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Bedaquiline for the treatment of drug-resistant tuberculosis

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References

  • Belard S, Janssen S, Osbak KK, et al. Limited access to drugs for resistant tuberculosis: a call to action. J Public Health (Oxf) 2014. [Epub ahead of print]
  • WHO. Global tuberculosis report 2014. Available from: http://apps.who.int/iris/bitstream/10665/137094/1/9789241564809_eng.pdf?ua=1 [Last accessed on 18 January 2015]
  • Calligaro GL, Moodley L, Symons G, et al. The medical and surgical treatment of drug-resistant tuberculosis. J Thorac Dis 2014;6(3):186-95
  • Sotgiu G, Mauch V, Migliori GB, et al. Evidence-based, agreed-upon health priorities to remedy the tuberculosis patient’s economic disaster. Eur Respir J 2014;43(6):1563-6
  • Diel R, Rutz S, Castell S, et al. Tuberculosis: cost of illness in Germany. Eur Respir J 2012;40(1):143-51
  • 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(1):169-79
  • 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(1):156-68
  • Sotgiu G, Pontali E, Migliori GB. Linezolid to treat MDR-/XDR-tuberculosis: available evidence and future scenarios. Eur Respir J 2015;45(1):25-9
  • Garcia-Prats AJ, Rose PC, Hesseling AC, et al. Linezolid for the treatment of drug-resistant tuberculosis in children: a review and recommendations. Tuberculosis (Edinb) 2014;94(2):93-104
  • 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(6):1430-42
  • Jindani A, Harrison TS, Nunn AJ, et al. High-dose rifapentine with moxifloxacin for pulmonary tuberculosis. N Engl J Med 2014;371(17):1599-608
  • Merle CS, Fielding K, Sow OB, et al. A four-month gatifloxacin-containing regimen for treating tuberculosis. N Engl J Med 2014;371(17):1588-98
  • Blair HA, Scott LJ. Delamanid: a review of its use in patients with multidrug-resistant tuberculosis. Drugs 2015;75(1):91-100
  • Sotgiu G, Pontali E, Centis R, et al. Delamanid (OPC-67683) for treatment of multi-drug-resistant tuberculosis. Expert Rev Anti Infect Ther 2015;13(3):305-15
  • Johnson & Johnson. SIRTURO® (bedaquiline) receives conditional approval in the European Union for the treatment of multi-drug resistant tuberculosis. Available from: www.investor.jnj.com/releasedetail.cfm?ReleaseID=831021 [Last accessed on 28 April 2014]
  • Lakshmanan M, Xavier AS. Bedaquiline - The first ATP synthase inhibitor against multi drug resistant tuberculosis. J Young Pharm 2013;5(4):112-15
  • Zumla AI, Gillespie SH, Hoelscher M, et al. New antituberculosis drugs, regimens, and adjunct therapies: needs, advances, and future prospects. Lancet Infect Dis 2014;14(4):327-40
  • Chahine EB, Karaoui LR, Mansour H. Bedaquiline: a novel diarylquinoline for multidrug-resistant tuberculosis. Ann Pharmacother 2014;48(1):107-15
  • Leibert E, Danckers M, Rom WN. New drugs to treat multidrug-resistant tuberculosis: the case for bedaquiline. Ther Clin Risk Manag 2014;10:597-602
  • Koul A, Dendouga N, Vergauwen K, et al. Diarylquinolines target subunit c of mycobacterial ATP synthase. Nat Chem Biol 2007;3(6):323-4
  • Haagsma AC, Abdillahi-Ibrahim R, Wagner MJ, et al. Selectivity of TMC207 towards mycobacterial ATP synthase compared with that towards the eukaryotic homologue. Antimicrob Agents Chemother 2009;53(3):1290-2
  • Andries K, Gevers T, Lounis N. Bactericidal potencies of new regimens are not predictive of their sterilizing potencies in a murine model of tuberculosis. Antimicrob Agents Chemother 2010;54(11):4540-4
  • Ibrahim M, Andries K, Lounis N, et al. Synergistic activity of R207910 combined with pyrazinamide against murine tuberculosis. Antimicrob Agents Chemother 2007;51(3):1011-15
  • Lounis N, Veziris N, Chauffour A, et al. Combinations of R207910 with drugs used to treat multidrug-resistant tuberculosis have the potential to shorten treatment duration. Antimicrob Agents Chemother 2006;50(11):3543-7
  • Lounis N, Gevers T, Van Den Berg J, et al. Impact of the interaction of R207910 with rifampin on the treatment of tuberculosis studied in the mouse model. Antimicrob Agents Chemother 2008;52:3568-72
  • Lanoix JP, Betoudji F, Nuermberger E. Novel regimens identified in mice for treatment of latent tuberculosis infection in contacts of patients with multidrug-resistant tuberculosis. Antimicrob Agents Chemother 2014;58(4):2316-21
  • Veziris N, Ibrahim M, Lounis N, et al. A once-weekly R207910-containing regimen exceeds activity of the standard daily regimen in murine tuberculosis. Am J Respir Crit Care Med 2009;179(1):75-9
  • Dhillon J, Andries K, Phillips PP, et al. Bactericidal activity of the diarylquinoline TMC207 against Mycobacterium tuberculosis outside and within cells. Tuberculosis (Edinb) 2010;90(5):301-5
  • Wallis RS, Jakubiec W, Mitton-Fry M, et al. Rapid evaluation in whole blood culture of regimens for XDR-TB containing PNU-100480 (sutezolid), TMC207, PA-824, SQ109, and pyrazinamide. PLoS One 2012;7(1):e30479
  • Rouan MC, Lounis N, Gevers T, et al. Pharmacokinetics and pharmacodynamics of TMC207 and its N-desmethyl metabolite in a murine model of tuberculosis. Antimicrob Agents Chemother 2012;56(3):1444-51
  • Ibrahim M, Truffot-Pernot C, Andries K, et al. Sterilizing activity of R207910 (TMC207)-containing regimens in the murine model of tuberculosis. Am J Respir Crit Care Med 2009;180(6):553-7
  • Tasneen R, Li SY, Peloquin CA, et al. Sterilizing activity of novel TMC207- and PA-824-containing regimens in a murine model of tuberculosis. Antimicrob Agents Chemother 2011;55(12):5485-92
  • Veziris N, Ibrahim M, Lounis N, et al. Sterilizing activity of second-line regimens containing TMC207 in a murine model of tuberculosis. PLoS One 2011;6(3):e17556
  • Zhang T, Li SY, Williams KN, et al. Short-course chemotherapy with TMC207 and rifapentine in a murine model of latent tuberculosis infection. Am J Respir Crit Care Med 2011;184(6):732-7
  • Svensson EM, Murray S, Karlsson MO, et al. Rifampicin and rifapentine significantly reduce concentrations of bedaquiline, a new anti-TB drug. J Antimicrob Chemother 2014. [Epub ahead of print]
  • Winter H, Egizi E, Murray S, et al. Evaluation of the pharmacokinetic interaction between repeated doses of rifapentine or rifampin and a single dose of bedaquiline in healthy adult subjects. Antimicrob Agents Chemother 2015;59(2):1219-24
  • Huitric E, Verhasselt P, Koul A, et al. Rates and mechanisms of resistance development in Mycobacterium tuberculosis to a novel diarylquinoline ATP synthase inhibitor. Antimicrob Agents Chemother 2010;54(3):1022-8
  • 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(8):2853-6
  • Huitric E, Verhasselt P, Andries K, et al. In vitro antimycobacterial spectrum of a diarylquinoline ATP synthase inhibitor. Antimicrob Agents Chemother 2007;51(11):4202-4
  • Matteelli A, Carvalho AC, Dooley KE, et al. TMC207: the first compound of a new class of potent anti-tuberculosis drugs. Future Microbiol 2010;5(6):849-58
  • Chan B, Khadem TM, Brown J. A review of tuberculosis: focus on bedaquiline. Am J Health Syst Pharm 2013;70(22):1984-94
  • Dooley KE, Park JG, Swindells S, et al. Safety, tolerability, and pharmacokinetic interactions of the antituberculous agent TMC207 (bedaquiline) with efavirenz in healthy volunteers: AIDS Clinical Trials Group Study A5267. J Acquir Immune Defic Syndr 2012;59(5):455-62
  • 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(11):6406-12
  • Sirturo, Sirturo full prescribing information. 2013. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/204384s000lbl.pdf
  • Haxaire M. Phase 2 open-label trial of TMC207 in an MDR-TB treatment regimen. In: 42nd Union World Conference on Lung Health, Lille, France; 2011
  • Rustomjee R, Diacon AH, Allen J, et al. Early bactericidal activity and pharmacokinetics of the diarylquinoline TMC207 in treatment of pulmonary tuberculosis. Antimicrob Agents Chemother 2008;52(8):2831-5
  • Diacon AH, Dawson R, von Groote-Bidlingmaier F, et al. 14-day bactericidal activity of PA-824, bedaquiline, pyrazinamide, and moxifloxacin combinations: a randomised trial. Lancet 2012;380(9846):986-93
  • Diacon AH, Dawson R, Von Groote-Bidlingmaier F, et al. Randomized dose-ranging study of the 14-day early bactericidal activity of bedaquiline (TMC207) in patients with sputum microscopy smear-positive pulmonary tuberculosis. Antimicrob Agents Chemother 2013;57(5):2199-203
  • Diacon AH, Pym A, Grobusch M, et al. The diarylquinoline TMC207 for multidrug-resistant tuberculosis. N Engl J Med 2009;360(23):2397-405
  • Diacon AH, Donald PR, Pym A, et al. Randomized pilot trial of eight weeks of bedaquiline (TMC207) treatment for multidrug-resistant tuberculosis: long-term outcome, tolerability, and effect on emergence of drug resistance. Antimicrob Agents Chemother 2012;56(6):3271-6
  • Diacon AH, Pym A, Grobusch MP, et al. Multidrug-resistant tuberculosis and culture conversion with bedaquiline. N Engl J Med 2014;371(8):723-32
  • Visser BJ, van Vugt M, Grobusch MP. Malaria: an update on current chemotherapy. Expert Opin Pharmacother 2014;15(15):2219-54
  • FDA; Highlights of prescribing information. Available from: www.accessdata.fda.gov/drugsatfda_docs/label/2012/204384s000lbl.pdf [Last accessed on 18 January 2015]
  • 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
  • Van Deun A, Maug AK, Salim MA, et al. Short, highly effective, and inexpensive standardized treatment of multidrug-resistant tuberculosis. Am J Respir Crit Care Med 2010;182(5):684-92
  • Resist-tb. DR-TB clinical trial progress report. Available from: www.resisttb.org/ [Last accessed on 18 January 2015]
  • Jenkins HE, Tolman AW, Yuen CM, et al. Incidence of multidrug-resistant tuberculosis disease in children: systematic review and global estimates. Lancet):2014;383(9928):1572-9
  • Zignol M, Sismanidis C, Falzon D, et al. Multidrug-resistant tuberculosis in children: evidence from global surveillance. Eur Respir J 2013;42(3):701-7
  • Schaaf HS, Garcia-Prats AJ, Hesseling AC, et al. Managing multidrug-resistant tuberculosis in children: review of recent developments. Curr Opin Infect Dis 2014;27(3):211-19
  • Poorana Ganga Devi NP, Swaminathan S. Drug-resistant tuberculosis: pediatric guidelines. Curr Infect Dis Rep 2013;15(5):356-63
  • Thee S, Detjen A, Wahn U, et al. Pyrazinamide serum levels in childhood tuberculosis. Int J Tuberc Lung Dis 2008;12(9):1099-101
  • Thee S, Detjen A, Wahn U, et al. Rifampicin serum levels in childhood tuberculosis. Int J Tuberc Lung Dis 2009;13(9):1106-11
  • Thee S, Garcia-Prats AJ, McIlleron HM, et al. Pharmacokinetics of ofloxacin and levofloxacin for prevention and treatment of multidrug-resistant tuberculosis in children. Antimicrob Agents Chemother 2014;58(5):2948-51
  • Thee S, Garcia-Prats AJ, Draper HR, et al. Pharmacokinetics and safety of moxifloxacin in children with multidrug-resistant tuberculosis. Clin Infect Dis 2015;60(4):549-56
  • CDC. Provisional CDC guidelines for the use and safety monitoring of bedaquiline fumarate (sirturo) for the treatment of multidrug-resistant tuberculosis. MMWR 2013;62(9
  • IMPAACT. IMPAACT Studies in Development. http://impaactnetwork.org/studies/developing.asp [Last accessed on 23 April 2014]
  • WHO. Interim guidance. Available from: www.who.int/mediacentre/news/notes/2013/bedaquiline_mdr_tb_20130613/en/ [Last accessed on 15 January 2015]
  • CDC. 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(RR-09):1-12
  • Migliori GB, Lienhardt C, Weyer K, et al. Ensuring rational introduction and responsible use of new TB tools: outcome of an ERS multisector consultation. Eur Respir J 2014;44(6):1412-17
  • WHO. Policy implementation package for new TB drug introduction. Available from: www.who.int/tb/PIPnewTBdrugs.pdf [Last accessed on 09 February 2015]
  • Blasi F, Dara M, van der Werf MJ, et al. Supporting TB clinicians managing difficult cases: the ERS/WHO Consilium. Eur Respir J 2013;41(3):491-4
  • D’Ambrosio L, Tadolini M, Dupasquier S, et al. ERS/WHO tuberculosis consilium: reporting of the initial 10 cases. Eur Respir J 2014;43(1):286-9
  • Horsburgh CRJr, Haxaire-Theeuwes M, Lienhardt C, et al. Compassionate use of and expanded access to new drugs for drug-resistant tuberculosis. Int J Tuberc Lung Dis 2013;17(2):146-52
  • Conradie F, Meintjes G, Hughes J, et al. Clinical access to Bedaquiline Programme for the treatment of drug-resistant tuberculosis. S Afr Med J 2014;104(3):164-6
  • STOP-TB-Partbership. Global drug facility. Availablr from http://stoptb.org/gdf/ [Last accessed on 15 Janurary 2015]
  • WHO. Cost-effectiveness of introducing bedaquiline in MDR-TB regimens - a explanatory analysis. Available from: www.who.int/tb/challenges/mdr/CEA_bdqreport_final.pdf?ua=1 [Last accessed on 15 January 2015]
  • WHO. The use of bedaquiline in the treatment of multi-drug resistant tuberculosis. Available from: www.who.int/tb/challenges/mdr/Report_EGM_BDQ_2013.pdf?ua=1 [Last accessed on 15 January 2015]
  • Tiberi S, De Lorenzo S, Centis R, et al. Bedaquiline in MDR/XDR-TB cases: first experience on compassionate use. Eur Respir J 2014;43(1):289-92
  • van Halsema C, Humphreys S, Bonington A. Extensively drug-resistant tuberculosis: early access to bedaquiline for a UK patient. Eur Respir J 2014;43(1):292-4
  • Danckers M, Lesko MB, Adamson R, et al. Compassionate use of bedaquiline in the treatment of pulmonary XDR-TB. Int J Tuberc Lung Dis 2014;18(12):1522-5
  • Udwadia ZF, Amale RA, Mullerpattan JB. Initial experience of bedaquiline use in a series of drug-resistant tuberculosis patients from India. Int J Tuberc Lung Dis 2014;18(11):1315-18
  • Guglielmetti L, Le Du 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 2014;60(2):188-94
  • Somoskovi A, Bruderer V, Homke R, et al. A mutation associated with clofazimine and bedaquiline cross-resistance in MDR-TB following bedaquiline treatment. Eur Respir J 2015;45(2):554-7
  • Hartkoorn RC, Uplekar S, Cole ST. Cross-resistance between clofazimine and bedaquiline through upregulation of MmpL5 in Mycobacterium tuberculosis. Antimicrob Agents Chemother 2014;58(5):2979-81
  • Andries K, Villellas C, Coeck N, et al. Acquired resistance of Mycobacterium tuberculosis to bedaquiline. PLoS One 2014;9(7):e102135
  • ClinicalTrials.gov. To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB. Available from: https://clinicaltrials.gov/ct2/show/results/NCT00910871?term=bedaquiline&phase=1&rank=1&sect=X4301256#othr [Last accessed on 12 January 2015]
  • Koul A, Vranckx L, Dhar N, et al. Delayed bactericidal response of Mycobacterium tuberculosis to bedaquiline involves remodelling of bacterial metabolism. Nat Commun 2014;5:3369
  • Reddy VM, Einck L, Andries K, et al. In vitro interactions between new antitubercular drug candidates SQ109 and TMC207. Antimicrob Agents Chemother 2010;54(7):2840-6
  • Shang S, Shanley CA, Caraway ML, et al. Activities of TMC207, rifampin, and pyrazinamide against Mycobacterium tuberculosis infection in guinea pigs. Antimicrob Agents Chemother 2011;55(1):124-31
  • Williams K, Minkowski A, Amoabeng O, et al. Sterilizing activities of novel combinations lacking first- and second-line drugs in a murine model of tuberculosis. Antimicrob Agents Chemother 2012;56(6):3114-20
  • TMC207-TiDP13-C110: interaction Study With Lopinavir/Ritonavir in Healthy Volunteer. Available from: https://clinicaltrials.gov/ct2/show/NCT00828529
  • TMC207-TiDP13-C117: interaction Study in Human Immunodeficiency Virus-type 1 (HIV-1) Infected Patients With Nevirapine (NVP). Available from: https://clinicaltrials.gov/ct2/show/NCT00910806
  • Safety, Tolerability, and Effect of TMC207 and Efavirenz in Healthy Volunteers. Available from: https://clinicaltrials.gov/ct2/show/NCT00992069
  • A Study of TMC207 in patients with moderately impaired hepatic function. Available from: https://clinicaltrials.gov/ct2/show/NCT01012284
  • TMC207TBC1003 - A study in healthy volunteers investigating the effect of single-dose TMC207 on the QT/QTc Interval Under Fed Conditions. Available from: https://clinicaltrials.gov/ct2/show/NCT01291563
  • A study to determine the relative oral bioavailability of single dose administration of TMC207, under fed and fasted conditions in healthy participants. Available from: https://clinicaltrials.gov/ct2/show/NCT00946842
  • TMC207 +/- Rifabutin/Rifampin. Available from: https://clinicaltrials.gov/ct2/show/NCT01341184
  • A study to assess the relative bioavailability of TMC207 following single-dose administrations of two pediatric formulations in healthy adult participants. Available from: https://clinicaltrials.gov/ct2/show/NCT01803373
  • PK interaction between rifapentine or rifampicin and a single dose of TMC207 in Healthy Subjects (TMC207-CL002). Available from: https://clinicaltrials.gov/ct2/show/NCT02216331
  • TMC207-C202: study to evaluate bactericidal activity of multiple oral doses of TMC207 in subjects with sputum-smear positive tuberculosis. Available from: https://www.clinicaltrials.gov/ct2/show/NCT00523926
  • Evaluation of early bactericidal activity in pulmonary tuberculosis with(J-M-Pa-Z). Available from: https://clinicaltrials.gov/ct2/show/NCT01215851
  • Evaluation of early bactericidal activity in pulmonary tuberculosis. Available from: https://clinicaltrials.gov/ct2/show/NCT01215110
  • Evaluation of early bactericidal activity in pulmonary tuberculosis with clofazimine (C)-TMC207 (J)-PA-824 (Pa)-Pyrazinamide (Z) (NC-003). Available from: https://clinicaltrials.gov/ct2/show/NCT01691534
  • TMC207-TiDP13-C208: anti-bacterial activity, safety, and tolerability of TMC207 in participants with multi-drug resistant mycobacterium tuberculosis (MDR-TB). Available from: https://clinicaltrials.gov/ct2/show/NCT00449644
  • A Phase 2 Open label partially randomized trial to evaluate the efficacy, safety and tolerability of combinations of bedaquiline, moxifloxacin, PA-824 and pyrazinamide in adult subjects with drug-sensitive or multi drug-resistant pulmonary tuberculosis. (NC-005). Available from: https://clinicaltrials.gov/ct2/show/NCT02193776

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