The US has approved the world’s first twice-yearly shot to prevent HIV, marking a significant step towards protecting millions of people worldwide. The shot, made by Gilead Sciences and called lenacapavir or Yeztugo, has shown remarkable efficacy in preventing HIV transmission, nearly eliminating new infections in two groundbreaking studies.

According to Greg Millett, public policy director at amfAR, The Foundation for AIDS Research, “This really has the possibility of ending HIV transmission.” The shot provides six months of protection, making it a more convenient and potentially more effective option than daily preventive pills.

Lenacapavir works by inhibiting HIV at multiple stages of its lifecycle, and its approval was based on data from the PURPOSE 1 and PURPOSE 2 trials. These trials demonstrated that the shot was highly effective in preventing HIV infections, with 100% efficacy in one study and 99.9% efficacy in the other.

Experts are hailing the approval as a major breakthrough, but concerns remain about access to the shot, particularly in low-income countries. Gilead has signed agreements with generic drug makers to produce low-cost versions of the shot for 120 countries, but HIV experts worry that middle-income countries may be left out.

The US list price for the shot is $28,218 a year, which Gilead says is similar to other PrEP options. The company has financial assistance programs in place, but advocates are concerned about the impact of potential Medicaid cuts and other healthcare changes on access to the shot.

Ian Haddock, who participated in the lenacapavir study, said, “Now I forget that I’m on PrEP because I don’t have to carry around a pill bottle… Men, women, gay, straight – it really just kinds of expands the opportunity for prevention.” Dr. Gordon Crofoot, who helped lead the study in men, emphasized the need for easier access to PrEP, saying, “Everyone in every country who’s at risk of HIV needs access to PrEP.”

Despite the challenges ahead, the approval of lenacapavir marks a significant step forward in the fight against HIV. With millions of people worldwide still at risk of infection, this new prevention option offers hope for a future where HIV transmission could be dramatically reduced or even eliminated.