New drugs in the treatment of drug-resistant tuberculosis in children. Experience with the use of delamanid in combination with bedaquiline

Abstract

OBJECTIVE: To determine the safety and effectiveness of delamanid in combination with bedaquiline in children for the treatment of multidrug-resistant tuberculosis. MATERIALS-METHODS: In 2023-2024, 18 children aged 3 to 17 years with MDR-TB were treated. Mycobacterium tuberculosis (MBT) was detected in 67% of children. The treatment regimen included bedaquiline,levofloxacin/moxifloxacin,linezolid,delamanid. The intensive phase of treatment with bedaquiline and delamanid was 6 months. The total course of chemotherapy (CT) was 9.6 months (9-12 months). The safety of treatment was assessed by clinical symptoms, laboratory and instrumental data. The duration of the QTc interval on the ECG was assessed. The effectiveness of treatment was assessed by the cessation of bacterial excretion, clinical and radiological dynamics. Study RESULTS: AEs were recorded in 5 out of 18 patients (27.8%). AEs were assessed as GRADE 1, 2. In 100% of cases, all AEs were treated without discontinuation of medications. We associated the appearance of complaints of headache, anxiety, and sleep disturbances with the use of delamanid (2 patients). An extension of the QTc interval to 450 ms was recorded in 2 patients; temporary discontinuation of the drugs was required, followed by their inclusion in the chemotherapy regimen. Positive clinical and radiological dynamics were observed in all patients by the end of the intensive phase of treatment. Bacterial excretion in children stopped in 100% of cases after 2 months of treatment. CONCLUSION: Treatment regimens for MDR-TB in children including bedaquiline and delamanid are safe and effective. Short courses of treatment promote greater adherence to treatment.

Keywords

• multidrug-resistant tuberculosis
• MDR-TB in children
• bedaquiline
• delamanid