The FDA approved the first long-acting injectable therapy for people living with HIV, the agency said late Thursday.
Injectable cabotegravir-rilpivirine (Cabenuva) was approved for people with HIV who are virologically suppressed on a stable antiviral regimen with no history of treatment failure. It is administered once a month.
“Having this treatment available for some patients provides an alternative for managing this chronic condition,” John Farley, MD, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in a statement.
In addition, the FDA approved a tablet formulation of cabotegravir (Vocabria), which the agency said should be taken with currently approved oral rilpivirine (Edurant) for a month prior to starting injectable cabotegravir-rilpivirine to ensure the medication is well tolerated.
They cited data from two randomized, open-label trials (ATLAS/FLAIR) of 1,182 adults with HIV, in which patients maintained virologic suppression with injectable cabotegravir-rilpivirine at the end of the study and showed no clinically relevant change in baseline CD4+ cell count.
The most common adverse events were injection site reactions, fever, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. The drug should not be used if patients have a previous known hypersensitivity reaction to cabotegravir or rilpivirine. Injectable cabotegravir-rilpivirine should not be used in patients who are not virally suppressed (defined as HIV RNA greater than 50 copies/mL).
Another open-label trial of the treatment published in December 2020 found dosing every 8 weeks was non-inferior to dosing every 4 weeks.