Lenacapavir approved in the U.S. for HIV prevention

In mid-June 2025, the U.S. Food and Drug Administration (FDA) approved the use of lenacapavir for the prevention of HIV. The drug will be sold under the brand name Yeztugo.

Lenacapavir’s approval is a major milestone, as the drug is given in two abdominal injections every six months. Lenacapavir is injected subcutaneously (just under the skin) by a healthcare provider. 

The manufacturer of lenacapavir, Gilead Sciences, has submitted a dossier on the drug to Health Canada. Gilead hopes that lenacapavir will also be approved for HIV prevention in Canada by June 2026. 

Most people who use HIV prophylaxis currently take pills (tenofovir + FTC), usually daily. There is also an injectable drug called cabotegravir (Apretude) that is taken ultimately every two months. However, cabotegravir must be injected deep into the buttocks by a healthcare provider. Such intramuscular injections can be painful. 

Lenacapavir’s advantage for prevention is that it only needs to be injected every six months (also by a healthcare provider). This can reduce the burden on people having to remember to take pills daily.

Getting injections of a potent HIV prevention drug every six months has the power to interest more people in HIV prevention, particularly some who could not or did not want to take daily pills. 

Lenacapavir could become a major option for many people who are interested in HIV prevention. It will be interesting to see how it is deployed in the U.S., as there may be lessons Canada and other countries can learn from this once the drug is approved here.

—Sean R. Hosein

REFERENCE:

Gilead Sciences. Yeztugo (Lenacapavir) Is Now the First and Only FDA-Approved HIV Prevention Option Offering 6 Months of Protection. Press Release. 18 June, 2025.