FDA approves new HIV prevention tool, though access questions linger

Lenacapavir, the antiretroviral that has shown almost 100% effectiveness at preventing HIV infections, now has U.S. Food and Drug Administration approval. FDA’s sign-off on Wednesday means the twice-yearly injectable should soon be available in the United States as a form of pre-exposure prophylaxis, or PrEP.

How quickly it will reach the communities in low- and middle-income countries, where the vast majority of the 1.3 million annual new HIV infections are happening, is another issue. Advocates worry that Gilead, the company that holds the patent to lenacapavir, will set a price that will limit its distribution, even as researchers contend that an annual supply can be produced for as little as $25 per person.

Those worries about cost have been exacerbated by U.S. cuts to global HIV prevention efforts, which have raised new questions about who will pay for lenacapavir.