Anvisa (National Health Surveillance Agency) approved, this Monday (12), a new indication for the drug Sunlenca (lenacapavir). Now, it is being used as PrEP (pre-exposure prophylaxis) to reduce the risk of HIV infection.
Lenacapavir is a biannual injectable medication developed by the pharmaceutical company Gilead Sciences. It acts as a capsid fusion inhibitor, which means it interferes with the virus’s capsid, a protein coat that protects the virus’s genetic material and the enzymes needed for replication. Its use is injectable, under the skin, requiring application only twice a year — once every six months.
In clinical studies, . In the PURPOSE 1 study, the drug was 100% effective in reducing the incidence of HIV in cisgender women. In PURPOSE 2, it was 96% effective in preventing infection in a more diverse audience, including cis men and trans people. Furthermore, the drug was 89% more effective than daily oral PrEP.
Anvisa’s approval comes months after the WHO (World Health Organization) recommended lenacapavir as an additional option for , classifying it as the best alternative after a vaccine.
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.
With approval, lenacapavir 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, according to a statement from Anvisa.
What is PrEP?
PrEP is considered an essential strategy for preventing HIV infection. The therapy consists of 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 the so-called “combined prevention”, which includes other measures such as regular testing for HIV, use of condoms, ART (antiretroviral treatment), PEP (post-exposure prophylaxis) and specific care for HIV-positive pregnant women.
