Objective — to study the programmatic results of the efficacy and tolerability of the standard combina­tion BPaL regimen for patients with multidrug-resistant tuberculosis failures and pre-XDR-TB. Materials and methods. Treatment of patients with BPaL regimen took place within the framework of the Project of the ICF «Organization for Appropriate Technology in Health» on the basis of the National Institute of Phthisiology and Pulmonology named after F.G. Yanovsky NAMS of Ukraine (NIFP NAMS) of Ukraine as the operational study «Pilot study to assess  the effectiveness and safety of antimycobacte­rial therapy with BPaL regimen in Ukraine». Recruitment lasted from November 2020 to March 2022. The composition of the BPaL regimen, which was prescribed in the operational study: bedaquiline — 400 mg daily for the first 2 weeks, with a subsequent transition to 200 mg every other day, linezolid 1200 mg daily (with the possibility of changing the dose or canceling it after at least 4 consecutive weeks of its use), pretomanid 200 mg daily. The standard duration of treatment is 6 months (26 weeks or 182 doses). Extended duration up to 9 months — if a positive culture result (or reversion) is registered after 4 months of treatment and insufficient dynamics after 6 months of treatment. The implementation plan was 135 patients with pre-XDR-TB or failure of previous courses without exclusion criteria. Results and discussion. Despite the significant challenges/barriers that have arisen on the way to the implementation of OS, the effectiveness of the BPaL regimen, obtained within the framework of the Project and implemented on the basis of the NIFP of NAMS of Ukraine, fully corresponds to the results of clinical trials of various variants of the BPaL regimen: successful treatment was obtained in 91.5 % patients. The regimen turned out to be quite safe: complete cancellation of BPaL due to SAEs was carried out only in 4 patients, all others, despite the occurrence of AEs of various degrees of severity in 81.4 % of patients, managed to maintain treatment and successfully complete BPaL. Moreover, complete removal of linezolid from the composition of BPaL was carried out only in 8.2 % of patients. The main AEs were expected to be myelosuppression and peripheral neuropathy (the main AEs of linezolid at a high dose of 1200 mg per day). But in addition to these adverse events, hepatotoxicity was recorded in almost every 4th patient. It should be noted that these data completely match with the results of clinical trials. Such high results were achieved thanks to the close cooperation of partners, training and education of specialists of NIFP NAMS of Ukraine, and as a result — careful treatment of each patient, close monitoring of the condition of each of them, and a people-oriented approach. Conclusions. Ukraine is the first country in the world where the treatment of TB patients with the BPaL regimen as part of operational studies with excellent results was performed, which also paved the way for the current expansion of BPaL treatment in Ukraine even during the war.

Introduction. The main thrust of the global tuberculosis response for decades has been focused on tuberculosis (TB) in adults. However, this approach has failed to achieve the expected results in TB control. Therefore, WHO has changed the paradigm of TB control with a focus on childhood TB. Objective. To investigate the epidemiological situation of childhood tuberculosis in Ukraine in dynamics, to define the main factors of negative changes, and to define the directions for improvement of antituberculosis care. Materials and Methods. Epidemiological, clinical, statistical. Results. The epidemiological situation in Ukraine remains difficult. Over the past 10 years, the relapse rate of TB in adults has increased significantly, from 13.6% to 23.0%, and the number of patients with drug-resistant (DR) TB (in children by 11.0% in 2020). The volume of professional examination of children for TB decreased significantly, which led to an increase in the structure of the disease of severe forms requiring surgical treatment, and a significant under-recognition of patients and individuals with latent TB infection. Etiological verification of the diagnosis in children is very difficult. Practically 50.0% of unhealthy inpatients, even with very scrupulous examination, fail to detect MBT by any method (in Ukraine this figure reaches 70.0%). Conclusions. In spite of positive dynamics of morbidity and mortality, WHO estimations show significant underdiagnosis of TB patients in Ukraine. The relapse rate in adults and DR-TB patients of all age groups is increasing; the percentage of children under 14 years old in the age structure is increasing. Early detection of TB infection in children is extremely important for TB control in the country, which requires free access of the child population to systematic screening for TB with the Mantoux test and a new skin test with highly specific TB biomarkers (ESAT-6, CFP-10). Modern methods of molecular-genetic diagnostics of TB are quickly and efficiently implemented in NIFP, treatment of children with DR-TB with new anti-TB drugs was started. For the first time in Ukraine, the Center of surgical treatment of children with tuberculosis of the respiratory organs was established at the Institute. Keywords. TB in children, epidemiological indicators, dynamics of morbidity, drug-resistant TB, improvement of anti-TB care.