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

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.