One Month of Rifapentine plus Isoniazid to Prevent HIV-Related Tuberculosis
One Month of Rifapentine plus Isoniazid to Prevent HIV-Related Tuberculosis
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DOI：
10.1056/nejmoa1806808
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发表时间：
2019-03-14
影响因子：
158.5
通讯作者：
Chaisson, R. E.
中科院分区：
文献类型：
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作者：
Swindells, S.;Ramchandani, R.;Chaisson, R. E.
结核病是人类免疫缺陷病毒（HIV）感染患者的主要杀手。预防性治疗是有效的，但目前的治疗方案是有限的，执行不力，完成率低。比较每日利福喷丁加异烟肼1个月方案的疗效和安全性的3期非劣效性试验（1个月组）联合异烟肼单药治疗9个月（9个月组）在艾滋病毒感染的患者谁是生活在结核病高发地区或谁有潜伏性结核感染的证据。主要终点是首次诊断为结核病或死于结核病或不明原因。如果每100人-年事件数的组间差异的95%置信区间的上限小于1.25，则显示非劣效性。在这些患者中，54%是女性;中位CD 4+计数为每立方毫米470个细胞，一半的患者正在接受抗逆转录病毒治疗。1个月组1488例患者中有32例（2%）报告了主要终点，9个月组1498例患者中有33例（2%）报告了主要终点，发生率分别为0.65/100人年和0.67/100人年（1个月组的率差为-0.02/100人-年; 95%置信区间的上限为0.30）。1个月组中6%的患者发生严重不良事件，9个月组中7%的患者发生严重不良事件（P= 0.07）。1个月组的治疗完成率显著高于9个月组（97% vs. 90%，P
BACKGROUNDTuberculosis is the leading killer of patients with human immunodeficiency virus (HIV) infection. Preventive therapy is effective, but current regimens are limited by poor implementation and low completion rates.METHODSWe conducted a randomized, open-label, phase 3 noninferiority trial comparing the efficacy and safety of a 1-month regimen of daily rifapentine plus isoniazid (1-month group) with 9 months of isoniazid alone (9-month group) in HIV-infected patients who were living in areas of high tuberculosis prevalence or who had evidence of latent tuberculosis infection. The primary end point was the first diagnosis of tuberculosis or death from tuberculosis or an unknown cause. Noninferiority would be shown if the upper limit of the 95% confidence interval for the between-group difference in the number of events per 100 person-years was less than 1.25.RESULTSA total of 3000 patients were enrolled and followed for a median of 3.3 years. Of these patients, 54% were women; the median CD4+ count was 470 cells per cubic millimeter, and half the patients were receiving antiretroviral therapy. The primary end point was reported in 32 of 1488 patients (2%) in the 1-month group and in 33 of 1498 (2%) in the 9-month group, for an incidence rate of 0.65 per 100 person-years and 0.67 per 100 person-years, respectively (rate difference in the 1-month group, -0.02 per 100 person-years; upper limit of the 95% confidence interval, 0.30). Serious adverse events occurred in 6% of the patients in the 1-month group and in 7% of those in the 9-month group (P= 0.07). The percentage of treatment completion was significantly higher in the 1-month group than in the 9-month group (97% vs. 90%, P