Rilpivirine Updates: Approved for Adolescents; Possible Risk of Depression

The U.S. Food and Drug Administration has approved rilpivirine for use in adolescents 12 to 18 years of age; it is not recommended for younger children. As in adults, it is suggested for use in ARV-naive individuals with HIV RNA levels of ≤100,000 copies/mL. The dosage is 25 mg daily, to be taken with a meal, and of course in combination with other ARV medications.

The rilpivirine package label has been updated to include information about the possibility of depression--in preapproval studies, depressive disorders occurred in 9% of adults (1% had Grade 3 or 4 symptoms, the same as in the efavirenz comparator arm) and in 19% of adolescents (5.6% Grade 3 or 4; there was no comparator regimen).