Overview
- Anvisa cleared lenacapavir (Sunlenca) for PrEP on January 12 for people aged 12 or older who weigh at least 35 kg.
- Fiocruz’s ImPrEP LEN Brasil will begin in Rio de Janeiro, Nova Iguaçu, São Paulo, Campinas, Salvador, Florianópolis and Manaus once specific injection supplies arrive.
- The study targets gay, bisexual and other men who have sex with men, plus transgender and non‑binary people designated male at birth, ages 16 to 30.
- Gilead and Fiocruz/Farmanguinhos signed a non‑binding memorandum to evaluate cooperation, including potential technology transfer that could enable local manufacturing before patent expiry.
- Nationwide access depends on CMED setting a price ceiling and Conitec and the Health Ministry evaluating incorporation into SUS, with Unitaid funding the study and Gilead donating doses as global prices remain high.