In a major breakthrough, the U.S. has approved the world’s first twice-a-year injection to prevent HIV — a long-acting medication that could change how millions protect themselves from the virus. The drug, called lenacapavir, is being hailed by experts as one of the most promising tools yet in the fight to end the HIV epidemic. But challenges around access and affordability may limit its true impact.A Powerful Alternative to Daily PillsLenacapavir, made by Gilead Sciences and sold under the brand name Yeztugo for prevention, has shown remarkable results in clinical trials. Unlike traditional pre-exposure prophylaxis (PrEP) options — such as daily pills or shots every two months — lenacapavir is injected just twice a year, making it the longest-lasting HIV prevention method available.The shot was tested in two major studies involving high-risk groups: one with young women and teenage girls in South Africa and Uganda, and another with gay men and gender-diverse individuals in several countries. In both cases, the results were striking. The women who received the shot had zero new HIV infections, compared to around 2% in those on daily pills. In the second study, the twice-yearly shot proved just as effective for men and gender non-conforming individuals.“This really has the possibility of ending HIV transmission,” said Greg Millett of amfAR, The Foundation for AIDS Research.How It Works?Yeztugo is administered as two small injections in the abdomen, forming a medication "depot" that slowly releases the drug into the body over six months. However, people must test negative for HIV before receiving it, as it doesn’t treat existing infections or prevent other sexually transmitted diseases.While the drug is already sold under the name Sunlenca for people living with HIV, this preventive form marks a new chapter in global public health efforts.Why Is Access A Challenge?Despite its potential, concerns remain over who will actually benefit from lenacapavir.In the U.S., only about 400,000 people currently use any form of PrEP — a small fraction of those who could benefit. And structural issues like cuts to public health funding, limited insurance access, and stigma pose significant barriers. Carl Schmid of the HIV+Hepatitis Policy Institute warned that current policies are “pulling the rug out of HIV prevention,” just as this breakthrough arrives.Gilead says the U.S. list price for Yeztugo is $28,218 per year, comparable to other PrEP options. The company says financial assistance is available, and it expects insurers to cover the shot — though that could change if the U.S. Supreme Court rules against current no-copay requirements.Globally, the challenge is even greater. While Gilead has struck deals with six generic drug makers to provide low-cost versions of the shot for 120 low-income countries, critics argue that middle-income nations have been left out. UNAIDS Executive Director Winnie Byanyima noted that at current prices, the shot “will change nothing” for many who need it.Despite the hurdles, experts are hopeful. The twice-a-year schedule could be a game-changer for those who find daily medication inconvenient or face stigma. As Houston-based advocate Ian Haddock put it, “Now I forget that I’m on PrEP because I don’t have to carry around a pill bottle.”If scaled up equitably, lenacapavir could bring the world a step closer to ending the HIV pandemic. But for that to happen, access — not just approval — must be the priority.