FDA approves first injectable HIV prevention drug

The Food and Drug Administration has approved the first long-acting injectable medication for use as pre-exposure prevention, or PrEP, against HIV.

According to the agency, the new drug, called Apretude, is an injectable given every two months as an alternative to HIV prevention pills, like Truvada and Descovy, which have been shown to reduce the risk of HIV by 99 percent when taken daily.

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Two FDA trials analyzing the safety and efficacy of the novel drug found that Apretude was more likely to reduce HIV than the daily oral medications — by 69 percent for cisgender men and transgender women who have sex with men and by 90 percent for cisgender women.

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“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 in a statement.

“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.

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Also speaking of the novel drug, the U.S. Centers for Disease Control and Prevention, expressed hope that the use of long-acting injectable PrEP would go a long way in the fight to curb the spread of HIV in high-risk individuals and groups who are less likely to adhere to daily medication.

“PrEP requires high levels of adherence to be effective and certain high-risk individuals and groups, such as young men who have sex with men, are less likely to adhere to daily medication.

“Other interpersonal factors, such as substance use disorders, depression, poverty and efforts to conceal medication also can impact adherence. It is hoped that the availability of a long-acting injectable PrEP option (like Apretude) will increase PrEP uptake and adherence in these groups,” the U.S CDC said.

The FDA stated that the side effects occurring more frequently among those who received Apretude 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. 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,” the statement read.