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 1,045], 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).>