HIV - EC Decision issued for Viiv's Vocabria/Rekambys injection initiation of LA treatment of HIV

ViiV Healthcare has announced that the European Commission has issued its Decision for the approval of Vocabria (cabotegravir) and Janssen Cilag's Rekambys (rilpivirine) injections initiation with or without an oral lead-in period for the long-acting treatment of HIV.

This decision is consecutive to an SmPC update, making optional the initiation with oral cabotegravir and rilpivirine for a month to assess tolerability to the medicines.

The EC Decision was based on the phase III FLAIR clinical trial (NCT02938520) Week 124 results, and supported by extensive safety and tolerability data from Phase II and Phase III studies of oral cabotegravir and rilpivirine, prior to intramuscular injections, where no safety signals that would require the use of an oral lead-in were identified.