Bedaquiline: A Novel Diarylquinoline for Multidrug-Resistant Tuberculosis

Annals of Pharmacotherapy

Volumn 48, Issue 1, 2014, Pages 107-115

  Chahine, Elias B ^a   Karaoui, Lamis R ^b   Mansour, Hanine ^b  

^a PALM BEACH ATLANTIC UNIVERSITY   (United States)

^b LEBANESE AMERICAN UNIVERSITY   (Lebanon)

Author keywords

antimycobacterial; bedaquiline; diarylquinoline; MDR TB; multi drug resistant tuberculosis

Indexed keywords

ANTIRETROVIRUS AGENT; BEDAQUILINE; CYTOCHROME P450 3A4; EFAVIRENZ; KETOCONAZOLE; LOPINAVIR PLUS RITONAVIR; NEVIRAPINE; RIFAMYCIN;

ACNE; ARTHRALGIA; DRUG EFFECT; DRUG EFFICACY; DRUG INDICATION; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; HEARING IMPAIRMENT; HUMAN; MULTIDRUG RESISTANT TUBERCULOSIS; MYCOBACTERIUM TUBERCULOSIS; NAUSEA; PHARMACODYNAMICS; PRIORITY JOURNAL; QT PROLONGATION; REVIEW;

ANTIMYCOBACTERIAL; BEDAQUILINE; DIARYLQUINOLINE; MDR-TB; MULTI-DRUG RESISTANT TUBERCULOSIS;

ANIMALS; ANTITUBERCULAR AGENTS; DIARYLQUINOLINES; DRUG INTERACTIONS; HUMANS; MYCOBACTERIUM TUBERCULOSIS; TUBERCULOSIS, MULTIDRUG-RESISTANT;

EID: 84892866241     PISSN: 10600280     EISSN: 15426270     Source Type: Journal    
DOI: 10.1177/1060028013504087     Document Type: Review

References (42)

1. World Health Organization. Tuberculosis fact sheets. http://www.who.int/mediacentre/factsheets/fs104/en/. Accessed May 7, 2012.
2. World Health Organization. Multidrug-resistant tuberculosis (MDR-TB): 2012 update. http://www.who.int/tb/publications/MDRFactSheet2012.pdf. Accessed May 7, 2013.
3. Singh H,Natt NK,Garewal N,Pugazhenthan T.Bedaquiline: a new weapon against MDR and XDR-TB.Int J Basic Clin Pharmacol. 2013;2:96-102.
4. Sotgiu G,Ferrara G,Matteelli A, et al.Epidemiology and clinical management of XDR-TB: a systematic review by TBNET.Eur Respir J. 2009;33:871-881.
5. Diel R,Rutz S,Castell S,Schaberg T.Tuberculosis: cost of illness in Germany.Eur Respir J. 2012;40:143-151.
6. Loddenkemper R,Sotgiu G,Mitnick CD.Cost of tuberculosis in the era of multidrug resistance: will it become unaffordable?.Eur Respir J. 2012;40:9-11.
7. Jacobson KR,Tierney DB,Jeon CY,Mitnick CD,Murray MB.Treatment outcomes among patients with extensively drug-resistant tuberculosis:systematic review and meta-analysis.Clin Infect Dis. 2010;51:6-14.
8. Gandhi NR,Moll A,Sturm AW, et al.Extensively drug-resistant tuberculosis as a cause of death in patients coinfected with tuberculosis and HIV in a rural area of South Africa.Lancet. 2006;368:1575-1580.
9. Mitchison AD.Shortening the treatment of tuberculosis: a new diarylquinoline drug promises faster treatment for tuberculosis.Nat Biotechnol. 2005;23:187-188.
10. Titusville, NJ: Janssen Therapeutics; 2012:.
11. Matteelli A,Carvahlo AC,Dooley KE,Kritski A.TMC207: the first compound of a new class of potent anti-tuberculosis drugs.Future Microbiol. 2010;5:849-858.
12. Protopopova M,Bogatcheva E,Nikonenko B, et al.In search of new cures for tuberculosis.Med Chem. 2007;3:301-316.
13. FDA news release [untitled]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm333695.htm. Accessed May 7, 2013.
14. Bedaquiline clinical trials. http://www.clinicaltrials.gov/ct2/results?term=bedaquiline. Accessed May 7, 2013.
15. Gumbo TGoodman and Gilman's The Pharmacological Basis of Therapeutics. 207 (R207910). In: BrutenLLChabnerBAKnollmannBC eds. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 12th ed.New York, NY: McGraw Hill; 2011:1561.Bruten LLChabner BAKnollmann BC, ed. New York, NY: McGraw Hill; 2011:1561.
16. Bedaquiline: compound summary. http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=5388906&loc=ec_rcs. Accessed May 22, 2013.
17. Bedaquiline fumarate: compound summary. http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=56841861. Accessed May 18, 2013.
18. Andries K,Verhasselt P,Guillemont J, et al.A diarylquinoline drug active on the ATP synthase of Mycobacterium tuberculosis.Science. 2005;307:223-227.
19. Huitric E,Verhasselt P,Andries K,Hoffner E.In vitro antimycobacterial spectrum of a diarylquinoline ATP synthase inhibitor.Antimicrob Agents Chemother. 2007;51:4202-4204.
20. Ji B,Chauffour A,Andries K,Jarlier V.Bactericidal activities of R207910 and other newer antimicrobial agents against Mycobacterium leprae in mice.Antimicrob Agents Chemother. 2006;50:1558-1560.
21. Petrella S,Cambau E,Chauffour A,Andries K,Jarlier V,Sougakoff W.Genetic basis for natural and acquired resistance to the diarylquinoline R207910 in mycobacteria.Antimicrob Agents Chemother. 2006;50:2853-2856.
22. Cole ST,Alzari PM.TB: a new target, a new drug.Science. 2005;307:214-215.
23. Diacon AH,Pym A,Grobusch M, et al.The diarylquinoline TMC207 for multidrug-resistant tuberculosis.N Engl J Med. 2009;360:2397-2405.
24. 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;56:1444-1451.
25. Leibert E,Rom WN.New drugs and regimens for treatment of TB.Expert Rev Anti Infect Ther. 2010;8:801-813.
26. 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;56:3271-3276.
27. 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;57:2199-2203.
28. 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;52:2831-2835.
29. Lounis N,Veziris N,Chauffour A,Truffot-Pernot C,Andries K,Jarlier V.Combinations of R207910 with drugs used to treat multidrug-resistant tuberculosis have the potential to shorten treatment duration.Antimicrob Agents Chemother. 2006;50:3543-3547.
30. Dhillon J,Andries K,Phillips PJP,Mitchison DA.Bactericidal activity of the diarylquinoline TMC207 against Mycobacterium tuberculosis outside and within cells.Tuberculosis. 2010;90:301-305.
31. Ibrahim M,Truffot-Pernot C,Andries K,Jarlier V,Veziris N.Sterilizing activity of R207910 (TMC207)-containing regimens in the murine model of tuberculosis.Am J Respir Crit Care Med. 2009;180:553-557.
32. Ibrahim M,Andries K,Lounis N, et al.Synergistic activity of R207910 combined with pyrazinamide against murine tuberculosis.Antimicrob Agents Chemother. 2007;51:1011-1015.
33. 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;380:986-993.
34. McNeelyDFDiaconAHPymA. TMC-207 versus placebo plus OBT for the treatment of MDR-TB: a prospective clinical trial. Oral Presentation at: 41st Union World Conference on Lung Health;November 13, 2010; Berlin, Germany. http://uwclh.conference2web.com/content/187?from_view=all&view_address=search%3Dmcneeley%26events%3D1%26groups%3D1%26sessions%3D35. Accessed May 30, 2013.
35. HaxaireM, TMC207 Team, DiaconAH. Use of bedaquiline (TMC207) for the treatment of MDR-TB. Data presented at: 43rd Union World Conference on Lung Health; November 16, 2012; Kuala Lumpur, Malaysia. http://uwclh.conference2web.com/content/2168/details?from_view=all&view_address=search%3Dhaxaire%26events%3D3%26sessions%3D301. Accessed May 30, 2013.
36. HaxaireM, TMC207 Team, DiaconAH. Phase 2 open-label trial of TMC207 in an MDR-TB treatment regimen. Data presented at: 42nd Union World Conference on Lung Health;October 30, 2011; Lille, France. http://uwclh.conference2web.com/content/1108/details?from_view=all&view_address=search%3Dhaxaire%26events%3D2. Accessed May 30, 2013.
37. Anti-Infective Drugs Advisory Committee Meeting Briefing Document TMC207 (bedaquiline) Treatment of Patients with MDR-TB. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM329260.pdf. Accessed May 31, 2013.
38. 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;59:455-462.
39. Svensson EM,Aweeka F,Park JG,Marzan F,Dooley KE,Karlsson MO.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;57:2780-2787.
40. Centers for Disease Control and Prevention. Reported Tuberculosis in the United States, 2011. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention; 2012. http://www.cdc.gov/tb/statistics/reports/2011. Accessed May 7, 2013.
41. Cohen J.Approval of novel TB drug celebrated-with restraint.Science. 2013;339:130.
42. Red Book Online. http://www.redbook.com/redbook/online. Accessed September 13, 2013.