HIV and AIDS: New injection Apretude® cabotegravir is 69% more effective than PrEP pills against HIV.

ANVISA recently approved the first injectable HIV medication in Brazil, Apretude® (cabotegravir). This innovation marks an important advance in the prevention of the AIDS virus, offering a more effective PrEP option with fewer doses. 

In this article, we will explore the details of this injectable, its advantages over existing medications, and the positive impact this new option will offer.

What does PrEP mean?

The term PrEP is an acronym for Pre-Exposure Prophylaxis. It is a prevention strategy and therapy. 

This type of medicine is used by people who no have the virus, but who are at greater risk of exposure, such as those who have unprotected sex with HIV-positive partners or who share injection needles.

PrEP consists of administering antiretroviral drugs before possible exposure to the virus. It acts by inhibiting the replication of HIV in the body and reducing the viral load, creating a barrier that prevents the virus from establishing itself in the body and causing the disease, thus reducing the risk of infection.

What is Apretude® Cabotegravir injection? 

O cabotegravir (Apretude®) is an antiretroviral PrEP medication injectable long-acting intramuscular injection, used in the prevention and treatment of the HIV virus (Human Immunodeficiency Virus). 

It belongs to a class of drugs known as integrase inhibitors, which act by inhibiting the action of the virus's integrase enzyme, thus preventing the virus from replicating and integrating into the genetic material of human cells.

This medicine cannot be considered a vaccine, as it does not stimulate the production of antibodies to fight the virus. 

It is administered by injection and has a prolonged action, which means that a single dose can offer protection for a long period.

This antiviral medication is considered one of the most recent innovations for HIV prevention, as there is still no vaccine available against the virus. 

Who can take it?

O Apretude®  It has been approved for use in people weighing over 35 kg and should only be administered after a negative HIV test result (to reduce the risk of creating resistance to the drug).

Dosage range: according to ANVISA, it must be applied every two months.

How is the injection different from current PrEP pills?

Currently, the drugs used in PrEP therapy to prevent HIV are administered orally, through tablets, such as Truvada (tenofovir/emtricitabine), which is available free of charge on the SUS, and which must be taken every day to be effective. 

However, the new injectable presents some innovations compared to oral medications. Here are the main differences:

1. Effectiveness: the injection has been shown to be “safe and highly effective” in clinical trials conducted in Brazil and other countries, showing 69% greater efficacy compared to daily oral tablets
2. Frequency of administration and prolonged action: the convenience of receiving injections every four to eight weeks instead of taking pills daily offers a more practical approach that is less prone to forgetting
3. Form of administration: While current medications are taken orally (by mouth), the new medication is administered through injections into the buttocks.

Safety, studies, tests and efficacy of Apretude® Cabotegravir

The drug has received approval from the FDA, the US regulatory agency, and the WHO (World Health Organization) recommended its use for the prevention of the HIV virus.

In Brazil, the Oswaldo Cruz Foundation (Fiocruz) also conducted studies to evaluate the safety and efficacy of the drug. ANVISA's approval is the result of these studies and represents an important step towards making this treatment available.

Apretude® has been shown to be safe and highly effective in clinical trials conducted here in Brazil, with women, men who have sex with men (MSM) and trans women who have sex with men. 

The results of these clinical trials indicated that the effectiveness is 69% higher compared to the daily oral tablets currently used for PrEP.

Availability in Brazil

The Oswaldo Cruz Foundation (Fiocruz) and Unitaid, a global health agency linked to the WHO, reported a study on the implementation of preventive HIV injections in Brazil to assess its feasibility of implementation in the SUS. 

This study aims to provide important data on the acceptance, adherence and impact of injectable PrEP in the Brazilian context.

With the approval of the medicine by the National Health Surveillance Agency (Anvisa) and its registration in the Official Gazette of the Union (DOU), the next step is to carry out the commercial, logistical and distribution procedures so that the medicine is available to the population.

There is still no set date for the start of commercialization in Brazil and the possibility of implementing this medicine by the SUS will still be analyzed. 

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Source: ANVISA It is Brazil Agency.