FDA Approves First Twice-Yearly Shot to Prevent HIV

WebMD

5 hours ago

June 19, 2025 – The FDA has approved the first twice-yearly shot to reduce the risk of HIV infections.
Originally approved in 2012, the drug – known as lenacapavir but sold under the name Yeztugo – offers a new way to protect against this life-threatening infection that affects more than a million people in the U.S. and has no cure. The shot is given before potential exposure to the virus.
HIV spreads through unprotected sex and shared needles (including dirty needles from tattoos and body piercings). It weakens the immune system, and in its advanced stage, the body can no longer fight off infections, leading to acquired immune deficiency syndrome (AIDS). Only about a third of eligible people in the U.S. use available HIV prevention, with especially low use among women, Black/African American and Hispanic communities, and people in the South. This is mainly due to stigma, low awareness about existing options, and challenges with daily pills or frequent shots.
Carlos del Rio, MD, a distinguished professor of medicine in the Division of Infectious Diseases at Emory University School of Medicine, said that getting a shot just twice a year could make it easier for people to stick with prevention.
"Yeztugo could be the transformative PrEP [pre-exposure prophylaxis] option we've been waiting for – offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic," said del Rio, who is also co-director of the Emory Center for AIDS Research in Atlanta.
Gilead, the drug's maker, said the FDA approved Yeztugo based on two major studies, which showed that it worked better than taking a daily pill form of PrEP in preventing HIV with a nearly 100% success rate. In one trial, none of the 2,134 women who received Yeztugo got HIV, while in the other, only two out of 2,179 people did. It was well tolerated with no new safety concerns, which led the academic journal Science to name lenacapavir as its 2024 "Breakthrough of the Year."
Yeztugo attacks a protective shell that HIV needs to stay alive, which helps stop the virus from growing and spreading. Most HIV drugs only work at one part of the virus's life cycle, but Yeztugo works at several points. It also still works even if other HIV drugs have stopped working. It is given as a shot under the skin and is only for people who test negative for HIV.
Before starting Yeztugo and before each shot, your provider will test for HIV to prevent the virus from developing resistance to the medication. The treatment begins with two shots and two tablets, followed by two more tablets the next day – then continues with one shot every six months.
If a shot is delayed by over two weeks, a weekly pill can be used for up to six months. If over 28 weeks pass with no treatment, patients may need to restart. If a patient gets HIV while on Yeztugo, they'll need full HIV treatment, as Yeztugo alone isn't enough. Yeztugo helps lower the risk of HIV when taken as prescribed, along with safe sex practices like using condoms.