Men kissing
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The FDA yesterday approved an injectable form of PrEP. The medication can be administered every two months to help prevent someone from acquiring HIV. 

As previously reported by Queerty, ViiV Healthcare, which is majority-owned by GlaxoSmithKline, has developed the injectable PrEP treatment called cabotegravir. It will be marketed under the brand name Apretude.

Anyone wanting to take Apretude must start by having two injections, one month apart. They can then move to an injection every two months. 

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

Related: FDA says injectable PrEP a ‘breakthrough’ therapy as it pends approval

It’s also vital to test anyone wanting the medication is HIV-negative. The FDA says Apretude will come with a boxed warning about this, as anyone with HIV who takes the drug may develop drug-resistance and limit their future treatment options.  

A health professional prepares an injection
(Photo: Shutterstock)

“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,” Dr. Debra Birnkrant, the director of antivirals division at the FDA’s Center for Drug Evaluation and Research, said

“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.”

Deborah Waterhouse, CEO, ViiV Healthcare, said in a press statement: “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.

“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.” 

Injectable PrEP Apretude to prevent HIV infection
Apretude is an injectable form of PrEP

Related: FDA approves first long-acting HIV medication: a monthly injection

The FDA approval comes after a trial on 7,700 participants in 13 countries. That study concluded 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. 

 

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