The US Food and Drug Administration has approved lenacapavir, a breakthrough HIV prevention drug that offers near-complete protection against infection with just two injections a year. According to clinical trial data, the twice-yearly injection is 99% effective at preventing HIV infection in cisgender women and cisgender men.
Lenacapavir works by disrupting the HIV virus’s ability to replicate, and its high efficacy has been hailed as “ridiculously high” by infectious disease researchers. However, concerns remain about access to the drug due to its high price – roughly $28,000 a year. Gilead Sciences, the manufacturer of lenacapavir, is working to make the drug more affordable for lower-income countries, with plans to provide up to 2 million people in these countries with lenacapavir at cost.
Despite the FDA’s approval, access to lenacapavir will depend on cost and distribution mechanisms. The Trump administration’s cuts to foreign aid could limit the drug’s availability in low- and middle-income countries, where it is desperately needed. Critics argue that the high price of lenacapavir could result in millions of people dying from HIV over the next several years due to lack of access.
The approval of lenacapavir marks a significant milestone in the fight against HIV/AIDS, offering a more convenient alternative to current standard treatments like Truvada. However, it also raises concerns about affordability and accessibility, particularly for marginalized communities that face barriers to accessing existing PrEP options.
Source: https://www.npr.org/sections/goats-and-soda/2025/06/18/g-s1-73130/hiv-prevention-drug-lenacapavir-fda-breakthrough