Cabenuva
Dosing schedules: Initiation dose is 600 mg CAB-LA + 900 mg RPV-LA (3 mL each). Then for every other month dosing, continue with this dose for month 2, and then every other month thereafter. For monthly dose, continue with a lower maintenance dose of 400 mg CAB-LA + 600 mg RPV-LA (2 mL each) every month.
For adults and adolescents age 12 and older weighing at least 77 pounds (35 kg) who are switching from a stable HIV regimen and have undetectable viral load (less than 50 copies per mL) with no history of antiretroviral treatment failure, no active hepatitis B infection and no drug resistance or suspected resistance to cabotegravir or rilpivirine. One month of daily oral lead-in therapy may be recommended before injections begin, consisting of a 25 mg tablet of rilpivirine (Edurant) and a 30 mg tablet of cabotegravir (Vocabria), which must be obtained from the contracted TheraCom Pharmacy. Oral rilpivirine must be taken with a meal. Start injections on the last day of oral lead-in or of your previous regimen. Smaller monthly dose may cause less pain or discomfort. See package insert for instructions on using oral medications during. Prior ART regimens or oral cabotegravir and rilpivirine may be used for bridging missed injections, however, oral cabotegravir is only available from the contracted pharmacy TheraCom, and all other ART will have to be obtained from another pharmacy. People may receive Cabenuva up to 7 days before or after the date scheduled for injections. Studies suggest injections for 2-month dosing that are delayed for more than 1 week will lead to significantly lower drug levels and may lead to resistance. See package insert for instructions on missed doses (recommendations differ based on the dosing being used). Increased monitoring is recommended when CrCl is less than 30 mL/min. The effect of severe liver impairment on Cabenuva is unknown. Longer needles (not included in the dosing kit) are recommended for people with a BMI (body mass index) greater than 30.
Injection instructions: Before preparing the injections, remove Cabenuva from the refrigerator and wait at least 15 minutes to allow the medicines to come to room temperature. The vials may remain in the carton at room temperature for up to 6 hours. Do not put back in the refrigerator. If not used within 6 hours, they should be discarded. Once the suspensions have been drawn into the respective syringes, the injections should be administered as soon as possible, but may remain in the syringes for up to 2 hours. The filled syringes should not be placed in the refrigerator and if not used within 2 hours, should be discarded. See section 2.9 of package label.
- See Edurant; cabotegravir is not available separately
- See package insert for more complete information on potential side effects and interactions.
viivhealthcare.com; cabenuva.com
(877) 844-8872
Loading dose and every other month dosing (600 mg/900 mg): $7,601.18
Maintenance dose (400 mg/600 mg): $5,067.46/month
JO-ANN JOSE, MD, MPH:
Cabenuva caused a lot of excitement when it first came out on the market, and for many people, it is an excellent treatment regimen that works really well, especially for people who do not want to or cannot take oral antiretroviral treatment optimally. We don’t have to worry about the side effects or contraindications for the pill version of rilpivirine. (When you take a drug orally, there is a potential for interaction with other things that might be in the stomach. That’s not the case with an injectable, because the drug is going directly into the bloodstream.) One of the most common side effects with Cabenuva are injection site reactions—soreness in the butt—but these may diminish with successive doses. There are a number of mutations that would preclude use of this regimen, so there are strict protocols around how this medication is dispensed. It works very well if you meet the criteria, but it requires commitment from you. Administering Cabenuva requires a clinical setting. If it looks like you might miss that window, you can temporarily go on bridging oral medication until you can take the next scheduled shot. Cabenuva has a high price point, and insurance usually has some very strict rules that come with a lot of paperwork.
Cabenuva cannot be taken with carbamazepine, eslicarbazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (more than one dose) or St. John’s wort. Clinical monitoring of methadone is recommended because it may need to be adjusted in some people due to decreased levels. Do not use with macrolide antibiotics like azithromycin, clarithromycin and erythromycin, which are expected to increase concentrations of rilpivirine and are associated with a risk of QT prolongation or possible torsades de pointes. Other medications that may increase the risk of QT prolongation when taken with Cabenuva—such as levofloxacin, moxifloxacin, aripiprazole, escitalopram, fluoxetine, donepezil and ondansetron—should be used with caution. Where possible, consider alternatives such as azithromycin, which increases rilpivirine concentrations less than other macrolides, but use with caution. Antacids do not interact with injections. Tell your provider or pharmacist about all medications, herbals and supplements you are taking or thinking of taking, prescribed or not, as there are other drug interactions which are not listed here.
Injection site reactions (ISRs) were the most common adverse event. ISRs were less common over time and were generally mild to moderate. Other adverse reactions were fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash. Serious post-injection reactions reported within minutes of administration (in less than 1% of people injected) may have been associated with inadvertent (partial) intravenous administration and began to resolve within a few minutes after injection in clinical studies. Individuals should be observed for approximately 10 minutes after injections. People with injection pain can use an ice pack or heating pack and are advised to stretch and remain active. It is strongly discouraged to massage the area. Liver toxicity has been reported with or without pre-existing liver disease or risk factors. People with underlying liver disease or marked elevations in transaminases may be at increased risk for rising transaminase level or worsening of current elevated levels. Monitor for signs of hypersensitivity. HHS guidelines recommend closely monitoring people with pre-existing psychiatric conditions on an INSTI. Data associate INSTIs with weight gain. There was a median weight gain of 3.3 pounds in Cabenuva trials. People with buttock implants or fillers may not be good candidates for this medication due to concerns about drug absorption. SEE HHS guidelines page H-49 at bit.ly/4j3BVoc.
Cabenuva is being studied for first-time therapy and for people who struggle with adherence (taking medication as directed). According to 2024 drug guide comments from Dr. Melanie Thompson, “Although Cabenuva is not FDA-approved for individuals whose virus is not suppressed, studies are being conducted to look at its safety and effectiveness for people who have repeatedly struggled with adherence to oral therapy. The LATITUDE study showed that monthly injections of Cabenuva were superior to continuing oral treatment in people who have struggled with oral therapy, but in this study most participants achieved viral suppression prior to switching to Cabenuva. Recently, the IAS-USA amended its guidelines to recommend Cabenuva for a narrowly defined group of people whose virus is not suppressed due to inability to take oral therapy consistently, and who are at high risk for disease progression or death. This group is defined as being unable to take oral therapy successfully in spite of extensive efforts and clinical support; having CD4 counts below 200/µL or a history of an AIDS-defining condition; and having virus that is sensitive to both cabotegravir and rilpivirine. The purpose of this recommendation is to balance the risk of virologic failure with the high risk of death in people with severe immune suppression and limited options. It should be emphasized that this regimen should not be used for people whose virus is not suppressed but whose CD4 counts are good and who have other options. For these persons, every effort should be made to suppress the virus before transitioning to Cabenuva.” Residual concentrations may remain in the body for more than a year after discontinuation. Therefore, it is essential to initiate an alternative, fully suppressive regimen no later than one month after the final injection doses of Cabenuva. If virologic failure is suspected, switch to an alternative regimen as soon as possible. Analyses indicate that having two of the following baseline factors may be associated with an increased risk of virologic failure: archived rilpivirine resistance mutations, HIV-1 subtypes A6/A1 or BMI greater than 30 kg/m2. People with a history of exposure to an NNRTI may consider obtaining a GenoSure Archive resistance test to assess archived mutations that may decrease susceptibility to rilpivirine. A slightly higher incidence of drug resistance was seen in clinical trials with the bimonthly regimen. Studies are evaluating other potential sites for injection. Pregnant people should talk with their provider about opting for more frequent viral load testing or switching to a preferred or alternative 3-drug regimen recommended in pregnancy. Pregnant individuals can voluntarily enroll in the Antiretroviral Pregnancy Registry through their provider; GO TO apregistry.com.
JUAN MICHAEL PORTER II:
Though pricey, being a long-acting injectable makes Cabenuva worth its weight in gold for people who struggle with taking a daily pill. Taking a daily pill for the rest of your life can be difficult for many reasons—depression, lost housing, constant traveling, fear. Even without those factors, everyone I know on Cabenuva is happy with their decision. The only complaint I’ve heard is soreness at the injection site. This can last for up to 12 days. That said, I’ve been told that receiving the shot while standing up makes recovery easier. Besides doctors who balk at the price and people who fear needles, the only people I know who are leery of Cabenuva are those who are in recovery from injection drug use.