Inferior clinical outcome of the CD4+ cell count guided antiretroviral treatment interruption strategy in the SMART study:: Role of CD4+ cell counts and HIV RNA levels during follow-up
Inferior clinical outcome of the CD4+ cell count guided antiretroviral treatment interruption strategy in the SMART study:: Role of CD4+ cell counts and HIV RNA levels during follow-up
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DOI：
10.1086/529523
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发表时间：
2008-04-15
影响因子：
6.4
通讯作者：
Phillips, Andrew N.
中科院分区：
文献类型：
--
作者：
Lundgren, Jens D.;Babiker, Abdel;Phillips, Andrew N.
研究背景和方法。这项SMART研究比较了两种抗逆转录病毒治疗策略-药物保护(DC)和病毒抑制(VS)-在5472名人类免疫缺陷病毒(HIV)感染者中，CD4(+)细胞计数为350个/亩L。根据最新的CD4(+)细胞计数和HIV RNA水平，报告了DC和VS组中机会性疾病或死亡(OD/死亡)和相对风险(RR)的发生率和预测因素。在平均16个月的随访中，DC患者比VS患者花费更多的时间在最新的CD_4(+)细胞计数>；350细胞/亩L(DC比，31%比8%)和最新的HIV RNA水平>；400拷贝/毫升(71%比28%)，并且有更高的OD/死亡率(3.4比1.3/100人年)。在随访期间，CD_4(+)细胞计数=350细胞/亩L--这一增加是由于DC组中HIV RNA水平较高所解释的。DC患者的OD/死亡风险较高与(1)在相对免疫缺陷的情况下花费更多的随访时间，以及(2)即使在CD4(+)细胞计数较高的情况下，在艾滋病毒复制不受控制的情况下生存时间更长。在给定的CD4(+)细胞计数下正在进行的艾滋病毒复制将患者置于过量吸食/死亡的风险中。临床试验。政府标识：NCT00027352。
Background and methods. The SMART study compared 2 strategies for using antiretroviral therapy-drug conservation (DC) and viral suppression (VS)-in 5472 human immunodeficiency virus (HIV)-infected patients with CD4(+) cell counts >350 cells/mu L. Rates and predictors of opportunistic disease or death (OD/death) and the relative risk (RR) in DC versus VS groups according to the latest CD4(+) cell count and HIV RNA level are reported.Results. During a mean of 16 months of follow-up, DC patients spent more time with a latest CD4(+) cell count >350 cells/mu L (for DC vs. VS, 31% vs. 8%) and with a latest HIV RNA level >400 copies/mL (71% vs. 28%) and had a higher rate of OD/death (3.4 vs. 1.3/100 person-years) than VS patients. For periods of follow-up with a CD4(+) cell count = 350 cells/mu L-an increase explained by the higher HIV RNA levels in the DC group.Conclusions. The higher risk of OD/death in DC patients was associated with (1) spending more follow-up time with relative immunodeficiency and (2) living longer with uncontrolled HIV replication even at higher CD4(+) cell counts. Ongoing HIV replication at a given CD4(+) cell count places patients at an excess risk of OD/death.Trial registration. ClinicalTrials. gov identifier: NCT00027352.