MercoPress. South Atlantic News Agency

Brazil's health watchdog gives nod to HIV vaccine

The biyearly drug is indicated for people aged 12 or over, weighing at least 35 kilos, at risk of catching the virus

Brazil's Health Regulatory Agency (Anvisa) approved on Monday the use of the drug Sunlenca (lenacapavir) for HIV-1 prevention as pre-exposure prophylaxis (PrEP), Agencia Brasil reported.

According to the experts, the drug is highly effective against the virus and, in addition to being available in an oral presentation, it can also be injected subcutaneously every six months, which facilitates adherence.

The medication is indicated for adults and adolescents aged 12 and over, weighing at least 35 kg, who are at risk of contracting the virus. Before starting treatment, a negative HIV-1 test result is mandatory.

The clinical studies presented demonstrated 100% efficacy of Sunlenca in reducing the incidence of HIV-1 in cisgender women, as well as 96% efficacy compared to baseline HIV incidence and 89% superiority over daily oral PrEP.

The six-month injection regimen showed good adherence and persistence, overcoming common challenges in daily regimens, according to Anvisa's press office.

Sunlenca is an innovative antiretroviral composed of lenacapavir, a first-class drug that acts by inhibiting multiple stages of HIV-1 capsid function, thus preventing the virus from replicating, making it unable to sustain reverse transcription, a process necessary for it to use host cells to multiply.

The agency warned that, although registration has been granted, the drug still depends on the maximum price being set by the Drug Market Regulation Chamber (CMED).

Its availability in Brazil's Unified Health System (SUS) will be evaluated by the National Commission for the Incorporation of Technologies in the Unified Health System (Conitec) and the Ministry of Health.

Pre-exposure prophylaxis (PrEP) is an essential 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 contracting the disease, significantly reducing the chances of transmission.

PrEP is part of what is known as “combined prevention,” which includes other measures such as regular HIV testing, condom use, antiretroviral treatment (ART), post-exposure prophylaxis (PEP), and specific care for HIV-positive pregnant women, the Agency clarified.

Lenacapavir was 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, which is not yet available for HIV prevention. (Source: Agencia Brasil)