Treatment outcomes of bedaquiline-based longer oral antitubercular regimens in Indian children above five years of age.

IF 1.2 Q4 RESPIRATORY SYSTEM

Lung India Pub Date : 2025-07-01 Epub Date: 2025-06-27 DOI:10.4103/lungindia.lungindia_609_24

Ira Shah, Dhruv N Gandhi, Ramsha Ansari, Himanshu Warse, Sachi Kalawadia, Tsering Yangchen, Daksha Shah, Varsha Puri, Sanjay Mattoo, Minnie Bodhanwala

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Abstract

Background and objective: This study evaluates the treatment outcomes and adverse drug reactions (ADRs) of longer oral bedaquiline (BDQ)-based (without delamanid) antitubercular therapy (ATT) regimens in children aged 5-18 years.

Methods: A retrospective study was conducted between June 2021 and February 2024. We included 105 children diagnosed with drug-resistant tuberculosis (DR-TB) and treated with longer oral BDQ-based regimens. Duration of treatment was based on clinico-radiological resolution and multiple ADRs. Data on demographics, clinical features, resistance patterns, treatment regimens, outcomes, and adverse effects were analyzed.

Results: Mean age was 11.29 ± 3.20 years, with a male-to-female ratio of 0.42:1. Prior ATT exposure was reported in 61 (58.1%), with previous treatment failure in 34 (55.7% of those with prior exposure) patients. BDQ was administered for a median duration of 6 months, with 14 (13.33%) requiring extension. BMLCC (bedaquiline-moxifloxacin-linezolid-cycloserine-clofazimine) regimen was received by 61 (58.1%), and BLCC ± additional drugs (bedaquiline-linezolid-clofazimine-cycloserine) regimen was received by 30 (28.6%) patients. Treatment completion was achieved in 75 (71.43%) patients with a mean duration of 22.50 ± 7.50 months, of which 35 (46.67%) required treatment for 18 months, 32 (42.67%) required treatment for more than 18 months, and 8 (10.67%) patients required treatment stoppage before 18 months in view of multiple ADRs. Fifty-one (48.6%) patients had ADRs, including QTc prolongation in 25 (23.8%), psychosis 11 (10.5%), and vomiting 7 (6.7%).

Conclusion: BDQ-based regimens are effective in treating pediatric DR-TB, with high treatment completion rates. However, the duration of treatment is 18 months or longer in most patients based on clinico-radiological resolution. ADRs, particularly QTcF prolongation, warrant close monitoring and follow-up.

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以贝达喹啉为基础的更长时间口服抗结核方案在印度5岁以上儿童中的治疗结果

背景与目的：本研究评估5-18岁儿童口服长效贝达喹啉（BDQ）（不含delamanid）抗结核治疗（ATT）方案的治疗结果和不良反应（adr）。方法：于2021年6月至2024年2月进行回顾性研究。我们纳入了105名被诊断为耐药结核病（DR-TB）的儿童，并接受了更长时间的口服bdq方案治疗。治疗时间以临床放射学缓解和多重不良反应为基础。分析了人口统计学、临床特征、耐药模式、治疗方案、结局和不良反应的数据。结果：平均年龄11.29±3.20岁，男女比例0.42:1。61例（58.1%）患者有ATT暴露史，34例（55.7%）患者有治疗失败史。BDQ治疗的中位持续时间为6个月，其中14例（13.33%）需要延长治疗时间。61例（58.1%）患者接受BMLCC（贝达喹啉-莫西沙星-利奈唑胺-环丝氨酸-氯法齐明）方案，30例（28.6%）患者接受BLCC±加药（贝达喹啉-利奈唑胺-氯法齐明-环丝氨酸）方案。75例（71.43%）患者完成治疗，平均持续时间为22.50±7.50个月，其中35例（46.67%）患者需要治疗18个月，32例（42.67%）患者需要治疗超过18个月，8例（10.67%）患者因多发adr需要在18个月前停止治疗。51例（48.6%）患者出现不良反应，其中QTc延长25例（23.8%），精神病11例（10.5%），呕吐7例（6.7%）。结论：以bdq为基础的方案治疗儿童耐药结核病是有效的，且治疗完成率高。然而，根据临床放射学的解决方案，大多数患者的治疗持续时间为18个月或更长。adr，特别是QTcF的延长，需要密切监测和跟进。

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