BEDAKVILIN – NEW ANTITUBERCULAR MEDICATION
Abstract
The main farmacologic data of bedaquiline, a novel oral diarylquinoline antimycobacterial agent are reviewed. Bedaquiline’s efficacy and safety, expected adverse events and proposal preventive measures are considered according to results of phase II clinical trials. The conditions for inclusion of the drug in the combination therapy of pulmonary tuberculosis are listed in accordance with the existing WHO Guidelines; these conditions are planned to release in Moscow.
About the Authors
S. E. Borisov
ГКУЗ «Московский городской научно-практический центр борьбы с туберкулезом Департамента здравоохранения города Москвы»
Russian Federation
Russian Federation
D. A. Ivanova
ГКУЗ «Московский городской научно-практический центр борьбы с туберкулезом Департамента здравоохранения города Москвы»
Russian Federation
Russian Federation
References
1. Инструкция по применению лекарственного препарата (Сиртуро). − URL:http://arvt.ru/sites/default/files/Bedaquiline_trade_name_SirturoOCR.pdf
2. Мишин В. Ю., Чуканов В. И., Григорьев Ю. Г. Побочное действие противотуберкулезных препаратов при стандартных и индивидуализированных режимах химиотерапии. − М.: Компьютербург, 2004. – 208 с.
3. Туберкулез в Российской Федерации 2011 г. Аналитический обзор статистических показателей, используемых в Российской Федерации. − М., 2012. – 280 с.
4. A study to evaluate the efficacy and safety of TMC207 in patients with pulmonary infection with multi-drug resistant Мycobacterium tuberculosis. − 2014. − URL: ClinicalTrials.gov Identifier: NCT01600963.
5. Andries K., Verhasselt P., Guillemont J. et al. R207910, a diarylquinoline active on ATP synthase of Mycobacterium tuberculosis // Science. − 2005. − № 307. − Р. 223-227.
6. 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. − URL: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM329258.pdf.
7. Chahine E. B., Karaoui L. R., Mansour H. Bedaquiline: a novel diarylquinoline for multidrug-resistant tuberculosis // Ann. Pharmacother. − 2014. − Vol. 48. − N. 1. – P. 107-115.
8. Chan B., Khadem T. M., Brown J. A review of tuberculosis: Focus on bedaquiline // Am. J. Health Syst. Pharm. − 2013. − Vol. 70. − N. 22. − P. 84-94.
9. Diacon A. H., Donald P. R., Pym A. et al. Randomized pilot trial of eight weeks of Bedaquiline (TMC207) treatment for multidrug-resistant tuberculosis: longterm outcome, tolerability, and effect on emergence of drug resistance // Antimicrob. Agents Chemother. − 2012. − Vol. 56. − N. 6. − P. 3271–3276.
10. Diacon A. H., Dawson R., Von Groote-Bidlingmajer F. et al. Randomized dose-ranging study of the 14-day early bactericidal activity of bedaquiline (TMC207) in patients with sputum microscopy smear-positive pulmonary tuberculosis //Antimicrob Agents Chemother. − 2013. − Vol. 57. − N. 5. − P. 2199–2203.
11. Global tuberculosis report 2013 . – Geneva, World Health Organization, 2013. − URL: http://www.who.int/tb/publications/global_report/en/index.html.
12. Lenaerts A. J., Hoff D., Aly S. et al. Location of persisting mycobacteria in a Guinea pig model of tuberculosis revealed by r207910 // Antimicrob. Agents Chemother. − 2007. − Vol. 51. − P. 3338-3345.
13. Mase S., Chorba T., Lobue P., Castro K. Provisional CDC guidelines for the use and safety monitoring of bedaquiline fumarate (Sirturo) for the treatment of multidrug-resistant tuberculosis //MMWR Recomm Rep. − 2013. − Vol. 62 (RR-09). − P. 1-12.
14. Rouan M. C., Lounis N., Gevers T. et al. Pharmacokinetics and pharmacodynamics of TMC207 and its N-desmethyl metabolite in a murine model of tuberculosis // Antimicrob. Agents Chemother. − 2012. − Vol. 56. – P. 1444–1451.
15. Rustomjee R., Diacon A. H., Allen J. et al. Early bactericidal activity and pharmacokinetics of the diarylquinoline TMC207 in treatment of pulmonary tuberculosis // Antimicrob. Agents Chemother. − 2008. − Vol. 52. − P. 2831–2835.
16. The use of bedaquiline in the treatment of multidrug-resistant tuberculosis: interim policy guidance. – Geneva: World Health Organization; 2013. − 57 p.
17. To evaluate the safety, tolerability, and efficacy of TMC207 as part of an individualized multi-drug resistant tuberculosis (MDR-TB) treatment regimen in participants with sputum smear-positive pulmonary MDR-TB. − 2014. − URL: http://clinicaltrials.gov/ct2/show/results/NCT00910871?term=bedaquiline&rank=10.
Review
For citations:
Borisov S.E., Ivanova D.A. BEDAKVILIN – NEW ANTITUBERCULAR MEDICATION. Tuberculosis and socially significant diseases. 2014;(1-2):44-51. (In Russ.)
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