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Apretude Becomes the First FDA Approved Long-term Injectable PreP to Prevent HIV

On Monday December 20th, 2021, Apretude (cabotegravir extended-release injectable suspension) was approved for use by the U.S Food and Drug Administration (FDA) for at risk adults and adolescents weighing at least 77 pounds for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.

Debra Birnkant, M.D, director of the Division of Antivirals in the FDA’s Center for Drugs Evaluation and Research, addressed the evolution of prevention of HIV.

“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”, referring to TRUVADA for PrEP.

Unlike TRUVADA for PrEP, the daily pill, Apretude is the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option to be given every two months after two initiative injections given one month apart. This is meant to increase the adherence to the drug, as the intended demographic for this type of drug is less likely to follow the routine of a once daily pill. Factors such as depression, poverty, substance use disorders, and efforts to conceal medication can affect adherence.

She continued, “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.”

"This new medication, cabotegravir, is a game changer," Kenneth Mayer, medical research director at Fenway Health in Boston, one of the sites where it was tested in clinical trials, told NPR.

Though a game-changer, Apretude has a list price of $3,700 per dose (or $22,200 per year, for six doses) and is expected to ship to wholesalers and specialty distributors in the U.S. early next year, NBC News reported.

According to the U.S Centers for Disease Control and Prevention, a notable gain in increasing PrEP for HIV prevention in the U.S in the preliminary data show in 2020, about 25% of the 1.2 million people for whom PrEP is recommended were prescribed it, which is an astronomical increase from the 2015’s data show of 3%.

Apretude is not prescriptible to individuals that do not have a confirmed negative HIV test, and will only be prescribed to individuals with a HIV-negative immediately prior to starting the drug and before each injection to reduce the risk of developing a resistance.


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