?
Lenacapavir is given as two injections under the skin of the abdomen, where it forms a small “depot” that slowly releases the drug over six months. People must test negative for HIV before each dose, and the shot only prevents HIV—not other sexually transmitted infections. While some people may experience injection-site pain, cold packs can help ease discomfort.
Challenges Ahead: Access and Affordability
Despite the excitement, there are hurdles. The U.S. list price for the shot is $28,218 a year—before insurance. Gilead says this is similar to other PrEP options and expects insurance coverage, but financial barriers remain. Most private insurers must cover PrEP without a co-pay, but a Supreme Court case could change that. Meanwhile, Medicaid and public health funding face potential cuts, and outreach programs for at-risk populations have been scaled back.
Globally, access is even more uncertain. Gilead has signed deals with six generic drug makers to produce low-cost versions for 120 low-income countries, but middle-income nations may be left out. “Everyone in every country who’s at risk of HIV needs access to PrEP,” says Dr. Gordon Crofoot, who led the men’s study. “We need easier access to highly effective PrEP like this.”
Will the Shot End HIV Transmission?
Experts are cautiously optimistic. “This really has the possibility of ending HIV transmission,” says Greg Millett of amfAR. But he warns that “gaping holes in the system” in the U.S. and abroad could limit the shot’s impact. If people can’t afford it or can’t get to a clinic twice a year, the shot could “change nothing,” says Winnie Byanyima of UNAIDS.
The Bottom Line
The approval of lenacapavir is a major step forward in the fight against HIV. It offers hope for millions, but only if we overcome the barriers to access and affordability. For now, the twice-yearly shot is a powerful new tool—one that could help end the HIV pandemic if we use it wisely.
