Bibliography
- Sotgiu G, Migliori GB. Facing multi-drug resistant tuberculosis. Pulm Pharmacol Ther 2014;32:144-8
- Fox W, Ellard GA, Mitchison DA. Studies on the treatment of tuberculosis undertaken by the British Medical Research Council tuberculosis units, 1946-1986, with relevant subsequent publications. Int J Tuberc Lung Dis 1999;3(10 Suppl 2):S231-79
- Leibert E, Rom WN. New drugs and regimens for treatment of TB. Expert Rev Anti Infect Ther 2010;8:801-13
- Piscitelli SC, Gallicano KD. Interactions among drugs for HIV and opportunistic infections. N Engl J Med 2001;344:984-96
- WHO. Guidance for national tuberculosis programmes on the management of tuberculosis in children. World Health Organization, Geneva, 2014. Available from: http://apps.who.int/iris/bitstream/10665/137094/1/9789241564809_eng.pdf?ua=1 [Last accessed 6 May 2015]
- Schaaf HS, Marais BJ, Whitelaw A, et al. Culture-confirmed childhood tuberculosis in Cape Town, South Africa: a review of 596 cases. BMC Infect Dis 2007;7:140
- Sloan DJ, Davies GR, Khoo SH. Recent advances in tuberculosis: new drugs and treatment regimens. Curr Respir Med Rev 2013;9:200-10
- Abubakar I, Zignol M, Falzon D, et al. Drug-resistant tuberculosis: time for visionary political leadership. Lancet Infect Dis 2013;13:529-39
- McGrath M, Gey van Pittius NC, et al. Mutation rate and the emergence of drug resistance in Mycobacterium tuberculosis. J Antimicrob Chemother 2014;69:292-302
- Dooley KE, Nuermberger EL, Diacon AH. Pipeline of drugs for related diseases: tuberculosis. Curr Opin HIV AIDS 2013;8:579-85
- Parida SK, Axelsson-Robertson R, Rao MV, et al. Totally drug-resistant tuberculosis and adjunct therapies. J Intern Med 2014;277(4):388-405
- WHO. Global tuberculosis report 2014. World Health Organization, Geneva, 2014. Available from: http://apps.who.int/iris/bitstream/10665/112360/1/9789241548748_eng.pdf [Last accessed 6 May 2014]
- Seddon JA, Perez-Velez CM, Schaaf HS, et al. On Behalf of the Sentinel Project on Pediatric Drug-Resistant Tuberculosis. Consensus statement on research definitions for drug-resistant tuberculosis in children. J Pediatric Infect Dis Soc 2013;2:100-9
- Calligaro GL, Moodley L, Symons G, et al. The medical and surgical treatment of drug-resistant tuberculosis. J Thorac Dis 2014;6:186-95
- Udwadia ZF, Amale RA, Ajbani KK, et al. Totally drug-resistant tuberculosis in India. Clin Infect Dis 2012;54:579-81
- Matteelli A, Roggi A, Carvalho AC. Extensively drug-resistant tuberculosis: epidemiology and management. Clin Epidemiol 2014;6:111-18
- Migliori GB, De Iaco G, Besozzi G, et al. First tuberculosis cases in Italy resistant to all tested drugs. Euro Surveill 2007;12:E070517.1
- 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;42:156-68
- van der Werf MJ, Kodmon C, Hollo V, et al. Drug resistance among tuberculosis cases in the European Union and European Economic Area, 2007 to 2012. Euro Surveill 2014;19:20733
- Orenstein EW, Basu S, Shah NS, et al. Treatment outcomes among patients with multidrug-resistant tuberculosis: systematic review and meta-analysis. Lancet Infect Dis 2009;9:153-61
- Pontali E, Matteelli A, Migliori GB. Drug-resistant tuberculosis. Curr Opin Pulm Med 2013;19:266-72
- Zumla AI, Gillespie SH, Hoelscher M, et al. New antituberculosis drugs, regimens, and adjunct therapies: needs, advances, and future prospects. Lancet Infect Dis 2014;14:327-40
- Nuermberger EL, Spigelman MK, Yew WW. Current development and future prospects in chemotherapy of tuberculosis. Respirology 2010;15:764-78
- Burman WJ. Rip Van Winkle wakes up: development of tuberculosis treatment in the 21st century. Clin Infect Dis 2010;50(Suppl 3):S165-72
- Kwon YS, Jeong BH, Koh WJ. Tuberculosis: clinical trials and new drug regimens. Curr Opin Pulm Med 2014;20:280-6
- Grosset JH, Singer TG, Bishai WR. New drugs for the treatment of tuberculosis: hope and reality. Int J Tuberc Lung Dis 2012;16:1005-14
- Park CK, Kwon YS. Respiratory review of 2014: tuberculosis and nontuberculous mycobacterial pulmonary disease. Tuberc Respir Dis (Seoul) 2014;77:161-6
- Ginsberg AM. Drugs in development for tuberculosis. Drugs 2010;70:2201-14
- Gothi D, Joshi JM. Resistant TB: newer drugs and community approach. Recent Pat Antiinfect Drug Discov 2011;6:27-37
- Villemagne B, Crauste C, Flipo M, et al. Tuberculosis: the drug development pipeline at a glance. Eur J Med Chem 2012;51:1-16
- Lakshmanan M, Xavier AS. Bedaquiline - The first ATP synthase inhibitor against multi drug resistant tuberculosis. J Young Pharm 2013;5:112-15
- Goel D. Bedaquiline: a novel drug to combat multiple drug-resistant tuberculosis. J Pharmacol Pharmacother 2014;5:76-8
- Tran SL, Cook GM. The F1Fo-ATP synthase of Mycobacterium smegmatis is essential for growth. J Bacteriol 2005;187:5023-8
- Haagsma AC, Podasca I, Koul A, et al. Probing the interaction of the diarylquinoline TMC207 with its target mycobacterial ATP synthase. PLoS ONE 2011;6:e23575
- Branco FS, Pinto AC, Boechat N. An update on the chemistry and medicinal chemistry of novel antimycobacterial compounds. Curr Top Med Chem 2013;13:2808-49
- 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
- Berney M, Hartman TE, Jacobs WRJr. A Mycobacterium tuberculosis cytochrome bd oxidase mutant is hypersensitive to bedaquiline. MBio 2014;5:e01275-14
- Andries K, Verhasselt P, Guillemont J, et al. A diarylquinoline drug active on the ATP synthase of Mycobacterium tuberculosis. Science 2005;307:223-7
- Rouan M-C, 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;56:1444-51
- 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;57:2199-203
- 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;52:2831-5
- Svensson EM, Murray S, Karlsson MO, Dooley KE. Rifampicin and rifapentine significantly reduce concentrations of bedaquiline, a new anti-TB drug. J Antimicrob Chemother 2015;70:1106-14
- Ramakrishnan K, Shenbagarathai R, Kavitha K, et al. Serum zinc and albumin levels in pulmonary tuberculosis patients with and without HIV. Jpn J Infect Dis 2008;61:202-4
- De Jonge MR, Koymans LHM, Guillemont JEG, et al. A computational model of the inhibition of Mycobacterium tuberculosis ATPase by a new drug candidate R207910. Proteins 2007;67:971-80
- Segala E, Sougakoff W, Nevejans-Chauffour A, et al. New mutations in the mycobacterial ATP synthase: new insights into the binding of the diarylquinoline TMC207 to the ATP synthase C-ring structure. Antimicrob Agents Chemother 2012;56:2326-34
- 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;50:2853-6
- 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;56:3271-6
- Hartkoorn RC, Uplekar S, Cole ST. Cross-resistance between clofazimine and bedaquiline through upregulation of MmpL5 in Mycobacterium tuberculosis. Antimicrob Agents Chemother 2014;58:2979-81
- Gupta S, Cohen KA, Winglee K, et al. Efflux inhibition with verapamil potentiates bedaquiline in Mycobacterium tuberculosis. Antimicrob Agents Chemother 2014;58:574-6
- 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;59:455-62
- Svensson EM, Aweeka F, Park JG, et al. Model-based estimates of the effects of efavirenz on bedaquiline pharmacokinetics and suggested dose adjustments for patients coinfected with HIV and tuberculosis. Antimicrob Agents Chemother 2013;57:2780-7
- Interim guidance on the use of bedaquiline to treat MDR-TB. Available from: www.who.int/tb/challenges/mdr/bedaquiline/en [Last accessed 10 May 2015]
- Barry CEIII. Unorthodox approach to the development of a new antituberculosis therapy. N Engl J Med 2009;360:2466-7
- Deoghare S. Bedaquiline: a new drug approved for treatment of multidrug-resistant tuberculosis. Indian J Pharmacol 2013;45:536-7
- Diacon AH, Pym A, Grobusch MP, et al. TMC207-C208 Study group. Multidrug-resistant tuberculosis and culture conversion with bedaquiline. N Engl J Med 2014;371:723-32
- Tiberi S, De Lorenzo S, Centis R, et al. Bedaquiline in MDR/XDR-TB cases: first experience on compassionate use. Eur Respir J 2014;43:289-92
- Treatment of patients with MDR-TB. Anti-infective drugs advisory committee meeting briefing document TMC207 (bedaquiline). Available from: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM329260.pdf [Last accessed 10 May 2015]
- Chahine EB, Karaoui LR, Mansour H. Bedaquiline: a novel diarylquinoline for multidrug-resistant tuberculosis. Ann Pharmacother 2014;48:107-15
- Provisional CDC guidelines for the use and safety monitoring of bedaquiline fumarate (Sirturo) for the treatment of multidrug-resistant tuberculosis. Available from: www.cdc.gov/mmwr/preview/mmwrhtml/rr6209a1.htm [Last accessed 10 May 2015]
- Wong EB, Cohen KA, Bishai WR. Rising to the challenge: new therapies for tuberculosis. Trends Microbiol 2013;21:493-501
- Goldenberg MM. Pharmaceutical approval update. PT 2013;38:150-2
- Mahajan R. Bedaquiline: first FDA-approved tuberculosis drug in 40 years. Int J Appl Basic Med Res 2013;3:1-2
- Cox EM. FDA accelerated approval letter to Janssen Research and Development. Food and Drug Administration, Washington, DC, 2012. Available from: www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/204384Orig1s000ltr.pdf [Last accessed 10 May 2015]
- Cox E, Laessig K. FDA approval of bedaquiline--the benefit-risk balance for drug-resistant tuberculosis. N Engl J Med 2014;371:689-91
- Diacon AH, Pym A, Grobusch M, et al. The diarylquinoline TMC207 for multidrug-resistant tuberculosis. N Engl J Med 2009;360:2397-405
- van Halsema C, Humphreys S, Bonington A. Extensively drug-resistant tuberculosis: early access to bedaquiline for a UK patient. Eur Respir J 2014;43:292-4
- FDA. Briefing package: TMC207 (bedaquiline). Treatment of patients with MDR-TB. Anti-Infective Drugs Advisory Committee Meeting Silver Spring, MD; November 28, 2012. Available from: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/anti-infectivedrugsadvisorycommittee/ucm329260.pdf [Last accessed 10 May 2015]
- Worley MV, Estrada SJ. Bedaquiline: a novel antitubercular agent for the treatment of multidrug-resistant tuberculosis. Pharmacotherapy 2014;34:1187-97
- 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:e17556
- Field SK, Fisher D, Jarand JM, et al. New treatment options for multidrug-resistant tuberculosis. Ther Adv Respir Dis 2012;6:255-68
- Xiaojin Li, Ujjini H, Manjunatha UH, et al. Synthesis and antitubercular activity of 7-(R)- and 7-(S)-methyl-2-nitro-6-(S)-(4-(trifluoromethoxy)benzyloxy)-6,7-dihydro-5H-imidazo[2,1-b][1,3]oxazines, analogues of PA-824. Bioorg Med Chem Lett 2009;18:2256-62
- Cole ST, Brosch R, Parkhill J, et al. Deciphering the biology of Mycobacterium tuberculosis from the complete genome sequence. Nature 1998;393:537-44
- Matsumoto M, Hashizume H, Tomishige T, et al. OPC-67683, a nitro-dihydro-imidazooxazole derivative with promising action against tuberculosis in vitro and in mice. PLoS Med 2006;3:e466
- No authors listed. OPC-67683. Tuberculosis (Edinb) 2008;88:132-3
- Xavier AS, Lakshmanan M. Delamanid: a new armor in combating drug-resistant tuberculosis. J Pharmacol Pharmacother 2014;5:222-4
- Mukherjee T, Boshoff H. Nitroimidazoles for the treatment of TB: past, present and future. Future Med Chem 2011;3:1427-1454.76
- Diacon AH, Dawson R, Hanekom M, et al. Early bactericidal activity of delamanid (OPC - 67683) in smear-positive pulmonary tuberculosis patients. Int J Tuberc Lung Dis 2011;15:949-54
- Diacon AH, Donald PR. The early bactericidal activity of antituberculosis drugs. Expert Rev Anti Infect Ther 2014;12:223-37
- Donald PR, Diacon AH. The early bactericidal activity of anti-tuberculosis drugs: a literature review. Tuberculosis (Edinb) 2008;88(Suppl 1):S75-83
- European Medicines Agency. Delamanid assessment report 2013. Available from: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002552/human_med_001699.jsp&mid=WC0b01ac058001d124 [Last accessed 10 May 2015]
- European Medicines Agency. Delamanid (Deltyba): summary of product characteristics. 2014. Available from: http://ec.europa.eu/health/documents/community-register/2014/20140428126881/anx_126881_en.pdf [Last accessed May 2015]
- Shimokawa Y, Sasahara K, Yoda N, et al. Delamanid does not inhibit or induce cytochrome p450 enzymes in vitro. Biol Pharm Bull 2014;37:1727-35
- Blair HA, Scott LJ. Delamanid: a review of its use in patients with multidrug-resistant tuberculosis. Drugs 2015;75:91-100
- Gler MT, Skripconoka V, Sanchez-Garavito E, et al. Delamanid for multidrug-resistant pulmonary tuberculosis. N Engl J Med 2012;366:2151-60
- Shin S, Furin J, Alcántara F. Hypokalemia among patients receiving treatment for multidrug-resistant tuberculosis. Chest 2004;125:974-80
- Skripconoka V, Danilovits M, Pehme L. Delamanid improves outcomes and reduces mortality in multidrug-resistant tuberculosis. Eur Respir J 2013;41:1393-400
- European medicines agency. Public summary of opinion on orphan designation. Media release. 15 Nov 2011. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2009/10/WC500006083.pdf [Last accessed 10 May 2015]
- Olaru ID, von Groote-Bidlingmaier F, Heyckendorf J, et al. Novel drugs against tuberculosis: a clinician’s perspective. Eur Respir J 2015;45:1119-31
- Ryan NJ, Lo JH. Delamanid: first global approval. Drugs 2014;74:1041-5
- Zhang Q, Liu Y, Tang S, et al. Clinical benefit of delamanid (OPC-67683) in the treatment of multidrug-resistant tuberculosis patients in China. Cell Biochem Biophys 2013;67:957-63
- Esposito S, D’Ambrosio L, Tadolini M, 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;44:811-15
- A phase 3 study assessing the safety and efficacy of bedaquiline plus PA-824 plus linezolid in subjects with drug resistant pulmonary tuberculosis. Available from: https://clinicaltrials.gov/ct2/show/record/NCT02333799 [Last accessed 10 May 2015]
- Pharmacokinetic study to evaluate anti-mycobacterial activity of TMC207 in combination with background regimen (BR) of multidrug resistant tuberculosis (MDR-TB) medications for treatment of children/adolescents pulmonary MDR-TB. Available from: https://clinicaltrials.gov/ct2/show/NCT02354014?term=studies+on+bedaquiline&rank=3 [Last accessed May 2015]
- 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;58:2316-23221; Erratum in: Antimicrob Agents Chemother 2015;59:1826
- Otsuka Pharmaceutical. Pharmacokinetic and safety trial to determine the appropriate dose for pediatric patients with multidrug resistant tuberculosis [NCT01856634]. Available from: http://clinicaltrials.gov/ct2/show/NCT01856634?term=NCT01856634&rank=1. [ Last accessed 10 May 2015]
- Otsuka Pharmaceutical. A 6-month safety, efficacy and pharmacokinetic trial of delamanid in pediatric patients with multidrug resistant tuberculosis [NCT01859923]. Available from: http://clinicaltrials.gov/ct2/show/NCT01859923?term=NCT01859923&rank=1. [Last accessed 10 May 2015]
- Diacon AH, Dawson R, von Groote-Bidlingmaier F, et al. Bactericidal activity of pyrazinamide and clofazimine alone and in combinations with pretomanid and bedaquiline. Am J Respir Crit Care Med 2015;191:943-53
- Dawson R, Diacon AH, Everitt D, et al. Efficiency and safety of the combination of moxifloxacin, pretomanid (PA-824), and pyrazinamide during the first 8 weeks of antituberculosis treatment: a phase 2b, open-label, partly randomised trial in patients with drug-susceptible or drug-resistant pulmonary tuberculosis. Lancet 2015;385:1738-47