FDA approves long-acting injectable HIV regimen for adolescents
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The FDA on Tuesday approved the first long-acting HIV treatment regimen for adolescents.
Cabenuva, which includes shots of cabotegravir (ViiV Healthcare) and rilpivirine (Janssen Pharmaceuticals), was first approved for adults last year as a monthly regimen and remains the only long-acting HIV treatment. The FDA recently approved a bimonthly dosing schedule for the injectable regimen, meaning it can be administered as few as six times per year.
The expanded indications means both options will now be available to virologically suppressed adolescents aged 12 years or older who weigh at least 35 kg, are on a stable ART regimen and have no history of treatment failure or resistance to either drug.
The FDA approval for adolescents was supported by studies conducted among adults and data from the Week 16 interim analysis of the ongoing MOCHA trial being run by ViiV and the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network.
ViiV said in a press release that the safety profile of Cabenuva in adolescents with the addition of either oral cabotegravir followed by injectable cabotegravir or oral rilpivirine followed by injectable rilpivirine was consistent with the safety profile of cabotegravir plus rilpivirine in adults.
“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 six times a year and removes the need for daily oral therapy altogether,” Lynn Baxter, North America head at ViiV Healthcare, said in the release.
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