Phase III ATLAS-2M study evaluating long-acting cabotegravir with rilpivirine administered every 2 months shows similar efficacy to once-monthly administration
The trial (n=1049) reports 2-monthly vs monthly dosing were similarly effective at achieving plasma HIV-1 RNA ≥ 50 copies/mL - 1.7% vs 1.0% respectively, adjusted difference 0.8%, 95% CI -0.6 to 2.2.
Source:
Biospace Inc.
SPS commentary:
In December 2019, the US FDA rejected cabotegravir in combination with rilpivirine for the treatment of HIV in virologically suppressed adults. The reasons outlined in the FDA complete response letter relate to chemistry manufacturing and controls, and there have been no reported safety issues.
A marketing authorisation application is currently being reviewed by the European Medicines Agency.