Game-Changing HIV Prevention: FDA Approves, WHO Backs Twice-Yearly Lenacapavir Shot
- Jul 15
- 3 min read
The fight against HIV has just received a powerful new weapon: lenacapavir, the first twice-yearly shot approved to prevent HIV infections. This is a major leap forward, addressing critical challenges in global public health.
The U.S. Food and Drug Administration (FDA) gave its stamp of approval on June 19, 2025. Less than a month later, on July 14, 2025, the World Health Organization (WHO) followed suit, issuing new guidelines recommending its use globally at the International AIDS Conference in Kigali, Rwanda. This dual endorsement signals a profound shift in how we approach HIV prevention.
Lenacapavir, manufactured by Gilead, was originally approved in 2012 as a treatment for HIV that no longer responded to several other medications. Now, its role in prevention is being hailed as a transformative PrEP (pre-exposure prophylaxis) option. Current HIV prevention efforts often face hurdles like stigma, low awareness, and the daily burden of pills or frequent shots. This twice-yearly injectable aims to simplify adherence significantly, potentially boosting uptake, especially among underserved communities like women, Black/African American, and Hispanic populations, and those who face challenges with access to healthcare.
Clinical trials have shown remarkable efficacy, with lenacapavir proving nearly 100% effective in preventing HIV, even outperforming daily oral PrEP. In one trial, none of the 2,134 women who received lenacapavir contracted HIV, and in another, only two out of 2,179 people did. This exceptional performance led the academic journal Science to name lenacapavir its 2024 "Breakthrough of the Year". It was also well tolerated with no new safety concerns.
Dr. Carlos del Rio of Emory University School of Medicine believes this long-acting option could be "the transformative PrEP option we've been waiting for," adding a powerful new tool in the mission to end the HIV epidemic. WHO Director-General Tedros Adhanom Ghebreyesus stated that while an HIV vaccine remains elusive, lenacapavir is "the next best thing".
So, how does it work? Lenacapavir operates differently from most HIV drugs. It attacks a protective shell vital for HIV's survival, stopping the virus from growing and spreading by working at several points in its life cycle. It remains effective even when other HIV drugs might have failed. It is part of a class of drugs known as capsid inhibitors. It is given as a shot under the skin and is strictly for individuals who test negative for HIV.
For those considering this option, the treatment begins with an initial two shots and two tablets, followed by two more tablets the next day, then a single shot every six months. HIV testing is required before starting lenacapavir and before each subsequent shot to prevent drug resistance. If a shot is delayed by over two weeks, a weekly pill can be used for up to six months, and if over 28 weeks pass with no treatment, patients may need to restart. If a patient gets HIV while on lenacapavir, they'll need full HIV treatment, as lenacapavir alone isn't enough. While highly effective, it must be used alongside safe sex practices like condoms for maximum protection. Common side effects reported include headaches, nausea, and reactions at the injection site.
This twice-yearly shot arrives at a critical juncture, with HIV prevention efforts stagnating and 1.3 million new HIV infections occurring in 2024. These infections disproportionately impact populations such as sex workers, men who have sex with men, transgender people, people who inject drugs, people in prisons, and children and adolescents. The WHO's recommendations, including a new emphasis on simplified rapid HIV testing to remove access barriers by eliminating complex and costly procedures, underscore a decisive move to diversify prevention options and empower individuals to take control of their health. Lenacapavir joins other WHO-recommended PrEP options like daily oral PrEP, injectable cabotegravir, and the dapivirine vaginal ring.
With global efforts now focused on implementing these new guidelines, lenacapavir marks a significant step towards reshaping the global response to HIV and potentially achieving the long-held goal of ending the epidemic as a public health problem. WHO urges governments, donors, and global health partners to begin rolling out lenacapavir immediately within national combination HIV prevention programmes, while collecting essential data on uptake, adherence, and real-world impact.
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