World Health Organization treatment guidelines for drug-resistant tuberculosis, 2016 update

European Respiratory Journal

Volumn 49, Issue 3, 2017, Pages

  Falzon, Dennis ^a   Schünemann, Holger J ^b   Harausz, Elizabeth ^c   González Angulo, Licé ^a   Lienhardt, Christian ^a   Jaramillo, Ernesto ^a   Weyer, Karin ^a  

^a WORLD HEALTH ORGANIZATION   (Switzerland)

^b HAMILTON HEALTH SCIENCES   (Canada)

^c WALTER REED ARMY INSTITUTE OF RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMIKACIN; AMINOSALICYLIC ACID; AMOXICILLIN PLUS CLAVULANIC ACID; BEDAQUILINE; CAPREOMYCIN; CILASTATIN; CLOFAZIMINE; CYCLOSERINE; DELAMANID; ETHAMBUTOL; ETHIONAMIDE; GATIFLOXACIN; IMIPENEM; ISONIAZID; KANAMYCIN; LEVOFLOXACIN; LINEZOLID; MEROPENEM; MOXIFLOXACIN; PROTIONAMIDE; PYRAZINAMIDE; RIFAMPICIN; STREPTOMYCIN; TERIZIDONE; THIOACETAZONE; TUBERCULOSTATIC AGENT;

ANTIBIOTIC RESISTANCE; ARTICLE; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DISEASE SEVERITY; DRUG SAFETY; HEALTH CARE POLICY; HUMAN; LUNG LOBECTOMY; LUNG RESECTION; MEDICATION COMPLIANCE; MORTALITY RATE; MULTIDRUG RESISTANT TUBERCULOSIS; MYCOBACTERIUM TUBERCULOSIS; PRACTICE GUIDELINE; PRIORITY JOURNAL; RELAPSE; SURVIVAL RATE; TREATMENT DURATION; TREATMENT FAILURE; WEDGE RESECTION; WORLD HEALTH ORGANIZATION; DISEASE MANAGEMENT; DRUG ADMINISTRATION; ISOLATION AND PURIFICATION;

ANTITUBERCULAR AGENTS; DISEASE MANAGEMENT; DRUG ADMINISTRATION SCHEDULE; HUMANS; MYCOBACTERIUM TUBERCULOSIS; PRACTICE GUIDELINES AS TOPIC; RIFAMPIN; TUBERCULOSIS, MULTIDRUG-RESISTANT; WORLD HEALTH ORGANIZATION;

EID: 85015613521     PISSN: 09031936     EISSN: 13993003     Source Type: Journal    
DOI: 10.1183/13993003.02308-2016     Document Type: Article

References (67)

1. General Assembly of the United Nations. High-level meeting on antimicrobial resistance. 2016. www.un.org/pga/71/2016/09/21/press-release-hl-meeting-on-antimicrobial-resistance Date last accessed: November 7, 2016.
2. Zignol M, Dean AS, Falzon D, et al. Twenty years of global surveillance of antituberculosis-drug resistance. N Engl J Med 2016; 375: 1081–1089.
3. Wright A, Zignol M, Van Deun A, et al. Epidemiology of antituberculosis drug resistance 2002–07: an updated analysis of the Global Project on Anti-Tuberculosis Drug Resistance Surveillance. Lancet 2009; 373: 1861–1873.
4. WHO. Guidelines for treatment of tuberculosis. 4th edn (WHO/HTM/TB/2009.420). 2009. http://whqlibdoc.who.int/publications/2010/9789241547833_eng.pdf Date last accessed: November 7, 2016.
5. Falzon D, Jaramillo E, Schünemann HJ, et al. WHO guidelines for the programmatic management of drug-resistant tuberculosis: 2011 update. Eur Respir J 2011; 38: 516–528.
6. WHO. Global tuberculosis report 2016 (WHO/HTM/TB/2016.13). 2016. www.who.int/tb/publications/global_report/en/ Date last accessed: November 7, 2016.
7. Falzon D, Mirzayev F, Wares F, et al. Multidrug-resistant tuberculosis around the world: what progress has been made? Eur Respir J 2015; 45: 150–160.
8. Médecins Sans Frontières, Stop TB Partnership. Out of Step 2015. TB Policies in 24 Countries. A survey of diagnostic and treatment practices. 2015. www.msfaccess.org/sites/default/files/MSF_assets/TB/Docs/TB_report_Out_of_Step_ENG_2015.pdf Date last accessed: November 7, 2016.
9. WHO. Towards universal access to diagnosis and treatment of multidrug-resistant and extensively drug-resistant tuberculosis by 2015. WHO progress report 2011 (WHO/HTM/TB/2011.3). 2011. http://whqlibdoc.who.int/publications/2011/9789241501330_eng.pdf Date last accessed: November 7, 2016.
10. Dye C, Williams BG, Espinal MA, et al. Erasing the world’s slow stain: strategies to beat multidrug-resistant tuberculosis. Science 2002; 295: 2042–2046.
11. WHO. Resolution WHA62.15. Prevention and control of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis. (WHA62/2009/REC/1). 2009. http://apps.who.int/gb/ebwha/pdf_files/WHA62-REC1/WHA62_REC1-en.pdf Date last accessed: November 7, 2016.
12. Uplekar M, Weil D, Lönnroth K, et al. WHO’s new end TB strategy. Lancet 2015; 385: 1799–1801.
13. WHO. Guidelines for the management of drug-resistant tuberculosis (WHO/TB/96.210 (Rev.1)). 1997. http://apps.who.int/iris/bitstream/10665/63465/1/WHO_TB_96.210_%28Rev.1%29.pdf Date last accessed: November 7, 2016.
14. WHO. Guidelines for establishing DOTS-Plus pilot projects for the management of multidrug-resistant tuberculosis (MDR-TB) (WHO/CDS/TB/2000.279). 2000. http://apps.who.int/iris/bitstream/10665/66368/1/WHO_CDS_TB_2000.279_eng.pdf Date last accessed: November 7, 2016.
15. WHO. Guidelines for the programmatic management of drug-resistant tuberculosis. 1st edn (WHO/HTM/TB/ 2006.361). 2006. http://apps.who.int/iris/bitstream/10665/246249/2/9789241546959-eng.pdf Date last accessed: November 7, 2016.
16. WHO. Policy guidance on drug susceptibility testing (DST) of second-line anti-tuberculosis drugs (WHO/HTM/ TB/2008.392). 2008. http://whqlibdoc.who.int/hq/2008/WHO_HTM_TB_2008.392_eng.pdf Date last accessed: November 7, 2016.
17. WHO. Guidelines for the programmatic management of drug-resistant tuberculosis, Emergency update 2008 (WHO/HTM/TB/2008.402). 2008. http://whqlibdoc.who.int/publications/2008/9789241547581_eng.pdf Date last accessed: November 7, 2016.
18. WHO. Guidelines for the programmatic management of drug-resistant tuberculosis, 2011 Update (WHO/HTM/ TB/2011.6). 2011. http://whqlibdoc.who.int/publications/2011/9789241501583_eng.pdf Date last accessed: November 7, 2016.
19. WHO. Rapid implementation of the Xpert MTB/RIF diagnostic test: technical and operational ‘How-to’; practical considerations. 2011. whqlibdoc.who.int/publications/2011/9789241501569_eng.pdf Date last accessed: November 7, 2016.
20. WHO. The use of bedaquiline in the treatment of multidrug-resistant tuberculosis. Interim policy guidance (WHO/HTM/TB/2013.6). 2013. http://apps.who.int/iris/bitstream/10665/84879/1/9789241505482_eng.pdf Date last accessed: November 7, 2016.
21. WHO. The use of delamanid in the treatment of multidrug-resistant tuberculosis. Interim policy guidance (WHO/ HTM/TB/2014.23). 2014. http://apps.who.int/iris/bitstream/10665/137334/1/WHO_HTM_TB_2014.23_eng.pdf Date last accessed: November 7, 2016.
22. WHO. Automated real-time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF assay for the diagnosis of pulmonary and extrapulmonary TB in adults and children. Policy update (WHO/HTM/TB/2013.16). 2013. http://apps.who.int/iris/bitstream/10665/112472/1/9789241506335_eng.pdf Date last accessed: November 7, 2016.
23. WHO. Companion handbook to the WHO guidelines for the programmatic management of drug-resistant tuberculosis (WHO/HTM/TB/2014.11). 2015. http://apps.who.int/iris/bitstream/10665/130918/1/9789241548809_eng.pdf Date last accessed: November 7, 2016.
24. WHO. Xpert MTB/RIF implementation manual: technical and operational ‘How-to’; practical considerations (WHO/HTM/TB/2014.1). 2014. http://apps.who.int/iris/bitstream/10665/112469/1/9789241506700_eng.pdf Date last accessed: November 7, 2016.
25. WHO. WHO treatment guidelines for drug-resistant tuberculosis, 2016 update (WHO/HTM/TB/2016.04). 2016. www.who.int/tb/areas-of-work/drug-resistant-tb/treatment/resources/en/ Date last accessed: November 7, 2016.
26. WHO. Implementing tuberculosis diagnostics: a policy framework (WHO/HTM/TB/2015.11). 2015. http://apps.who.int/iris/bitstream/10665/162712/1/9789241508612_eng.pdf Date last accessed: November 7, 2016.
27. WHO. The use of delamanid in the treatment of multidrug-resistant tuberculosis in children and adolescents. Interim policy guidance (WHO/HTM/TB/2016.14). 2016. http://apps.who.int/iris/bitstream/10665/250614/1/9789241549899-eng.pdf Date last accessed: November 7, 2016.
28. WHO. The use of molecular line probe assays for the detection of resistance to second-line anti-tuberculosis drugs. Policy guidance (WHO/HTM/TB/2016.07). 2016. www.who.int/tb/publications/lpa-mdr-diagnostics/en/ Date last accessed: November 7, 2016.
29. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008; 336: 924–926.
30. WHO. WHO handbook for guideline development. 2nd edn. 2014. http://apps.who.int/medicinedocs/documents/s22083en/s22083en.pdf Date last accessed: November 7, 2016.
31. Guyatt G, Oxman AD, Akl EA, et al. GRADE guidelines: 1. Introduction – GRADE evidence profiles and summary of findings tables. J Clin Epidemiol 2011; 64: 383–394.
32. Schünemann HJ, Wiercioch W, Etxeandia I, et al. Guidelines 2.0: systematic development of a comprehensive checklist for a successful guideline enterprise. CMAJ 2014; 186: E123–E142.
33. WHO. Guideline Development Group (GDG) Meetings: revision of the interim policy on bedaquiline for MDR-TB treatment and special session on delamanid use in children. 2016. www.who.int/tb/areas-of-work/treatment/gdg_bedaquiline_delamanid/en/ Date last accessed: November 7, 2016.
34. The Cochrane Collaboration. Cochrane Handbook for Systematic Reviews of Interventions. 2011. http://handbook.cochrane.org/ Date last accessed: November 7, 2016.
35. WHO. Active tuberculosis drug-safety monitoring and management (aDSM). Framework for implementation (WHO/HTM/TB/2015.28). 2015. http://apps.who.int/iris/bitstream/10665/204465/1/WHO_HTM_TB_2015.28_eng.pdf Date last accessed: November 7, 2016.
36. WHO. WHO treatment guidelines for drug-resistant tuberculosis, 2016 update (WHO/HTM/TB/2016.04) Online Annexes 4, 5, 6. 2016. http://apps.who.int/iris/bitstream/10665/250125/5/9789241549639-webannexes-eng.pdf Date last accessed: November 7, 2016.
37. Van Deun A, Maug AKJ, Salim MAH, et al. Short, highly effective, and inexpensive standardized treatment of multidrug-resistant tuberculosis. Am J Respir Crit Care Med 2010; 182: 684–692.
38. International Union Against Tuberculosis and Lung Disease. MDR-TB study in Francophone Africa. 2013. http://liverpool.worldlunghealth.org/updates/francophone-africa-announces-breakthrough-results-at-union-conference Date last accessed: February 13, 2017.
39. Kuaban C, Noeske J, Rieder HL, et al. High effectiveness of a 12-month regimen for MDR-TB patients in Cameroon. Int J Tuberc Lung Dis 2015; 19: 517–524.
40. Piubello A, Harouna SH, Souleymane MB, 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.
41. Ahuja SD, Ashkin D, Avendano M, 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.
42. Aung K, van Deun A, Declercq E, 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.
43. Lee M, Lee J, Carroll MW, et al. Linezolid for treatment of chronic extensively drug-resistant tuberculosis. N Engl J Med 2012; 367: 1508–1518.
44. Tang S, Yao L, Hao 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.
45. Tang S, Yao L, Hao X, et al. Clofazimine for the treatment of multidrug-resistant tuberculosis: prospective, multicenter, randomized controlled study in China. Clin Infect Dis 2015; 60: 1361–1367.
46. Winters N, Butler-Laporte G, Menzies D. Efficacy and safety of World Health Organization group 5 drugs for multidrug-resistant tuberculosis treatment. Eur Respir J 2015; 46: 1461–1470.
47. Fox GJ, Mitnick CD, Benedetti A, et al. Surgery as an adjunctive treatment for multidrug-resistant tuberculosis: an individual patient data metaanalysis. Clin Infect Dis 2016; 62: 887–895.
48. Harris RC, Khan MS, Martin LJ, et al. The effect of surgery on the outcome of treatment for multidrug-resistant tuberculosis: a systematic review and meta-analysis. BMC Infect Dis 2016; 16: 262.
49. Harris RC, Grandjean L, Martin LJ, et al. The effect of early versus late treatment initiation after diagnosis on the outcomes of patients treated for multidrug-resistant tuberculosis: a systematic review. BMC Infect Dis 2016; 16: 193.
50. Case definition for extensively drug-resistant tuberculosis. Wkly Epidemiol Rec 2006; 81: 408.
51. WHO. Frequently asked questions about the implementation of the new WHO recommendation on the use of the shorter MDR-TB regimen under programmatic conditions. 2016. www.who.int/entity/tb/areas-of-work/drug-resistanttb/treatment/FAQshorter_MDR_regimen.pdf Date last accessed: February 13, 2017.
52. MSF Field Research. Research Protocol – Effectiveness of a simplified short regimen for Multidrug Resistant Tuberculosis treatment in Karakalpakstan, Uzbekistan. 2014. http://fieldresearch.msf.org/msf/handle/10144/322296 Date last accessed: November 7, 2016.
53. WHO. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Recommendations for a public health approach. 2nd edn. 2016. http://apps.who.int/iris/bitstream/10665/208825/1/9789241549684_eng.pdf Date last accessed: November 7, 2016.
54. WHO. Definitions and reporting framework for tuberculosis – 2013 revision (WHO/HTM/TB/2013.2). 2013. www.who.int/iris/bitstream/10665/79199/1/9789241505345_eng.pdf Date last accessed: November 7, 2016.
55. WHO. WHO global database for TB active drug safety monitoring home page. www.who.int/tdr/research/tb_hiv/adsm/en/ Date last accessed: November 7, 2016.
56. WHO. TB data home page. www.who.int/tb/country/en/ Date last accessed: November 7, 2016.
57. Mitnick CD, White RA, Lu C, et al. Multidrug-resistant tuberculosis treatment failure detection depends on monitoring interval and microbiological method. Eur Respir J 2016; 48: 1160–1170.
58. Guyatt GH, Schünemann HJ, Djulbegovic B, et al. Guideline panels should not GRADE good practice statements. J Clin Epidemiol 2015; 68: 597–600.
59. Nasser SMU, Cooke G, Kranzer K, et al. Strength of recommendations in WHO guidelines using GRADE was associated with uptake in national policy. J Clin Epidemiol 2015; 68: 703–707.
60. Mitnick CD, Rodriguez CA, Hatton ML, et al. Programmatic management of drug-resistant tuberculosis: an updated research agenda. PLoS One 2016; 11: e0155968.
61. Nunn AJ, Rusen ID, Van Deun A, et al. Evaluation of a standardized treatment regimen of anti-tuberculosis drugs for patients with multi-drug-resistant tuberculosis (STREAM): study protocol for a randomized controlled trial. Trials 2014; 15: 353.
62. ClinicalTrials.gov. Safety and efficacy trial of delamanid for 6 months in patients with multidrug resistant tuberculosis. https://clinicaltrials.gov/ct2/show/NCT01424670 Date last accessed: November 7, 2016.
63. Zignol M, Dean AS, Alikhanova N, et al. Population-based resistance of Mycobacterium tuberculosis isolates to pyrazinamide and fluoroquinolones: results from a multicountry surveillance project. Lancet Infect Dis 2016; 16: 1185–1192.
64. Stellenbosch University Dept of Paediatrics and Child Health. A phase III cluster randomised placebo-controlled trial to assess the efficacy of preventive therapy in child and adolescent contacts of MDR-TB (TB-CHAMP). http://gtr.rcuk.ac.uk/projects?ref=MR/M007340/1 Date last accessed: November 7, 2016.
65. ANZCTR. The V-QUIN MDR TRIAL: a randomized controlled trial of six months of daily levofloxacin for the prevention of tuberculosis among household contacts of patients with multi-drug resistant tuberculosis https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369817 Date last accessed: November 7, 2016.
66. WHO. Implementing the End TB Strategy: the essentials (WHO/HTM/TB/2015.31). 2015. www.who.int/tb/publications/2015/end_tb_essential.pdf Date last accessed: November 7, 2016.
67. UN Department of Economic and Social Affairs. Sustainable Development Goals. 2015. https://sustainabledevelopment.un.org/sdgs Date last accessed: November 7, 2016.