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First Injectable Medication To Prevent HIV Approved By FDA


Ben Taub

Freelance Writer

clockDec 22 2021, 12:30 UTC

The new drug provides a high level of protection against HIV infection. Image: MedstockPhotos/

People at risk of contracting HIV may soon be able to protect themselves against the virus without having to take daily medication, after the US Food and Drug Administration (FDA) approved the world’s first injectable pre-exposure prophylaxis (PrEP) drug. Unlike existing PrEP tablets which must be administered each day in order to provide protection, the new treatment only needs to be taken once every two months, and may therefore represent a more practical option for those who struggle to adhere to daily medication.

Known as Apretude, the drug has been approved for use by at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) in order to minimize their chances of acquiring HIV through sexual contact. In a statement, the FDA explained that PrEP is currently recommended for about 1.2 million at-risk people in the US, and while uptake among this group is rising, only 25 percent actually received a prescription in 2020.


According to the Administration, demographics such as men who have sex with men, people with substance use disorders, and those from poorer backgrounds often have difficulty adhering to daily medication. It is therefore hoped that Apretude – which must be injected twice in the first month and bi-monthly thereafter – could help these groups to remain protected.  

“This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option,” explained Dr Debra Birnkrant of the FDA’s Center for Drug Evaluation and Research.


When taken as prescribed, oral PrEP drugs, such as Truvada and Descovy, are considered highly effective, yet the FDA says that Apretude has proven itself superior to these treatments in two placebo-controlled studies. The first of these involved 4,566 cisgender men and transgender women who have sex with men, and revealed that those who received Apretude were 69 percent less likely to contract HIV than those who took Truvada.


The second study, which included 3,224 at-risk cisgender women, showed that participants who took Apretude were 90 percent less likely to become infected than those who were given Truvada.

It’s worth noting, however, that while Apretude appears highly effective at preventing infection, it cannot treat HIV once the illness has been acquired. It is therefore recommended only for people who have tested negative for the condition, and the FDA warns that continuing to use the medication after becoming infected could lead to the emergence of drug-resistant HIV variants.

Those who do contract the virus after initiating a course of Apretude should therefore transition to a complete HIV treatment regimen.

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