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 development of eff ective test systems for tuberculosis (TB) diagnosis and the study of factors infl uencing their sensitivity and specifi city constitute urgent tasks given the unstable epidemiological situation with TB in Ukraine and the world. The study aimed to determine the clinical and laboratory features of pulmonary TB that may aff ect the sensitivity of IgG TB antibody detection in human serum by the immuno-enzyme test system "IB-Chem Anti-Mycobacterium tuberculosis", which was developed at the Palladin Institute of Biochemistry of the NAS of Ukraine and uses recombinant fusion protein MPT83-MPT63 as an antigen. Methods. Sera of 62 patients with chemoresistant pulmonary TB were tested for TB antibodies using an indirect enzyme-linked immunosorbent assay. Dependence of the obtained results on clinical symptoms and signs of pulmonary TB, the frequency of diff erent types of antibiotic resistance, cellular and biochemical parameters of blood were analysed. Results. The sensitivity of the immuno-enzyme test system "IB-Chem Anti-Mycobacterium tuberculosis" for detecting human IgG TB antibodies using recombinant fusion protein MPT83-MPT63 was found to constitute 71.0%; it reached 81.3% in patients with destructive pulmonary TB. Conclusion. The developed test system should primarily be used for the TB diagnosis in patients with destructive changes in the lungs where the diagnostic effi ciency of this test system reaches high indicators.

BACKGROUND. Often in practice there are combinations of several diseases, or tuberculosis of the respiratory organs develops against the background of various comorbidities, including HIV. OBJECTIVE. To demonstrate best clinical practices for selecting the optimal individualized treatment regimen (ITR) in a patient with multidrug-resistant tuberculosis (MDR-TB) associated with HIV in the setting of severe immunosuppression and complicated by poor tolerability. MATERIALS AND METHODS. Presented clinical analysis of newly diagnosed generalized MDR-TB associated with HIV, treated for ITR for 9 months, which was assigned according to the World Health Organization step-by-step algorithm based on phenotypic drug susceptibility testing data. At the time of assessment, the patient was taking 273 doses of ITR. ITR required extended monitoring and selection during its first months of treatment, as it was accompanied by severe intolerance to antimycobacterial drugs.   RESULTS AND DISCUSSION. The expressed adverse events of 3-4 degrees were managed at the expense of carrying out the strengthened clinical and laboratory monitoring and consultations of narrow experts that allowed to select optimum ITR and in addition to carry out symptomatic treatment. Such tactics led to the normalization of hematological parameters with the disappearance of clinical manifestations of other adverse events and provided high intermediate results of treatment at the 9th month of ITR. Steady negativity of smear and culture (from1st month of treatment), positive radiological dynamics and significant improvement of well-being were obtained. CONCLUSIONS. Management of patients with MDR-TB/HIV co-infection with severe immunosuppression in patients who are treated by ITR requires enhanced monitoring of adverse reactions and rapid changes in the composition of ITR and early symptomatic treatment to ensure better adherence to treatment and positive outcomes.