Collins S E, Jean Juste M A, Koenig S P, Secours R, Ocheretina O, Bernard D, Riviere C, Calnan M, Dunning A, Hurtado Rúa S M, Johnson W D, Pape J W, Fitzgerald D W, Severe P
Center for Global Health, Department of Medicine, Weill Cornell Medical College, New York, New York, USA.
Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes (GHESKIO), Port au Prince, Haiti.
Int J Tuberc Lung Dis. 2015 Jan;19(1):50-7. doi: 10.5588/ijtld.14.0217.
Port-au-Prince, Haiti.
To determine long-term effects of early vs. delayed initiation of antiretroviral therapy (ART) on immune recovery and tuberculosis (TB) risk in human immunodeficiency virus (HIV) infected individuals.
Open-label randomized controlled trial of immediate ART in HIV-infected adults with CD4 counts between 200 and 350 cells/mm(3) vs. deferring ART until the CD4 count was <200 cells/mm(3). The primary comparisons were CD4 counts over time and risk for incident TB, with 5 years of follow-up.
A total of 816 participants were enrolled, with 408 in each treatment arm. The early treatment group started ART within 2 weeks, while the deferred treatment group started ART a median of 1.3 years after enrollment. After 5 years, the mean CD4 count in the early treatment group was significantly higher than in the deferred treatment group (496 cells/mm(3), 95% confidence interval [CI] 477-515 vs. 373 cells/mm(3), 95%CI 357-389; P < 0.0001). TB risk was higher in the deferred treatment group (unadjusted HR 2.41, 95%CI 1.56-3.74; P < 0.0001) and strongly correlated with lower CD4 counts in time-dependent multivariate analysis.
Delays in ART initiation for HIV-infected adults with CD4 counts of 200-350 cells/mm(3) can result in long-term immune dysfunction and persistent increased risk for TB.
海地太子港。
确定在人类免疫缺陷病毒(HIV)感染者中,早期与延迟开始抗逆转录病毒治疗(ART)对免疫恢复和结核病(TB)风险的长期影响。
对CD4细胞计数在200至350个细胞/mm³之间的HIV感染成人进行开放标签随机对照试验,一组立即开始ART,另一组将ART推迟至CD4细胞计数<200个细胞/mm³。主要比较指标为随时间变化的CD4细胞计数和新发TB的风险,随访5年。
共纳入816名参与者,每个治疗组408人。早期治疗组在2周内开始ART,而延迟治疗组在入组后中位数1.3年开始ART。5年后,早期治疗组的平均CD4细胞计数显著高于延迟治疗组(496个细胞/mm³,95%置信区间[CI] 477 - 515 vs. 373个细胞/mm³,95%CI 357 - 389;P < 0.0001)。延迟治疗组的TB风险更高(未调整的风险比2.41,95%CI 1.56 - 3.74;P < 0.0001),并且在时间依赖性多变量分析中与较低的CD4细胞计数密切相关。
对于CD4细胞计数为200 - 350个细胞/mm³的HIV感染成人,延迟开始ART可能导致长期免疫功能障碍,并持续增加患TB的风险。