First Injectable HIV Prevention Drug Gets Approval From FDA

The drug, Apretude, can be taken every two months and is injected in place of daily HIV prevention pills like PReP treatments Truvada and Descovy.

A sign for the Food And Drug Administration in Maryland

Image via Getty/Sarah Silbiger

A sign for the Food And Drug Administration in Maryland

The Food and Drug Administration announced on Tuesday that it has approved the first PReP medication to be taken via injection instead of as a pill for HIV prevention. 

The drug, Apretude, can be taken every two months and is injected in place of daily HIV prevention pills. PReP treatment Truvada was approved in 2012, while Descovy became the second to be approved in 2019. FDA trials found that Apretude—made by ViiV Healthcare—was more likely to prevent HIV than the oral medications, seemingly due to the adherence to the less frequent regimen in comparison to taking a daily pill. It was 69 percent more likely to prevent HIV for cisgender men and trans women who have sex with men, and by 90 percent for cisgender women, per NBC.

Today we approved the first injectable treatment for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prevention to reduce the risk of sexually acquired HIV.

— U.S. FDA (@US_FDA) December 20, 2021

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

The Centers for Disease Control and Prevention share that 25% of the 1.2 million who were recommended PrEP were prescribed it last year. As of 2019, 285,000 people were using PrEP.

“People who are vulnerable to acquiring HIV, especially those in Black and Latinx communities who are disproportionately impacted in the US, may want options beyond daily oral pills,” ViiV Healthcare CEO Deborah Waterhouse said. “Apretude was studied in one of the most diverse and comprehensive HIV prevention trial programs to date, which also included some of the largest numbers of transgender women and Black men who have sex with men ever enrolled in an HIV prevention trial.”

The new version of PrEP costs $3,700 per dose and is expected to start shipping in 2022.

PrEP4All managing director Kenyon Farrow said that while he’s happy to “see the FDA approval of another option for people who want to use PrEP,” he fears that it may “take years to make it real for most people.” Insurers will not be required to cover all costs for Apretude, despite the government announcing in July that almost all insurers must cover Truvada and Descovy with no cost sharing, including lab tests and clinic visits required to maintain such prescriptions.

“Due to COVID, public health systems are already overburdened and much of the workforce needed to implement this large scale are leaving the field due to burnout,” he wrote in an email to NBC. “Because it will need to be administered in clinical settings, it won’t be treated as a pharmacy benefit by payers, but instead as a clinical benefit, which will take time to implement the proper coding for billing, as well as education and training for nurses who will likely bear the brunt of the work to implement.”

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