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FDA approves injectable PrEP: One shot every two months

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Photo by Artem Podrez / Pexels
Photo by Artem Podrez / Pexels

The US FDA — the agency charged with approving new medications — has given its blessing to an injectable form of PrEP that only needs to be administered once every two months.

The official announcement came on December 20.

"Today's approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill," said Dr. Debra Birnkrant, the director of antivirals division at the FDA's Center for Drug Evaluation and Research.

"This injection, given every two months, will be critical to addressing the HIV epidemic in the US, including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option."

The newly approved medication is called cabotegravir and will be marketed under the name Apretude. It is the same drug that the FDA approved for use as an HIV treatment in January 2021.

In the HIV medication Cabenuva, cabotegravir is combined with rilpivirine in an injectable form.

Cabotegravir is made by ViiV Healthcare, a pharmaceutical company owned by pharma giant GlaxoSmithKline.

"People who are vulnerable to acquiring HIV, especially those in Black and Latinx communities who are disproportionately impacted in the US, may want options beyond daily oral pills," Deborah Waterhouse, CEO, ViiV Healthcare, said in a statement.

"That's why ViiV Healthcare is proud that Apretude was studied in one of the most diverse and comprehensive HIV prevention trial programs to date, which also included some of the largest numbers of transgender women and Black men who have sex with men ever enrolled in an HIV prevention trial."

Patients who are prescribed Apretude must start by having two injections, one month apart. They can then move to one injection every two months.

Before having their first injection, they can take cabotegravir tablets (marketed as Vocabria) for four weeks in order to monitor their tolerance of the drug ahead of their first injection.

As with other PrEP meds, anyone wanting the medication must be tested to establish they are HIV-negative. The FDA says Apretude will come with a boxed warning about this, because HIV-positive people taking the drug may develop drug resistance and limit their future treatment options.

The FDA approval comes after a trial on 7,700 participants in 13 countries. That study concluded that Apretude was even more effective than daily PrEP pills at preventing HIV infection.

Shipping of Apretude to wholesalers in the US will begin in early 2022.