FDA approves first injectable HIV prevention medication

Lara Adejoro

The United States Food and Drug Administration has approved Apretude for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV. 

Apretude is given first as two initiation injections administered one month apart, and then every two months thereafter. Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug. 

In a statement, the Director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, Debra Birnkrant, M.D. said the 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.

“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.

According to the US Centers for Disease Control and Prevention, notable gains have been made in increasing PrEP use for HIV prevention in the U.S. but there remains significant room for improvement. 

The FDA said side effects occurring more frequently in participants who received Apretude compared to participants who received Truvada in either trial include injection site reactions, headache, pyrexia (fever), fatigue, back pain, myalgia, and rash.

Apretude includes a boxed warning to not use the drug unless a negative HIV test is confirmed as it must only be prescribed to individuals confirmed to be HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing drug resistance.


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