US FDA approves 2-monthly dosing option for long-acting injectable cabotegravir/rilpivirine

Simon Collins, HIV i-Base

On 1 February 2022, the US FDA expanded the indication for long-acting cabotegravir and rilpivirine to allow two-months dosing.

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.

References

1. 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).
   https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2022/january/viiv-healthcare-announces-fda-approval-of-cabenuva-for-use-every-two-months
2. 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