Brazil's National Health Surveillance Agency (Anvisa) has approved lenacapavir, sold as Sunlenca, for use as pre-exposure prophylaxis (PrEP) against HIV-1. The drug, given via subcutaneous injection every six months, demonstrated up to 100% efficacy in clinical trials with vulnerable populations. The approval paves the way for regulatory steps that could lead to its availability in the Unified Health System (SUS).
Brazil's National Health Surveillance Agency (Anvisa) announced the approval of Sunlenca (lenacapavir) on Monday, 12, for preventing HIV-1 infections through sexual transmission. The drug is indicated for adults and adolescents over 12 years old, weighing at least 35 kg, who are at risk of infection and have tested negative for the virus.
Regarded as innovative, lenacapavir inhibits key stages of viral replication. It can be taken as tablets or via semiannual subcutaneous injections, improving adherence compared to daily regimens. According to Anvisa, clinical studies showed "100% efficacy in reducing HIV-1 incidence among cisgender women, 96% efficacy compared to baseline HIV incidence, and 89% superiority to daily oral PrEP".
The drug was approved in the United States in June of last year for prevention and is already in use in Canada and European countries. A 2024 study involving 5,338 women from Uganda and South Africa confirmed 100% protection. In March 2025, a phase 1 analysis indicated potential for annual dosing.
Brazil, which already provides PrEP via daily tablets and on-demand options, could see strengthened combined prevention strategies with lenacapavir, including testing, condom use, and antiretroviral therapy. Anvisa noted that "the semiannual regimen showed good adherence and persistence, overcoming common challenges in daily schedules". In July of last year, the World Health Organization (WHO) added the drug to PrEP options, deeming it the best alternative short of a vaccine.
Next steps involve price setting by the Chamber for Regulation of the Pharmaceutical Market (CMED) and review by the National Commission for Incorporation of Technologies in the SUS (Conitec) and the Ministry of Health. No date has been set for SUS availability.
