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Volume 25, Number 5—May 2019
Research

Outcomes of Bedaquiline Treatment in Patients with Multidrug-Resistant Tuberculosis

Lawrence MbuagbawComments to Author , Lorenzo Guglielmetti, Catherine Hewison, Nyasha Bakare, Mathieu Bastard, Eric Caumes, Mathilde Fréchet-Jachym, Jérôme Robert, Nicolas Veziris, Naira Khachatryan, Tinatin Kotrikadze, Armen Hayrapetyan, Zaza Avaliani, Holger J. Schünemann, and Christian Lienhardt
Author affiliations: St. Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada (L. Mbuagbaw); Centre for the Development of Best Practices in Health, Yaoundé, Cameroon (L. Mbuagbaw); McMaster University, Hamilton (L. Mbuagbaw, H.J. Schünemann); Centre d'Immunologie et des Maladies Infectieuses, INSERM, Paris (L. Guglielmetti, E. Caumes, J. Robert, N. Veziris); Centre Hospitalier de Bligny, Bris-sous-Forges, France (L. Guglielmetti, M. Fréchet-Jachym); Sorbonne Université, Paris, France (L. Guglielmetti, J. Robert, N. Veziris); Médecins Sans Frontières, Paris (C. Hewison); Janssen Research & Development, LLC, Titusville, New Jersey, USA (N. Bakare); Epicentre, Paris (M. Bastard); Hôpitaux Universitaires de l'Est Parisien, Paris (N. Veziris); Médecins Sans Frontières, Yerevan, Armenia (N. Khachatryan); Médecins Sans Frontières, Tbilisi, Georgia (T. Kotrikadze); National Tuberculosis Control Centre, Yerevan (A. Hayrapetyan); National Centre for Tuberculosis and Lung Disease, Tbilisi (Z. Avaliani); World Health Organization, Geneva, Switzerland (C. Lienhardt); Université de Montpellier, Montpellier, France (C. Lienhardt)

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Table 1

Characteristics of cohorts in study of bedaquiline treatment for multidrug-resistant tuberculosis

Cohort Design Location Sample size Inception date Type of care
Pym 2013 (14)
 Phase II, single-arm open-label trial
 31 sites, 11 countries*
 233
 2009 Aug
 Research
Guglielmetti 2017 (15)
 Retrospective cohort
 France
 45
 2010 Jan
 Expanded access
Ndjeka 2018 (16)
 Prospective cohort
 South Africa
 195
 2013 Mar
 Compassionate use
Hewison 2018 (17)
 Prospective cohort
 Armenia
 62
 2013 Apr
 Compassionate use
Prospective cohort Georgia 30 Compassionate use (20), programmatic use (10)

*China, Estonia, Republic of Korea, Latvia, Peru, Philippines, Russian Federation, South Africa, Thailand, Turkey, Ukraine.

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References
  1. World Health Organization. Global tuberculosis report 2018. 2018 [cited 2018 Dec 11]. https://www.who.int/tb/publications/global_report
  2. World Health Organization. Drug-resistant TB: totally drug-resistant TB FAQ. 2018 [cited 2018 12 Feb]. http://www.who.int/tb/areas-of-work/drug-resistant-tb/totally-drug-resistant-tb-faq
  3. Bonnet  M, Bastard  M, du Cros  P, Khamraev  A, Kimenye  K, Khurkhumal  S, et al. Identification of patients who could benefit from bedaquiline or delamanid: a multisite MDR-TB cohort study. Int J Tuberc Lung Dis. 2016;20:177–86. DOIPubMedGoogle Scholar
  4. Borisov  SE, Dheda  K, Enwerem  M, Romero Leyet  R, D’Ambrosio  L, Centis  R, et al. Effectiveness and safety of bedaquiline-containing regimens in the treatment of MDR- and XDR-TB: a multicentre study. Eur Respir J. 2017;49:1700387. DOIPubMedGoogle Scholar
  5. Falzon  D, Schünemann  HJ, Harausz  E, González-Angulo  L, Lienhardt  C, Jaramillo  E, et al. World Health Organization treatment guidelines for drug-resistant tuberculosis, 2016 update. Eur Respir J. 2017;49:1602308. DOIPubMedGoogle Scholar
  6. World Health Organization. WHO treatment guidelines for multidrug- and rifampicin-resistant tuberculosis 2018 update. 2018 [cited 2019 Jan 15]. https://www.who.int/tb/publications/2018/WHO.2018.MDR-TB.Rx.Guidelines.prefinal.text.pdf
  7. Ahuja  SD, Ashkin  D, Avendano  M, Banerjee  R, Bauer  M, Bayona  JN, et al.; Collaborative Group for Meta-Analysis of Individual Patient Data in MDR-TB. Multidrug resistant pulmonary tuberculosis treatment regimens and patient outcomes: an individual patient data meta-analysis of 9,153 patients. PLoS Med. 2012;9:e1001300. DOIPubMedGoogle Scholar
  8. Nathanson  E, Gupta  R, Huamani  P, Leimane  V, Pasechnikov  AD, Tupasi  TE, et al. Adverse events in the treatment of multidrug-resistant tuberculosis: results from the DOTS-Plus initiative. Int J Tuberc Lung Dis. 2004;8:1382–4.PubMedGoogle Scholar
  9. Diacon  AH, Dawson  R, Von Groote-Bidlingmaier  F, Symons  G, Venter  A, Donald  PR, 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;57:2199–203. DOIPubMedGoogle Scholar
  10. Diacon  AH, Pym  A, Grobusch  MP, de los Rios  JM, Gotuzzo  E, Vasilyeva  I, et al.; TMC207-C208 Study Group. Multidrug-resistant tuberculosis and culture conversion with bedaquiline. N Engl J Med. 2014;371:723–32. DOIPubMedGoogle Scholar
  11. Lu  X, Smare  C, Kambili  C, El Khoury  AC, Wolfson  LJ. Health outcomes of bedaquiline in the treatment of multidrug-resistant tuberculosis in selected high burden countries. BMC Health Serv Res. 2017;17:87. DOIPubMedGoogle Scholar
  12. World Health Organization. The use of bedaquiline in the treatment of multidrug-resistant tuberculosis: interim policy guidance. 2013 [cited 2018 Mar 19]. http://apps.who.int/iris/bitstream/10665/84879/1/9789241505482_eng.pdf
  13. World Health Organization. Report of the Guideline Development Group Meeting on the use of bedaquiline in the treatment of multidrug-resistant tuberculosis 2016 [cited 2018 Mar 19]. http://apps.who.int/iris/bitstream/10665/254712/1/WHO-HTM-TB-2017.01-eng.pdf
  14. Pym  AS, Diacon  AH, Tang  SJ, Conradie  F, Danilovits  M, Chuchottaworn  C, et al.; TMC207-C209 Study Group. Bedaquiline in the treatment of multidrug- and extensively drug-resistant tuberculosis. Eur Respir J. 2016;47:564–74. DOIPubMedGoogle Scholar
  15. Guglielmetti  L, Jaspard  M, Le Dû  D, Lachâtre  M, Marigot-Outtandy  D, Bernard  C, et al.; French MDR-TB Management Group. Long-term outcome and safety of prolonged bedaquiline treatment for multidrug-resistant tuberculosis. Eur Respir J. 2017;49:1601799. DOIPubMedGoogle Scholar
  16. Ndjeka  N, Schnippel  K, Master  I, Meintjes  G, Maartens  G, Romero  R, et al. High treatment success rate for multidrug-resistant and extensively drug-resistant tuberculosis using a bedaquiline-containing treatment regimen. Eur Respir J. 2018;52:1801528. DOIPubMedGoogle Scholar
  17. Hewison  C, Bastard  M, Khachatryan  N, Kotrikadze  T, Hayrapetyan  A, Avaliani  Z, et al. Is 6 months of bedaquiline enough? Results from the compassionate use of bedaquiline in Armenia and Georgia. Int J Tuberc Lung Dis. 2018;22:766–72. DOIPubMedGoogle Scholar
  18. Vandenberk  B, Vandael  E, Robyns  T, Vandenberghe  J, Garweg  C, Foulon  V, et al. Which QT correction formulae to use for QT monitoring? J Am Heart Assoc. 2016;5:e003264. DOIPubMedGoogle Scholar
  19. World Health Organization. Companion handbook to the 2011 WHO guidelines for the programmatic management of drug-resistant tuberculosis. 2014 [cited 2018 Mar 16]. http://www.who.int/tb/publications/pmdt_companionhandbook/
  20. US Food and Drug Administration. Code of Federal Regulations Title 21. 2017 [cited 2018 Mar 16]. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.32
  21. Ali  MK, Karanja  S, Karama  M. Factors associated with tuberculosis treatment outcomes among tuberculosis patients attending tuberculosis treatment centres in 2016-2017 in Mogadishu, Somalia. Pan Afr Med J. 2017;28:197.PubMedGoogle Scholar
  22. Guglielmetti  L, Le Dû  D, Jachym  M, Henry  B, Martin  D, Caumes  E, et al.; MDR-TB Management Group of the French National Reference Center for Mycobacteria and the Physicians of the French MDR-TB Cohort. Compassionate use of bedaquiline for the treatment of multidrug-resistant and extensively drug-resistant tuberculosis: interim analysis of a French cohort. Clin Infect Dis. 2015;60:188–94. DOIPubMedGoogle Scholar
  23. Guyatt  G, Oxman  AD, Akl  EA, Kunz  R, Vist  G, Brozek  J, et al. GRADE guidelines: 1. Introduction-GRADE evidence profiles and summary of findings tables. J Clin Epidemiol. 2011;64:383–94. DOIPubMedGoogle Scholar
  24. Cegielski  JP, Kurbatova  E, van der Walt  M, Brand  J, Ershova  J, Tupasi  T, et al.; Global PETTS Investigators. Multidrug-resistant tuberculosis treatment outcomes in relation to treatment and initial versus acquired second-line drug resistance. Clin Infect Dis. 2016;62:418–30.PubMedGoogle Scholar
  25. Schnippel  K, Ndjeka  N, Maartens  G, Meintjes  G, Master  I, Ismail  N, et al. Effect of bedaquiline on mortality in South African patients with drug-resistant tuberculosis: a retrospective cohort study. Lancet Respir Med. 2018;6:699–706. DOIPubMedGoogle Scholar
  26. Zhao  Y, Fox  T, Manning  K, Stewart  A, Tiffin  N, Khomo  N, 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. 2018 Aug 24 [Epub ahead of print].
  27. Ahmad  N, Ahuja  SD, Akkerman  OW, Alffenaar  JC, Anderson  LF, Baghaei  P, et al.; Collaborative Group for the Meta-Analysis of Individual Patient Data in MDR-TB treatment–2017. Treatment correlates of successful outcomes in pulmonary multidrug-resistant tuberculosis: an individual patient data meta-analysis. Lancet. 2018;392:821–34. DOIPubMedGoogle Scholar
  28. Guglielmetti  L, Tiberi  S, Burman  M, Kunst  H, Wejse  C, Togonidze  T, et al.; TBnet; of the TBnet QTc survey. QT prolongation and cardiac toxicity of new tuberculosis drugs in Europe: a Tuberculosis Network European Trialsgroup (TBnet) study. Eur Respir J. 2018;52:1800537. DOIPubMedGoogle Scholar
  29. Skrahina  A, Hurevich  H, Falzon  D, Zhilevich  L, Rusovich  V, Dara  M, et al. Bedaquiline in the multidrug-resistant tuberculosis treatment: Belarus experience. Int J Mycobacteriol. 2016;5(Suppl 1):S62–3. DOIPubMedGoogle Scholar
  30. Olaru  ID, Heyckendorf  J, Andres  S, Kalsdorf  B, Lange  C. Bedaquiline-based treatment regimen for multidrug-resistant tuberculosis. Eur Respir J. 2017;49:1700742. DOIPubMedGoogle Scholar
  31. World Health Organization. WHO best-practice statement on the off-label use of bedaquiline and delamanid for the treatment of multidrug-resistant tuberculosis. 2017 [cited 2018 May 28]. http://apps.who.int/iris/bitstream/handle/10665/258941/WHO-HTM-TB-2017.20-eng.pdf
  32. Higgins  JPT, Thompson  SG, Deeks  JJ, Altman  DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557–60. DOIPubMedGoogle Scholar

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Page created: April 18, 2019
Page updated: April 18, 2019
Page reviewed: April 18, 2019
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