The Medicines Market Regulation Chamber still needs to define the maximum price for the sale of the drug
The National Health Surveillance Agency (Anvisa) approved this Monday (12) the use of Sunlenca, the commercial name of as a pre-exposure prophylaxis (PrEp) option for . The drug is indicated, according to the agency, for “adults and adolescents aged 12 and over, weighing at least 35 kg, who are at risk of contracting the virus”. The drug is available in tablet form, to be used at the beginning of treatment, and injection administered every six months.
Pre-exposure prophylaxis is a strategy to prevent HIV infection, using retroviral medications, in people who do not have the virus, but are at risk of contracting the disease. According to the procedure is part of a series of care called “combined prevention”, which includes testing, use of condoms and antiretroviral treatment (ART), in addition to specific measures for HIV-positive pregnant women.
“Sunlenca is an innovative antiretroviral composed of lenacapavir, a first-class drug that acts by inhibiting multiple stages of HIV capsid function. This action prevents the virus from replicating, making it unable to sustain reverse transcription,” Anvisa explained in a note.
Since July 2015, the World Health Organization (WHO) as a PrEp option for HIV. At the time, the director general of the international entity, said that, despite the uncertainty surrounding the development of a vaccine against the virus, the medicine proves to be an effective solution.
A presented data from clinical studies that ensure the drug’s effectiveness in preventing almost all types of HIV infections. “With approval, Sunlenca becomes a new tool to reduce the risk of HIV transmission, offering a biannual regimen that facilitates adherence and reduces the burden on health systems”, explained the agency.
The Medicines Market Regulation Chamber (Cmed) still needs to define the maximum price for the sale of the drug. The evaluation for availability in the Unified Health System (SUS) is the responsibility of the National Commission for the Incorporation of Technologies in the Unified Health System (Conitec) and the .
