Publication date: Jul 01, 2025
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. 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. 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%). 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.
Semantics
| Type | Source | Name |
|---|---|---|
| drug | DRUGBANK | Bedaquiline |
| disease | MESH | adverse drug reactions |
| drug | DRUGBANK | Delamanid |
| drug | DRUGBANK | 5-amino-1 3 4-thiadiazole-2-thiol |
| disease | MESH | drug-resistant tuberculosis |
| disease | MESH | treatment failure |
| drug | DRUGBANK | Moxifloxacin |
| drug | DRUGBANK | Linezolid |
| drug | DRUGBANK | Cycloserine |
| drug | DRUGBANK | Clofazimine |
| disease | MESH | psychosis |
| disease | MESH | tuberculosis |
| pathway | KEGG | Tuberculosis |