Here’s What You Need to Know About the Injectable PrEP Option, Apretude

Back in December, the Food and Drug Administration announced that Apretude, the first-ever long-acting injectable option to prevent HIV infection, had been approved in a move that could prove to be a game-changer in the fight against HIV.

While Gilead’s Truvada pill has been approved for use as pre-exposure prophylaxis, or PrEP, since 2012 — and, when taken daily, lowers users’ risks from contracting HIV through sex by about 99 percent — taking the medication without fail has proven to be challenging and off-putting for some. “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 states. “Other interpersonal factors, such as substance use disorders, depression, poverty and efforts to conceal medication also can impact adherence.” The FDA hopes that with the option of a long-acting injectable that doesn’t need to be taken daily, more at-risk groups will take an interest and be more successful in using preventive medication as prescribed. 

That’s part of what makes Apretude such an exciting breakthrough. The long-acting nature of the medication means daily doses will no longer be required to help protect against contracting HIV through sex. However, as with all new drugs, there are naturally a lot of questions. If you’ve been considering talking to your health care provider about taking Apretude, here’s what you need to know first. 

Who is injectable PrEP for?

According to the FDA, Apretude has been approved for in adults and adolescents ages 12 and older who are considered at-risk for contracting HIV from sex. 

Critically, it’s also only for use if you’ve been confirmed to be HIV-negative. It’s been approved for the prevention of HIV, not treatment of the virus, and using Apretude with an active HIV infection can lead to developing drug resistance, which can make HIV treatment more difficult. This is why a negative HIV test is required before starting the medication and before each injection. 

How does Apretude work?

This medication is what’s known as an integrase inhibitor, which means it prevents HIV from entering into the body’s cells and replicating. When someone who’s taking an integrase inhibitor is exposed to HIV, the medication goes to work preventing the virus from spreading throughout the body. 

Unlike Truvada or Descovy, Apretude requires a medical professional to administer it because it must be injected into the muscle in the buttocks. When starting the medication, patients receive two injections one month apart and then an injection every two months after that.

How effective is injectable PrEP?

In studies, Apretude was even more effective in reducing the risk of contracting HIV than daily oral PrEP. According to ViiV Healthcare, the drug manufacturer, in a clinical study with 4,566 cisgender men and transgender women at risk of contracting HIV, there was a 69 percent reduction in the risk of doing so versus the use of a daily oral medication. HIV transmissions also occurred three times less often. In a second study, with 3,224 cisgender women, it reduced the risk of infection 90 percent compared to daily oral medication, and transmission of HIV occurred 12 times less.

Rare, breakthrough HIV infections are possible on Apretude. In a large clinical trial, seven breakthrough cases were found. Experts categorized them as "rare."

What are the potential side effects of injectable PrEP?

Like all medications, Apretude does have potential side effects. The most common is a reaction at the site of injection. In a study published in The New England Journal of Medicine, 80 percent of participants experienced at least one reaction at the injection site, although most were mild to moderate in severity. Other common side effects include diarrhea, headache, fever, tiredness, sleep problems, nausea, and dizziness. The drug labeling also includes warnings regarding hypersensitivity reactions, liver damage, and depressive disorders.

How much does injectable PrEP cost? And how do I get it? 

Apretude is not yet widely available. However, ViiV expects to begin shipping the drug to wholesalers and distributors sometime early this year. As for the out-of-pocket cost, it will likely depend on insurance coverage. Currently, Apretude is listed at $3,700 per dose but again, that amount may be covered in part or fully by a patient’s insurance. 

Viiv will offer a copay card that will cover up to $7,850 in out-of-pocket expenses each calendar year. This is applicable to those with private insurance.  Congressmen Mondaire Jones and Ritchie Torres wrote a letter signed by 56 other members urging the government "to require public and private insurance to make Apretude available for free to all people for whom PrEP is recommended — just like oral PrEP is today.