THERAPEUTIC MONITORING OF BEDAQUILINE DRUG USE IN THE TREATMENT OF CHILDREN WITH MULTIDRUG-RESISTANT RESPIRATORY TUBERCULOSIS

Abstract

Use of Bedaquiline in children is studied relatively rarely therefore, according to the WHO experts, it is necessary to further conduct the research on the effectiveness and safety of including of the Bedaquiline drug in chemotherapy regimens in children as well as to obtain the new data on the characteristics of its metabolism in routine clinical practice. The purpose of this research was to evaluate the therapeutic monitoring performance of the Bedaquiline drug use in treatment of pediatric patients with multidrug-resistant tuberculosis (TB). Materials and methods used: pharmacokinetic (PK) parameters were determined in 10 patients of both genders aged 6 to 17 y/o who had received Bedaquiline drug as part of complex therapy in the treatment regimen for multidrug-resistant TB (MDR-TB). All patients had not received anti-tuberculosis drugs previously. Results: during the period of initial daily administration (saturation) of the Bedaquiline drug, Cmax was 3901 ng/ml, Cmin 165 ng/ml, Me 1672 (781.7-2562.3; 95% CI) ng/ml. During the period of maintenance dose intake (3 times per week) prior to taking the drug, Cmax was 987 ng/ml, Cmin 251 ng/ml, Me 504 (340.2-667.7; 95% CI) ng/ml, two hours after Bedaquiline intake Cmax was 2387 ng/ml, Cmin 576 ng/ml, Me 1429 (1005.9-1852.1; 95% CI) ng/ml. Conclusion: the data obtained coincide with the bibliographical data on the Bedaquiline PK in children aged 5 to 8 y/o issues.