FDA Approves Long-Acting HIV Prevention Drug That Doesn’t Need Daily Dose

The US Food and Drug Administration (FDA) has just approved a new type of treatment for HIV, which involves prevention rather than cure.

Apretude, a cabotegravir extended-release injectable suspension, was developed by ViiV Healthcare, a pharmaceutical company with a focus on HIV and AIDS. 

This drug is given as two initiation injections one month apart, then once every two months following the initiation. This method may be more convenient than getting patients to rely on daily oral tablets. 

This pre-exposure prophylaxis (PrEP) will reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 77 pounds, and with a negative HIV-1 test before the initiation. 

PrEP, previously approved in just two other medicines, has been credited for the notable decline in HIV cases in the US, according to the US Centers for Disease Control and Prevention. 

“With Apretude, people can reduce the risk of acquiring HIV with as few as six injections a year,” Deborah Waterhouse, CEO of ViiV, states. 

“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,” she explains, adding that the trials the drug underwent were “one of the most diverse and comprehensive” ones to date, including both cis and transgender men. 

Per the FDA, two clinical trials showed promising results: Participants with Apretude showed 69% and 90% less risk of getting infected with HIV than those who took Truvada, an existing daily oral drug for HIV PrEP.

“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,” shares Debra Birnkrant of the FDA.

She states that the injection is “critical” in combatting the HIV epidemic in the US, “helping high-risk individuals … where adherence to daily medication has been a major challenge or not a realistic option.”

ViiV Healthcare will begin shipping Apretude in the US early next year. The drug hasn’t been approved outside the US just yet, but the firm has made submissions to other regulatory authorities.

[via Gizmodo, cover image ID 84962469 © Scyther5 | Dreamstime.com]