Ruan Qiao-Ling, Yang Qing-Luan, Ma Chun-Lian, Lin Miao-Yao, Huang Xi-Tian, Mao Ya-Pin, Gao Ji-Mei, Li Jin-Ju, Zhang Xia-Ning, You Zhi-Xiang, Zheng Quan-Qing, Ren Yan-Fei, Liu Xue-Feng, Shao Ling-Yun, Zhang Wen-Hong
Department of Infectious Diseases, Shanghai Key Laboratory of Infectious Diseases and Biosafety Emergency Response, National Medical Center for Infectious Diseases, Huashan Hospital, Fudan University, Shanghai, People's Republic of China.
The First People's Hospital of Wenling, Zhejiang, People's Republic of China.
Emerg Microbes Infect. 2025 Dec;14(1):2502010. doi: 10.1080/22221751.2025.2502010. Epub 2025 May 16.
Tuberculosis preventive treatment (TPT) is essential for the end TB Strategy, but shorter and better tolerated regimens are needed to boost its coverage and acceptance.
Silicosis patients aged 18 to 65 years received a novel 1H3P3 regimen (400 mg isoniazid and 450 mg rifapentine, thrice-weekly for 4 weeks) under direct observation and were actively followed up for 3 years. The safety and efficacy were compared to the 3-month, once-weekly isoniazid/rifapentine (3HP) group and observation group from our previous trials.
A total of 279 eligible participants were enrolled, and 238 participants provided informed consent. All eligible participants had a median age of 56 years (IQR 52-60), 163 (68.5%) participants had a Bacillus Calmette-Guerin vaccine scar, and 74 (31.1%) participants were QuantiFERON-TB Gold In-Tube positive. There were 88 adverse events from 66 (27.7%) participants and only one (0.4%) participant had a Grade 3 adverse event. The completion rate was 92.0% (219/238). Six (2.5%) participants were diagnosed with active TB, five of which were bacterial confirmed cases. The cumulative active TB rate was 1.67 cases per 100 person-years. Compared to the previous study, the 1H3P3 regimen significantly reduced the 3-year cumulative active TB rate than the observation group (HR = 0.26, Log-rank = 0.02) and was comparable with the 3HP group (HR = 0.74, Log-rank = 0.69), while significantly reducing adverse events.
The 1HP TPT regimen was both safe and effective among silicosis patients. Further work is necessary to test the regimen in other high-risk populations. ClinicalTrials.gov identifier: NCT06022146 and NCT03900858.
结核病预防性治疗（TPT）对终结结核病战略至关重要，但需要更短且耐受性更好的治疗方案来提高其覆盖率和接受度。
18至65岁的矽肺病患者在直接观察下接受了一种新型的1H3P3方案（400毫克异烟肼和450毫克利福喷汀，每周三次，共4周），并进行了3年的积极随访。将其安全性和有效性与我们之前试验中的3个月每周一次的异烟肼/利福喷汀（3HP）组和观察组进行比较。
共纳入279名符合条件的参与者，238名参与者提供了知情同意书。所有符合条件的参与者中位年龄为56岁（四分位间距52 - 60），163名（68.5%）参与者有卡介苗接种疤痕，74名（31.1%）参与者结核感染T细胞检测阳性。66名（27.7%）参与者出现88起不良事件，只有1名（0.4%）参与者出现3级不良事件。完成率为92.0%（219/238）。6名（2.5%）参与者被诊断为活动性结核病，其中5例为细菌确诊病例。累积活动性结核病发病率为每100人年1.67例。与之前的研究相比，1H3P3方案与观察组相比显著降低了3年累积活动性结核病发病率（风险比 = 0.26，对数秩检验 = 0.02），与3HP组相当（风险比 = 0.74，对数秩检验 = 0.69），同时显著减少了不良事件。
1HP TPT方案在矽肺病患者中既安全又有效。有必要进一步开展工作，在其他高危人群中测试该方案。ClinicalTrials.gov标识符：NCT06022146和NCT03900858。
