Efficacy and safety of delamanid -containing regimens of anti-tuberculosis chemotherapy in real clinical practice: a cohort study

The spread of multidrug- and extensively drug-resistant tuberculosis (MDR- and XDR-TB) is stimulating the search for new drugs and chemotherapy regimens. Delamanid (Dlm) has been used in Russia since 2021; its efficacy and safety as part of chemotherapy regimens, advantages and limitations in Russian clinical practice have not been fully studied.

The aim was a comparative analysis of the efficacy and safety of DR-TB chemotherapy regimens with and without Dlm in real clinical practice.

Method. The observational study included 200 HIV-uninfected adult patients with pulmonary drug-resistant TB; 100 рatients of prospective cohort received Dlm-containing chemotherapy regimens (since 2021), and 100 patients of retrospective cohort – similar regimens without Dlm (in 2016–2020). The effectiveness of treatment was analyzed in those who completed the course («per protocol»), and among all who started treatment («intention-to-treat»).

Results. The effectiveness of treatment per protocol in patients completed the 24-week course was 94.1% vs. 87% (p > 0.05), in those who completed the main course of treatment – 91.0% vs. 80.5% in prospective and retrospective cohorts, respectively (p = 0.06). In the ITT analysis, a bacteriological response was noted in 93.2% vs. 87.7%; mortality was 3% and 5% in the group with and without Dlm, respectively (p > 0.05). In patients with a disease duration of up to 12 months, the time to sputum conversion was shorter for Dlm-containing regimens (median 4 wks vs 8 wks, p = 0.002). There were no differences in the frequency of significant adverse reactions (grades 3–4, 26% vs. 25%, respectively, p > 0.05); neurotoxic reaction (36% vs. 21%, p < 0.05), QT prolongation and gastrointestinal reactions were more frequent in the prospective cohort.

Conclusion. The inclusion of delamanid in modern chemotherapy regimens for MDR-TB helps to increase the effectiveness of treatment, especially in patients with disease duration up to a year; prevention and monitoring of neurotoxic reactions are necessary.

1. Багдасарян Т.Р., Плеханова М.А., Смирнов В.Ю., Григорьева Е.А., Тимакова Ю.И., Гончаров А.С. Опыт применения деламанида при лечении туберкулеза легких с множественной лекарственной устойчивостью // Туберкулез и болезни легких. – 2024. – Т. 102, № 4. – С. 78–82. https://doi.org/10.58838/2075-1230-2024-102-4-78-82

2. Васильева И.А., Стерликов С.А., Тестов В.В., Михайлов А.Ю., Голубев Н.А., Кучерявая Д.А., Пономарев С.Б. Ресурсы и деятельность противотуберкулезных организаций Российской Федерации в 2023–2024 гг. — М.: ФГБУ НМИЦ ФПИ Минздрава России, 2025. – 91 с.

3. Зимина В.Н., Викторова И.Б. Деламанид – новый противотуберкулезный препарат: применение, ограничения, перспективы // Туберкулез и болезни легких. – 2021. – Т. 99, № 2. – С. 58-66. https://doi.org/10.21292/2075-1230-2021-99-2-58-66

4. Можокина Г.Н., Самойлова А.Г., Васильева И.А., Абрамченко А.В. Деламанид: анализ эффективности и безопасности // Туберкулез и болезни легких. – 2023. – Т. 101, № 6. – С. 102-110. https://doi.org/10.58838/2075-1230-2023-101-6-102-110

5. Тихонов А.М., Тарасов Р.В., Полякова A.С., Ковалевская М.Н., Шорохова В.А., Мерзликина П.Д. Эффективность и безопасность комплексного лечения больных лекарственно-устойчивым туберкулезом легких с применением деламанида // Acta biomedical scientifica. – 2025.

6. Химова Е.С., Волченков Г.В., Перхин Д.В. и др. Операционное исследование эффективности и безопасности 9-месячной терапии туберкулеза с множественной и пре-широкой лекарственной устойчивостью микобактерии в Российской Федерации // Вестник Российской академии медицинских наук. – 2025. – Т. 80, № 2. – C. 97-108. doi:10.15690/vramn18020

7. Химова Е.С., Перхин Д.В., Свешникова О.М., Махмаева С.В., Верховая В.Н., Елисеев П.И., Никишова Е.И., Марьяндышев А.О. Деламанид в лечении МЛУ/пре-ШЛУ ТБ в Архангельской области в 2019–2021 годах // Туберкулез и болезни легких. – 2023. – Т. 101, № 3. – С. 62-68. https://doi.org/10.58838/2075-1230-2023-101-3-62-68

8. Ahmed S.H., Haider H., Moeed A., Mahmood A., Shivani N., Shuja S.H., Hayat J., Jamil B., Fatima R. Efficacy and safety of bedaquiline and delamanid in the treatment of drug-resistant tuberculosis in adults: A systematic review and meta-analysis // Indian J Tuberc. – 2024. – Vol.71, №1. – Р. 79-88. doi: 10.1016/j.ijtb.2023.05.005.