×
ADVERTISEMENT

MARCH 25, 2022

FDA: Cabenuva No Longer Requires Oral Lead-In Period

By Landon Gray

The FDA updated the label for cabotegravir-rilpivirine (CAB/RPV; Cabenuva, ViiV Healthcare/Janssen), noting that an oral lead-in is no longer required before use of the injectable formulation.

The long-acting treatment is indicated once monthly or every two months for HIV-1 in virologically suppressed adults (HIV-1 RNA <50 copies/mL). Because of the long half-life of the therapy, the FDA originally called for an oral lead-in before using the injectable.