FDA Signs Off on Updated HIV Drug Cabenuva Label

The FDA has approved an updated label for ViiV Healthcare’s long-acting human immunodeficiency virus (HIV) drug, Cabenuva (cabotegravir, rilpivirine), making the oral lead-in phase before taking the injected drug optional.

The oral lead-in phase normally involves taking cabotegravir and rilpivirine tablets daily for one month prior to starting cabotegravir and rilpivirine injections in order to assess patient tolerability to the medicines. The injected formulation can be taken either once a month or once every two months.

The label change was supported by phase 3 trial results that showed similar efficacy in participants who received the injections alone compared with those given the prior oral treatment.