Background The duration of the protective effect of TB preventive therapy (TPT) is controversial. Some studies have found that the protective effect of TPT is lost after cessation of therapy among people living with HIV in settings with very high tuberculosis incidence, but others have found long-term protection in low incidence settings. Methods We estimated the incidence rate (IR) of new tuberculosis disease (TB) for up to 12 years after randomization to four months of rifampin or nine months of isoniazid, among 991 Brazilian participants in a TPT trial in the state of Rio de Janeiro, with incidence 68.6/100,000 population in 2022. Adjusted hazard ratios (aHR) of independent variables for incident TB were calculated. Results Overall TB incidence rate (IR) was 1.7 (1.01; 2.7)/1,000 person years (PY). The TB IR among those who did not complete TPT was higher than in those who completed [2.9/1000 PY (95% CI: 1.3; 5.6) versus 1.1/1000 PY (95% CI: 0.4; 2.3), IR ratio (IRR)= 2.7 (95% CI: 1.0; 7.2)]. TB IR was higher within 28 months after randomization [IR: 3.5/1000 PY (1.6; 6.6) PY, compared to 1.1/1000 PY (95% CI: 0.5; 2.1) between 28 and 143 months, IRR= 3.1, 95% CI: 1.2-8.2]. Treatment non-completion was the only variable associated with incident TB [aHR= 3.2 (1.1; 9.7)]. Conclusion In a mostly HIV non-infected population, a complete course of TPT conferred long-term protection against tuberculosis.

中文翻译：

---

结核病预防治疗在中/高结核病发病率环境中的长期保护作用

背景 结核病预防治疗（TPT）保护作用的持续时间存在争议。一些研究发现，在结核病发病率极高的环境中，艾滋病毒感染者停止治疗后，TPT 的保护作用就会消失，但其他研究发现，在结核病发病率较低的环境中，TPT 具有长期保护作用。方法 我们对里约热内卢州一项 TPT 试验中的 991 名巴西参与者进行了随机分组，分别接受 4 个月利福平或 9 个月异烟肼治疗后长达 12 年的新结核病 (TB) 发病率 (IR) 估计。到 2022 年，发病率为 68.6/100,000 人。计算了结核病自变量的调整后风险比 (aHR)。结果 总体结核病发病率 (IR) 为 1.7 (1.01; 2.7)/1,000 人年 (PY)。未完成 TPT 的患者的 TB IR 高于已完成的患者 [2.9/1000 PY (95% CI: 1.3; 5.6) vs 1.1/1000 PY (95% CI: 0.4; 2.3)，IR 比率 (IRR) )= 2.7 (95% CI: 1.0; 7.2)]。随机分组后 28 个月内，TB IR 较高 [IR：3.5/1000 PY (1.6; 6.6) PY，而 28 至 143 个月期间为 1.1/1000 PY (95% CI: 0.5; 2.1)，IRR= 3.1, 95% CI：1.2-8.2]。治疗未完成是与结核病发生相关的唯一变量[aHR= 3.2 (1.1; 9.7)]。结论 在大多数未感染 HIV 的人群中，完整疗程的 TPT 可提供长期预防结核病的保护作用。