Preview

Tuberculosis and Lung Diseases

Advanced search

Experience of using bedaquiline in the treatment of pulmonary tuberculosis patients with multiple drug resistance

Abstract

Safety and efficiency of chemotherapy regimens including the new anti-tuberculosis drug of bedaquiline have been evaluated in 49 patients suffering from pulmonary tuberculosis with multiple and extensive drug resistance. The chemotherapy tolerance monitoring has detected the causality between bedaquiline intake as per Naranjo score in 12.2% of the patients, all reactions were reversible, but the cancellation of the drug was needed in 5 cases out of 6. The efficiency evaluation of six month treatment with bedaquiline showed satisfactory results as per the main efficiency criterion – sputum conversion. Sputum smear conversion was registered in 80.0% of patients, sputum conversion confirmed by culture was registered in 66.7% of patients with cessation or significant reduction of intoxication syndrome – in 83.3% of patients. The positive changes in X-ray were observed in 63.3% of cases, but cavity closure was achieved only in 25% of patients which was due to continuity of the preceding follow-up with the development of expressed fibrosis lesions in the lung tissue of the examined patients. The conclusion was made about satisfactory tolerance and efficiency of the new anti-tuberculosis drug of bedaquiline.

About the Authors

T. I. Morozova
Saratov Regional Clinical TB Dispensary; V. I. Razumovsky Saratov State Medical University
Russian Federation
Saratov


O. N. Otpuschennikova
Saratov Regional Clinical TB Dispensary; V. I. Razumovsky Saratov State Medical University
Russian Federation
Saratov


N. P. Doktorova
Saratov Regional Clinical TB Dispensary; V. I. Razumovsky Saratov State Medical University
Russian Federation
Saratov


A. N. Danilov
Saratov Regional Clinical TB Dispensary
Russian Federation
Saratov


References

1. Borisov S.E., Ivanushkina T.N., Ivanova D.А. et al. Efficiency and safety of six month treatment regimens with bedaquiline in the chemotherapy of respiratory tuberculosis patients. Tub. i Sots. Znach. Zabolevaniya, 2015, no. 3, pp. 30-49. (In Russ.)

2. Use guidelines for Sirturo®. Change no. 1. (In Russ.) LP-002281, 17.07.2015. Available at http://www.grls.rosminzdrav.ru (Accessed as of 10/31/2015).

3. Kasaeva T.Ch., Sterlikov S.А., Son I.M. et al. Otraslevye i ekonomicheskye pokazateli protivotuberkuleznoy raboty v 2012-2013 gg. Analitichesky obzor osnovnykh pokazateley i statisticheskiye materialy. [Economic rates for TB control in 2012-2013. Analysis of main rates and statistic materials.] Ed. by S.A. Sterlikov, Moscow, RIO TsNIIOIZ Publ., 2014, 72 p.

4. Nechaeva O.B. Epidemic situation on  tuberculosis in  the  Russian Federation (main tendencies). Doklad na s»ezde ftiziatrov Rossii, 2015. [Presentation at the Conference of Russian TB Doctors, 2015]. Voronezh, Central Research Institute for Public Health Organization and Informatization, Russian Ministry of Health. website. Available at http://www.mednet.ru/images/stories/files/CMT/epid_situaciya_sezd_ftiziatrov.pdf (Accessed as of 10/31/2015.)

5. Edict no. 951 by RF MoH as of 12.12.2014 On Approval of Guidelines for Improvement of Respiratory Tuberculosis Diagnostics and Treatment. (In Russ.) Moscow, 2014,

6. Federalnye klinicheskiye rekomendatsii po diagnostike i lecheniyu tuberkuleza organov dykhaniya s mnozhestvennoy lekarstennoy ustoichivostyu vozbuditelya. [Federal clinical recommendations for diagnosis and treatment of respiratory tuberculosis with multiple drug resistance]. Moscow, Tver, OOO Izdatelstvo Triada Publ., 2014, 72 p.

7. Briefing package division of anti-infective products office of antimicrobial products CDER, FDA: Sirturo™ (bedaquiline 100 mg tablets) for the treatment of adults (≥ 18 years) as part of combination therapy of pulmonary multi-drug resistant tuberculosis (MDRTB). 2012, 69 p. Available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM329258.pdf. (Accessed as of 10/28/2015).

8. Diacon A.H., M.D., Pym A., Ph.D. et al. Multidrug-resistant tuberculosis and culture conversion with Bedaquiline. N. Engl. J. Med., 2014, vol. 371, pp. 723-732. August 21; 371(8):723-32. doi: 10.1056/NEJMoa1313865.

9. The use of bedaquiline in the treatment of multidrug-resistant tuberculosis. Interim policy guidance (WHO/HTM/TB/2013.6). Geneva, World Health Organization. 2013.


Review

For citations:


Morozova T.I., Otpuschennikova O.N., Doktorova N.P., Danilov A.N. Experience of using bedaquiline in the treatment of pulmonary tuberculosis patients with multiple drug resistance. Tuberculosis and Lung Diseases. 2016;94(2):29-35. (In Russ.)

Views: 7533


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2075-1230 (Print)
ISSN 2542-1506 (Online)