Tradeoffs in Introduction Policies for the Anti-Tuberculosis Drug Bedaquiline: A Model-Based Analysis

PLoS Medicine

Volumn 13, Issue 10, 2016, Pages

  Kunkel, Amber ^a,b   Cobelens, Frank G ^c,d   Cohen, Ted ^b  

^a HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^b YALE UNIVERSITY   (United States)

^c ACADEMIC MEDICAL CENTER   (Netherlands)

^d KNCV TUBERCULOSIS FOUNDATION   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

BEDAQUILINE; QUINOLINE DERIVATIVE; TUBERCULOSTATIC AGENT;

ARTICLE; BACTERIAL TRANSMISSION; DISEASE COURSE; DRUG SENSITIVITY; HUMAN; INFECTION CONTROL; INFECTION RISK; LIFE EXPECTANCY; NONHUMAN; TREATMENT RESPONSE; TUBERCULOSIS; ADULT; COHORT ANALYSIS; DECISION SUPPORT SYSTEM; DRUG APPROVAL; HEALTH CARE POLICY; MALE; MARKOV CHAIN; RISK ASSESSMENT; TRANSMISSION; TUBERCULOSIS, MULTIDRUG-RESISTANT;

ADULT; ANTITUBERCULAR AGENTS; COHORT STUDIES; DECISION SUPPORT TECHNIQUES; DIARYLQUINOLINES; DRUG APPROVAL; HEALTH POLICY; HUMANS; LIFE EXPECTANCY; MALE; MARKOV CHAINS; RISK ASSESSMENT; TUBERCULOSIS, MULTIDRUG-RESISTANT;

EID: 84994300391     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.1002142     Document Type: Article

References (38)

1. World Health Organization. Global Tuberculosis Report 2015. Geneva: 2015.
2. Lienhardt C, Raviglione M, Spigelman M, Hafner R, Jaramillo E, Hoelscher M, et al. New drugs for the treatment of tuberculosis: needs, challenges, promise, and prospects for the future. J Infect Dis. 2012;205Suppl 2:S241–9. Epub 2012/03/27. doi: 10.1093/infdis/jis03422448022.
3. Brigden G, Hewison C, Varaine F, New developments in the treatment of drug-resistant tuberculosis: clinical utility of bedaquiline and delamanid. Infect Drug Resist. 2015;8:367–78. Epub 2015/11/21. doi: 10.2147/idr.s6835126586956; PubMed Central PMCID: PMC4634826.
4. Olaru ID, von Groote-Bidlingmaier F, Heyckendorf J, Yew WW, Lange C, Chang KC, Novel drugs against tuberculosis: a clinician's perspective. Eur Respir J. 2014. Epub 2014/11/29. doi: 10.1183/09031936.0016231425431273.
5. World Health Organization. The use of bedaquiline in the treatment of multidrug-resistant tuberculosis: interim policy guidance. Geneva: 2013.
6. Zumla A, Nahid P, Cole ST, Advances in the development of new tuberculosis drugs and treatment regimens. Nat Rev Drug Discov. 2013;12(5):388–404. Epub 2013/05/01. doi: 10.1038/nrd400123629506.
7. Brigden G, Nyang'wa BT, du Cros P, Varaine F, Hughes J, Rich M, et al. Principles for designing future regimens for multidrug-resistant tuberculosis. Bull World Health Organ. 2014;92(1):68–74. Epub 2014/01/07. doi: 10.2471/blt.13.12202824391302; PubMed Central PMCID: PMC3865549.
8. Diacon AH, Pym A, Grobusch MP, de los Rios JM, Gotuzzo E, Vasilyeva I, et al. Multidrug-resistant tuberculosis and culture conversion with bedaquiline. The New England journal of medicine. 2014;371:723–32. doi: 10.1056/NEJMoa131386525140958.
9. Cox E, Laessig K, FDA approval of bedaquiline—the benefit-risk balance for drug-resistant tuberculosis. N Engl J Med. 2014;371(8):689–91. Epub 2014/08/21. doi: 10.1056/NEJMp131438525140952.
10. Mingote LR, Namutamba D, Apina F, Barnabas N, Contreras C, Elnour T, et al. The use of bedaquiline in regimens to treat drug-resistant and drug-susceptible tuberculosis: a perspective from tuberculosis-affected communities. Lancet. 2015;385(9966):477–9. Epub 2014/07/16. doi: 10.1016/s0140-6736(14)60523-725018118.
11. Kakkar AK, Dahiya N, Current issues with the use of bedaquiline. Ann Pharmacother. 2014;48(5):666. Epub 2014/02/13. doi: 10.1177/106002801452158924519480.
12. Dalton T, Cegielski P, Akksilp S, Asencios L, Campos Caoili J, Cho SN, et al. Prevalence of and risk factors for resistance to second-line drugs in people with multidrug-resistant tuberculosis in eight countries: a prospective cohort study. Lancet. 2012;380(9851):1406–17. Epub 2012/09/04. doi: 10.1016/s0140-6736(12)60734-x22938757.
13. Styblo K. Epidemiology of Tuberculosis: Selected Papers. The Hague: Royal Netherlands Tuberculosis Foundation (KNCV); 1991.
14. Trunz BB, Fine P, Dye C, Effect of BCG vaccination on childhood tuberculous meningitis and miliary tuberculosis worldwide: a meta-analysis and assessment of cost-effectiveness. Lancet. 2006;367(9517):1173–80. Epub 2006/04/18. doi: 10.1016/s0140-6736(06)68507-316616560.
15. Vynnycky E, Fine PE, The natural history of tuberculosis: the implications of age-dependent risks of disease and the role of reinfection. Epidemiol Infect. 1997;119(2):183–201. Epub 1997/11/18. 9363017; PubMed Central PMCID: PMC2808840.
16. Gagneux S, Long CD, Small PM, Van T, Schoolnik GK, Bohannan BJ, The competitive cost of antibiotic resistance in Mycobacterium tuberculosis. Science. 2006;312(5782):1944–6. Epub 2006/07/01. doi: 10.1126/science.112441016809538.
17. Luciani F, Sisson SA, Jiang H, Francis AR, Tanaka MM, The epidemiological fitness cost of drug resistance in Mycobacterium tuberculosis. Proc Natl Acad Sci U S A. 2009;106(34):14711–5. Epub 2009/08/27. doi: 10.1073/pnas.090243710619706556; PubMed Central PMCID: PMC2732896
18. Bottger EC, Springer B, Tuberculosis: drug resistance, fitness, and strategies for global control. Eur J Pediatr. 2008;167(2):141–8. Epub 2007/11/08. doi: 10.1007/s00431-007-0606-917987316.
19. Grandjean L, Gilman RH, Martin L, Soto E, Castro B, Lopez S, et al. Transmission of Multidrug-Resistant and Drug-Susceptible Tuberculosis within Households: A Prospective Cohort Study. PLoS Med. 2015;12(6):e1001843; discussion e. Epub 2015/06/24. doi: 10.1371/journal.pmed.100184326103620; PubMed Central PMCID: PMC4477882.
20. Becerra MC, Appleton SC, Franke MF, Chalco K, Arteaga F, Bayona J, et al. Tuberculosis burden in households of patients with multidrug-resistant and extensively drug-resistant tuberculosis: a retrospective cohort study. Lancet. 2011;377(9760):147–52. Epub 2010/12/15. doi: 10.1016/s0140-6736(10)61972-121145581.
21. Smith KL, Saini D, Bardarov S, Larsen M, Frothingham R, Gandhi NR, et al. Reduced virulence of an extensively drug-resistant outbreak strain of Mycobacterium tuberculosis in a murine model. PLoS ONE. 2014;9(4):e94953. Epub 2014/04/16. doi: 10.1371/journal.pone.009495324733050; PubMed Central PMCID: PMC3986381.
22. Naidoo CC, Pillay M, Increased in vitro fitness of multi- and extensively drug-resistant F15/LAM4/KZN strains of Mycobacterium tuberculosis. Clin Microbiol Infect. 2014;20(6):O361–9. Epub 2013/10/15. doi: 10.1111/1469-0691.1241524118525.
23. Tostmann A, Kik SV, Kalisvaart NA, Sebek MM, Verver S, Boeree MJ, et al. Tuberculosis transmission by patients with smear-negative pulmonary tuberculosis in a large cohort in the Netherlands. Clin Infect Dis. 2008;47(9):1135–42. Epub 2008/10/01. doi: 10.1086/59197418823268.
24. Behr MA, Warren SA, Salamon H, Hopewell PC, Ponce de Leon A, Daley CL, et al. Transmission of Mycobacterium tuberculosis from patients smear-negative for acid-fast bacilli. Lancet. 1999;353(9151):444–9. Epub 1999/02/16. 9989714.
25. Cegielski JP, Dalton T, Yagui M, Wattanaamornkiet W, Volchenkov GV, Via LE, et al. Extensive drug resistance acquired during treatment of multidrug-resistant tuberculosis. Clin Infect Dis. 2014;59(8):1049–63. Epub 2014/07/25. doi: 10.1093/cid/ciu57225057101; PubMed Central PMCID: PMC4184341.
26. Falzon D, Gandhi N, Migliori GB, Sotgiu G, Cox H, Holtz TH, et al. Resistance to fluoroquinolones and second-line injectable drugs: impact on MDR-TB outcomes. The European respiratory journal: official journal of the European Society for Clinical Respiratory Physiology. 2012:1–24. doi: 10.1183/09031936.0013471223100499.
27. Chiang CY, Enarson DA, Yu MC, Bai KJ, Huang RM, Hsu CJ, et al. Outcome of pulmonary multidrug-resistant tuberculosis: a 6-yr follow-up study. Eur Respir J. 2006;28(5):980–5. Epub 2006/07/14. doi: 10.1183/09031936.06.0012570516837502.
28. Pym AS, Diacon AH, Tang SJ, Conradie F, Danilovits M, Chuchottaworn C, et al. Bedaquiline in the treatment of multidrug- and extensively drug-resistant tuberculosis. Eur Respir J. 2015. Epub 2015/12/10. doi: 10.1183/13993003.00724–201526647431.
29. Guglielmetti L, Le Dû D, Jachym M, Henry B, Martin D, Caumes E, et al. Compassionate use of bedaquiline for the treatment of multidrug-resistant and extensively drug-resistant tuberculosis: interim analysis of a French cohort. Clinical infectious diseases: an official publication of the Infectious Diseases Society of America. 2015;60:188–94. doi: 10.1093/cid/ciu78625320286.
30. Ndjeka N, Conradie F, Schnippel K, Hughes J, Bantubani N, Ferreira H, 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(8):979–85. Epub 2015/07/15. doi: 10.5588/ijtld.14.094426162365.
31. Franke MF, Appleton SC, Bayona J, Arteaga F, Palacios E, Llaro K, et al. Risk factors and mortality associated with default from multidrug-resistant tuberculosis treatment. Clin Infect Dis. 2008;46(12):1844–51. Epub 2008/05/09. doi: 10.1086/58829218462099; PubMed Central PMCID: PMC2577177.
32. Sanchez-Padilla E, Marquer C, Kalon S, Qayyum S, Hayrapetyan A, Varaine F, et al. Reasons for defaulting from drug-resistant tuberculosis treatment in Armenia: a quantitative and qualitative study. Int J Tuberc Lung Dis. 2014;18(2):160–7. Epub 2014/01/17. doi: 10.5588/ijtld.13.036924429307.
33. Gelmanova IY, Ahmad Khan F, Becerra MC, Zemlyanaya NA, Unakova IA, Andreev YG, et al. Low rates of recurrence after successful treatment of multidrug-resistant tuberculosis in Tomsk, Russia. Int J Tuberc Lung Dis. 2015;19(4):399–405. Epub 2015/04/11. doi: 10.5588/ijtld.14.041525859994.
34. Kurbatova E, Gammino VM, Bayona J, Becerra MC, Danilovitz M, Falzon D, et al. Predictors of sputum culture conversion among patients treated for multidrug-resistant tuberculosis. International Journal of Tuberculosis and Lung Disease. 2012;16:1335–43. doi: 10.5588/ijtld.11.081123107633.
35. Shah NS, Pratt R, Armstrong L, Robison V, Castro KG, Cegielski JP, Extensively drug-resistant tuberculosis in the United States, 1993–2007. Jama. 2008;300(18):2153–60. Epub 2008/11/13. doi: 10.1001/jama.300.18.215319001626.
36. 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. doi: 10.1371/journal.pmed.100130022952439.
37. Dodd PJ, Knight GM, Lawn SD, Corbett EL, White RG, Predicting the long-term impact of antiretroviral therapy scale-up on population incidence of tuberculosis. PLoS ONE. 2013;8(9):e75466. Epub 2013/09/27. doi: 10.1371/journal.pone.007546624069418; PubMed Central PMCID: PMC3775764.
38. World Health Organization. WHO treatment guidelines for drug-resistant tuberculosis: 2016 update. Geneva: 2016.