A New Injectable HIV Drug, Cabenuva Approved by FDA
by Pharmchoices
A new HIV-1 injection that involves a two-month dosing interval, rilpivirine and cabotegravir (Cabenuva) has been issued approval by the FDA (US Food and Drug Administration). This medication is the first injectable complete HIV drug to be approved by the FDA.
Cabenuva is used to treat adults living with HIV in adults. The initial approval by the FDA was in January 2021, for the injection to be administered once monthly in virologically suppressed adults. It is a complete treatment regimen for HIV-1 and can be used to replace the current treatment of the patient.
The injection was co-developed by the Jansen Pharmaceutical Companies of Johnson & Johnson, together with ViiV Healthcare.
The approval to 2-month dosing interval followed a global clinical trial involving 1045 adults living with HIV-1. The trial results showed that Cabenuva, when administered every two months (8 weeks) at the doses of 3mL of cabotegravir and rilpivirine each, is not inferior to the dosing of 2ml of both cabotegravir and rilpivirine administered every 4 weeks.
After 48 weeks of the clinical trial, they found out that viral suppression for both monthly and 2-monthly dosing was 93.5% and 94.3% respectively. Also, patients with a viral load above 50 copies per mil were 1.7% for a 2-month injection and 1.0% for monthly dosing. The adverse effects of patients receiving the monthly dosing were also similar to those receiving 2-monthly dosing.
Before a patient is initiated on the injection, he/she will take one tablet each of cabotegravir and rilpivirine for at least 28 days to monitor how well their body tolerates the drug. If the healthcare giver is satisfied after a month, he/she can initiate the injection. The two injections can be given on both sides of the buttocks.
Common side effects are pyrexia, nausea, headache, rashes, dizziness, injection site reactions, musculoskeletal pains.
The patient to be initiated on the drug must not present with treatment failure or allergic reaction, resistance to cabotegravir or rilpivirine. Also, patients on carbamazepine, rifabutin, rifapentine, phenytoin, oxcarbazepine, St John’s wort (Hypericum perforatum), rifampin, dexamethasone (more than a single-dose treatment) should not take the medication.
There should be caution in giving the medication to those with liver diseases. There is not enough data for side effects in pregnancy. It should be noted that the medication lasts up to 12 months in the body after injection.
