Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, Atlanta, Georgia.
Mississippi State Department of Health, Jackson.
Clin Infect Dis. 2017 Oct 1;65(7):1085-1093. doi: 10.1093/cid/cix505.
Randomized controlled trials have demonstrated that the newest latent tuberculosis (LTBI) regimen, 12 weekly doses of directly observed isoniazid and rifapentine (3HP), is as efficacious as 9 months of isoniazid, with a greater completion rate (82% vs 69%); however, 3HP has not been assessed in routine healthcare settings.
Observational cohort of LTBI patients receiving 3HP through 16 US programs was used to assess treatment completion, adverse drug reactions, and factors associated with treatment discontinuation.
Of 3288 patients eligible to complete 3HP, 2867 (87.2%) completed treatment. Children aged 2-17 years had the highest completion rate (94.5% [155/164]). Patients reporting homelessness had a completion rate of 81.2% (147/181). In univariable analyses, discontinuation was lowest among children (relative risk [RR], 0.44 [95% confidence interval {CI}, .23-.85]; P = .014), and highest in persons aged ≥65 years (RR, 1.72 [95% CI, 1.25-2.35]; P < .001). In multivariable analyses, discontinuation was lowest among contacts of patients with tuberculosis (TB) disease (adjusted RR [ARR], 0.68 [95% CI, .52-.89]; P = .005) and students (ARR, 0.45 [95% CI, .21-.98]; P = .044), and highest with incarceration (ARR, 1.43 [95% CI, 1.08-1.89]; P = .013) and homelessness (ARR, 1.72 [95% CI, 1.25-2.39]; P = .001). Adverse drug reactions were reported by 1174 (35.7%) patients, of whom 891 (76.0%) completed treatment.
Completion of 3HP in routine healthcare settings was greater overall than rates reported from clinical trials, and greater than historically observed using other regimens among reportedly nonadherent populations. Widespread use of 3HP for LTBI treatment could accelerate elimination of TB disease in the United States.
随机对照试验已经证明，最新的潜伏性结核（LTBI）方案，即直接观察下每周 12 剂异烟肼和利福平（3HP），与 9 个月的异烟肼一样有效，完成率更高（82%比 69%）；然而，3HP 尚未在常规医疗环境中进行评估。
利用美国 16 个项目中接受 3HP 治疗的 LTBI 患者的观察性队列，评估治疗完成情况、药物不良反应以及与治疗中断相关的因素。
在 3288 名符合条件完成 3HP 的患者中，2867 名（87.2%）完成了治疗。2-17 岁的儿童完成率最高（94.5%[155/164]）。报告无家可归的患者完成率为 81.2%（147/181）。单变量分析中，儿童的中断率最低（相对风险[RR]，0.44[95%置信区间{CI}，0.23-0.85]；P=0.014），年龄≥65 岁的患者最高（RR，1.72[95%CI，1.25-2.35]；P<0.001）。多变量分析中，与结核病（TB）患者接触者（调整后的 RR[ARR]，0.68[95%CI，0.52-0.89]；P=0.005）和学生（ARR，0.45[95%CI，0.21-0.98]；P=0.044）的中断率最低，而监禁（ARR，1.43[95%CI，1.08-1.89]；P=0.013）和无家可归（ARR，1.72[95%CI，1.25-2.39]；P=0.001）的中断率最高。1174 名（35.7%）患者报告了药物不良反应，其中 891 名（76.0%）完成了治疗。
在常规医疗环境中完成 3HP 的比例总体上高于临床试验报告的比例，也高于既往报告的非依从人群中使用其他方案的比例。广泛使用 3HP 治疗 LTBI 可能会加速美国结核病的消除。
