New and repurposed drugs for pediatric multidrug-resistant tuberculosis practice-based recommendations

American Journal of Respiratory and Critical Care Medicine

Volumn 195, Issue 10, 2017, Pages 1300-1310

  Harausz, Elizabeth P ^a   Garcia Prats, Anthony J ^b   Seddon, James A ^c   Schaaf, H Simon ^b   Hesseling, Anneke C ^b   Achar, Jay ^d   Bernheimer, Jonathan ^d   Cruz, Andrea T ^e   D'Ambrosio, Lia ^f,g   Detjen, Anne ^h   Graham, Stephen M ⁱ   Hughes, Jennifer ^d   Jonckheere, Sylvie ^d   Marais, Ben J ^j   Migliori, Giovanni Battista ^f   McKenna, Lindsay ^k   Skrahina, Alena ^l   Tadolini, Marina ^m   Wilson, Peyton ⁿ   Furin, Jennifer ^o  

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

^b UNIVERSITY OF STELLENBOSCH   (South Africa)

^c IMPERIAL COLLEGE LONDON   (United Kingdom)

^d MÉDECINS SANS FRONTIÈRES   (Switzerland)

^e BAYLOR COLLEGE OF MEDICINE   (United States)

^f IRCCS   (Italy)

^g Public Health Consulting Group SAGL   (Switzerland)

^h UNITED NATIONS   (United States)

ⁱ UNIVERSITY OF MELBOURNE   (Australia)

^j UNIVERSITY OF SYDNEY   (Australia)

^k Treatment Action Group   (United States)

^l National Research and Practical Centre for Pulmonology and Tuberculosis   (Belarus)

^m UNIVERSITY OF BOLOGNA   (Italy)

ⁿ BOSTON CHILDREN S HOSPITAL   (United States)

^o HARVARD MEDICAL SCHOOL   (United States)

more..

Author keywords

Adolescent; Child; Multidrug resistant tuberculosis; Mycobacterium tuberculosis; Pediatric

Indexed keywords

BEDAQUILINE; CLOFAZIMINE; DELAMANID; LINEZOLID; NEW DRUG; TUBERCULOSTATIC AGENT;

ADOLESCENT; ANTIMICROBIAL THERAPY; CHILD; COMBINATION DRUG THERAPY; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG FATALITY; DRUG REPOSITIONING; DRUG SAFETY; DRUG TOLERABILITY; HUMAN; META ANALYSIS (TOPIC); MULTICENTER STUDY (TOPIC); MULTIDRUG RESISTANT TUBERCULOSIS; PEDIATRICS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PRIORITY JOURNAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SYSTEMATIC REVIEW (TOPIC); TUBERCULOSIS, MULTIDRUG-RESISTANT;

ADOLESCENT; ANTITUBERCULAR AGENTS; CHILD; HUMANS; PRACTICE GUIDELINES AS TOPIC; TUBERCULOSIS, MULTIDRUG-RESISTANT;

EID: 85019879034     PISSN: 1073449X     EISSN: 15354970     Source Type: Journal    
DOI: 10.1164/rccm.201606-1227CI     Document Type: Review

References (65)

1. Jenkins HE, Tolman AW, Yuen CM, Parr JB, Keshavjee S, Pérez-Vélez CM, Pagano M, Becerra MC, Cohen T. Incidence of multidrug-resistant tuberculosis disease in children: systematic review and global estimates. Lancet 2014;383:1572-1579.
2. Brigden G, Furin J, Van Gulik C, Marais B. Getting it right for children: improving tuberculosis treatment access and new treatment options. Expert Rev Anti Infect Ther 2015;13:451-461.
3. Seddon JA, Hesseling AC, Godfrey-Faussett P, Schaaf HS. High treatment success in children treated for multidrug-resistant tuberculosis: an observational cohort study. Thorax 2014;69:458-464.
4. Ettehad D, Schaaf HS, Seddon JA, Cooke GS, Ford N. Treatment outcomes for children with multidrug-resistant tuberculosis: a systematic review and meta-analysis. Lancet Infect Dis 2012;12:449-456.
5. Guglielmetti L, Le Dû D,Jachym M,Henry B, Martin D,Caumes E,Veziris N, Métivier N, Robert J; 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;60:188-194.
6. Ndjeka N, Conradie F, Schnippel K, Hughes J, Bantubani N, Ferreira H, Maartens G, Mametja D, Meintjes G, Padanilam X, et al. Treatment of drug-resistant tuberculosis with bedaquiline in a high HIV prevalence setting: an interim cohort analysis. Int J Tuberc Lung Dis 2015;19:979-985.
7. Van Deun A, Maug AK, Salim MA, Das PK, Sarker MR, Daru P, Rieder HL. Short, highly effective, and inexpensive standardized treatment of multidrug-resistant tuberculosis. Am J Respir Crit Care Med 2010;182:684-692.
8. Aung KJ, Van Deun A, Declercq E, Sarker MR, Das PK, Hossain MA, Rieder HL. Successful "9-month Bangladesh regimen" for multidrug-resistant tuberculosis among over 500 consecutive patients. Int J Tuberc Lung Dis 2014;18:1180-1187.
9. World Health Organization (WHO). WHO treatment guidelines for drug resistant tuberculosis: 2016 update. WHO/HTM/TB/2016.04. Geneva, Switzerland: World Health Organization; 2016.
10. Becerra MC, Swaminathan S. Commentary: a targets framework: dismantling the invisibility trap for children with drug-resistant tuberculosis. J Public Health Policy 2014;35:425-454.
11. Nachman S, Ahmed A, Amanullah F, Becerra MC, Botgros R, Brigden G, Browning R, Gardiner E, Hafner R, Hesseling A, et al. Towards early inclusion of children in tuberculosis drugs trials: a consensus statement. Lancet Infect Dis 2015;15:711-720.
12. Monedero I, Furin J. Programmatic management of children with drug-resistant tuberculosis: common sense and social justice. Public Health Action 2015;5:92.
13. Hafkin J, Frias M, Hesseling A, Garcia-Prats AJ, Schaaf HS, Gler M, Hittel N, Wells C, Geiter L, Mallikaanjun S. Pharmacokinetics and safety of delamanid in pediatric MDR-TB patients, ages 6-17 years. Poster presented at the International Conference on Antimicrobial Agents and Chemotherapy. September 18-21, 2015, San Diego, CA. Poster A-960.
14. Hafkin J, Frias M, De Leon A, Hittel N, Geiter L, Wells C, Mallikaarjun S. Long-term safety, tolerability, and pharmacokinetics of delamanid in pediatric MDR-TB patients ages 12-17 years. Poster presented at the 46th Union World Conference on Lung Health. December 2-6, 2015, Cape Town, South Africa. Poster EP-115-04.
15. Paccaly A, Peterson C, Patil S, Briemont P, Kim J, Harlin M, Wells C. Absence of clinically relevant drug interaction between delamanid, a new drug for multidrug-resistant tuberculosis (MDR-TB) and tenofovir or lopinavir/ritonavir in healthy subjects. Presented at the International AIDS Conference. July 22-27, 2012, Washington, DC. WEPE043.
16. Ndjeka N. Incorporation of bedaquiline in the South African National TB Programme. Poster #754 presented at the International Conference on Retroviruses and Opportunistic Infections. February 2016, Boston, MA. Available from: http://www.croiconference.org/sites/default/files/posters-2016/754.pdf [accessed 2016 June 10].
17. Furin J. The use of new and repurposed drugs in children with MDR-TB. Presented at the 5th Regional TB Symposium - Eastern Europe and Central Asia. March 22, 2016, Tbilisi, Georgia. Available from: http://www.tb-symposium.org/ [accessed 2016 June 10].
18. Seddon JA, Furin JJ, Gale M, Del Castillo Barrientos H, Hurtado RM, Amanullah F, Ford N, Starke JR, Schaaf HS; Sentinel Project on Pediatric Drug-Resistant Tuberculosis. Caring for children with drug-resistant tuberculosis: practice-based recommendations. Am J Respir Crit Care Med 2012;186:953-964.
19. Sentinel Project on Pediatric Drug-Resistant Tuberculosis. Boston, MA [accessed 2016 Sept 17]. Available from: www.sentinel-project.org
20. World Health Organization (WHO). Active tuberculosis drug safety monitoring and management (aDSM): a framework for implementation. WHO/HTM/TB/2015.28. Geneva, Switzerland: World Health Organization; 2015.
21. World Health Organization (WHO). Nutritional care and support for persons with tuberculosis. ISBN: 978 92 4 150641 0. Geneva, Switzerland: World Health Organization; 2013.
22. World Health Organization (WHO). Companion handbook to the WHO guidelines for the programmatic management of multidrug-resistant tuberculosis. ISBN 978 92 4 154880 9. Geneva, Switzerland: World Health Organization; 2014.
23. Skripconoka V, Danilovits M, Pehme L, Tomson T, Skenders G, Kummik T, Cirule A, Leimane V, Kurve A, Levina K, et al. Delamanid improves outcomes and reduces mortality in multidrug-resistant tuberculosis. Eur Respir J 2013;41:1393-1400.
24. Gler MT, Skripconoka V, Sanchez-Garavito E, Xiao H, Cabrera-Rivero JL, Vargas-Vasquez DE, Gao M, Awad M, Park SK, Shim TS, et al. Delamanid for multidrug-resistant pulmonary tuberculosis. N Engl J Med 2012;366:2151-2160.
25. Gupta R, Geiter LJ, Hafkin J, Wells CD. Delamanid and QT prolongation in the treatment of multidrug-resistant tuberculosis. Int J Tuberc Lung Dis 2015;19:1261-1262.
26. Médecins Sans Frontières. Call to action: accelerate access to DR-TB drugs. Available from: http://www.msfaccess.org/content/call-action-accelerate-access-dr-tb-drugs[accessed 2016 June 10].
27. RESIST-TB. DR-TB clinical trials progress report. Available from: http://www.resisttb.org/?page-id=1602[accessed 2016 April 26].
28. World Health Organization (WHO). The use of delamanid in the treatment of multidrug-resistant tuberculosis: interim policy guidance. WHO/HTM/TB2014.23. Geneva, Switzerland: World Health Organization; 2014.
29. Garcia-Prats A, Donald P, Hesseling A, Schaaf HS. Second-line antituberculosis drugs in children: a commissioned review for the World Health Organization 19th Expert Committee on the Selection and Use of Essential Medicines. January 11, 2013. Available from; http://www.who.int/selection-medicines/committees/expert/19/applications/TB-624-C-R.pdf [accessed 2016 May 5].
30. Esposito S, D'Ambrosio L, Tadolini M, Schaaf HS, Caminero Luna J, Marais B, Centis R, Dara M, Matteelli A, Blasi F, et al. ERS/WHO Tuberculosis Consilium assistance with extensively drug-resistant tuberculosis management in a child: case study of compassionate delamanid use. Eur Respir J 2014;44:811-815.
31. Seddon JA, Hesseling AC, Schaaf HS. Retooling existing tuberculosis drugs for children. Clin Infect Dis 2013;56:167-168.
32. Tadolini M, Garcia-Prats AJ, D'Ambrosio L, Hewison C, Centis R, Schaaf HS, Marais BJ, Ferreira H, Caminero JA, Jonckheere S, 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.
33. Harausz E, Cox H, Rich M, Mitnick CD, Zimetbaum P, Furin J. QTc prolongation and treatment of multidrug-resistant tuberculosis. Int J Tuberc Lung Dis 2015;19:385-391.
34. Seddon JA, Thee S, Jacobs K, Ebrahim A, Hesseling AC, Schaaf HS. Hearing loss in children treated for multidrug-resistant tuberculosis. J Infect 2013;66:320-329.
35. Ahuja SD, Ashkin D, Avendano M, Banerjee R, Bauer M, Bayona JN, Becerra MC, Benedetti A, Burgos M, Centis R, 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.
36. Migliori GB, Sotgiu G, Gandhi NR, Falzon D, DeRiemer K, Centis R, Hollm-Delgado MG, Palmero D, Pérez-Guzmán C, Vargas MH, et al.; Collaborative Group for Meta-Analysis of Individual Patient Data in MDR-TB. Drug resistance beyond extensively drug-resistant tuberculosis: individual patient data meta-analysis. Eur Respir J 2013;42:169-179.
37. Diacon AH, Pym A, Grobusch MP, de los Rios JM, Gotuzzo E, Vasilyeva I, Leimane V, Andries K, Bakare N, De Marez T, et al.; TMC207-C208 Study Group. Multidrug-resistant tuberculosis and culture conversion with bedaquiline. N Engl J Med 2014;371:723-732.
38. Bélard S, Heuvelings CC, Janssen S, Grobusch MP. Bedaquiline for the treatment of drug-resistant tuberculosis. Expert Rev Anti Infect Ther 2015;13:535-553.
39. Pontali E, Sotgiu G, D'Ambrosio L, Centis R, Migliori GB. Bedaquiline and multidrug-resistant tuberculosis: a systematic and critical analysis of the evidence. Eur Respir J 2016;47:394-402.
40. DR-TB STAT. April 2016 task force update [accessed 2016 Apr 26]. Available from: http://www.stoptb.org/wg/mdrtb/taskforces.asp?tf=4
41. World Health Organization (WHO). The use of bedaquiline in the treatment of multidrug-resistant tuberculosis: interim guidance. ISBN 978 92 4 150548 2. Geneva, Switzerland: World Health Organization; 2013.
42. Centers for Disease Control and Prevention. Provisional CDC guidelines for the use and safety monitoring of bedaquiline fumarate (Sirturo) for the treatment of multidrug-resistant tuberculosis. MMWR Recomm Rep 2013;62:1-12.
43. [Published erratum appears in MMWR Recomm Rep 62:906.]
44. Furin J, Brigden G, Lessem E, Rich M, Vaughan L, Lynch S. Global progress and challenges in implementating new medications for treating multidrug-resistant tuberculosis. Emerg Infect Dis 2016;22(3).
45. International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT). IMPAACT protocols snapshot: in development through closed to accrual. November 29, 2016. Available from: http://impaactnetwork.org/DocFiles/Index/StudyStatusTbl.pdf [accessed 2016 June 10].
46. Lewis JM, Hine P, Walker J, Khoo SH, Taegtmeyer M, Squire SB, Sloan DJ. 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.
47. Svensson EM, Dooley KE, Karlsson MO. Impact of lopinavir-ritonavir or nevirapine on bedaquiline exposures and potential implications for patients with tuberculosis-HIV coinfection. Antimicrob Agents Chemother 2014;58:6406-6412.
48. Pandie M, Wiesner L, McIlleron H, Hughes J, Siwendu S, Conradie F, Variava E, Maartens G. 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.
49. Lachâtre M, Rioux C, Le Dû D,Fréchet-Jachym M, Veziris N, Bouvet E, Yazdanpanah Y. Bedaquiline plus delamanid for XDR tuberculosis. Lancet Infect Dis 2016;16:294.
50. Tadolini M, Lingtsang RD, Tiberi S, Enwerem M, D'Ambrosio L, Sadutshang TD, Centis R, Migliori GB. First case of extensively drug-resistant tuberculosis treated with both delamanid and bedaquiline. Eur Respir J 2016;48:935-938.
51. Matteelli A, D'Ambrosio L, Centis R, Tadolini M, Migliori GB. Compassionate and optimum use of new tuberculosis drugs. Lancet Infect Dis 2015;15:1131-1132.
52. 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.
53. Sotgiu G, Centis R, D'Ambrosio L, Alffenaar JW, Anger HA, Caminero JA, Castiglia P, De Lorenzo S, Ferrara G, Koh WJ, 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.
54. Lee M, Lee J, Carroll MW, Choi H, Min S, Song T, Via LE, Goldfeder LC, Kang E, Jin B, et al. Linezolid for treatment of chronic extensively drug-resistant tuberculosis. N Engl J Med 2012;367:1508-1518.
55. Park IN, Hong SB, Oh YM, Kim MN, Lim CM, Lee SD, Koh Y, Kim WS, Kim DS, Kim WD, et al. Efficacy and tolerability of daily-half dose linezolid in patients with intractable multidrug-resistant tuberculosis. J Antimicrob Chemother 2006;58:701-704.
56. Koh WJ, Kwon OJ, Gwak H, Chung JW, Cho SN, Kim WS, Shim TS. Daily 300 mg dose of linezolid for the treatment of intractable multidrug-resistant and extensively drug-resistant tuberculosis. J Antimicrob Chemother 2009;64:388-391.
57. Rose PC, Hallbauer UM, Seddon JA, Hesseling AC, Schaaf HS. Linezolid-containing regimens for the treatment of drug-resistant tuberculosis in South African children. Int J Tuberc Lung Dis 2012;16:1588-1593.
58. Kjöllerström P, Brito MJ, Gouveia C, Ferreira G, Varandas L. Linezolid in the treatment of multidrug-resistant/extensively drug-resistant tuberculosis in paediatric patients: experience of a paediatric infectious diseases unit. Scand J Infect Dis 2011;43:556-559.
59. Tan TQ. Update on the use of linezolid: a pediatric perspective. Pediatr Infect Dis J 2004;23:955-956.
60. Garcia-Prats AJ, Rose PC, Hesseling AC, Schaaf HS. Linezolid for the treatment of drug-resistant tuberculosis in children: a review and recommendations. Tuberculosis (Edinb) 2014;94:93-104.
61. Madariaga MG, Swindells S, McKee EE. Oxazolidinones and human immunodeficiency virus. Antimicrob Agents Chemother 2007;51:1130, author reply 1130.
62. du Toit LC, Pillay V, Danckwerts MP. Tuberculosis chemotherapy: current drug delivery approaches. Respir Res 2006;7:118.
63. Tang S, Yao L, Hao X, Liu Y, Zeng L, Liu G, Li M, Li F, Wu M, Zhu Y, et al. Clofazimine for the treatment of multidrug-resistant tuberculosis: prospective, multicenter, randomized controlled study in China. Clin Infect Dis 2015;60:1361-1367.
64. Kroger A, Pannikar V, Htoon MT, Jamesh A, Katoch K, Krishnamurthy P, Ramalingam K, Jianping S, Jadhav V, Gupte MD, et al. International open trial of uniform multi-drug therapy regimen for 6 months for all types of leprosy patients: rationale, design and preliminary results. Trop Med Int Health 2008;13:594-602.
65. Stop TB Partnership. Stop TB Partnership's Global Drug Facility announces a 70% price reduction for linezolid: another critical step towards achieving equitable access to MDR-TB treatment. April 28, 2016. Available from: http://www.stoptb.org/news/stories/2016/ns16-013.asp [accessed 2016 May 5].