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On January 21, 2021, the U.S. Food & Drug Administration (FDA) approved Cabenuva, a long-acting injectable drug combination used for HIV treatment. People living with HIV who decide to use this new treatment will receive injections every four weeks instead of taking daily pills. This approval is an historic moment in HIV, as it is the first complete long-acting injectable HIV regimen. We hope you are as excited as we are with this huge step forward for HIV treatment.
What is Cabenuva and who is it for?
Cabenuva contains two different types of HIV drugs: the new drug cabotegravir, which is in the integrase strand transfer inhibitor (also known as INSTIs) class of HIV drugs, and rilpivirine, part of the non-nucleoside reverse transcriptase inhibitor class (also known as NNRTIs or “non-nukes”) class of drugs. If you want to learn more about HIV drug classes and how HIV medications work, we recommend visiting the HIV/AIDS glossary on HIV.gov
If you are an adult living with HIV, have had an undetectable viral load (defined as less than 50 copies/mL) for at least 3 months on your current HIV medication, and want to switch to a long-acting regimen, Cabenuva might be right for you. You must have no history of treatment failure (HIV drugs not working to suppress your viral load) and no known or suspected drug resistance to cabotegravir or rilpivirine. Another requirement is that you do not have active HBV (Hepatitis B) infection, unless you are also taking an oral HBV active regimen. Cabotegravir is not for people who are pregnant or planning on becoming pregnant.
How to make the switch
If you want to switch to Cabenuva, you first need to take the pill form of the medications every day for one month. This is to make sure your body can tolerate these medications. The pill form of the two drugs in Cabenuva are Edurant, which is rilpivirine, and Vocabria, the tablet version of cabotegravir.
After you take the pills every day for a month and you know your body can tolerate them, you can start getting monthly injections. You will need to make an appointment with your HIV clinic and attend an office visit to get the injections. You will get two injections in the buttocks once a month. If you know you will need to miss a Cabenuva injection appointment, you can take Vocabria and Edurant pills as a short-term regimen. This might come in handy if you will be travelling out of town for a few weeks. You may also be able to temporarily get the Cabenuva injections at a clinic near where you are traveling in the U.S.
Pros and cons to consider before switching
Now that an injectable HIV medication is available, it gives you more choices for your HIV treatment. This is definitely a good thing, as it gives you options to choose what works best for your life. At the same time, you might want to consider a few things before switching.
May be more convenient than a daily pill
You only have to think about HIV treatment 12 times a year, instead of every day
Privacy - no pill bottles that could reveal your HIV status to others
Easier to adhere to HIV treatment
Taking two pills every day for a month before starting injections
You will have to make an office visit once a month
If you miss this appointment, contact your HIV clinic right away to discuss your options
The injections (shots) in your buttocks may be uncomfortable and/or painful
Side effects and clinical trials
Before being approved by the FDA, Cabenuva was studied in clinical trials. The names of the trials are ATLAS and FLAIR, and they included more than 1,100 PLWH in 16 countries. The studies found that 48 weeks of monthly injectable Cabenuva suppressed HIV as well as a standard daily three-drug HIV regimen.
Cabenuva is safe and generally well tolerated. The most common side effect is injection site reactions, such as pain, redness or swelling. Other side effects, like fever, fatigue, headache, and muscle pain, nausea, sleep disorders, dizziness and rash, are less common.
Can I afford Cabenuva?
We expect Cabenuva to be covered by health insurance. Sometimes it can take time for individual insurance companies to add new medications to their formulary. Because Cabenuva needs to be given in a clinic, health insurers are likely to cover it as a medical benefit rather than a pharmacy benefit. We also expect that Cabaenuva will eventually be covered by ADAP (AIDS Drug Assistance Program) for those who are eligible. It will take some time for ADAP to develop a new system to cover injectable medications given in clinic.
How can I get Cabenuva at the UW Health HIV Care and Prevention Clinic?
Cabenuva is FDA approved and we expect this to become available over the next few months. The HIV Care and Prevention Clinic is working hard on how we will provide this medication to our interested patients. Because it is a new way to provide HIV treatment, we need to create some new systems to be able to provide this service safely in clinic. If you are interested, we recommend you ask your health care provider during your next appointment.
In the future, you may not need to get Cabenuva injections every month. Researchers are looking at whether it’s possible that you only need to get injections every other month, or maybe even less frequently. Injectable cabotegravir alone (one of the drugs in Cabenuva) is also being studied for pre-exposure prophylaxis (PrEP).