FDA approves Apretude for HIV pre-exposure prevention

December 21, 2021
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A new injectable treatment for HIV pre-exposure prevention, or PrEP, has been approved by the Federal Drug Administration. 

The drug, Apretude, is approved for at-risk adults and adolescents who weigh at least 77 pounds to reduce the risk of sexually acquired HIV, the FDA announced Monday

“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,” Debra Birnkrant, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said in the announcement. 

After the initial two injections, Apretude is administered one month apart, then every two months after that. The hope is that high-risk individuals, like men who have sex with men, will have better adherence to taking the PrEP injectable option every two months versus taking a pill everyday. 

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In a trial with 4,566 men and transgender women who have sex with men, participants received Apretude or Truvada, a daily PrEP medication. The results showed those who took Apretude had a 69% less risk of getting infected with HIV compared to those who took Truvada, according to the FDA. 

In a second trial, 3,224 cisgender women received either Apretude or Truvada. At the end, the women who took Apretude had a 90% less risk of getting infected with HIV versus those who took Truvada. 

Some side effects reported by participants who took Apretude include: injection site reactions, headache, fatigue, back pain, muscle aches and rash. 

Apretude is only to be prescribed if a negative HIV test is confirmed prior to taking drug to prevent developing drug resistance. The label warns of hypersensitivity reactions, liver damage and depressive disorders. 

 “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,” Birnkrant said. 

Follow reporter Asha Gilbert @Coastalasha. Email: [email protected]


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