Brazil Approves Twice-Yearly Lenacapavir Injection for HIV Prevention

Overview

• Anvisa registered Sunlenca (lenacapavir) for PrEP in adults and adolescents aged 12 or older who weigh at least 35 kg, with an HIV‑negative test required before use.
• The regimen begins with an oral induction phase followed by subcutaneous injections administered every six months.
• Large clinical trials showed near‑complete protection, including 100% efficacy in a cisgender women cohort, about 96% efficacy versus background incidence, and superiority to daily oral PrEP.
• Sales depend on CMED establishing a maximum price, and public provision will be evaluated by Conitec and the Health Ministry, with high international prices and Brazil’s exclusion from some generic licenses raising access concerns.
• The approval also covers use in treatment‑experienced patients with HIV‑1 resistant to multiple antiretroviral classes.