People with HIV may have to take multiple medicines just to keep the virus under control. Medicines for HIV are usually taken every day, and it is crucial that people do not miss their dose or else the condition becomes harder to treat. Remembering to take medicine every day can be hard for some people.
Cabenuva (KAB-en-ew-vah) was approved in 2021 for the treatment of HIV. It is the first complete treatment for HIV that is given by injection either once a month or once every two months. A complete treatment medicine has multiple medicines that work in different ways to manage HIV.
How Does It Work for HIV?
HIV is a virus found in blood, breast milk, and sexual fluids. HIV weakens your immune system by attacking certain white blood cells. HIV can turn into AIDS when you start becoming sick because your body can no longer fight off infections, but HIV does not always turn into AIDS.
HIV is commonly spread through sexual intercourse with a person who has the virus as well as from sharing needles. Children can get HIV from their mothers in these ways:
- Before birth through the placenta
- During childbirth
- After childbirth through the mother’s breast milk
HIV cannot be cured, meaning your body can never get rid of the virus. Taking medicines can help manage the amount of virus that is in your body. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is the most common type of HIV, while HIV-2 is less common, with most cases being in West Africa.
HIV symptoms are similar to flu symptoms and can include fever, rash, chills, tiredness, and muscle aches.
Cabenuva is used in people 12 and older to treat their HIV-1 infection. It contains two medicines for HIV: cabotegravir and rilpivirine. The medicines work in different ways to prevent the virus from replicating and spreading through the body. The goal of taking this medicine is to lower the virus level to undetectable and keep it there. Undetectable levels (less than 50 copies/mL) of the virus mean the amount of virus in the blood is below the level that can be measured by a lab test.
Cabenuva is used to replace people’s current HIV regimen if they meet certain requirements (the amount of virus in your body is undetectable, have had no history of HIV treatment failure, and have had no history of the medicines in Cabenuva not working for you).
How Do I Receive It?
Cabenuva is an injection given in your buttocks by your health care provider, either once a month or once every 2 months. It is given as two injections, one containing cabotegravir and the other containing rilpivirine. You and your health care provider may have a conversation to see which schedule works best for you.
When you start taking Cabenuva, you may need a higher dose for a period of time or you may need to receive your injections more frequently. Your health care provider may decide to have you take the two medicines in Cabenuva (cabotegravir and rilpivirine) by mouth. These medicines would be taken once a day with food, a month before you start receiving Cabenuva (also known as oral lead-in). This can help determine how you are tolerating the medicine before you receive the injection. Your health care provider could also start the Cabenuva injections without you having to take the oral lead-in.
If you receive Cabenuva once a month, your health care provider will give the first dose. Afterward, your health care provider will give the continuous dose once every month.
If you receive Cabenuva once every 2 months, your health care provider will give the initiation dose. This will be given as two doses, 1 month apart from each other. After the initiation doses are complete, your health care provider will give the continuous dose once every 2 months.
You will work with your healthcare provider to plan on when to come in (every month or every 2 months) for your injection. This is called the target treatment date. If you cannot come in to receive your dose on the target treatment date, you can receive Cabenuva 7 days before or 7 days after the target treatment date. This time is called the flexible treatment window.
Call your health care provider if you plan to miss your scheduled dose by more than 7 days. If you miss your scheduled dose by more than 7 days, it may become harder to treat your HIV-1 and you may have to take cabotegravir and rilpivirine by mouth to replace the missed injections.
How Was It Studied for HIV-1?
Two studies were conducted where Cabenuva was given once monthly.
In the first study, people who never took medicine for HIV-1 were given daily by-mouth dolutegravir/abacavir/lamivudine for 20 weeks. Those whose HIV levels were less than 50 cells/mL after taking these medicines either kept taking these medicines or switched over to by-mouth Cabenuva for 1 month followed by monthly Cabenuva injections. The study looked at the number of people who had virus levels of 50 copies/mL or more at week 48. About half of the people in the study (51%) were less than 35 years old and included White Americans, African Americans, and those classified as “Other.”
In the second study, people who were on medicines for HIV-1 and had virus levels of 50 copies/mL or less either stayed on their medicine or were switched to Cabenuva once-a-month injections. The study looked at the number of people who had virus levels of 50 copies/mL or more at week 48. People in the study were between the ages of 34 and 51 and included White Americans, Black Americans, Asian Americans, and those classified as “Other.”
One clinical study was conducted where Cabenuva was given once every 2 months. In the study, people who were on HIV-1 medicines and had virus levels at or below 50 copies/mL received either once-a-month or once-every-2-months dosing of Cabenuva. The study looked at the number of people whose virus levels were 50 copies/mL or above at week 48 and included White Americans, Black Americans, and those classified as “Other.”
What Benefits Were Seen?
For the two clinical studies that looked at once-monthly dosing of Cabenuva, the results showed that Cabenva showed a similar percentage of people who had virus levels of 50 copies/mL or more to those taking their current by-mouth HIV-1 medicines. In the first study, 2.1% of people receiving Cabenuva once-monthly injections vs 2.5% of people who took by-mouth HIV-1 medicines had virus levels of 50 copies/mL or above. In the second study, 1.6% of people receiving Cabenuva once monthly injections vs 1.0% of people who took by-mouth HIV-1 medicines had virus levels of 50 copies/mL or above. This means that Cabenuva was just as effective as the by-mouth medicines for managing HIV-1.
Cabenuva given once every 2 months showed similar results compared to once-a-month dosing when looking at the percentage of people who had virus levels greater than or equal to 50 cells/mL (2% vs 1%, respectively). This study helped show that Cabenuva could be given once every 2 months and be as effective as a once-a-month dosing.
How Long Does It Take to Work?
Cabenuva keeps the same level of medicine in your body between appointments. The medicine can start working as soon as you take it, but you won’t feel any different. Your health care provider will monitor your virus levels as you receive Cabenuva.
How Can I Manage Side Effects?
The most common side effects seen with Cabenuva are:
- Pain, itching, swelling, or redness near the injection site
- Fever
- Tiredness
- Headache
- Muscle or joint pain
- Nausea
- Sleeping problems
- Dizziness
- Rash
Because Cabenuva is given as an injection in the buttocks, you may experience some skin reactions around the injection site including a rash. This should go away within a few days after receiving the injection, but call your health care provider if this gets worse.
You may experience fever, muscle pain, or headache while receiving Cabenuva. Taking over-the-counter medicines such as Tylenol or ibuprofen can help, but call your healthcare provider if this gets worse.
If you experience tiredness or dizziness while receiving Cabenuva, do not drive or operate heavy machinery till you know how the medicine affects you.
If you experience nausea while receiving Cabenuva, there are a few steps you can take to help manage it. These include drinking plenty of water, eating smaller, more frequent meals, eating bland foods such as toast, bread, or crackers, and avoiding greasy foods and strong smells.
Sleeping problems may occur while taking Cabenuva. Following a sleeping schedule, avoiding screen time before bed, limiting caffeine, and techniques such as meditating can help.
What Type of Drug Interactions Can Happen?
Certain medicines should not be taken with Cabenuva because it may cause Cabenuva to not work as well and make it harder to treat the virus. These medicines include:
- Medicines used for seizures such as carbamazepine (Carbatrol, Tegretol, and others), oxcarbazepine (Oxtellar, Trileptal), phenobarbital, and phenytoin (Dilantin, Phenytek, and others)
- Medicines used to treat tuberculosis (TB) such as rifampin (Rimactane) or rifapentine (Priftin)
- Rifabutin (Mycobutin), which is used to prevent a bacterial infection that can be caused by HIV called mycobacterium avium complex disease (MAC)
- Dexamethasone, which is a steroid used to treat inflammation
- St. John’s wort, which is an herbal supplement that can be used to treat depression
It is not recommended to take other medicines for HIV while taking Cabenuva. Cabenuva is classified as a complete HIV regimen.
Taking certain antibiotics such as azithromycin (Zithromax), clarithromycin, or erythromycin (Ery-Tab and others) can increase the risk of heart rhythm problems and can increase the blood levels of Cabenuva, which can increase the risk of side effects.
If you are taking methadone for pain or opioid use disorder, your health care provider may need to monitor your methadone blood levels. Taking Cabenuva with methadone may lower methadone blood levels, and your health care provider may have to change your dose of methadone.
What Are Other Unique Considerations to Be Aware Of?
Cabenuva is for adults and children 12 years of age and older who weigh at least 77 pounds (35 kilograms). It is not known if Cabenuva is safe and effective in children less than 12 years old weighing less than 77 pounds (35 kilograms).
If your health care provider would like you to receive Cabenuva at a medical facility, they may refer you to an alternative site for administration (ASA). Your health care provider may refer you to an ASA if the location of the ASA is convenient for you, if they offer appointment times that work with your schedule, and depending on your insurance coverage. If your health care provider would like you to receive Cabenuva at an ASA, your health care provider must refer you, and you must continue to see your health care provider for your HIV. The ASA does not replace your health care provider.
What Do I Need to Do to Get It? Is There a Cost-Savings Program?
If your health care provider is working with a specialty pharmacy to order Cabenuva, you should expect a call from the specialty pharmacy to confirm your insurance coverage and schedule the first shipment of the medicine. You may have to schedule your Cabenuva refill shipment with the specialty pharmacy before each injection appointment. Talk to your health care provider about how to receive Cabenuva.
The manufacturer has a savings program called ViiV Connect that may allow you to pay as little as $0 per dose. Whether you are eligible depends on the type of insurance you have. You can find out more at www.cabenuva.com/savings-and-support/cabenuva-support or call 844-588-3288.
