Three Months of Rifapentine and Isoniazid for Latent Tuberculosis Infection
Three Months of Rifapentine and Isoniazid for Latent Tuberculosis Infection
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DOI：
10.1056/nejmoa1104875
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发表时间：
2011-12-08
影响因子：
158.5
通讯作者：
Chaisson, Richard E.
中科院分区：
文献类型：
--
作者：
Sterling, Timothy R.;Villarino, M. Elsa;Chaisson, Richard E.
背景治疗结核分枝杆菌潜伏感染是控制和消除结核病的重要组成部分。目前的标准方案异烟肼治疗9个月是有效的，但受到毒性和治疗完成率低的限制。方法我们在结核病高危人群中进行了一项开放的、随机的非劣势试验，对利福喷丁(900 Mg)加异烟肼(900 Mg)直接观察每周一次的3个月(联合治疗组)和9个月每天自我给予异烟肼(300 Mg)(单用异烟肼组)进行比较。受试者来自美国、加拿大、巴西和西班牙，并进行了33个月的跟踪调查。结果在改良意向治疗分析中，联合治疗组3986例受试者中有7例发展为结核病(累积率为0.19%)，异烟肼组3745例受试者中有15例发展为结核病(累积率为0.43%)，两者相差0.24个百分点。联合治疗完成率为82.1%，单纯异烟肼治疗完成率为69.0%(P
BACKGROUNDTreatment of latent Mycobacterium tuberculosis infection is an essential component of tuberculosis control and elimination. The current standard regimen of isoniazid for 9 months is efficacious but is limited by toxicity and low rates of treatment completion.METHODSWe conducted an open-label, randomized noninferiority trial comparing 3 months of directly observed once-weekly therapy with rifapentine (900 mg) plus isoniazid (900 mg) (combination-therapy group) with 9 months of self-administered daily isoniazid (300 mg) (isoniazid-only group) in subjects at high risk for tuberculosis. Subjects were enrolled from the United States, Canada, Brazil, and Spain and followed for 33 months. The primary end point was confirmed tuberculosis, and the noninferiority margin was 0.75%.RESULTSIn the modified intention-to-treat analysis, tuberculosis developed in 7 of 3986 subjects in the combination-therapy group (cumulative rate, 0.19%) and in 15 of 3745 subjects in the isoniazid-only group (cumulative rate, 0.43%), for a difference of 0.24 percentage points. Rates of treatment completion were 82.1% in the combination-therapy group and 69.0% in the isoniazid-only group (P