Effect of early versus deferred antiretroviral therapy for HIV on survival.

Effect of early versus deferred antiretroviral therapy for HIV on survival.
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DOI:
10.1056/nejmoa0807252
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发表时间:
2009-04-30
期刊:
The New England journal of medicine
影响因子:
--
通讯作者:
NA-ACCORD Investigators
NA-ACCORD Investigators
中科院分区:
其他
文献类型:
--
作者:
Kitahata MM;Gange SJ;Abraham AG;Merriman B;Saag MS;Justice AC;Hogg RS;Deeks SG;Eron JJ;Brooks JT;Rourke SB;Gill MJ;Bosch RJ;Martin JN;Klein MB;Jacobson LP;Rodriguez B;Sterling TR;Kirk GD;Napravnik S;Rachlis AR;Calzavara LM;Horberg MA;Silverberg MJ;Gebo KA;Goedert JJ;Benson CA;Collier AC;Van Rompaey SE;Crane HM;McKaig RG;Lau B;Freeman AM;Moore RD;NA-ACCORD Investigators

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对无症状的人类免疫缺陷病毒(HIV)感染患者开始抗逆转录病毒治疗的最佳时间尚不确定。我们进行了两项平行分析,涉及1996年至2005年期间在美国和加拿大接受医疗护理的17,517名无症状HIV感染者。没有一个病人以前接受过抗逆转录病毒治疗。在每组中,我们根据抗逆转录病毒治疗开始时的CD 4+细胞计数(351至500个细胞/立方毫米或>500个细胞/立方毫米)对患者进行分层。在每组中,我们比较了当CD 4+计数高于两个阈值时开始治疗的患者(早期治疗组)与延迟治疗直到CD 4+计数低于这些阈值的患者(延迟治疗组)的相对死亡风险。在第一次分析中,涉及8362例患者,2084例(25%)在CD 4+计数为351至500个细胞/立方毫米时开始治疗,6278例(75%)延迟治疗。在对日历年、患者队列、人口统计学和临床特征进行校正后,与早期治疗组相比,延迟治疗组患者的死亡风险增加了69%(延迟治疗组的相对风险为1.69; 95%置信区间[CI]为1.26 - 2.26; P<0.001)。第二项分析涉及9155例患者,2220例(24%)在CD 4+计数超过500个细胞/立方毫米时开始治疗,6935例(76%)延迟治疗。延迟治疗组患者的死亡风险增加了94%(相对危险度,1.94; 95%CI,1.37 - 2.79; P<0.001)。与延迟治疗相比,在CD 4+计数低于两个预先设定的阈值之前早期开始抗逆转录病毒治疗显著改善了生存率。
The optimal time for the initiation of antiretroviral therapy for asymptomatic patients with human immunodeficiency virus (HIV) infection is uncertain. We conducted two parallel analyses involving a total of 17,517 asymptomatic patients with HIV infection in the United States and Canada who received medical care during the period from 1996 through 2005. None of the patients had undergone previous antiretroviral therapy. In each group, we stratified the patients according to the CD4+ count (351 to 500 cells per cubic millimeter or >500 cells per cubic millimeter) at the initiation of antiretroviral therapy. In each group, we compared the relative risk of death for patients who initiated therapy when the CD4+ count was above each of the two thresholds of interest (early-therapy group) with that of patients who deferred therapy until the CD4+ count fell below these thresholds (deferred-therapy group). In the first analysis, which involved 8362 patients, 2084 (25%) initiated therapy at a CD4+ count of 351 to 500 cells per cubic millimeter, and 6278 (75%) deferred therapy. After adjustment for calendar year, cohort of patients, and demographic and clinical characteristics, among patients in the deferred-therapy group there was an increase in the risk of death of 69%, as compared with that in the early-therapy group (relative risk in the deferred-therapy group, 1.69; 95% confidence interval [CI], 1.26 to 2.26; P<0.001). In the second analysis involving 9155 patients, 2220 (24%) initiated therapy at a CD4+ count of more than 500 cells per cubic millimeter and 6935 (76%) deferred therapy. Among patients in the deferred-therapy group, there was an increase in the risk of death of 94% (relative risk, 1.94; 95% CI, 1.37 to 2.79; P<0.001). The early initiation of antiretroviral therapy before the CD4+ count fell below two prespecified thresholds significantly improved survival, as compared with deferred therapy.