Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 96-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study

Results from the week 96 analysis of this study show every 8-week dosing of long-acting cabotegravir and rilpivirine was non-inferior to every 4-week dosing (2% v 1%, respectively, with HIV-1 RNA ≥50 copies/mL; adjusted treatment difference of 1.0 [95% CI −0.6 to 2.5]).

SPS commentary:

The results of the primary endpoint of this study (same endpoint at week 48) have already been published.

Vocabria (cabotegravir) 600 mg prolonged-release suspension for injection has just been licensed in the UK for use in combination with rilpivirine injection, for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class. Prior to the initiation of the injection therapy, an oral regimen of the two drugs should be taken for at least 28 days to assess tolerability. Cabotegravir injection is licensed for administration monthly (600mg initially then 400mg) or every 2 months (600mg monthly for two months and then 600mg every 2 months).

The Lancet HIV