Safety and outcome of bedaquiline and delamanid-based longer oral regimen in Indian children less than 5 years with drug-resistant tuberculosis

Background Paediatric drug-resistant tuberculosis (DR-TB) remains a significant challenge, especially in high-burden countries like India. While bedaquiline (BDQ) and delamanid (DLM) are shown to be successful in treating multi-drug-resistant TB (MDR-TB) in older children, evidence of their safety and effectiveness in children under 5 is limited. We set out to evaluate the clinical outcomes and safety of BDQ and concurrent BDQ and DLM-based regimens in children under 5 years with DR-TB in a tertiary care Mumbai, India. Methods A retrospective study was conducted on 23 children under 5 years diagnosed with DR-TB and treated with BDQ or BDQ and DLM-based longer oral regimens between December 2021 and May 2024. Data on treatment regimens, drug resistance patterns, adverse effects, and outcomes were collected. Treatment was stopped based on clinico-radiological response. Results Among the 23 children, 8 (34.78%) completed treatment, 12 (52.17%) were still undergoing therapy, 1 (4.34%) was lost to follow-up, and 2 (8.69%) died. For those who completed treatment, the average duration of treatment was 19.25 months. Weight gain was observed in 19 (82.6%) patients. Adverse drug reactions were noted in 8 (34.78%) patients, of which 2 (25%) had vomiting, 2 (25%) had hallucinations, 1 (12.5%) had psychosis, 4 (50%) had anaemia, and 3 (37.5%) had QTcF prolongation while on treatment. Conclusion BDQ and DLM-based regimens appear effective and generally well tolerated in treating DR-TB in children under 5. However, a longer course of treatment of over 18 months is required. Careful monitoring for side effects, especially QTc prolongation, remains critical.