US FDA approves 2-monthly dosing option for long-acting injectable cabotegravir/rilpivirine
Simon Collins, HIV i-Base
This now matches the indication approved by the EMA in Europe.
This was based on similar viral efficacy and tolerability in the phase 2b ATLAS-2M study where two-monthly injections were non-inferior to monthly dosing.
- ViiV press release. ViiV Healthcare announces US FDA approval of Cabenuva (cabotegravir, rilpivirine) for use every two months, expanding the label of the first and only complete long-acting HIV treatment. (1 February 2022).
- Overton E et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomized, multicentre, open-label, phase 3b non-inferiority