Effectiveness and Safety of the Regimens Containing Bedaquiline in Patients with TB and HIV-infection

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The objective: to analyze effectiveness and safety of bedaquiline administered concurrently with antiretroviral therapy in treatment regimens for patients with such comorbidities as HIV infection and multiple drug resistant and extensively drug resistant tuberculosis.Subjects and Methods. Effectiveness and safety of chemotherapy regimens containing bedaquiline in the treatment of patients in 2017-2019 was analyzed. The study included 40 patients with multiple drug resistant and extensively drug resistant tuberculosis (MDR/XDR-TB) and HIV infection receiving antiretroviral (ART) therapy.Results. Treatment of tuberculosis in this category of patients who completed the main course of chemotherapy was found to be effective in 70.6%. The effectiveness was significantly higher in the following patients: those with intact immune status (88.9% and 51.6%, p=0.04) due to a significant reduction in the proportion of fatal outcomes from 19.4% to 0; those with preserved susceptibility to fluoroquinolones (81.8% and 51.7%, p=0.08) due to a 3.4-fold reduction in the proportion of unfavourable treatment outcomes (from 31.0% to 9.1%) and a 1.9-fold reduction in the proportion of treatment outcomes that could not be evaluated (from 17.2% to 9.1%). The analysis showed good tolerability of bedaquiline included in MDR/XDR-TB treatment regimens in combination with antiretroviral therapy. The frequency of AEs associated with the bedaquiline-containing regimen made 7.5%. When prescribing bedaquiline, preference should be given to ART regimens that do not contain NNRTIs and PIs (the incidence of adverse treatment outcomes when bedaquiline is prescribed in combination with NNRTIs is 1.7 times higher; the incidence of adverse events (AEs) associated with the use of a bedaquiline-containing regimen in combination with PIs is 2.7 times higher than when prescribing ART regimens without PIs (including those associated with bedaquiline – 5.2 times). In 1-3 years after the effective course of chemotherapy with bedaquiline during antiretroviral therapy, tuberculosis relapse rate made 9.1%.