In 2021, injectable PrEP was approved in the United States. This approval is a game-changer when it comes to HIV prevention!
Injectable PrEP works the same way as oral PrEP to prevent HIV in HIV-negative people. Like Truvada and Descovy, it repurposes drugs originally used for HIV treatment.
Injectable PrEP is manufactured by ViiV Healthcare and sold under the name Apretude. It contains one drug, cabotegravir, that’s already used to treat HIV-positive people. The injectable version of this drug used for HIV treatment is called Cabenuva, which is already available in Canada. Apretude isn’t yet approved in Canada, but it should be available in 2023 or 2024.
The major difference between Apretude and oral PrEP is that it’s an injection instead of pills. Both forms of PrEP are over 99% effective at preventing HIV if taken as prescribed. They are also well-tolerated with minimal side effects (see our “side effects” section for more info).
Injectable PrEP would require slightly more frequent visits to your healthcare provider. After starting Apretude, you’d need to make injection appointments every two months and STI testing every three months.
As of now, only oral PrEP is available in Canada. For Truvada, this is often at low or no cost because there are generic versions of the medication that are much cheaper. These generic drugs are also on provincial formularies, which means provincial drug assistance programs cover them.
When Apretude is approved in Canada, it won’t be on these formularies right away. You will need private insurance unless you pay out of pocket, which will likely be quite expensive.
Apretude is in a liquid formulation that’s injected into the buttocks. You can either start it by going straight to the injections or have an optional “lead-in” period for 30 days. The “lead-in” period is when you take a pill version of the drug to make sure you can tolerate it before switching to injections.
When starting injectable PrEP, you receive your first two injections one month apart. After this, you move to one injection every two months, which means you will only need six appointments per year to receive protection against HIV.
A healthcare provider gives these injections – you cannot inject yourself at home.
Oral PrEP is most effective when taken every day. However, if you miss doses, this can lower the amount of protection it gives you.
There can be many different reasons why someone misses doses: someone could just be forgetful, or other factors like mental health challenges or unstable housing make it harder for individuals to take daily pills.
Injectable PrEP makes it easier for anyone who struggles with daily medication. It also gives people more control over their lives, especially if they are worried about someone finding their pills. Injectable PrEP makes it easier to follow a recommended dose schedule and receive maximum protection because all you need is one appointment every two months.
This means that you can go out partying for a few days or go on vacation without needing to take your PrEP with you!
Oral PrEP is already over 99% effective at preventing HIV if taken as prescribed. Clinical trials have shown that injectable PrEP is even more effective than this.
Two clinical trials compared Apretude to Truvada.
One trial included trans women and gay, bisexual and other men who have sex with men; the other trial included cisgender women. In the first trial, participants on Apretude had a 69% lower risk of HIV infection than those on Truvada.
In the second trial, participants on Apretude had a 90% lower risk of HIV infection than those on Truvada.
Both trials were stopped early after Apretude was shown to be more effective than Truvada.
The most common side effects reported in clinical trials were injection site reactions like pain or swelling. These were usually mild or moderate and passed in a few days. A small number of participants reported diarrhea, headache, fever and/or fatigue.
One downside of injectable PrEP is that you can’t stop immediately if you get side effects. Since the drug is long-acting, it can take a while to leave your system. Some people may opt for the 30-day lead-in period with cabotegravir tablets to make sure they can tolerate the drug.
Canada was one of the first countries to approve Cabenuva, the injectable HIV treatment that uses the same drug as Apretude. However, the version of this drug for HIV prevention hasn’t been approved yet. Although the FDA has approved injectable PrEP in the United States, Canada’s approval process can take a long time. This means injectable PrEP may not be available in Canada until 2023 or 2024.
After Apretude is approved, the next step is making it accessible to everyone who needs it. This path to accessibility can take a while, and will vary depending on where you are because each province has their own drug formulary.
Despite this long process, the arrival of injectable PrEP is still an incredibly exciting development! As the landscape of PrEP changes and newer treatments become available, you can count on Freddie to keep you up-to-date with the latest healthcare information.
References
Apretude (cabotegravir), ViiV Healthcare (2021)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215499s000lbl.pdf
FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention, U.S. Food & Drug Administration (2021)
https://www.fda.gov/news-events/press-announcements/fda-approves-first-injectable-treatment-hiv-pre-exposure-prevention
ViiV Healthcare announces US FDA approval of Apretude (cabotegravir extended-release injectable suspension), the first and only long-acting injectable option for HIV prevention, GSK (2021)
https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-announces-us-fda-approval-of-apretude-cabotegravir-extended-release-injectable-suspension-the-first-and-only-long-acting-injectable-option-for-hiv-prevention/
