Efficacy and safety of regimen containing bedaquiline in children with drug-resistant tuberculosis

• Published in: Medicinskij sovet no. 16; pp. 138 - 146
• Main Authors: Aksenova, V. A., Klevno, N. I., Kazakov, A. V., Kudlay, D. A., Pakhlavonova, A. D., Sokolskaya, E. A., Nakonechnaya, S. L.
• Format: Journal Article
• Language: English
• Published: Remedium Group LLC 30-10-2021
• Subjects: bedaquiline; children; multidrug resistant bacteria; treatment; tuberculosis
• ISSN: 2079-701X; 2658-5790
• DOI: 10.21518/2079-701X-2021-16-138-146

Introduction.
The treatment of children with multidrug-resistant and extensively drug-resistant tuberculosis (MDR / XDR-TB) is a difficult task due to many factors: the duration of treatment, the lack of drugs with children’s dosages, age restrictions (according to the drug instructions).
Purpose of the study.
To assess the efficacy and safety of regimen with the inclusion of bedaquiline in children and adolescent with respiratory tuberculosis with drug-resistant tuberculosis.
Materials and methods.
The study is prospective, cohort, non-comparative from the period 2017–2019. We included 24 patients aged 5 to 17 years with MDR-TB (established or suspected) began regimen containing bedaquiline for 24 weeks. The duration of observation of patients included in the study was 24 months.
Results.
We can state a sufficient level of safety of using the latter for 24 weeks: adverse events presumably associated directly with the intake of bedaquiline were noted in only 1 patient out of 24 (4.2%; 95% CI 0.7-20.3). The efficacy of a regimen containing bedaquiline in combination with other anti-tuberculosis reserve drugs is beyond doubt: positive clinical and radiological dynamics and cessation of bacterial excretion by the end of the 24-week course of treatment were noted in all patients included in the study. In the course of 2-year follow-up, no exacerbation of the tuberculous process was observed in any case. All patients achieved clinical cure of tuberculosis.
Conclusion.
Regimen containing bedaquiline for children aged 5–17 years with multidrug-resistant tuberculosis is effective and safe.