Anvisa Approves Lenacapavir for HIV Prevention and Drug‑Resistant Treatment in Brazil

Overview

• Authorization covers PrEP for adolescents and adults aged 12 or older who weigh at least 35 kg, with a laboratory‑confirmed negative HIV test required before use.
• The long‑acting regimen is given as subcutaneous injections every six months after an oral induction phase, and protection stops if injections are discontinued.
• Clinical trials reported very high efficacy, including up to 100% protection in cisgender women and about 96% in diverse populations, aligning with a 2025 WHO recommendation and prior U.S. and EU approvals.
• Anvisa also cleared lenacapavir for patients with multi‑drug resistant HIV, adding an option for cases that have failed other antiretroviral classes.
• Commercial availability awaits CMED’s maximum price decision, with public provision dependent on CONITEC evaluation, and reports highlight cost concerns such as U.S. prices around US$28,000 per year and limited generic licensing.