KNCV Tuberculosis Foundation, The Hague, The Netherlands.
Lelie Care Group, Rotterdam, The Netherlands.
PLoS One. 2024 Nov 19;19(11):e0310773. doi: 10.1371/journal.pone.0310773. eCollection 2024.
Previously, drug-resistant tuberculosis (DR-TB) patients were treated with long, toxic, and relatively ineffective regimens. However, in recent years, there have been major improvements made. The 2020 World Health Organization DR-TB Treatment guidelines recommended the use of a 6-months all-oral BPaL (bedaquiline, pretomanid and linezolid) regimen under operational research (OR) conditions for selected DR-TB patients.
The processes, challenges, and interim results of introducing BPaL under OR conditions in 7 countries supported under the Korea International Cooperation Agency/TB Alliance-funded "Leveraging Innovation for Faster Treatment of Tuberculosis (LIFT-TB)" project are described here. The OR objectives were to explore the feasibility of introducing the BPaL regimen, and to estimate its effectiveness and safety in a select group of DR-TB patients.
Between November 2020 and the end of March 2023, a total of 574 patients had been enrolled. Interim treatment success stands at an encouraging 90.9% (280/308). Although adverse events of special interest (AESI) were common, they were manageable, and only 1 patient had to discontinue the complete BPaL treatment regimen. In addition, no unexpected adverse events (AE) were seen.
With careful advocacy, frequent communication with partners, and following steps to strengthen essential aspects of the delivery system, the project's experiences show that BPaL OR was feasible across different country settings. Project documents were constantly updated. The sharing of information, experiences, and interim results had a significant positive and motivating effect within and across countries. Interim OR results show excellent patient responses and are comparable to those seen under trial conditions. Although common, the observed AEs and AESIs were manageable, and no unexpected AEs were seen.
此前，耐多药结核病（DR-TB）患者接受的是长期、有毒且相对无效的治疗方案。然而，近年来，已经取得了重大进展。2020 年世界卫生组织（WHO）DR-TB 治疗指南建议在操作性研究（OR）条件下，为选定的 DR-TB 患者使用 6 个月全口服 BPaL（贝达喹啉、普托马尼和利奈唑胺）方案。
本研究介绍了在韩国国际协力团/结核病联盟资助的“利用创新加速结核病治疗（LIFT-TB）”项目下支持的 7 个国家，在 OR 条件下引入 BPaL 的过程、挑战和中期结果。OR 目标是探索引入 BPaL 方案的可行性，并在选定的 DR-TB 患者群体中估计其疗效和安全性。
2020 年 11 月至 2023 年 3 月底，共纳入 574 例患者。中期治疗成功率令人鼓舞，达到 90.9%（280/308）。尽管特殊关注的不良事件（AESI）常见，但都可管理，仅有 1 例患者不得不停止完整的 BPaL 治疗方案。此外，未观察到意外不良事件（AE）。
通过精心倡导、与合作伙伴频繁沟通，并采取措施加强交付系统的基本方面，该项目的经验表明，BPaL OR 在不同国家环境下是可行的。项目文件不断更新。信息、经验和中期结果的共享在国家内部和国家之间产生了显著的积极和激励效果。中期 OR 结果显示出患者的出色反应，与试验条件下观察到的结果相当。虽然常见，但观察到的 AESI 和 AESI 是可管理的，并且未观察到意外的 AE。
