The Food and Drug Administration (FDA) has expanded the approval of Cabenuva (cabotegravir and rilpivirine) injection to include the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies/mL) who are 12 years of age or older and weigh at least 35kg on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Previously, the treatment was approved only in adult patients.
The expanded approval was supported by data from studies in the adult population and by data from open-label, noncomparative phase 1/2 MOCHA study (ClinicalTrials.gov Identifier: NCT03497676), which evaluated the safety, tolerability and pharmacokinetics of Cabenuva in 23 patients aged 12 to 17 years. An interim analysis of data showed that the safety profile in adolescents with the addition of either oral cabotegravir followed by injectable cabotegravir (n=8) or oral rilpivirine (n=15) followed by injectable rilpivirine (n=13) was consistent with the safety profile established with cabotegravir plus rilpivirine in adults.
The majority of patients (86%) reported a grade 1 or 2 adverse reaction. The adverse reactions reported by more than 1 patient (regardless of severity) were injection site pain (n=13) and insomnia (n=2). All injection site reactions were grade 1 or 2. Moreover, there were 2 patients who reported grade 3 adverse reactions of hypersensitivity and insomnia.
Based on these findings, the safety of Cabenuva in adolescents is expected to be similar to adults, as there was no clinically significant difference in drug exposure for the components of Cabenuva. Efficacy in adolescents was extrapolated from adults with support from pharmacokinetic analyses showing similar drug exposure.
Lynn Baxter, Head of North America at ViiV Healthcare, said: “Adolescents living with HIV and their caregivers face notable treatment challenges with daily oral HIV therapy, including the stress and difficulties of taking medication every day. With today’s approval for Cabenuva, we are bringing this younger population a first-of-its-kind HIV treatment that is dosed as few as 6 times a year and removes the need for daily oral therapy altogether.”
Cabenuva is supplied as 400mg/600mg and 600mg/900mg kits, each containing a single-dose vial of cabotegravir and rilpivirine.
The FDA recently approved updated labeling for Cabenuva making the oral lead-in with cabotegravir and rilpivirine tablets optional.
ViiV Healthcare announces US FDA approval of Cabenuva (cabotegravir, rilpivirine) for virologically suppressed adolescents living with HIV who are 12 years of age or older and weigh at least 35kg. News release. ViiV Healthcare. Accessed March 29, 2022. https://www.businesswire.com/news/home/20220329005875/en/ViiV-Healthcare-Announces-US-FDA-Approval-of-Cabenuva-cabotegravir-rilpivirine-for-Virologically-Suppressed-Adolescents-Living-With-HIV-Who-Are-12-Years-of-Age-or-Older-and-Weigh-at-Least-35-kg