Injectable PrEP Option Approved by FDA

The first-ever long-acting injectable option to prevent HIV infection among those at-risk for the disease was approved by the Food and Drug Administration, the agency announced today.

Apretude, from GlaxoSmithKline, will be available for anyone considered at-risk for HIV and weighs at least 77 pounds. The injection is administered as two shots given one month apart, and then an injection every two months after that. Patients will be given the option of beginning oral cabotegravir (Vocabria) for four weeks if there is concern over how they will tolerate the injectable.  

Gilead's Truvada pill was approved for use as pre-exposure prophylaxis in 2012, allowing men who have sex with men — and other groups at high risk of infection — a safe, relatively convenient way to prevent HIV. Daily pill adherence is easier said than done though, as the FDA points out in their announcement about Apretude.

"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," the FDA release states. "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 will increase PrEP uptake and adherence in these groups."

While PrEP usage has been increasing for years, it still remains relatively low — only about 25 percent of the 1.2 million people for whom PrEP is recommended are actually prescribed it.

The FDA approved Apretude after two randomized, double-blind trials, with HIV-negative men and transgender women in the first trial and HIV-negative cisgender women in the second.

Side effects for Apretude may include injection site reactions, headache, fever, fatigue, back pain, myalgia and rash.

Injectables are already changing the game of HIV treatment, as well as prevention. Early this year, the FDA approved ViiV Healthcare's Cabenuva, the first long-acting injectable HIV regimen.