First HIV Prevention Injection Approved by the FDA

On Monday, the agency announced the approval of another option for at-risk people trying to avoid sexually transmitted HIV. This new pre-exposure prophylaxis (PrEP) treatment is called Apretude and can be taken by adults and adolescents who weigh at least 77 pounds and test negative for HIV immediately before receiving the injection.

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According to the FDA's statement, Apretude is initially administered as two injections done one month apart, though people can also start by taking "oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug." After that, patients receive shots every two months, which replaces the need to take oral HIV prevention medications like Truvada and Descovy every day.

Additionally, two randomized, double-blind clinical trials found that HIV-negative cis men and trans women taking Apretude had "69% less risk of getting infected with HIV when compared to participants who took Truvada," per the FDA. Meanwhile, he second trial, which also included cis women, found that the risk was 90% lower with Apretude. However, the agency also noted that Apretude is more likely to cause side effects, including headache, fatigue and back pain.

“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 the Division of Antivirals at the FDA's Center for Drug Evaluation and Research, said.

She went on to add, “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.”

Read the FDA's official announcement here.

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