Brazil’s National Health Regulatory Agency (Anvisa) has given the nod to the country’s first injectable HIV prevention drug, Cabotegravir.
Although its approval was announced in the Official Journal of the Union (DOU) on June 5, the timeline for its market availability remains undetermined.
This breakthrough medication is classified as a pre-exposure prophylaxis (PrEP), designed to avert potential HIV infections.
Given the absence of a vaccine against the virus, this injectable PrEP signifies a significant advancement in HIV prevention.
The U.S. Food and Drug Administration (FDA) approved Cabotegravir in 2021, followed by an endorsement from the World Health Organization (WHO) in the same year for its utilization in preventing HIV.
Additionally, the Oswaldo Cruz Foundation (Fiocruz) and Unitaid, a global health entity linked to the WHO, announced last year they were exploring the introduction of the drug into Brazil and its possible integration into the Unified Health System (SUS).
SUS, one of the world’s largest and most intricate public health systems, provides comprehensive health care, spanning from primary care to organ transplants, to the entire population of Brazil at no cost.
Following its establishment, SUS ensured universal access to public health services, effectively making comprehensive health care a right for all Brazilians.
Distinct from existing medications
Cabotegravir stands apart from currently available drugs due to its injectable form and extended period of efficacy.
Contemporary PrEP is administered orally and requires daily intake for effectiveness. In contrast, the new medication entails an initial two-dose regimen with a four-week gap, succeeded by an injection every eight weeks.
Administered intramuscularly into the buttocks, studies indicate Cabotegravir to be 69 percent more effective than daily oral tablets and safe for use.
Trials of the drug were conducted on women, men who have sex with men (MSM), and transwomen who have sex with men in Brazil.
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