Phase IIIb ATLAS-2M study of Cabenuva + Edurant shows continued efficacy to week 96 in HIV.- ViiV Healthcare

ViiV Healthcare presented positive long-term data from its global phase IIIb ATLAS-2M study of the first complete, long-acting regimen of Cabenuva + Edurant (cabotegravir and rilpivirine) for the treatment of HIV. Week 96 findings reinforce the primary (proportion of participants with plasma HIV-1 RNA at least 50 c/mL at Week 48 (Snapshot, ITT-E)), and secondary endpoints (proportion of participants with plasma HIV-1 RNA at least 50 or <50 c ml at week 96 snapshot itt-e initially assessed at week 48 and now showing efficacy of both monthly dosing and every 2-month dosing over the long-term in virologically supressed adults with hiv-1. atlas-2m met its primary endpoint at week 48 demonstrating that the efficacy of long-acting cabotegravir and rilpivirine dosed every 2-months every eight weeks was non-inferior to monthly dosing every four weeks. week 48 primary endpoint proportion of participants with plasma hiv-1 rna at least 50 c ml results showed every 2-month dosing 9 522 1.7 and monthly dosing 5 523 1.0 were similarly effective adjusted difference: 0.8 95 confidence interval ci: -0.6 2.2. week 96 findings reinforced the primary endpoint: the efficacy of every 2-month dosing was non-inferior to monthly dosing of long-acting cabotegravir and rilpivirine with 2.1 11 522 and 1.1 6 523 of participants respectively having hiv-1 rna at least 50 c ml adjusted difference: 1.0 95 ci: -0.6-2.5. the 96-week atlas-2m study secondary endpoint showed that rates of virologic suppression were similar between the two arms with 91.0 475 522 of participants in the every 2-month dosing arm and 90.2 472 523 in the monthly dosing arm achieving hiv-1 rna><50 c ml adjusted difference: 0.8 95 ci: -2.8-4.3. week 96 findings reported confirmed virologic failures cvfs defined as two consecutive viral loads at least 200 c ml in 1.7 9 522 of participants in the every 2-month dosing arm and 0.4 2 523 in the monthly dosing arm. the rate of cvf was low overall 1 11 1045 with only one participant in the every 2-month dosing arm meeting the criterion in the second year of therapy. this patient developed a rilpivirine resistance-associated mutation ram y181c and no integrase inhibitor insti rams. safety profiles were comparable between the two treatment arms with no new safety signals identified since the 48-week analysis. these data were presented at the virtual conference on retroviruses and opportunistic infections croi 2021.>