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The US Food and Drug Administration has just approved lenacapavir, an injectable form of HIV prevention that is almost 100 percent effective and requires only two doses per year. Science magazine described the medicine the most important scientific advance of 2024.
In clinical trials, lenacapavir proved to be 99.9 percent effective in preventing HIV infection through sexual transmission in people weighing more than 35 kilograms. The drug, an antiretroviral, works not by stimulating an immune response, but by blocking HIV from reproducing during its early stages—specifically, by disrupting the function of the virus’s capsid protein. This happens so long as the body receives injections every six months.
Lenacapavir has already been approved in some countries as a treatment for HIV in people with forms of the virus that are resistant to other treatments. However, prior to this week, its prophylactic use had not been approved anywhere, making the FDA’s decision a significant new development in the fight against the HIV/AIDS epidemic.
The drug is not the first medicine that can be taken preemptively to protect against an HIV infection: pre-exposure prophylaxis (PrEP) pills were already available in many countries, including the United States. But these must be taken every day, and ensuring ongoing access to these medicines, and that people actually remember to take them, is a known challenge. It’s hoped the long-lasting effects of lenacapavir will make it easier for people to stay protected against the virus.