FDA Approves Apretude, Bimonthly Injection to Help Prevent HIV

Shortly following a 2021 CDC update of its HIV pre-exposure prophylaxis (PrEP) clinical practice guidelines, the U.S. Food and Drug Administration (FDA) has announced its approval of the world’s first injectable treatment to help prevent HIV.

Rather than taking a daily pill, which is the current requirement of  PrEP, the new drug, Apretude, requires two initial shots one month apart, followed by one shot every two months.

GlaxoSmithKline, the pharmaceutical company behind Apretude, says the new treatment is more convenient that Truvada, which is the most common form of PrEP currently available as daily pill.

The first Apretude trial involved cisgender men and transgender women who have sex with men and compared the new treatment with Truvada, concluding participants using Apretude were 69 percent less likely to get HIV. Another trial with cisgender women found that those taking Apretude were 90 percent less likely to get HIV than those taking Truvada. Each trial started participants on a daily pill for up to five weeks before switching to injections.

The FDA says that those interested in Apretude can either begin injections right away or start with four weeks of taking pills to gauge how their bodies respond to the medication. PrEP is currently recommended for about 1.2 million people considered to be high risk for contracting HIV, though as of 2020, only 25 percent are taking it, which is still a significant increase from the 3 percent taking PrEP in 2015, though still leaves the majority of at-risk people vulnerable.

“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,” says Debra Birnkrant, director of the Division of Antivirals at the FDA’s Center for Drug Evaluation and Research, in a press release.

“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,” she says.

According to NBC News, as it stands, insurers will not be required to cover all cost for the new injectable version of PrEP, and Apretude currently has a list price of $3,700 per dose, slated to begin shipping to wholesalers and specialty distributors in the U.S. early this year.

Photo courtesy of ViiV Healthcare