CD4+count-guided interruption of antiretroviral treatment
CD4+count-guided interruption of antiretroviral treatment
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DOI：
10.1056/nejmoa062360
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发表时间：
2006-11-30
影响因子：
158.5
通讯作者：
Rappoport, C.
中科院分区：
文献类型：
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作者：
El-Sadr, W. M.;Lundgren, J. D.;Rappoport, C.
背景：尽管使用联合抗逆转录病毒治疗降低了发病率和死亡率，但其有效性受到不良事件、依从性问题和人类免疫缺陷病毒（HIV）耐药性的限制。方法：我们将CD4+细胞计数超过350 /立方毫米的HIV感染者随机分配到持续使用抗逆转录病毒治疗（病毒抑制组）或间歇性使用抗逆转录病毒治疗（药物保护组）。间歇性使用包括延迟治疗直到CD4+计数下降到每立方毫米250以下然后使用治疗直到CD4+计数增加到每立方毫米350以上。主要终点是机会性疾病的发展或任何原因导致的死亡。一个重要的次要终点是主要的心血管、肾脏或肝脏疾病。结果：共有5472名参与者（2720人分配到药物保护组，2752人分配到病毒抑制组）在修改药物保护组方案之前平均随访16个月。在基线时，CD4+计数的中位数和最低点分别为每立方毫米597和250,71.7%的参与者血浆HIV RNA水平为每毫升400拷贝或更少。药物保护组中有120名参与者（3.3件/ 100人年）发生机会性疾病或任何原因导致的死亡，病毒抑制组中有47名参与者（1.3件/ 100人年）(药物保护组与病毒抑制组的风险比为2.6；95%可信区间[CI]， 1.9 ~ 3.7； P
BACKGROUND:Despite declines in morbidity and mortality with the use of combination antiretroviral therapy, its effectiveness is limited by adverse events, problems with adherence, and resistance of the human immunodeficiency virus (HIV).METHODS:We randomly assigned persons infected with HIV who had a CD4+ cell count of more than 350 per cubic millimeter to the continuous use of antiretroviral therapy (the viral suppression group) or the episodic use of antiretroviral therapy (the drug conservation group). Episodic use involved the deferral of therapy until the CD4+ count decreased to less than 250 per cubic millimeter and then the use of therapy until the CD4+ count increased to more than 350 per cubic millimeter. The primary end point was the development of an opportunistic disease or death from any cause. An important secondary end point was major cardiovascular, renal, or hepatic disease.RESULTS:A total of 5472 participants (2720 assigned to drug conservation and 2752 to viral suppression) were followed for an average of 16 months before the protocol was modified for the drug conservation group. At baseline, the median and nadir CD4+ counts were 597 per cubic millimeter and 250 per cubic millimeter, respectively, and 71.7% of participants had plasma HIV RNA levels of 400 copies or less per milliliter. Opportunistic disease or death from any cause occurred in 120 participants (3.3 events per 100 person-years) in the drug conservation group and 47 participants (1.3 per 100 person-years) in the viral suppression group (hazard ratio for the drug conservation group vs. the viral suppression group, 2.6; 95% confidence interval [CI], 1.9 to 3.7; P