Injectable medication is a new HIV prevention option in Brazil

Brazil (DF) – The National Agency for Sanitary Vigilance (Anvisa) approved the registration of the drug Apretude (cabotegravir), in the pharmaceutical forms of tablet and injectable suspension, with indication of prevention of contagion by the HIV virus, for use in individuals aged at least 35 kilos.

According to the agency, cabotegravir is an antiretroviral from the class of integrase enzyme inhibitors, which prevents the insertion of HIV viral DNA into human DNA – a mechanism of action that prevents replication or reproduction of the virus and its ability to infect. new cells.

“The injectable medicine represents a new option, as it can prevent HIV without the need to take a pill every day”

highlighted Anvisa.

Understand

The so-called pre-exposure prophylaxis (PrEP) in Brazil is indicated for sexually active, uninfected people, but with an increased risk of exposure to HIV, and until then consisted of taking daily pills to allow the body to be prepared to face a possible contact with the virus.

According to Anvisa, injectable cabotegravir, administered every two months, comes as a possibility especially for people with difficulty adhering to the use of oral and daily PrEP.

Apretude oral tablet, on the other hand, is indicated to assess cabotegravir tolerability, that is, the individual’s ability to withstand the effects of the drug before administration of the injectable format, or as a PrEP option for those who missed the scheduled dose of the injectable drug.

clinical studies

Also according to Anvisa, one of the main Phase 3 clinical trials that helped to prove the safety and efficacy of cabotegravir was carried out in 43 research centers in six countries besides Brazil: United States, Peru, Argentina, Thailand, Vietnam and South Africa.

The agency approved the conduction of clinical trials in four Brazilian research centers, located in the following institutions: Fundação Faculdade de Medicina MEC MPAS, Hospital Nossa Senhora da Conceição SA, São Paulo State Department of Health and Evandro Chagas Clinical Research Institute/ Fiocruz.

“Apretude has been shown to reduce the risk of sexually acquired HIV-1 infection in people weighing 35 kg or more and at risk of contracting HIV-1 infection (the most common virus responsible for most cases of AIDS in the world)”

highlighted Anvisa.

Vaccine?

Despite configuring yet another strategy in combating the transmission of the virus through PrEP, Anvisa emphasized that cabotegravir cannot be considered a vaccine against HIV, as it does not activate the immune system in the production of antibodies to fight HIV, nor does it prevent the disease transmission.

“A vaccine protects for a long time or even for a lifetime. PrEP, on the other hand, works differently, that is, protection is provided by blocking the paths that the virus takes to infect the human cell. So, if the person abandons the treatment, the medicine stops working and protects against HIV.”

care

The drug, like any other type of PrEP, should only be prescribed to individuals who are confirmed to be HIV negative. To reduce the risk of developing drug resistance, HIV testing should be done before starting the drug and before each new injection.

“For the indication of the use of any PrEP therapy, the previous diagnosis of HIV infection must be excluded clinically and laboratory”

reinforced the agency.

SUS

The incorporation of cabotegravir by the Unified Health System (SUS), according to Anvisa, is a decision that is up to the Ministry of Health. For this, the drug must initially pass the endorsement of the National Commission for the Incorporation of Technologies in the Unified Health System (Conitec).

Market

Although the registration of Apretude has already been granted by the agency, for it to be made available on the market, approval of the drug’s price by the Medicines Market Regulation Chamber is required.

*With information from Agência Brasil

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