Brazil’s National Health Surveillance Agency (Anvisa), the federal body responsible for regulating medicines, vaccines, and health products, approved on Monday (12) the use of Sunlenca (lenacapavir) for the prevention of HIV-1 as pre-exposure prophylaxis (PrEP). The drug shows high efficacy against the virus and, in addition to an oral tablet, is available as a subcutaneous injection that needs to be administered only once every six months, significantly improving treatment adherence.
The indication applies to adults and adolescents aged 12 and over, weighing at least 35 kg, who are at risk of acquiring HIV. A confirmed negative HIV-1 test is mandatory before starting treatment.
Clinical trials submitted to Anvisa showed 100% efficacy in reducing HIV-1 incidence among cisgender women, as well as 96% efficacy compared to baseline HIV incidence and 89% greater effectiveness than daily oral PrEP.
According to Anvisa, the six-month injection regimen demonstrated strong adherence and persistence, overcoming common challenges associated with daily medication schedules.
Sunlenca is an innovative antiretroviral containing lenacapavir, a first-in-class drug that inhibits multiple stages of the HIV-1 capsid’s function. By disrupting viral replication, lenacapavir prevents the virus from sustaining reverse transcription, a process required for HIV to use host cells to multiply.
Anvisa cautioned that, although the drug has been approved, it still depends on the definition of a maximum price by Brazil’s Drug Market Regulation Chamber (CMED). Its inclusion in Brazil’s public healthcare system, the Unified Health System (SUS), will be assessed by the National Commission for the Incorporation of Technologies into SUS (Conitec) and the Ministry of Health.
Prevention strategy
Pre-exposure prophylaxis (PrEP) is a key strategy for preventing HIV infection. It involves the use of antiretroviral drugs by people who do not have the virus but are at risk of exposure, significantly reducing the likelihood of transmission.
PrEP is part of Brazil’s “combination prevention” approach, which also includes regular HIV testing, condom use, antiretroviral treatment (ART), post-exposure prophylaxis (PEP), and specific care for pregnant people living with HIV.
In July 2025, the World Health Organization (WHO) recommended lenacapavir as an additional PrEP option, describing it as the most effective preventive alternative since a vaccine, still unavailable for HIV prevention.
