Efficacy and Safety of Chemotherapy Regimens With Bedaquiline in Patients With Respiratory Tuberculosis: Immediate and Final Results

Borisov, Sergey; Филиппов, А. В.; Ivanova, Diana; Иванушкина, Т. Н.; Литвинова, Н. В.; Garmash, Yu.Yu.

doi:10.21292/2075-1230-2019-97-5-28-40

Cited by 21 publications

(11 citation statements)

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“…When analyzing the data obtained, we noted the absence of a comprehensive description of comorbidities among patients in some studies. Unfortunately, long-term results of treatment patients with MDR and XDR were carried out only in five studies [ 25 , 26 , 30 , 35 , 36 , 37 ]. In other studies, data analysis was carried out until the end of the drug intake.…”

Section: Methodsmentioning

confidence: 99%

Efficacy of Tuberculosis Treatment in Patients with Drug-Resistant Tuberculosis with the Use of Bedaquiline: The Experience of the Russian Federation

Старшинова

Dovgalyk

Belyaeva³

et al. 2022

Antibiotics

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In the conditions of the continued growth of multiple- and extensive drug-resistant tuberculosis, use of the new highly effective anti-tuberculosis drugs in this patient category is of great relevance. The aim of the study was determination the efficacy of treatment in patients with multidrug- and extensive drug-resistant tuberculosis using bedaquiline based on studies published in the Russian Federation. Materials and methods: The authors analyzed data published in studies from 2014 to 2022; 41 publications were included in total and 17 articles corresponded to the study design. The results of treatment of 1404 tuberculosis patients with MDR/XDR TB were described. Bedaquiline was used according to the standard scheme with a description of the treatment results after 24–26 weeks. Treatment efficacy was estimated according to accepted criteria. Results of the study: The analysis showed that the treatment efficacy on conversion was achieved in 79.5% of cases (95% Cl 76.5–82.3), and recovery was observed in 82.0% of cases (95% Cl 78.6–85.1). Departure from the therapy was observed in rare cases (9.8%; 95% Cl 7.9–12.2). Deaths were recorded in 6.5% of cases (95% Cl 4.9–8.3), which were associated with the severe disease and concomitant pathology in 74.3%. The development of adverse events was noted in half of the patients (55.7%); however, bedaquiline cancellation occurred in a few cases (7.0%; 95% Cl 3.0–13.0). From analyzing data in patients with MDR and XDR TB, the efficacy of treatment was 89.9% (95% Cl 85.9–93.2) and 71.9% (95% Cl 66.2–77.1), respectively. Conclusion: Use of bedaquiline in treatment makes it possible to achieve recovery of patients with MDR/XDR TB in 82.0% of cases with patients dropping out of treatment in 9.8%. At the same time, in patients with MDR TB, recovery was achieved in 89.9% of cases, while in patients with XDR TB, 71.9% of cases recovered.

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Section: Methodsmentioning

confidence: 99%

Efficacy of Tuberculosis Treatment in Patients with Drug-Resistant Tuberculosis with the Use of Bedaquiline: The Experience of the Russian Federation

Старшинова

Dovgalyk

Belyaeva³

et al. 2022

Antibiotics

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“…Проведен ретроспективный анализ данных пациентов, завершивших участие в проспективном открытом нерандомизированном одноцентровом исследовании эффективности и безопасности режимов ХТ, включающих бедаквилин, у больных ТБ органов дыхания на базе ГБУЗ «МНПЦ борьбы с туберкулезом ДЗМ» в 2014-2018 гг., результаты которого опубликованы [1].…”

Section: материалы и методыunclassified

“…Всего в ретроспективное исследование включено 122 взрослых больных ТБ без ВИЧ-инфекции (из 315 принимавших участие в исследовании [1]), режимы лечения которых полностью соответствовали декларируемым ВОЗ в руководстве 2019 г. [14], с обязательным назначением всех трех препаратов группы А, а информация о безопасности и переносимости лечения была наиболее полной (пациенты получали лечение в условиях круглосуточного стационара с регулярным клинико-лабораторным мониторингом).…”

Section: материалы и методыunclassified

“…Результаты контролируемых КИ не могут дать объективного ответа на перечисленные вопросы. Строгие критерии отбора делают невозможным экстраполяцию полученных данных на больных с наибольшим риском развития НР и вынужденной отмены препаратов -с тяжелой сопутствующей патологией, анамнезом лекарственной непереносимости, алкоголизмом, наркоманией, преимущественно формирующих российскую популяцию больных ТБ с МЛУ/ШЛУ МБТ [1,2]. Таким образом, объективная оценка безопасности предлагаемых режимов предполагает минимальный перечень критериев отбора и максимальное приближение к «полевым» условиям клинической практики в рамках так называемых real-life-исследований [8].…”

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“…Возможность такой оценки получена при анализе данных одноцентрового нерандомизированного наблюдательного исследования, проводимого с 2014 г. в ГБУЗ «Московский городской научно-практический центр борьбы с туберкулезом Департамента здравоохранения города Москвы» (ГБУЗ «МНПЦ борьбы с туберкулезом ДЗМ») с целью изучения эффективности и безопасности бедаквилинсодержащих режимов ХТ у больных ТБ с МЛУ/ШЛУ возбудителя [1]. Его преимуществами являются программное назначение комбинации максимально эффективных препаратов (частично предвосхитившее принципы нового руководства ВОЗ) всем, кто в этом нуждается, минимум критериев отбора и возможность длительного наблюдения пациентов в соответствии с традициями real-life study [8].…”

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Safety of treatment regimens in multiple drug resistant tuberculosis patients compiled as per the new WHO recommendations as of 2019

Ivanova¹,

Borisov²,

Родина³

et al. 2020

Tuberk. bolezni lëgk.

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The objective: safety assessment of chemotherapy regimens compiled in accordance with the recommendations of World Health Organization (WHO), 2019, in patients with multiple drug resistant tuberculosis (MDR) in clinical practice settings.Subjects: Frequency, patterns, severity and risk factors of adverse events (AE) of chemotherapy regimens compiled in accordance with the WHO recommendations as of 2019 were analyzed in 122 patients with MDR and XDR respiratory tuberculosis within programmatic use of new anti-tuberculosis drugs.Results. The frequency of AE made 64.8% (95% CI 55.9-72.7%), gastrointestinal, cardiovascular and allergic events prevailed, the comorbidity was the risk factor of AE development (OR 6.44; 95% CI 1.91-21.76). AEs of with severity degrees 3-4 were observed in 24.6% (95% CI 17.8-33.0%), neurotoxic, ototoxic and hepatotoxic reactions prevailed; risk factors included female sex (OR 3.15, 95% CI 1.32-7.53) and complications of chemotherapy in the past (OR 3.50%, 95% CI 1.49-8.70). At least one anti-tuberculosis drug was canceled due to AE in 26.2% (95% CI 19.2-34.7%), and any of Group A drugs was canceled during the first 6 months of chemotherapy in 13.9% (95% CI 8.8-21.3%) of patients.

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Сlinical and economic evaluation of various etiotropic chemotherapy regimens in patients with respiratory tuberculosis with multidrug and extensively drug resistance

et al. 2023

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Objective: analysis of clinical and economic efficiency of various etiotropic chemotherapy regimes in patients with respiratory tuberculosis with multidrug- and extensively drug-resistant (MDR and XDR) pathogen using the pharmacoeconomic modeling method (Markov model).Material and methods. A single-centre, observational, retrospective, cohort study was performed, which included patients who received treatment in clinics and affiliated organizations of the main Moscow tuberculosis institution during 2014–2019 regarding respiratory tuberculosis with the MDR/XDR pathogen. The data of 1387 patients were analysed, of which 1093 patients received “optimized basic regimen” (OBR) in accordance with the Federal Clinical Recommendations of 2015, 294 patients received etiotropic therapy in accordance with the recommendations of the World Health Organization of 2018–2019. To evaluate economic efficiency, the pharmacoeconomic costeffectiveness analysis and pharmacoeconomic modeling were used. When assessing the economic costs of treatment, the direct costs (medical and non-medical) were taken into account.Results. The study results showed that 68.4% of patients in the group with bedaquiline-containing chemotherapy regimens reached the outcome of “treatment successfully completed” (patient was cured or transfered into the III group of dispensary follow-up) compared to 51.8% in the OBR group. The use of “new” etiotropic therapy regimens is most economically justified in patients with ХDR-tuberculosis with repeated treatment courses: incremental cost-effectiveness ratios (ICER) were 24,530.20 and 21,526.50 rubles per 1 patient. Markov model was developed, transitions from one state to another were evaluated according to the results of clinical observations during the first 2 years of research.Conclusion. The use of the dynamic model of the patient state made it possible to refine the estimates of the effectiveness of the compared etiotropic chemotherapy regimens for tuberculosis with MDR/XDR pathogen. Based on the results of modeling the dynamics of patients in the interval of 2 to 10 years of treatment, the use of “new” regimens provides a significant increase in the proportion of treatment success (by 16.1–29.8% in different groups of patients and at different times), a decrease in mortality (by 6.1–11.0%), and in the proportion of those who interrupted treatment (by 8.0–21.8%) in comparison with OBR.

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Efficacy and Safety of Chemotherapy Regimens With Bedaquiline in Patients With Respiratory Tuberculosis: Immediate and Final Results

Cited by 21 publications

References 11 publications

Efficacy of Tuberculosis Treatment in Patients with Drug-Resistant Tuberculosis with the Use of Bedaquiline: The Experience of the Russian Federation

Efficacy of Tuberculosis Treatment in Patients with Drug-Resistant Tuberculosis with the Use of Bedaquiline: The Experience of the Russian Federation

Safety of treatment regimens in multiple drug resistant tuberculosis patients compiled as per the new WHO recommendations as of 2019

Сlinical and economic evaluation of various etiotropic chemotherapy regimens in patients with respiratory tuberculosis with multidrug and extensively drug resistance

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