Vicky W L Chang, Qingbin Li, David Barnes, Anthony L Byrne, Jin-Gun Cho, SooWei Foo, Hazel Goldberg, Timothy Gray, Zinta Harrington, Lydia M Rofail, Evan Ulbricht, Gregory J Fox
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引用次数: 0
Abstract
Background: Treatment of tuberculosis infection (TBI) is a key pillar of the World Health Organization End TB Strategy. Two short-course rifamycin-based regimens-3 months of weekly isoniazid plus rifapentine (3HP) and 4 months of daily rifampicin (4RIF)-are widely recommended; however, they have not previously been directly compared in a randomized controlled trial. We compared treatment completion between 3HP and 4RIF among individuals with TBI.
Methods: We conducted a multicenter, open-label, parallel-group randomized controlled trial across 7 tuberculosis clinics in Sydney, Australia, between July 2019 and June 2024. Participants of any age with TBI were randomized 1:1, stratified by site, to receive either weekly 3HP or daily 4RIF. All doses were self-administered. Participants in the 3HP group received weekly Short Message Service (SMS) adherence reminders; both groups received standard clinic follow-up. The primary outcome was treatment completion, defined as ingestion of ≥90% of prescribed doses. Analyses were conducted on an intention-to-treat basis.
Results: A total of 210 participants were enrolled (106 assigned to 3HP and 104 to 4RIF). Treatment completion was significantly higher in the 3HP group (84.9%) than in the 4RIF group (65.4%; relative risk, 1.30 [95% confidence interval, 1.22-1.38]; P < .001). Adverse events of any grade occurred in 24.5% of participants receiving 3HP and 20.2% receiving 4RIF. No treatment-related deaths were reported.
Conclusions: Weekly 3HP supported by SMS reminders achieved significantly higher treatment completion than daily 4RIF, with similar safety. These findings support broader implementation of 3HP to optimize adherence and outcomes in TBI treatment programs.
Clinical trials registration: Australian New Zealand Clinical Trials Registry (ACTRN12618001672246).
背景：结核病感染治疗是世卫组织终止结核病战略的一个关键支柱。两种短期利福霉素治疗方案——每周异烟肼加利福喷丁治疗12周（3HP）和每日利福平治疗16周（4RIF）——被广泛推荐；然而，他们之前没有在随机对照试验中进行直接比较。我们比较了TBI患者中3HP和4RIF的治疗完成情况。方法：我们于2019年7月至2024年6月在澳大利亚悉尼的7家结核病诊所进行了一项多中心、开放标签、平行组随机对照试验。任何年龄的TBI患者按1:1随机分组，按地点分层，接受每周3HP或每天4RIF。所有剂量均为自我给药。3HP组的参与者每周收到遵守提醒短信；两组均接受标准的临床随访。主要终点是治疗完成，定义为摄入≥90%的处方剂量。分析是在意向治疗基础上进行的。结果：共有210名参与者入组（106名分配到3HP， 104名分配到4RIF）。3HP组的治疗完成率（84.9%）明显高于4RIF组（65.4%）；相对危险度1.30,95% CI 1.22-1.38；结论：短信提醒支持的每周3HP治疗完成率明显高于每日4RIF治疗，且安全性相似。这些发现支持更广泛地实施3HP，以优化TBI项目的依从性和结果。
期刊介绍：
Clinical Infectious Diseases (CID) is dedicated to publishing original research, reviews, guidelines, and perspectives with the potential to reshape clinical practice, providing clinicians with valuable insights for patient care. CID comprehensively addresses the clinical presentation, diagnosis, treatment, and prevention of a wide spectrum of infectious diseases. The journal places a high priority on the assessment of current and innovative treatments, microbiology, immunology, and policies, ensuring relevance to patient care in its commitment to advancing the field of infectious diseases.
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