Tuberc Respir Dis.  2017 Oct;80(4):336-343. 10.4046/trd.2017.0049.

WHO Treatment Guidelines for Drug-Resistant Tuberculosis, 2016 Update: Applicability in South Korea

• Jeon D

• KMID: 2420575
• DOI: http://doi.org/10.4046/trd.2017.0049

Abstract

Despite progress made in tuberculosis control worldwide, the disease burden and treatment outcome of multidrug-resistant tuberculosis (MDR-TB) patients have remained virtually unchanged. In 2016, the World Health Organization released new guidelines for the management of MDR-TB. The guidelines are intended to improve detection rate and treatment outcome for MDR-TB through novel, rapid molecular testing and shorter treatment regimens. Key changes include the introduction of a new, shorter MDR-TB treatment regimen, a new classification of medicines and updated recommendations for the conventional MDR-TB regimen. This paper will review these key changes and discuss the potential issues with regard to the implementation of these guidelines in South Korea.

Keyword

Tuberculosis; Tuberculosis, Multidrug-Resistant; World Health Organization; Guideline

MeSH Terms

Classification
Humans
Korea*
Treatment Outcome
Tuberculosis
Tuberculosis, Multidrug-Resistant*
World Health Organization

Reference

1. World Health Organization. Global tuberculosis report 2016. WHO/HTM/TB/2016.13 [Internet]. Geneva: World Health Organization;2016. cited 2017 May 1. Available from: http://www.who.int/tb/publications/global_report/en.

2. Bai GH, Park YK, Choi YW, Bai JI, Kim HJ, Chang CL, et al. Trend of anti-tuberculosis drug resistance in Korea, 1994–2004. Int J Tuberc Lung Dis. 2007; 11:571–576.

3. Park YS, Hong SJ, Boo YK, Hwang ES, Kim HJ, Cho SH, et al. The national status of tuberculosis using nationwide medical records survey of patients with tuberculosis in Korea. Tuberc Respir Dis. 2012; 73:48–55.

4. Korea Centers for Disease Control & Prevention. Annual report on the notified tuberculosis patients in Korea 2016 [Internet]. Cheongju: Korea Centers for Disease Control & Prevention;2017. cited 2017 May 1. Available from: http://tbzero.cdc.go.kr.

5. Kim HJ, Hong YP, Kim SJ, Lew WJ, Lee EG. Ambulatory treatment of multidrug-resistant pulmonary tuberculosis patients at a chest clinic. Int J Tuberc Lung Dis. 2001; 5:1129–1136.

6. Park SK, Lee WC, Lee DH, Mitnick CD, Han L, Seung KJ. Self-administered, standardized regimens for multidrug-resistant tuberculosis in South Korea. Int J Tuberc Lung Dis. 2004; 8:361–368.

7. Kim HR, Hwang SS, Kim HJ, Lee SM, Yoo CG, Kim YW, et al. Impact of extensive drug resistance on treatment outcomes in non-HIV-infected patients with multidrug-resistant tuberculosis. Clin Infect Dis. 2007; 45:1290–1295.

8. Kwon YS, Kim YH, Suh GY, Chung MP, Kim H, Kwon OJ, et al. Treatment outcomes for HIV-uninfected patients with multidrug-resistant and extensively drug-resistant tuberculosis. Clin Infect Dis. 2008; 47:496–502.

9. Kim DH, Kim HJ, Park SK, Kong SJ, Kim YS, Kim TH, et al. Treatment outcomes and long-term survival in patients with extensively drug-resistant tuberculosis. Am J Respir Crit Care Med. 2008; 178:1075–1082.

10. Park JK, Koh WJ, Kim DK, Kim EK, Kim YI, Kim HJ, et al. Treatment outcomes and prognostic factors in patients with multidrug-resistant tuberculosis in Korean private hospitals. Tuberc Respir Dis. 2010; 69:95–102.

11. Jeon DS, Shin DO, Park SK, Seo JE, Seo HS, Cho YS, et al. Treatment outcome and mortality among patients with multidrug-resistant tuberculosis in tuberculosis hospitals of the public sector. J Korean Med Sci. 2011; 26:33–41.

12. Kwak N, Kim HR, Yoo CG, Kim YW, Han SK, Yim JJ. Changes in treatment outcomes of multidrug-resistant tuberculosis. Int J Tuberc Lung Dis. 2015; 19:525–530.

13. Jeong BH, Jeon K, Park HY, Kwon OJ, Lee KS, Kim HK, et al. Outcomes of pulmonary MDR-TB: impacts of fluoroquinolone resistance and linezolid treatment. J Antimicrob Chemother. 2015; 70:3127–3133.

14. Kang YA, Shim TS, Koh WJ, Lee SH, Lee CH, Choi JC, et al. Choice between levofloxacin and moxifloxacin and multidrug-resistant tuberculosis treatment outcomes. Ann Am Thorac Soc. 2016; 13:364–370.

15. World Health Organization. WHO treatment guidelines for drug-resistant tuberculosis, 2016 update. WHO/HTM/TB/2016.04 [Internet]. Geneva: World Health Organization;2016. cited 2017 May 1. Available from: http://www.who.int/tb/areas-of-work/drug-resistant-tb/treatment/resources/en/.

16. World Health Organization. Guidelines for the programmatic management of drug-resistant tuberculosis. WHO/HTM/TB/2006.361 [Internet]. Geneva: World Health Organization;2016. cited 2017 May 1. Available from: http://www.who.int/tb/areas-of-work/drug-resistant-tb/programmatic_guidelines_for_mdrtb/en/.

17. World Health Organization. Guidelines for the programmatic management of drug-resistant tuberculosis, emergency update 2008. WHO/HTM/TB/2008.402 [Internet]. Geneva: World Health Organization;2008. cited 2017 May 1. Available from: http://www.who.int/tb/publications/tb-drugresistance-guideline/en/.

18. World Health Organization. Guidelines for the programmatic management of drug-resistant tuberculosis: 2011 update. WHO/HTM/TB/2011.6 [Internet]. Geneva: World Health Organization;2011. cited 2017 May 1. Available from: http://www.who.int/tb/areas-of-work/drug-resistant-tb/programmatic_guidelines_for_mdrtb/en/.

19. Jeon D. Medical management of drug-resistant tuberculosis. Tuberc Respir Dis. 2015; 78:168–174.

20. Park JS. Issues related to the updated 2014 Korean guidelines for tuberculosis. Tuberc Respir Dis. 2016; 79:1–4.

21. World Health Organization. Companion handbook to the WHO guidelines for the programmatic management of drug-resistant tuberculosis. WHO/HTM/TB/2014.11 [Internet]. Geneva: World Health Organization;2014. cited 2017 May 1. Available from: http://www.who.int/tb/publications/pmdt_companionhandbook/en/.

22. Johnston JC, Shahidi NC, Sadatsafavi M, Fitzgerald JM. Treatment outcomes of multidrug-resistant tuberculosis: a systematic review and meta-analysis. PLoS One. 2009; 4:e6914.

23. Kim DH, Kim HJ, Park SK, Kong SJ, Kim YS, Kim TH, et al. Treatment outcomes and survival based on drug resistance patterns in multidrug-resistant tuberculosis. Am J Respir Crit Care Med. 2010; 182:113–119.

24. Ahuja SD, Ashkin D, Avendano M, Banerjee R, Bauer M, Bayona JN, et al. Multidrug resistant pulmonary tuberculosis treatment regimens and patient outcomes: an individual patient data meta-analysis of 9,153 patients. PLoS Med. 2012; 9:e1001300.

25. Falzon D, Gandhi N, Migliori GB, Sotgiu G, Cox HS, Holtz TH, et al. Resistance to fluoroquinolones and second-line injectable drugs: impact on multidrug-resistant TB outcomes. Eur Respir J. 2013; 42:156–168.

26. Cox H, Ford N. Linezolid for the treatment of complicated drug-resistant tuberculosis: a systematic review and meta-analysis. Int J Tuberc Lung Dis. 2012; 16:447–454.

27. Sotgiu G, Centis R, D’Ambrosio L, Alffenaar JW, Anger HA, Caminero JA, et al. Efficacy, safety and tolerability of linezolid containing regimens in treating MDR-TB and XDR-TB: systematic review and meta-analysis. Eur Respir J. 2012; 40:1430–1442.

28. Lee M, Lee J, Carroll MW, Choi H, Min S, Song T, et al. Linezolid for treatment of chronic extensively drug-resistant tuberculosis. N Engl J Med. 2012; 367:1508–1518.

29. Lee M, Cho SN, Barry CE 3rd, Song T, Kim Y, Jeong I. Linezolid for XDR-TB: final study outcomes. N Engl J Med. 2015; 373:290–291.

30. Tang S, Yao L, Hao X, Zhang X, Liu G, Liu X, et al. Efficacy, safety and tolerability of linezolid for the treatment of XDR-TB: a study in China. Eur Respir J. 2015; 45:161–170.

31. Dey T, Brigden G, Cox H, Shubber Z, Cooke G, Ford N. Outcomes of clofazimine for the treatment of drug-resistant tuberculosis: a systematic review and meta-analysis. J Antimicrob Chemother. 2013; 68:284–293.

32. Gopal M, Padayatchi N, Metcalfe JZ, O’Donnell MR. Systematic review of clofazimine for the treatment of drug-resistant tuberculosis. Int J Tuberc Lung Dis. 2013; 17:1001–1007.

33. Chang KC, Yew WW, Tam CM, Leung CC. WHO group 5 drugs and difficult multidrug-resistant tuberculosis: a systematic review with cohort analysis and meta-analysis. Antimicrob Agents Chemother. 2013; 57:4097–4104.

34. Tang S, Yao L, Hao X, Liu Y, Zeng L, Liu G, et al. Clofazimine for the treatment of multidrug-resistant tuberculosis: prospective, multicenter, randomized controlled study in China. Clin Infect Dis. 2015; 60:1361–1367.

35. World Health Organization. The use of bedaquiline in the treatment of multidrug-resistant tuberculosis: interim policy guidance. WHO/HTM/TB/2013.6 [Internet]. Geneva: World Health Organization;2013. cited 2017 May 1. Available from: http://www.who.int/tb/publications/tb-drugresistance-guideline/en/.

36. World Health Organization. The use of delamanid in the treatment of multidrug-resistant tuberculosis: interim policy guidance. WHO/HTM/TB/2014.23 [Internet]. Geneva: World Health Organization;2014. cited 2017 May 1. Available from: http://www.who.int/tb/publications/tb-drugresistance-guideline/en/.

37. Caminero JA, Scardigli A. Classification of antituberculosis drugs: a new proposal based on the most recent evidence. Eur Respir J. 2015; 46:887–893.

38. endTB clinical and programmatic guide for patient management with new TB drugs. Version 3.3, 24/10/2016 [Internet]. endTB;2016. cited 2017 May 1. Available from: http://www.endtb.org/resources/endtb-clinical-guide-v33.

39. Joint Committee for the Revision of Korean Guidelines for Tuberculosis, Korean Centers for Disease Control and Prevention. Korean guidelines for tuberculosis. 3rd ed. Seoul and Cheongwon: Joint Committee for the Revision of Korean Guidelines for Tuberculosis, Korea Centers for Disease Control and Prevention;2017.

40. Chang KC, Leung CC, Yew WW, Leung EC, Leung WM, Tam CM, et al. Pyrazinamide may improve fluoroquinolone-based treatment of multidrug-resistant tuberculosis. Antimicrob Agents Chemother. 2012; 56:5465–5475.

41. Franke MF, Becerra MC, Tierney DB, Rich ML, Bonilla C, Bayona J, et al. Counting pyrazinamide in regimens for multidrug-resistant tuberculosis. Ann Am Thorac Soc. 2015; 12:674–679.

42. Mitnick CD, Franke MF, Rich ML, Alcantara Viru FA, Appleton SC, Atwood SS, et al. Aggressive regimens for multidrug-resistant tuberculosis decrease all-cause mortality. PLoS One. 2013; 8:e58664.

43. Franke MF, Appleton SC, Mitnick CD, Furin JJ, Bayona J, Chalco K, et al. Aggressive regimens for multidrug-resistant tuberculosis reduce recurrence. Clin Infect Dis. 2013; 56:770–776.

44. Velasquez GE, Becerra MC, Gelmanova IY, Pasechnikov AD, Yedilbayev A, Shin SS, et al. Improving outcomes for multidrug-resistant tuberculosis: aggressive regimens prevent treatment failure and death. Clin Infect Dis. 2014; 59:9–15.

45. Yuen CM, Kurbatova EV, Tupasi T, Caoili JC, Van Der Walt M, Kvasnovsky C, et al. Association between regimen composition and treatment response in patients with multidrug-resistant tuberculosis: a prospective cohort study. PLoS Med. 2015; 12:e1001932.

46. Ahmad Khan F, Gelmanova IY, Franke MF, Atwood S, Zemlyanaya NA, Unakova IA, et al. Aggressive regimens reduce risk of recurrence after successful treatment of MDR-TB. Clin Infect Dis. 2016; 63:214–220.

47. Van Deun A, Maug AK, Salim MA, Das PK, Sarker MR, Daru P, et al. Short, highly effective, and inexpensive standardized treatment of multidrug-resistant tuberculosis. Am J Respir Crit Care Med. 2010; 182:684–692.

48. Aung KJ, Van Deun A, Declercq E, Sarker MR, Das PK, Hossain MA, et al. Successful ‘9-month Bangladesh regimen’ for multidrug-resistant tuberculosis among over 500 consecutive patients. Int J Tuberc Lung Dis. 2014; 18:1180–1187.

49. Piubello A, Harouna SH, Souleymane MB, Boukary I, Morou S, Daouda M, et al. High cure rate with standardised short-course multidrug-resistant tuberculosis treatment in Niger: no relapses. Int J Tuberc Lung Dis. 2014; 18:1188–1194.

50. Kuaban C, Noeske J, Rieder HL, Ait-Khaled N, Abena Foe JL, Trebucq A. High effectiveness of a 12-month regimen for MDR-TB patients in Cameroon. Int J Tuberc Lung Dis. 2015; 19:517–524.

51. World Health Organization. Frequently asked questions about the implementation of the new WHO recommendation on the use of the shorter MDR-TB regimen under programmatic conditions. Version: 20 December 2016 [Internet]. Geneva: World Health Organization;2016. cited 2017 May 1. Available from: http://www.who.int/tb/areas-of-work/drug-resistant-tb/treatment/resources/en/.

52. World Health Organization. Policy guidance on the molecular second-line line-probe assay. WHO/HTM/TB/2016.07 [Internet]. Geneva: World Health Organization;2016. cited 2017 May 1. Available from: http://www.who.int/tb/areas-of-work/drug-resistant-tb/treatment/resources/en/.

53. Mok JH, Kang BH, Lee T, Lee HK, Jang HJ, Cho YJ, et al. Additional drug resistance patterns among multidrug-resistant tuberculosis patients in Korea: implications for regimen design. J Korean Med Sci. 2017; 32:636–641.

54. Jeong HY, Kim H, Kwon S, Ryoo S. Evaluation of the GenoType(R) MTBDRsl assay in Korean patients with MDR or XDR tuberculosis. Infect Dis (Lond). 2016; 48:361–366.

55. Kim SC, Jeon BY, Kim JS, Choi IH, Kim J, Woo J, et al. Performance of the BacT Alert 3D System versus solid media for recovery and drug susceptibility testing of Mycobacterium tuberculosis in a tertiary hospital in Korea. Tuberc Respir Dis. 2016; 79:282–288.

56. Heysell SK, Moore JL, Peloquin CA, Ashkin D, Houpt ER. Outcomes and use of therapeutic drug monitoring in multidrug-resistant tuberculosis patients treated in virginia, 2009–2014. Tuberc Respir Dis. 2015; 78:78–84.

57. Sotgiu G, Tiberi S, D’Ambrosio L, Centis R, Alffenaar JW, Caminero JA, et al. Faster for less: the new “shorter” regimen for multidrug-resistant tuberculosis. Eur Respir J. 2016; 48:1503–1507.

58. Lange C, Duarte R, Frechet-Jachym M, Guenther G, Guglielmetti L, Olaru ID, et al. Limited benefit of the new shorter multidrug-resistant tuberculosis regimen in Europe. Am J Respir Crit Care Med. 2016; 194:1029–1031.