The effectiveness and safety of complex treatment of patients with drug-resistant pulmonary tuberculosis using delamanide

Background. In 2020, a new anti-tuberculosis drug, delamanid, was first approved and introduced in Russia for the treatment of drug-resistant TB (DR), and therefore it is interesting to study its effectiveness and safety.

The aim. To evaluate the efficacy and safety of delamanid-containing chemotherapy regimens in patients with multidrug-resistant tuberculosis as part of complex treatment compared with standard regimens.

Methods. A bidirectional cohort study was conducted, including 76 patients with pulmonary tuberculosis with DR TB, divided into two comparable groups. Group 1 included 38 patients in thechemotherapyregimenwhoweretreatedwithdelamanide, the group was recruited prospectively. Group 2 included 38 patients who used chemotherapy regimens without the inclusion of delamanide, the group was recruited retrospectively.

Results. The effectiveness of treatment of patients with DR TB pulmonary tuberculosis according to the criterion of cessation of bacterial excretion was 27 (79,4 %) people in group 1 against 19 people (51,4 %) in group 2 (p = 6,115, χ2 = 0,024), according to the criterion of elimination of cavities 23 patients (71,9 %) cases against 15 patients (45,5 %), respectively (p = 4,670, χ2 = 0,044). In group 1 of patients, surgical treatment was performed in the early stages of therapy by 2 months – in 9 patients (28,1 %) cases against 3 people (10,3 %) – in group 2, by 4 months – in 12 patients (37,5 %) cases against 5 patients (17,2 %), respectively. There was no statistically significant difference in adverse event frequency between the groups (p > 0,05)

Conclusion. The timely use of surgical methods in patients with DR TB of the lungs, combined with the presence of delamanide in the chemotherapy regimen, made it possible to achieve higher treatment effectiveness.

1. WHO. Global tuberculosis report 2024. Geneva: World Health Organization; 2024. Licence: CC BYNC-SA 3.0 IGO. URL: https://www.who.int/teams/global-programme-on-tuberculosis-and-lung-health/tb-reports/global-tuberculosis-report-2024 [date of access: December 12, 2024.

2. Russkih AE, Kutuzova DM, Lovacheva OV, Samoilova AG, Vasilyeva IA. Short-term treatment regimens for patients with multidrug-resistant tuberculosis. The current situation and future prospects. Tuberculosis and lung diseases. 2020; 98(12): 57-66. (In. Russ.). doi: 10.21292/2075-1230-2020-98-12-57-66

3. Ahmad N, Ahuja SD, Akkerman OW, еt al. Treatment correlates of successful outcomes in pulmonary multidrug-resistant tuberculosis: an individual patient data meta-analysis. Lancet. 2018; 392(10150): 821–834. doi: 10.1016/S01406736(18)31644-1

4. Clinical recommendations “Tuberculosis in adults”, 2024; 32-35. (in Russ.). URL: https://tub-spb.ru/wp-content/uploads/2022/06/klinicheskie-rekomendaczii-tuberkulez-u-vzroslyh-utv.-minzdravom-rossii.pdf [date of access: December 12, 2024.

5. Olayanju O, Esmail A, Limberis J, Dheda K. A regimen containing bedaquiline and delamanid compared to bedaquiline in patients with drug-resistant tuberculosis. Eur Respir J. 2020; 55(1): 1901181. doi: 10.1183/13993003.01181-2019

6. Maryandyshev AO, Lorsanov SM, Khaydarkhanova ZB, Khunkarsultanov SB, Perkhin DV, Sveshnikova OM, et al. Treatment outcomes of regimens containing delamanid within therapy of multiple and extensive drug resistant tuberculosis in the Russian Federation. Tuberculosis and Lung Diseases. 2019; 97(11): 67-68. (In Russ.). doi: 10.21292/2075-1230-2019-97-11-67-68

7. Bagdasaryan TR, Plekhanova MA, Smirnov VYu, Grigorieva EA, Timakova YuI, Goncharov AS. Experience of Using Delamanid in the Treatment of Multiple Drug-Resistant Tuberculosis. Tuberculosis and Lung Diseases. 2024; 102(4): 78-82. (In Russ.). doi:10.58838/2075-1230-2024-102-4-78-82

8. Zimina VN, Viktorova IB. Delamanid is a new anti-tuberculosis drug: use, limitations, and prospects. Tuberculosis and Lung Diseases. 2021; 99(2): 58-66. (In Russ.). doi: 10.21292/20751230-202199-2-58-66

9. Sinitsyn MV, Kalinina MV, Belilovsky EM, Galstyan AS, Reshetnikov MN, Plotkin DV. Treatment of tuberculosis in modern conditions. Therapeutic Archive. 2020; 92(8): 86-94. (In Russ.).

10. Zakharov AV, Tikhonov AM, Polyakova AS, et al. Clinical aspects and effectiveness of complex treatment of pulmonary tuberculosis with a broad drug-resistant pathogen in patients of different registration groups. TB Bulletin. 2022; 1: 54-68. (In Russ.).

11. Skryagina EM. Efficacy and safety of delamanide-containing regimens in patients with tuberculosis with multiple and broad drug resistance. Medical business: a scientific and practical therapeutic journal. 2021; 4(79): 35-40. (In Russ.).

12. World Health Organization. WHO practical guide to tuberculosis. Module 4. Treatment: treatment of drugsensitive tuberculosis. Copenhagen: WHO Regional Office for Europe, 2023. License: CC BY-NCSA 3.0 IGO. (In Russ.).

13. Motta I, Boeree M, Chesov D, Dheda K, Günther G, Horsburgh CR Jr, et al. Recent advances in the treatment of tuberculosis. Clin Microbiol Infect. 2024; 30(9): 11071114. doi: 10.1016/j.cmi.2023.07.013

14. Farhat M, Cox H, Ghanem M, Denkinger CM, Rodrigues C, Abd El Aziz MS, et al. Drug-resistant tuberculosis: a persistent global health concern. Nat Rev Microbiol. 2024; 22(10): 617-635. doi: 10.1038/s41579-024-01025-1

15. Ghazvini K, Keikha M. The elimination of drug-resistant tuberculosis from a pulmonary resection surgery perspective. Int J Surg. 2022; 104: 106790. doi: 10.1016/j.ijsu.2022.106790