April 6, 2022
On March 29, the FDA, Healio reports, approved Cabenuva as the first long-acting HIV treatment regimen for adolescents. The approval was supported by studies conducted among adults and data from the Week 16 interim analysis of an ongoing MOCHA trial being run by one of the pharmaceutical companies involved in development and the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network.
Cabenuva includes shots of cabotegravir (ViiV Healthcare, the aforementioned pharmaceutical company) and rilpivirine (Janssen Pharmaceuticals). The treatment was first approved as a monthly regimen for adults last year and remains the only long-acting HIV treatment. Recently, the FDA has approved it on a bimonthly injectable dosing schedule meaning it can be administered as few as six times per year.
Citing a safety profile comparable to adults, ViiV stated in a press release Cabenuva represented a first-of-its-kind treatment for adolescents. 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 now have an option that does not include daily oral therapy.
PIDS member Rosemary (Rosey) Olivero commented, “Those practicing pediatric HIV care are thrilled that the FDA has approved Cabenuva in the adolescent population. Adolescents living with HIV may carry a high burden of stigma, behavioral health issues and medication adherence fatigue related to their HIV care. Up till now, we’ve needed to wait until our patients turn 18 years old to use the long-term injectable medication for long-term suppression of HIV. In the aftermath of the COVID-19 pandemic, as adolescents continue to struggle with depression, anxiety and other behavioral health diagnoses, having this effective, convenient injectable medication to offer our adolescents living with HIV is extremely exciting.”