Animesh Sinha, Roland Klebe, Michael L Rekart, Jose Luis Alvarez, Alena Skrahina, Natalia Yatskevich, Varvara Solodovnikova, Dzmitry Viatushka, Nargiza Parpieva, Khasan Safaev, Irina Liverko, Zinaida Tigay, Soe Moe, Aleksandr Khristusev, Sholpan Allamuratova, Sanjar Mirzabaev, Muzaffar Achilov, Nazgul Samieva, Nathalie Lachenal, Corinne Simone Merle, Fatimata Bintou Sall, Camilo Gomez Restrepo, Cecilio Tan, Norman Sitali, Matthew J Saunders
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Operational research is urgently required to evaluate these regimens in non-trial settings.</p><p><strong>Methods: </strong>This was a prospective cohort study of patients with microbiologically confirmed MDR/RR-TB and pre-extensively drug-resistant TB (pre-XDR-TB) initiated on BPaL-based regimens in Belarus and Uzbekistan (February 2022-June 2023). All clinical care and research procedures were delivered by treating physicians. After treatment completion, patients were followed up at 6 and 12 months, including collecting sputum to ascertain recurrence. The primary objective was to estimate the effectiveness (cured or treatment completed) and safety (the occurrence of serious adverse events) of BPaL-based regimens.</p><p><strong>Results: </strong>A total of 677 patients initiated treatment with BPaL-based regimens during the study. We documented successful treatment outcomes in 95.3% (427/448) of patients with MDR/RR-TB treated with BPaL plus moxifloxacin and 90.4% (207/229) of patients with pre-XDR-TB treated with BPaL plus clofazimine. 10.2% (69/677) experienced serious adverse events including 24 deaths (3.5%), 11 of which occurred during treatment. 83.3% (20/24) of deaths were not related to TB or TB treatment. Of patients who were successfully treated and completed 12-month follow-up, 0.5% (2/383) had recurrence.</p><p><strong>Conclusions: </strong>BPaL-based regimens for MDR/RR-TB and pre-XDR-TB are safe and highly effective in non-trial settings. 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引用次数: 0
摘要
背景：在2020年，开始耐多药/耐利福平结核病（MDR/RR-TB）治疗的患者中，只有63%获得成功治疗。24周全口服贝达喹啉、普雷托马尼和利奈唑胺（BPaL）方案已证明治疗成功率较高，并已被世界卫生组织推荐。迫切需要进行业务研究，以便在非试验环境中评价这些方案。方法：这是一项前瞻性队列研究，研究对象是白俄罗斯和乌兹别克斯坦（2022年2月至2023年6月）微生物学证实的MDR/RR-TB和广泛耐药前结核病（pre-XDR-TB）患者，他们开始使用基于bpal的方案。所有临床护理和研究程序均由主治医生提供。治疗结束后，随访6个月和12个月，包括收集痰液以确定是否复发。主要目的是评估基于bpal方案的有效性（治愈或治疗完成）和安全性（严重不良事件的发生）。结果：在研究期间，共有677名患者开始接受基于bpal的方案治疗。我们记录了95.3%（427/448）的MDR/ dr - tb患者接受BPaL +莫西沙星治疗的成功治疗结果，90.4%（207/229）的前xdr - tb患者接受BPaL +氯法齐明治疗。10.2%（69/677）发生严重不良事件，包括24例死亡（3.5%），其中11例发生在治疗期间。83.3%（20/24）的死亡与结核病或结核病治疗无关。在成功治疗并完成12个月随访的患者中，0.5%（2/383）复发。结论：在非试验环境中，基于bpal的MDR/RR-TB和pre-XDR-TB治疗方案是安全和高效的。应考虑在全球广泛实施这些方案，并需要进一步研究以评估其在其他关键人群中的表现。
The Effectiveness and Safety of Bedaquiline, Pretomanid, and Linezolid (BPaL)-Based Regimens for Rifampicin-Resistant Tuberculosis in Non-Trial Settings-A Prospective Cohort Study in Belarus and Uzbekistan.
Background: Only 63% of patients initiating multidrug-resistant/rifampicin-resistant tuberculosis (MDR/RR-TB) treatment in 2020 were treated successfully. 24-Week all-oral bedaquiline, pretomanid, and linezolid (BPaL)-based regimens have demonstrated higher rates of treatment success and have been recommended by the World Health Organization. Operational research is urgently required to evaluate these regimens in non-trial settings.
Methods: This was a prospective cohort study of patients with microbiologically confirmed MDR/RR-TB and pre-extensively drug-resistant TB (pre-XDR-TB) initiated on BPaL-based regimens in Belarus and Uzbekistan (February 2022-June 2023). All clinical care and research procedures were delivered by treating physicians. After treatment completion, patients were followed up at 6 and 12 months, including collecting sputum to ascertain recurrence. The primary objective was to estimate the effectiveness (cured or treatment completed) and safety (the occurrence of serious adverse events) of BPaL-based regimens.
Results: A total of 677 patients initiated treatment with BPaL-based regimens during the study. We documented successful treatment outcomes in 95.3% (427/448) of patients with MDR/RR-TB treated with BPaL plus moxifloxacin and 90.4% (207/229) of patients with pre-XDR-TB treated with BPaL plus clofazimine. 10.2% (69/677) experienced serious adverse events including 24 deaths (3.5%), 11 of which occurred during treatment. 83.3% (20/24) of deaths were not related to TB or TB treatment. Of patients who were successfully treated and completed 12-month follow-up, 0.5% (2/383) had recurrence.
Conclusions: BPaL-based regimens for MDR/RR-TB and pre-XDR-TB are safe and highly effective in non-trial settings. These regimens should be considered for widespread implementation globally, and further research is needed to evaluate their performance in other key populations.
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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