"HIV 'vaccine' approved by FDA

The US Food and Drug Administration (FDA) has approved the drug Apretude (Cabotegravir), used to reduce the risk of HIV infection. Unlike other preparations of similar use, it must be administered by injection every two months, rather than daily as a tablet.

Apretude (Cabotegravir) is a drug used in healthy individuals to prevent HIV infection. It is first administered as two initiation injections 30 days apart and then every two months thereafter. Patients can start treatment with the preparation or take Cabotegravir (Vocabria) orally for four weeks to assess how well they tolerate the drug. The preparation has been approved by the US Food and Drug Administration (FDA), which hopes it will help fight the HIV epidemic in the country.

- Today's approval is an important tool in the effort to end the HIV epidemic by providing the first option for preventing infection that does not require taking a daily pill. The formulation, administered every two months, will be critical to addressing the HIV epidemic in the United States, helping high-risk individuals and some people for whom taking daily medication has been a major challenge or an unrealistic option - Debra Birnkrant, MD, director of the FDA's Division of Antiviral Drugs, said.

According to the FDA, drugs to prevent HIV infection were prescribed to approximately 300 000 people in 2020. As experts point out, taking pills every day is quite a challenge for many people.

- Interpersonal factors such as substance use disorders, depression, poverty and attempts to hide medication can affect adherence - reads the FDA statement.

It is hoped that the availability of long-acting options in the form of injections will help with adherence in these groups.

Apretude should only be used in people with a confirmed negative HIV test, which must be carried out before each injection so as to reduce the risk of drug resistance. The drug (in Europe it is only known as Vocabria) has previously been approved by the EMA and the UK. It is also due to be assessed by the AOTMiT in January.

Source: medexpress.co.uk


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