Structured treatment interruption in patients with multidrug-resistant human immunodeficiency virus
Structured treatment interruption in patients with multidrug-resistant human immunodeficiency virus
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DOI：
10.1056/nejmoa035103
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发表时间：
2003-08-28
影响因子：
158.5
通讯作者：
Baxter, JD
中科院分区：
文献类型：
--
作者：
Lawrence, J;Mayers, DL;Baxter, JD
背景技术背景：我们比较了两种策略治疗感染多药耐药的人类免疫缺陷病毒（HIV）的患者。方法：患者与多药耐药的HIV和HIV RNA水平超过5000拷贝每毫升被随机分配到一个为期四个月的结构性中断治疗，然后改变抗逆转录病毒治疗方案（治疗中断组）或立即改变方案（对照组）。进行了基因型和表型耐药性试验。评估疾病进展、死亡、基因型耐药性、CD 4细胞计数、HIV RNA水平和生活质量的变化。在中位随访11.6个月后，治疗中断组138例患者中有22例发生疾病进展或死亡，对照组132例患者中有12例发生疾病进展或死亡（P=0.01），治疗中断组的风险比为2.57（95%置信区间，1.2至5.5）。每组有8例死亡。在治疗中断组中，64.0%的患者在4个月内完全或部分恢复为野生型。与对照组相比，治疗中断组的平均CD 4细胞计数从0个月到4个月降低了85个细胞/立方毫米（P
BACKGROUND: We compared two strategies for treating patients infected with multidrug-resistant human immunodeficiency virus (HIV).METHODS: Patients with multidrug-resistant HIV and HIV RNA levels of more than 5000 copies per milliliter were randomly assigned to a four-month structured interruption of treatment followed by a change in antiretroviral regimen (treatment-interruption group) or to an immediate change in regimen (control group). Genotypic and phenotypic resistance testing was performed. Disease progression, death, and changes in genotypic resistance, CD4 cell counts, HIV RNA levels, and quality of life were assessed.RESULTS: After a median follow-up of 11.6 months, disease progression or death occurred in 22 of the 138 patients in the treatment-interruption group and in 12 of the 132 patients in the control group (P=0.01), with a hazard ratio of 2.57 (95 percent confidence interval, 1.2 to 5.5) for the treatment-interruption group. There were eight deaths in each group. In the treatment-interruption group, the mutant HIV populations completely or partially reverted to wild type by four months in 64.0 percent of patients. As compared with the control group, the treatment-interruption group had a mean CD4 cell count that was 85 cells per cubic millimeter lower from months 0 through 4 (P