Lenacapavir-USFDA Approves First Twice-Yearly HIV Prevention Injection

The U.S. Food and Drug Administration (FDA) has approved lenacapavir, a long-acting injectable drug that offers nearly complete protection against HIV with just two doses per year.

• Marketed under the brand name Yeztugo and developed by Gilead Sciences, this is the world’s first twice-yearly HIV prevention shot, potentially transforming the landscape of pre-exposure prophylaxis (PrEP).

How It Works

• Lenacapavir belongs to a novel class of drugs known as capsid inhibitors. It blocks the protein shell (capsid) that the HIV virus requires to replicate, thereby preventing infection.
• Unlike traditional oral PrEP pills that require daily adherence, lenacapavir is administered just once every six months via injection. This provides a discreet, highly effective, and convenient alternative, especially beneficial for individuals facing challenges with daily medication due to stigma, accessibility, or lifestyle barriers.

Global Outlook and Pending Approvals

• While the FDA has greenlighted the drug in the U.S., approvals are still pending in multiple countries, including Europe, Australia, Canada, South Africa, Brazil, and Latin America.
• The World Health Organization (WHO) is expected to issue global guidance regarding the use of lenacapavir on July 14, during the International AIDS Conference in Kigali.

(Source: BS)