HIV clinical trials · 2010
Impact of baseline antiretroviral resistance status on efficacy outcomes among patients receiving maraviroc plus optimized background therapy in the MOTIVATE 1 and 2 trials.
Сравнительное исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Nelson Mark, Fisher Martin, Gonzalez-Garcia Juan, Rockstroh Jürgen K, Weinstein David, Valdez Hernan, Mayer Howard, van der Ryst Elna, Goodrich James M, Dang Nathalie
Аннотация
PURPOSE: The MOTIVATE studies assessed maraviroc with optimized background therapy (OBT) in treatment-experienced patients with R5 HIV-1. This post hoc analysis compared outcomes between patients with and without HIV-1 resistance to epsilon3 classes of antiretrovirals at screening (triple-class-resistant [TCR] versus not-TCR [nTCR]).
METHODS: Week 48 changes (N = 635) in HIV-1 RNA and CD4+ cells were compared between TCR and nTCR groups receiving twice-daily maraviroc+OBT or placebo+OBT.
RESULTS: HIV-1 RNA change from baseline on maraviroc was significantly greater in the nTCR group (-2.05 vs -1.74 log(10) copies/mL; 95% CI difference 0.05-0.58 log(10)) though proportions <400 or <50 copies/mL were not. Week 48 CD4 increases were significantly greater in the nTCR group overall (mean +150 vs +110 cells/mm(3); 95% CI difference 18-62 cells/mm(3)) and in those with <50 RNA copies/mL (nTCR +192 vs +126 cells/mm(3); 95% CI difference, 19-93 cells/mm(3)) or receiving > or = 2 active OBT agents (weighted score; nTCR +184 vs +125 cells/mm3; 95% CI difference 8-110 cells/mm(3)).
CONCLUSIONS: Virologic suppression on maraviroc was greater in the nTCR than the TCR group, though proportions <50 or 400 copies/mL were not significantly different. Optimal CD4 increases on maraviroc appeared to accrue from initiation before development of TCR virus.
METHODS: Week 48 changes (N = 635) in HIV-1 RNA and CD4+ cells were compared between TCR and nTCR groups receiving twice-daily maraviroc+OBT or placebo+OBT.
RESULTS: HIV-1 RNA change from baseline on maraviroc was significantly greater in the nTCR group (-2.05 vs -1.74 log(10) copies/mL; 95% CI difference 0.05-0.58 log(10)) though proportions <400 or <50 copies/mL were not. Week 48 CD4 increases were significantly greater in the nTCR group overall (mean +150 vs +110 cells/mm(3); 95% CI difference 18-62 cells/mm(3)) and in those with <50 RNA copies/mL (nTCR +192 vs +126 cells/mm(3); 95% CI difference, 19-93 cells/mm(3)) or receiving > or = 2 active OBT agents (weighted score; nTCR +184 vs +125 cells/mm3; 95% CI difference 8-110 cells/mm(3)).
CONCLUSIONS: Virologic suppression on maraviroc was greater in the nTCR than the TCR group, though proportions <50 or 400 copies/mL were not significantly different. Optimal CD4 increases on maraviroc appeared to accrue from initiation before development of TCR virus.