Multidrug-resistant tuberculosis and beyond: An updated analysis of the current evidence on bedaquiline

European Respiratory Journal

Volumn 49, Issue 3, 2017, Pages

  Pontali, Emanuele ^a   D'Ambrosio, Lia ^b,c   Centis, Rosella ^b   Sotgiu, Giovanni ^d   Migliori, Giovanni Battista ^b  

^a GALLIERA HOSPITAL   (Italy)

^b WORLD HEALTH ORGANIZATION   (Switzerland)

^c Public Health Consulting Group SAGL   (Switzerland)

^d UNIVERSITY OF SASSARI   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

AMINOSALICYLIC ACID; BEDAQUILINE; CLOFAZIMINE; DELAMANID; ISONIAZID; LINEZOLID; LOPINAVIR PLUS RITONAVIR; NEVIRAPINE; QUINOLINE DERIVED ANTIINFECTIVE AGENT; RIFAMPICIN; QUINOLINE DERIVATIVE; TUBERCULOSTATIC AGENT;

ADD ON THERAPY; ANTIBIOTIC RESISTANCE; ATYPICAL MYCOBACTERIOSIS; BACTERIUM ISOLATE; CHILD CARE; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG HALF LIFE; DRUG METABOLISM; DRUG SAFETY; DRUG USE; EDITORIAL; EVIDENCE BASED MEDICINE; HUMAN; MINIMUM INHIBITORY CONCENTRATION; MULTIDRUG RESISTANT TUBERCULOSIS; MYCOBACTERIUM AVIUM; MYCOBACTERIUM INTRACELLULARE; MYCOBACTERIUM TUBERCULOSIS; POSTMARKETING SURVEILLANCE; PRACTICE GUIDELINE; PRIORITY JOURNAL; QT PROLONGATION; WORLD HEALTH ORGANIZATION;

ANTITUBERCULAR AGENTS; DIARYLQUINOLINES; HUMANS; PRACTICE GUIDELINES AS TOPIC; TUBERCULOSIS, MULTIDRUG-RESISTANT; WORLD HEALTH ORGANIZATION;

EID: 85020554242     PISSN: 09031936     EISSN: 13993003     Source Type: Journal    
DOI: 10.1183/13993003.00146-2017     Document Type: Editorial

References (82)

1. World Health Organization. Global tuberculosis report 2016. WHO/HTM/TB/2016.13. Geneva, World Health Organization, 2016.
2. Migliori GB, Sotgiu G, Gandhi NR, et al. Drug resistance beyond extensively drug resistant tuberculosis: individual patient data meta-analysis. Eur Respir J 2013; 42: 169–179.
3. Falzon D, Gandhi N, Migliori GB, et al. Resistance to fluoroquinolones and second-line injectable drugs: impact on multidrug-resistant TB outcomes. Eur Respir J 2013; 42: 156–168.
4. 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.
5. Falzon D, Schünemann HJ, Harausz E, et al. WHO treatment guidelines for drug-resistant tuberculosis, 2016 update. Eur Respir J 2017; 49: 1602308.
6. Sotgiu G, Pontali E, Migliori GB. Linezolid to treat MDR-/XDR-tuberculosis: available evidence and future scenarios. Eur Respir J 2015; 45: 25–29.
7. Pontali E, Sotgiu G, D’Ambrosio L, et al. Bedaquiline and MDR-TB: a systematic and critical analysis of the evidence. Eur Respir J 2016; 47: 394–402.
8. Sotgiu G, Pontali E, Migliori GB. Linezolid to treat MDR-/XDR-tuberculosis: available evidence and future scenarios. Eur Respir J 2015; 45: 25–29.
9. Villar M, Sotgiu G, D’Ambrosio L, et al. Linezolid safety, tolerability and efficacy to treat multidrug- and extensively drug-resistant tuberculosis. Eur Respir J 2011; 38: 730–733.
10. De Lorenzo S, Centis R, D’Ambrosio L, et al. On linezolid efficacy and tolerability. Eur Respir J 2012; 39: 770–772.
11. Sotgiu G, Centis R, D’Ambrosio L, 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.
12. Sotgiu G, Centis R, D’Ambrosio L, et al. Linezolid to treat extensively drug-resistant TB: retrospective data are confirmed by experimental evidence. Eur Respir J 2013; 42: 288–290.
13. 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.
14. Sotgiu G, Centis R, D’Ambrosio L, et al. Low minimal inhibitory concentrations of linezolid against multidrug-resistant tuberculosis strains. Eur Respir J 2015; 45: 287–289.
15. De Lorenzo S, Alffenaar JW, Sotgiu G, et al. Efficacy and safety of meropenem-clavulanate added to linezolid-containing regimens in the treatment of MDR-/XDR-TB. Eur Respir J 2013; 41: 1386–1392.
16. Tiberi S, Payen MC, Sotgiu G, et al. Effectiveness and safety of meropenem/clavulanate-containing regimens in the treatment of multidrug and extensively drug-resistant tuberculosis. Eur Respir J 2016; 47: 1235–1243.
17. Tiberi S, Sotgiu G, D’Ambrosio L, et al. Effectiveness and safety of imipenem-clavulanate added to an optimized background regimen (OBR) versus OBR control regimens in the treatment of multidrug-resistant and extensively drug-resistant tuberculosis. Clin Infect Dis 2016; 62: 1188–1190.
18. Tiberi S, Sotgiu G, D’Ambrosio L, et al. Comparison of effectiveness and safety of imipenem/clavulanate-versus meropenem/clavulanate-containing regimens in the treatment of multidrug and extensively drug-resistant tuberculosis. Eur Respir J 2016; 47: 1758–1766.
19. Tiberi S, D’Ambrosio L, De Lorenzo S, et al. Ertapenem in the treatment of multidrug-resistant tuberculosis: first clinical experience. Eur Respir J 2016; 47: 333–336.
20. Matteelli A, D’Ambrosio L, Centis R, et al. Compassionate and optimum use of new tuberculosis drugs. Lancet Infect Dis 2015; 15: 1131–1132.
21. Dalcolmo M, Gayoso R, Sotgiu G, et al. Effectiveness and safety of clofazimine within a standard multidrug-resistant tuberculosis regimen in Brazil: first nationwide report on over 2,500 cases. Eur Respir J 2017; 49: 1602445.
22. Gopal M, Padayatchi N, Metcalfe JZ, et al. Systematic review of clofazimine for the treatment of drug-resistant tuberculosis. Int J Tuberc Lung Dis 2013; 17: 1001–1007.
23. Lönnroth K, Migliori GB, Abubakar I, et al. Towards tuberculosis elimination: an action framework for low-incidence countries. Eur Respir J 2015; 45: 928–952.
24. D’Ambrosio L, Dara M, Tadolini M, et al. Tuberculosis elimination: theory and practice in Europe. Eur Respir J 2014; 43: 1410–1420.
25. World Health Organization. Sixty-Second World Health Assembly. Geneva, 18–22 May 2009. Resolution WHA62.15. Prevention and control of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis. Resolutions and decisions; annexes. Document WHA62/2009/REC/1. Geneva, World Health Organization, 2009. Available at: http://apps.who.int/gb/ebwha/pdf_files/WHA62-REC1/WHA62_REC1-en.pdf
26. Uplekar M, Weil D, Lönnroth K, et al. WHO’s new End TB Strategy. Lancet 2015; 385: 1799–1801.
27. Sotgiu G, Tiberi S, D’Ambrosio L, et al. WHO recommendations on shorter treatment of multidrug-resistant tuberculosis. Lancet 2016; 387: 2486–2487.
28. Sotgiu G, Tiberi S, D’Ambrosio L, et al. Faster for less, the new ‘Shorter’ regimen for multidrug-resistant tuberculosis. Eur Respir J 2016; 48: 1503–1507.
29. Sotgiu G, Migliori GB. Effect of the short-course regimen on the global epidemic of multidrug-resistant tuberculosis. Lancet Respir Med 2017; in press [https://doi.org/10.1016/S2213-2600(16)30432-5].
30. Javaid A, Ahmad N, Khan AH, et al. Applicability of the World Health Organization recommended new shorter regimen in a multidrug-resistant tuberculosis high burden country. Eur Respir J 2017; 49: 1601967.
31. van der Werf MJ, Hollo V, Ködmön C, et al. Eligibility for shorter treatment of multidrug-resistant tuberculosis in the European Union. Eur Respir J 2017; 49: 1601992.
32. Dalcolmo M, Gayoso R, Sotgiu G, et al. Resistance profile to the drugs composing the “shorter” regimen for multidrug-resistant TB in Brazil, 2000-2015. Eur Respir J 2017; 49: 1602309.
33. Guglielmetti L, Le Dû D, Veziris N, et al. Is bedaquiline as effective as fluoroquinolones in the treatment of multidrug-resistant tuberculosis? Eur Respir J 2016; 48: 582–585.
34. Udwadia ZF, Ganatra S, Mullerpattan JB. Compassionate use of bedaquiline in highly drug-resistant tuberculosis patients in Mumbai, India. Eur Respir J 2017; 49: 1601699.
35. Guglielmetti L, Jaspard M, Le Dû D, et al. Long-term outcome and safety of prolonged bedaquiline treatment for multidrug- resistant tuberculosis. Eur Respir J 2017; 49: 1601799.
36. Lewis JM, Hine P, Walker J, et al. First experience of effectiveness and safety of bedaquiline for 18 months within an optimised regimen for XDR-TB. Eur Respir J 2016; 47: 1581–1584.
37. Skrahina A, Hurevich H, Falzon D, et al. Bedaquiline in the multidrug-resistant tuberculosis treatment: Belarus experience. Int J Mycobacteriol 2016; 5: Suppl. 1, S62–S63.
38. Pandie M, Wiesner L, McIlleron H, et al. Drug-drug interactions between bedaquiline and the antiretrovirals lopinavir/ritonavir and nevirapine in HIV-infected patients with drug-resistant TB. J Antimicrob Chemother 2016; 71: 1037–1040.
39. Brill MJ, Svensson EM, Pandie M, et al. Confirming model-predicted pharmacokinetic interactions between bedaquiline and lopinavir/ritonavir or nevirapine in patients with HIV and drug-resistant tuberculosis. Int J Antimicrob Agents 2016; in press [https://doi.org/10.1016/j.ijantimicag.2016.10.020].
40. van Heeswijk RP, Dannemann B, Hoetelmans RM. Bedaquiline: a review of human pharmacokinetics and drug-drug interactions. J Antimicrob Chemother 2014; 69: 2310–2318.
41. Liu K, Li F, Lu J, et al. Bedaquiline metabolism: enzymes and novel metabolites. Drug Metab Dispos 2014; 42: 863–866.
42. Svensson EM, Rossenu S, Karlsson MO. Bedaquilines exposure-response relationship revealed through modeling of mycobacterial load. Lisbon (Portugal): Population Approach Group Europe; 2016. p. C-01.
43. Cariem R, Cox V, de Azevedo V, et al. The experience of bedaquiline implementation at a decentralised clinic in South Africa. Public Health Action 2016; 6: 190–192.
44. Ndjeka N, Conradie F, Schnippel K, et al. Treatment of drug-resistant tuberculosis with bedaquiline in a high HIV prevalence setting: an interim cohort analysis. Int Tuberc Lung Dis 2015; 9: 979–985.
45. Furin J, Brigden G, Lessem E, et al. Global progress and challenges in the implementation of new medications treating multidrug-resistant tuberculosis. Emerg Infect Dis 2016; 22: e151430.
46. Stinson K, Goemaere E, Coetzee D, et al. Cohort profile: the Khayelitsha antiretroviral programme, Cape Town, South Africa. Int J Epidemiol 2016; in press.
47. Vesenbeckh S, Schönfeld N, Krieger D, et al. Bedaquiline as a potential agent in the treatment of M. intracellulare and M. avium infections. Eur Respir J 2017; 49: 1601969.
48. Huitric E, Verhasselt P, Andries K, et al. In vitro antimycobacterial spectrum of a diarylquinoline ATP synthase inhibitor. Antimicrob Agents Chemother 2007; 51: 4202–4204.
49. Griffith DE, Aksamit T, Brown-Elliott BA, et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med 2007; 175: 367–416.
50. Philley JV, Wallace RJ Jr, Benwill JL, et al. Preliminary results of bedaquiline as salvage therapy for patients with nontuberculous mycobacterial lung disease. Chest 2015; 148: 499–506.
51. Brown-Elliott BA, Philley JV, Griffith DE, et al. In vitro susceptibility testing of bedaquiline against Mycobacterium avium complex. Antimicrob Agents Chemother 2017; 61: e01798-16.
52. Alexander DC, Vasireddy R, Vasireddy S, et al. The emergence of mmpT5 variants during bedaquiline treatment of Mycobacterium intracellulare lung disease. J Clin Microbiol 2017; 55: 574–584.
53. McKenna L, Mingote LR. Paediatric study of bedaquiline remains an “open issue”. Eur Respir J 2016; 48: 956–957.
54. Tadolini M, Garcia-Prats AJ, D’Ambrosio L, et al. Compassionate use of new drugs in children and adolescents with multidrug-resistant and extensively-drug resistant tuberculosis: early experiences and challenges. Eur Respir J 2016; 48: 938–943.
55. Ettehad D, Schaaf HS, Seddon JA, et al. Treatment outcomes for children with multidrug-resistant tuberculosis: a systematic review and meta-analysis. Lancet Infect Dis 2012; 12: 449–456.
56. Migliori GB, Manissero D, Sotgiu G. Multidrug-resistant tuberculosis in children can be treated. Lancet Infect Dis 2012; 12: 425–426.
57. Harausz EP, Garcia-Prats AJ, Seddon JA, et al. New/repurposed drugs for pediatric multidrug-resistant tuberculosis: practice-based recommendations. Am J Respir Crit Care Med 2016; in press [https://doi.org/10.1164/rccm.201606-1227CI].
58. ClinicalTrials.gov. A service of the U.S. National Institutes of Health. Available at: https://clinicaltrials.gov/ct2/show/NCT02354014?term=NCT02354014&rank=1. Date last accessed: January 16, 2017.
59. ClinicalTrials.gov. A service of the U.S. National Institutes of Health. Available at: https://clinicaltrials.gov/ct2/show/NCT02906007?term=NCT02906007&rank=1. Date last accessed: January 16, 2017.
60. World Health Organization. The use of bedaquiline in the treatment of multidrug-resistant tuberculosis. Interim policy guidance. WHO/HTM/TB/2013.6. Geneva, World Health Organization, 2013.
61. World Health Organization. The use of delamanid in the treatment of multidrug-resistant tuberculosis. Interim policy guidance. WHO/HTM/TB2014.23. Geneva, World Health Organization, 2014.
62. Tadolini M, Lingtsang RD, Tiberi S, et al. First case of extensively drug-resistant tuberculosis treated with both delamanid and bedaquiline. Eur Respir J 2016; 48: 935–938.
63. Lachâtre M, Rioux C, Le Dû D, et al. Bedaquiline plus delamanid for XDR tuberculosis. Lancet Infect Dis 2016; 16: 294.
64. Tadolini M, Lingtsang RD, Tiberi S, et al. Cardiac safety of extensively drug-resistant tuberculosis regimens including bedaquiline, delamanid and clofazimine. Eur Respir J 2016; 48: 1527–1529.
65. ClinicalTrials.gov. A service of the U.S. National Institutes of Health. Available at: https://clinicaltrials.gov/ct2/show/NCT02583048?term=NCT02583048&rank=1. Date last accessed: January 16, 2017.
66. Migliori GB, Pontali E, Sotgiu G, et al. Combined use of delamanid and bedaquiline to treat multidrug-resistant and extensively drug-resistant tuberculosis: a systematic review. Int J Mol Sci 2017; 18: E341.
67. Dedicoat M. Using bedaquiline and delamanid in combination and safely. Int J Tuberc Lung Dis 2016; 20: 1282.
68. Bonnet M, Bastard M, du Cros P, et al. Identification of patients who could benefit from bedaquiline or delamanid: a multisite MDR-TB cohort study. Int J Tuberc Ling Dis 2016; 20: 177–186.
69. Ferlazzo G. Dlm-Bdq combination: programmatic aspects and preliminary results of patients receiving Dlm and Bdq combination in MSFNTP projects. Satellite session (SS) 02. Pushing the boundaries: use of new TB drugs, the MSF experience presented at the 47th Union World Conference on Lung Health. Liverpool, UK: 26 October–29 October 2016. Available from: www.msf.org.uk/sites/uk/files/MSFsatellitesessionTB_doublesided_oct20FINAL.pdf
70. Pym AS, Diacon AH, Tang SJ, et al. Bedaquiline in the treatment of multi- and extensively drug-resistant tuberculosis. Eur Respir J 2016; 47: 564–574.
71. Andries K, Villellas C, Coeck N, et al. Acquired resistance of Mycobacterium tuberculosis to bedaquiline. PLoS One 2014; 9: e102135.
72. Hoffmann H, Kohl TA, Hofmann-Thiel S, et al. Delamanid and bedaquiline resistance in Mycobacterium tuberculosis ancestral Beijing genotype causing extensively drug-resistant tuberculosis in a Tibetan refugee. Am J Respir Crit Care Med 2016; 193: 337–340.
73. Petrella S, Cambau E, Chauffour A, et al. Genetic basis for natural and acquired resistance to the diarylquinoline R207910 in mycobacteria. Antimicrob Agents Chemother 2006; 50: 2853–2856.
74. Andries K, Verhasselt P, Guillemont J, et al. A diarylquinoline drug active on the ATP synthase of Mycobacterium tuberculosis. Science 2005; 307: 223–227.
75. Hartkoorn RC, Uplekar S, Cole ST. Cross-resistance between clofazimine and bedaquiline through upregulation of MmpL5 in Mycobacterium tuberculosis. Antimicrob Agents Chemother 2014; 58: 2979–2981.
76. Gupta S, Cohen KA, Winglee K, et al. Efflux inhibition with verapamil potentiates bedaquiline in Mycobacterium tuberculosis. Antimicrob Agents Chemother 2014; 58: 574–576.
77. Villellas C, Coeck N, Meehan CJ, et al. Unexpected high prevalence of resistance-associated Rv0678 variants in MDR-TB patients without documented prior use of clofazimine or bedaquiline. J Antimicrob Chemother 2016; in press [https://doi.org/10.1093/jac/dkw502].
78. Veziris N, Bernard C, Guglielmetti L, et al. Rapid emergence of Mycobacterium tuberculosis bedaquiline resistance: lessons not to repeat past errors. Eur Respir J 2017; 49: 1601719.
79. Salfinger M, Migliori GB. Bedaquiline: 10 years later, the drug susceptibility testing protocol is still pending. Eur Respir J 2015; 45: 317–321.
80. Salfinger M, Migliori GB. Bedaquiline: finding the pores on the pot. Eur Respir J 2015; 46: 289–291.
81. Kaniga K, Cirillo DM, Hoffner S, et al. A multilaboratory, multicountry study to determine bedaquiline MIC quality control ranges for phenotypic drug susceptibility testing. J Clin Microbiol 2016; 54: 2956–2962.
82. Guglielmetti L, Le Dû D, Jachym M, et al. 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: 188–194.