The multivariate analysis of results of bedaquiline use in the therapy of MDR/XDR pulmonary tuberculosis
https://doi.org/10.21292/2075-1230-2020-98-7-56-62
Abstract
The objective of the study: to perform the multivariate analysis of treatment outcomes in patients with multiple/extensive drug resistant tuberculosis (MDR/XDR TB), including those with HIV infection, whose chemotherapy regimens included bedaquiline.
Subjects and methods: 70 patients with MDR/XDR TB were enrolled in the retrospective two-center study, the multivariate analysis of treatment outcomes with bedaquiline-containing regimen was carried out.
Results: the performed multivariate analysis demonstrated high efficacy and good tolerability of bedaquiline-containing regimens for MDR/XDR TB treatment even despite the continuous ineffective treatment of patients in the past. The prolonged intake of bedaquiline for more than 24 weeks was not associated with a high level of adverse reactions. It was found that the use of cycloserine/terizidone made a significant contribution to the favorable outcome of chemotherapy. The factors associated with the most unfavorable treatment outcomes were the following: age above 60 years, concurrent chronic obstructive pulmonary disease, alcohol and/or drug addiction, and smoking.
About the Authors
N. V. StavitskayaRussian Federation
Natalia V. Stavitskaya, Doctor of Medical Sciences, Acting Director
81a, Okhotskaya St., Novosibirsk, 630040
Phone: +7 (383) 203-78-25
I. G. Felker
Russian Federation
Irina G. Felker, Head of Scientific Organizational Department
81a, Okhotskaya St., Novosibirsk, 630040
Phone: +7 (383) 203-76-91
E. M. Zhukova
Russian Federation
Elena M. Zhukova, Leading Researcher
81a, Okhotskaya St., Novosibirsk, 630040
Phone: +7 (383) 203-83-57
А. I. Tlif
Russian Federation
Asiet I. Tlif, Endocrinologist
1b, Village of Sukmanikha, Schelkovsky Raion, Moscow Region, 141132
Phone: +7 (496) 255-80-28
N. P. Doktorova
Russian Federation
Natalia P. Doktorova, Candidate of Medical Sciences, Researcher
Build. 2, 4, Dostoevskiy St., Moscow, 127473
D. А. Kudlay
Russian Federation
Dmitry A. Kudlay, Doctor of Medical Sciences, Professor of Pharmacology Department of Pharmacy Institute
8, Bd. 2, Trubetskaya St., Moscow, 119991
Phone: +7 (499) 248-05-53
References
1. Balasanyants G.S. Experience of using bedaquiline in the multimodality therapy of tuberculosis patients with concurrent HIV infection. Tuberculosis and Lung Diseases, 2017, vol. 95, no. 9, pp. 49-54. (In Russ.)
2. Borisov S.E., Fillipov А.V., Ivanova D.А., Ivanushkina T.N., Litvinova N.V., Garmash Yu.Yu. Efficacy and safety of chemotherapy regimens with bedaquiline in patients with respiratory tuberculosis: immediate and final results. Tuberculosis and Lung Diseases, 2019, vol. 97, no. 5, pp. 28-40. (In Russ.)
3. Vasilyeva I.А., Samoylova А.G., Lovacheva O.V., Chernousova L.N., Bagdasaryan T.R. The effect of different TB drugs and antimicrobial agents on the efficacy of treatment of tuberculosis patients with multiple drug resistance. Tuberculosis and Lung Diseases, 2017, vol. 95, no. 10, pp. 9-16. (In Russ.) doi: 10.21292/2075-1230-2017-95-10-9-15.
4. Golubchikov P.N., Kruk E.А., Mishustin S.P., Petrenko T.I., Kudlay D.А. Experience of treating extensive drug resistant tuberculosis patients including continuous use of bedaquiline, in Tomsk Region: immediate and postponed results. Tuberculosis and Lung Diseases, 2019, vol. 97, no. 8, pp. 38-45. (In Russ.)
5. Zhukova E.M., Vokhminova L.G., Kudlay D.А. The effect of the current chemotherapy of MDR/XDR tuberculosis on QT interval changes in ECG. Tuberculosis and Lung Diseases, 2019, vol. 97, no. 11, pp. 19-22. (In Russ.) http://doi.org/10.21292/2075-1230-2019-97-11-19-22.
6. Use guidelines for Sirturo®. Registration number: ЛП-002281. (In Russ.) Epub., Available: http://www.ros-med.info/reestrls/info.php?action=info&id=26223. (Accessed 20.05.2020).
7. Kondakova M.N., Khabirov V.V., Zhemkov V.F., Shpakovskaya L.R., Daynovets А.V., Elkin А.V. Impact of bedaquiline on the efficacy of comprehensive therapy of respiratory tuberculosis. Tuberculosis and Lung Diseases, 2018, vol. 96, no. 6, pp. 39-43. (In Russ.)
8. Parolina L.E., Morozova T.I., Otpuschennikova O.N., Razina А.Yu., Doktorova N.P. Clinical efficacy of pulmonary tuberculosis treatment with multiple drug resistance of mycobacteria. Tuberculosis and Lung Diseases, 2015, no. 5, pp. 138-139. (In Russ.)
9. Pirogova N.D., Leshok S.N., Schipunova L.V., Beloborodova N.G. Use of bedaquiline in the chemotherapy regimen for multiple drug resistant tuberculosis in the HIV positive patient. Tuberculosis and Lung Diseases, 2019, vol. 97, no. 10, pp. 53-58. (In Russ.)
10. Tikhonov А.M., Burakova M.V., Vaniev E.V., Romanov V.V., Vasilyeva I.А. Efficiency of chemotherapy with bedaquiline in drug resistant pulmonary tuberculosis patients. Tuberculosis and Lung Diseases, 2018, vol. 96, no. 2, pp. 22-26. (In Russ.)
11. Tikhonova L.Yu., Sokolova V.V., Tarasyuk I.А., Ekimenko А.M., Cherenkova M.А., Kudlay D.А. Experience of treatment of multiple drug resistant tuberculosis patients with bedaquiline in Amur Region. Tuberculosis and Lung Diseases, 2018, vol. 96, no. 6, pp. 45-50. (In Russ.)
12. Federalnye klinicheskiye rekomendatsii po diagnostike i lecheniyu tuberkuleza organov dykhaniya s mnozhestvennoy i shirokoy lekarstennoy ustoichivostyu vozbuditelya. [Federal clinical recommendations for diagnosis and treatment of respiratory tuberculosis with multiple and extensive drug resistance]. Moscow, 2015.
13. Borisov S.E., Dheda K., Enwerem M. et al. Effectiveness and safety of bedaquiline-containing regimens in the treatment of MDR- and XDR-TB: a multicentre study. Eur. Respir. J., 2017, vol. 49, no. 5, pp. 1700387.
14. Global tuberculosis report 2019 WHO/CDS/TB/2019.15, Geneva, World Health Organization, 2018. 283 p.
15. Guglielmetti L., Jaspard M., Le Du D., Lachatre M., Marigot-Outtandy D., Bernard C., Veziris N., Robert J., Yazdanpanah Y., Caumes E., Frechet-Jachym M. Long-term outcome and safety of prolonged bedaquiline treatment for multidrug-resistant tuberculosis. Eur. Respir. J., 2017, vol. 49, pp. 1601799.
16. Jones J., Mudaly V., Voget J., Naledi T., Maartens G., Cohen K. Adverse drug reactions in South African patients receiving bedaquiline-containing tuberculosis treatment: an evaluation of spontaneously reported cases. BMC Infect. Dis., 2019, vol. 19, no. 1, pp. 544.
17. Kim J.H., Kwon O.J., Kim Y.S., Park M.S., Hwang S., Shim T.S. Bedaquiline in multidrug-resistant tuberculosis treatment: Safety and efficacy in a Korean subpopulation. Respir. Investig., 2020, vol. 58, no. 1, pp. 45-51.
18. Mbuagbaw L., Guglielmetti L., Hewison C. et al. Outcomes of Bedaquiline treatment in patients with multidrug-resistant tuberculosis. Emerg. Infect. Dis., 2019, vol. 25, no. 5, pp. 936-943.
19. O'Donnell M.R., Padayatchi N., Daftary A., Orrell C., Dooley K.E., Rivet Amico K., Friedland G. Antiretroviral switching and bedaquiline treatment of drug-resistant tuberculosis HIV co-infection. Lancet HIV, 2019, vol. 6, no. 3, pp. e201-e204.
20. Pym A.S., Diacon A.H., Tang S.J. et al. Bedaquiline in the treatment of multidrugand extensively drug-resistant tuberculosis. Eur. Respir. J., 2016, vol. 47, no. 2, pp. 564-574.
21. Schnippel K., Ndjeka N., Maartens G. et al. Effect of bedaquiline on mortality in South African patients with drug-resistant tuberculosis: a retrospective cohort study. Lancet Respir. Med., 2018, vol. 6, no. 9, pp. 699-706.
22. World Health Organization. WHO consolidated guidelines on drug-resistant tuberculosis treatment. WHO/CDS/TB/2019.3. Geneva, World Health Organization, 2019. (Epub.), Available at: https://www.who.int/tb/publications/2019/consolidated-guidelines-drug-resistant-TB-treatment/en/ (Accessed 29.05.2020).
23. Wu S., Zhang Y., Sun F. et al. Adverse events associated with the treatment of multidrug resistant tuberculosis: a systematic review and meta-analysis. Am. J. Ther., 2013, (Epub.), Available at: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0061918/ (Accessed 29.05.2020).
24. Zhao Y., Fox T., Manning K. et al. Improved treatment outcomes with Bedaquiline when substituted for second-line injectable agents in multidrug-resistant tuberculosis: a retrospective cohort study. Clin. Infect. Dis., 2019, vol. 68, no. 9, pp. 1522-1529.
Review
For citations:
Stavitskaya N.V., Felker I.G., Zhukova E.M., Tlif А.I., Doktorova N.P., Kudlay D.А. The multivariate analysis of results of bedaquiline use in the therapy of MDR/XDR pulmonary tuberculosis. Tuberculosis and Lung Diseases. 2020;98(7):56-62. (In Russ.) https://doi.org/10.21292/2075-1230-2020-98-7-56-62