The National Health Surveillance Agency (Anvisa) approved this Monday (12) the use of the drug Sunlenca (lenacapavir) to prevent HIV-1, as pre-exposure prophylaxis (PrEP). The drug is highly effective against the virus and, in addition to being presented as a tablet, for oral use, it is available as a subcutaneous injection that only needs to be administered every six months, which facilitates adherence.
The indication is aimed at adults and adolescents aged 12 and over, weighing at least 35 kg, who are at risk of contracting the virus. Before starting treatment, it is mandatory to perform a negative test for HIV-1.
The clinical studies presented demonstrated 100% effectiveness of Sunlenca in reducing the incidence of HIV-1 in cisgender women; plus 96% efficacy compared to baseline HIV incidence and 89% higher than daily oral PrEP.
The six-monthly injection regimen showed good adherence and persistence, overcoming common challenges in daily regimens, Anvisa reported, through its press office.
According to Anvisa, Sunlenca is an innovative antiretroviral drug composed of lenacapavir, a first-class drug that works by inhibiting multiple stages of HIV-1 capsid function.
This action prevents the virus from replicating, making it unable to sustain reverse transcription, a process necessary for it to use the host’s cells to multiply.
The agency warned that, although registration has been granted, the medicine still depends on the definition of the maximum price by the Medicines Market Regulation Chamber (CMED).
Its availability in the Unified Health System (SUS) will be evaluated by the National Commission for the Incorporation of Technologies in the Unified Health System (Conitec) and by the Ministry of Health.
Prevention
Pre-exposure prophylaxis (PrEP) is an essential strategy for preventing HIV infection. It involves the use of antiretroviral medications by people who do not have the virus but are at risk of contracting the disease, significantly reducing the chances of transmission.
PrEP is part of the so-called “combined prevention”, which includes other measures, such as regular testing for HIV, use of condoms, antiretroviral treatment (ART), post-exposure prophylaxis (PEP) and specific care for HIV-positive pregnant women.clarified the Agency.
Lenacapavir began to be recommended by the World Health Organization (WHO) in July 2025 as an additional option for PrEP, classifying it as the best alternative after a vaccine, a resource that is not yet available in the case of HIV prevention.
