New drugs and treatment regimens

Current Respiratory Medicine Reviews

Volumn 9, Issue 3, 2013, Pages 200-210

  Sloan, Derek J ^a   Davies, Geraint R ^a   Khoo, Saye H ^a  

^a ROYAL LIVERPOOL UNIVERSITY HOSPITAL   (United Kingdom)

Author keywords

Bedaquiline (TMC 207); Delamanid (OPC 67683); Gatifloxacin; Moxifluxacin; PA 824; Rifampicin; Rifapentine; Sterilising activity

Indexed keywords

6,7 DIHYDRO 2 NITRO 6 (4 TRIFLUOROMETHOXYBENZYLOXY) 5H IMIDAZO[2,1 B][1,3]OXAZINE; 7 (7 AMINO 7 METHYL 5 AZASPIRO[2.4]HEPTAN 5 YL) 6 FLUORO 1 (2 FLUOROCYCLOPROPYL) 1,4 DIHYDRO 8 METHOXY 4 OXO 3 QUINOLINECARBOXYLIC ACID; 8 METHOXYQUINOLONE DERIVATIVE; AMIKACIN; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; AZD 5847; BEDAQUILINE; BTZ 043; CAPREOMYCIN; CLOFAZIMINE; DELAMANID; ETHAMBUTOL; ETHYLENEDIAMINE DERIVATIVE; GATIFLOXACIN; ISONIAZID; KANAMYCIN; LINEZOLID; MOXIFLOXACIN; N (2 ADAMANTYL) N' GERANYLETHYLENEDIAMINE; NITROIMIDAZOLE DERIVATIVE; OXAZOLIDINONE DERIVATIVE; POSIZOLID; PYRAZINAMIDE; QUINOLONE DERIVATIVE; RIFAMPICIN; RIFAMYCIN; RIFAPENTINE; STREPTOMYCIN; SUTEZOLID; TUBERCULOSTATIC AGENT; UNCLASSIFIED DRUG; UNINDEXED DRUG;

ANTIMICROBIAL ACTIVITY; ARTICLE; BONE MARROW SUPPRESSION; COMBINATION CHEMOTHERAPY; DRUG COST; DRUG POTENTIATION; DRUG RESISTANT TUBERCULOSIS; DRUG SUSCEPTIBLE TUBERCULOSIS; DRUG TREATMENT FAILURE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNE RESPONSE; MINIMUM INHIBITORY CONCENTRATION; MIXED INFECTION; MONOTHERAPY; MULTIDRUG RESISTANT TUBERCULOSIS; MYCOBACTERIUM TUBERCULOSIS; NONHUMAN; OPTIC NERVE DISEASE; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; SPUTUM CULTURE; TREATMENT OUTCOME; TREATMENT RESPONSE; TUBERCULOSIS;

EID: 84888112787     PISSN: 1573398X     EISSN: 18756387     Source Type: Journal    
DOI: 10.2174/1573398X113099990017     Document Type: Article

References (95)

1. Koch R. Weitere mitteilungen uber ein heilmittel gegen tuberculose. Deutsche Medizinsche Wochenschrift 1891; 171: 101-2.
2. Bodington G. An essay on the treatment and cure of pulmonary consumption. 1840; London: Sinopkin, Marshall, Hamilton and Kent.
3. Temple L. Surgery of pulmonary tuberculosis: a historical approach, in Clinical Tuberculosis. P. Davies, Editor. 1998, Chapman and Hall: London. pp. 21-33.
4. Schatz A, E Bugie, and S Waksman. Streptomycin, a substance exhibiting antibiotic activity against gram-positive and gramnegative bacteria. Proceedings of the Society for Experimental and Biological Medicine, 1944; 55: pp. 66-9.
5. Lehmann J. Para-Aminosalicylic acid in the treatment of tuberculosis. Lancet 1946; I: 15-6.
6. Bernstein J, Lott WA, Steinberg BA, Yale HL. Chemotherapy of experimental tuberculosis V. Isonicotinic acid hydrazide (Nydrazid) and related compounds. Am Rev Tuberc 1952; 65: 357-64.
7. MRC. Streptomycin treatment of tuberculous meningitis. Lancet 1948; 1: 582-96.
8. MRC. Streptomycin treatment of pulmonary tuberculosis. Br Med J 1948; 2: 769-82.
9. MRC. The prevention of streptomycin resistance by combined chemotherapy. Br Med J 1952; 1: 1157-62.
10. MRC. The treatment of pulmonary tuberculosis with isoniazid. Br Med J 1952; 2: 735-46.
11. MRC. Isoniazid in the treatment of pulmonary tuberculosis. Second Report. Br Med J 1953; 1: 521-36.
12. Mitchison DA. Development of streptomycin resistant strains of tubercle bacilli in pulmonary tuberculosis. Results of simultaneous sensitivity tests in liquid and on solid media. Thorax 1950; 5: 144-61.
13. Selkon JB, Devadatta S, Kulkarni KG, et al. The emergence of isoniazid-resistant cultures in patients with pulmonary tuberculosis during treatment with isoniazid alone or isoniazis plus PAS. Bull World Health Organ 1964; 31: 273-94.
14. MRC. Long term chemotherapy in the treatment of chronic pulmonary tuberculosis with cavitation. Tubercle 1962; 43: 201-67.
15. MRC. Co-operative controlled trial of a standard regimen of streptomycin, PAS and isoniazid and three alternative regimens of chemotherapy in Britain. Tubercle 1973; 54: 99-129.
16. 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.
17. East African/British Medical Research Councils. Controlled clinical trial of five short-course (4-month) chemotherapy regimens in pulmonary tuberculosis. Second report of the 4th study. Am Rev Respir Dis 1981; 123(2): 165-70.
18. East African and British Medical Research Councils. Controlled clinical trial of five short-course (4-month) chemotherapy regimens in pulmonary tuberculosis. First report of 4th study. Lancet 1978; 2(8085): 334-8.
19. Salomon JA, Lloyd-Smith JO, Getz WM, et al. Prospects for advancing tuberculosis control efforts through novel therapies. PLoS Med 2006; 3(8): e273.
20. 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.
21. Gandhi NR, Nunn P, Dheda K, et al. Multidrug-resistant and extensively drug-resistant tuberculosis: a threat to global control of tuberculosis. Lancet 2010; 375(9728): 1830-43.
22. World Health Organisation, Global Tuberculosis Report 2012. 2012: Geneva.
23. Abdool Karim SS, Naidoo K, Grobler A, et al. Timing of initiation of antiretroviral drugs during tuberculosis therapy. N Engl J Med 2010; 362(8): 697-706.
24. Blanc FX, Sok T, Laureillard D, et al. Earlier versus later start of antiretroviral therapy in HIV-infected adults with tuberculosis. N Engl J Med 2011; 365(16): 1471-81.
25. Abdool Karim SS, Naidoo K, Grobler A, et al. Integration of antiretroviral therapy with tuberculosis treatment. N Engl J Med 2011; 365(16): 1492-501.
26. Piscitelli SC, Gallicano KD. Interactions among drugs for HIV and opportunistic infections. N Engl J Med 2001; 344(13): 984-96.
27. Burman WJ. Issues in the management of HIV-related tuberculosis. Clin Chest Med 2005; 26(2): 283-94, vi-vii.
28. Ma Z, Lienhardt C, McIlleron H, Nunn AJ, Wang X. Global tuberculosis drug development pipeline: the need and the reality. Lancet 2010; 375(9731): 2100-9.
29. Mitchison DA. Basic mechanisms of chemotherapy. Chest 1979; 76(6 Suppl): 771-81.
30. Jindani A, Aber VR, Edwards EA, Mitchison DA. The early bactericidal activity of drugs in patients with pulmonary tuberculosis. Am Rev Respir Dis 1980; 121(6): 939-49.
31. Sirgel FA, Donald PR, Odhiambo J, et al. A multicentre study of the early bactericidal activity of anti-tuberculosis drugs. J Antimicrob Chemother 2000; 45(6): 859-70.
32. Davies GR, Brindle R, Khoo SH, Aarons LJ. Use of nonlinear mixed-effects analysis for improved precision of early pharmacodynamic measures in tuberculosis treatment. Antimicrob Agents Chemother 2006; 50(9): 3154-6.
33. Rustomjee R, Lienhardt C, Kanyok T, et al. A Phase II study of the sterilising activities of ofloxacin, gatifloxacin and moxifloxacin in pulmonary tuberculosis. Int J Tuberc Lung Dis 2008; 12(2): 128-38.
34. Sloan DJ, Corbett EL, Butterworth AE, et al. Optimizing outpatient serial sputum colony counting for studies of tuberculosis treatment in resource-poor settings. J Clin Microbiol 2012; 50(7): 2315-20.
35. Piccaro G, Giannoni F, Filippini P, Mustazzolu A, Fattorini L. Activity of drug combinations against Mycobacterium tuberculosis grown in aerobic and hypoxic acidic conditions. Antimicrob Agents Chemother 2013; 57(3): 1428-33.
36. Lienhardt C, Raviglione M, Spigelman M, et al. New drugs for the treatment of tuberculosis: needs, challenges, promise, and prospects for the future. J Infect Dis 2012; 205 Suppl 2: S241-9.
37. Burman WJ. Rip Van Winkle wakes up: development of tuberculosis treatment in the 21st century. Clin Infect Dis 2010; 50 Suppl 3: S165-72.
38. van Niekerk C, Ginsberg A. Assessment of global capacity to conduct tuberculosis drug development trials: do we have what it takes? Int J Tuberc Lung Dis 2009; 13(11): 1367-72.
39. Davies GR. Early clinical development of anti-tuberculosis drugs: science, statistics and sterilizing activity. Tuberculosis (Edinb) 2010; 90(3): 171-6.
40. Nuermberger EL, Spigelman MK, Yew WW. Current development and future prospects in chemotherapy of tuberculosis. Respirology 2010; 15(5): 764-78.
41. Forrest GN, Tamura K. Rifampin combination therapy for nonmycobacterial infections. Clin Microbiol Rev 2010; 23(1): 14-34.
42. Jayaram R, Gaonkar S, Kaur P, et al. Pharmacokineticspharmacodynamics of rifampin in an aerosol infection model of tuberculosis. Antimicrob Agents Chemother 2003; 47(7): 2118-24.
43. Steingart KR, Jotblad S, Robsky K, et al. Higher-dose rifampin for the treatment of pulmonary tuberculosis: a systematic review. Int J Tuberc Lung Dis 2011; 15(3): 305-16.
44. Rosenthal IM, Williams K, Tyagi S, et al. Potent twice-weekly rifapentine-containing regimens in murine tuberculosis. Am J Respir Crit Care Med 2006; 174(1): 94-101.
45. Rosenthal IM, Zhang M, Williams KN, et al. Daily dosing of rifapentine cures tuberculosis in three months or less in the murine model. PLoS Med 2007 4(12): e344.
46. Dorman SE, Goldberg S, Stout JE, et al. Substitution of rifapentine for rifampin during intensive phase treatment of pulmonary tuberculosis: study 29 of the tuberculosis trials consortium. J Infect Dis 2012; 206(7): 1030-40.
47. Jindani A, Hatherill M, Charalambous S, et al. A Multicentre Randomised Clinical Trial to Evaluate High-dose Rifapentine with a Quinolone for Treatment of Pulmonary TB: The RIFAQUIN Trial. In: 20th Conference on Retroviruses and Opportunistic Infections. Atlanta, USA; 2013.
48. Davies G, Cerri S, Richeldi L. Rifabutin for treating pulmonary tuberculosis. Cochrane Database Syst Rev 2007(4): CD005159.
49. Burman W, Benator D, Vernon A, et al. Acquired rifamycin resistance with twice-weekly treatment of HIV-related tuberculosis. Am J Respir Crit Care Med 2006; 173(3): 350-6.
50. Singh R, Marshall N, Smith CJ, et al. No impact of rifamycin selection on tuberculosis treatment outcome in HIV coinfected patients. AIDS 2013; 27(3): 481-4.
51. Mitscher LA. Bacterial topoisomerase inhibitors: quinolone and pyridone antibacterial agents. Chem Rev 2005; 105(2): 559-92.
52. Nuermberger EL, Yoshimatsu T, Tyagi S, et al. Moxifloxacincontaining regimens of reduced duration produce a stable cure in murine tuberculosis. Am J Respir Crit Care Med 2004; 170(10): 1131-4.
53. Nuermberger EL, Yoshimatsu T, Tyagi S, et al. Moxifloxacincontaining regimen greatly reduces time to culture conversion in murine tuberculosis. Am J Respir Crit Care Med 2004; 169(3): 421-6.
54. Burman WJ, Goldberg S, Johnson JL, et al. Moxifloxacin versus ethambutol in the first 2 months of treatment for pulmonary tuberculosis. Am J Respir Crit Care Med 2006; 174(3): 331-8.
55. Dorman SE, Johnson JL, Goldberg S, et al. Substitution of moxifloxacin for isoniazid during intensive phase treatment of pulmonary tuberculosis. Am J Respir Crit Care Med 2009; 180(3): 273-80.
56. Conde MB, Efron A, Loredo C, et al. Moxifloxacin versus ethambutol in the initial treatment of tuberculosis: a double-blind, randomised, controlled phase II trial. Lancet 2009; 373(9670): 1183-9.
57. Weiner M, Burman W, Luo CC, et al. Effects of rifampin and multidrug resistance gene polymorphism on concentrations of moxifloxacin. Antimicrob Agents Chemother 2007; 51(8): 2861-6.
58. Dooley K, Flexner C, Hackman J, et al. Repeated administration of high-dose intermittent rifapentine reduces rifapentine and moxifloxacin plasma concentrations. Antimicrob Agents Chemother 2008; 52(11): 4037-42.
59. Ginsburg AS, Hooper N, Parrish N, et al. Fluoroquinolone resistance in patients with newly diagnosed tuberculosis. Clin Infect Dis 2003; 37 (11): 1448-52.
60. Andries K, Verhasselt P, Guillemont J, et al. A diarylquinoline drug active on the ATP synthase of Mycobacterium tuberculosis. Science 2005; 307(5707): 223-7.
61. Koul A, Vranckx L, Dendouga N, et al. Diarylquinolines are bactericidal for dormant mycobacteria as a result of disturbed ATP homeostasis. J Biol Chem 2008; 283(37): 25273-80.
62. Rao SP, Alonso S, Rand L, Dick T, Pethe K et al. The protonmotive force is required for maintaining ATP homeostasis and viability of hypoxic, nonreplicating Mycobacterium tuberculosis. Proc Natl Acad Sci USA 2008; 105(33): 11945-50.
63. Cohen J. Infectious disease. Approval of novel TB drug celebrated-with restraint. Science 2013; 339(6116): 130.
64. Ibrahim M, Andries K, Lounis N, et al. Synergistic activity of R207910 combined with pyrazinamide against murine tuberculosis. Antimicrob Agents Chemother 2007; 51(3): 1011-5.
65. 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.
66. FDA. Anti-Infective Drugs Advisory Committee Meeting Briefing Document: TMC-207 (bedaquiline) Treatment of Patients with MDR-TB DNA 204-384. 2012.
67. Diacon AH, Pym A, Grobusch M, et al. The diarylquinoline TMC207 for multidrug-resistant tuberculosis. N Engl J Med 2009; 360(23): 2397-405.
68. Diacon AH, Donald PR, Pym A, et al. Randomized pilot trial of eight weeks of bedaquiline (TMC207) treatment for multidrugresistant tuberculosis: long-term outcome, tolerability, and effect on emergence of drug resistance. Antimicrob Agents Chemother 2012; 56(6): 3271-6.
69. Avorn J. Approval of a tuberculosis drug based on a paradoxical surrogate measure. JAMA 2013; 309(13): 1349-50.
70. 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.
71. Huitric E, Verhasselt P, Koul A, Andries K, Hoffner S, Andersson DI. Rates and mechanisms of resistance development in Mycobacterium tuberculosis to a novel diarylquinoline ATP synthase inhibitor. Antimicrob Agents Chemother 2010; 54(3): 1022-8.
72. Ashtekar DR, Costa-Perira R, Nagrajan K, Vishvanathan N, Bhatt AD, Rittel W. In vitro and in vivo activities of the nitroimidazole CGI 17341 against Mycobacterium tuberculosis. Antimicrob Agents Chemother 1993; 37(2): 183-6.
73. Stover CK, Warrener P, VanDevanter DR, et al. A small-molecule nitroimidazopyran drug candidate for the treatment of tuberculosis. Nature 2000; 405(6789): 962-6.
74. 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(11): e466.
75. Mukherjee T, Boshoff H. Nitroimidazoles for the treatment of TB: past, present and future. Future Med Chem 2011; 3(11): 1427-54.
76. Tasneen R, Tyagi S, Williams K, Grosset J, Nuermberger E. Enhanced bactericidal activity of rifampin and/or pyrazinamide when combined with PA-824 in a murine model of tuberculosis. Antimicrob Agents Chemother 2008; 52(10): 3664-8.
77. Diacon AH, Dawson R, Hanekom M, et al. Early bactericidal activity and pharmacokinetics of PA-824 in smear-positive tuberculosis patients. Antimicrob Agents Chemother 2010; 54(8): 3402-7.
78. Gler MT, Skripconoka V, Sanchez-Garavito E, et al. Delamanid for multidrug-resistant pulmonary tuberculosis. N Engl J Med 2012; 366(23): 2151-60.
79. 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.
80. 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.
81. 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.
82. Dietze R, Hadad DJ, McGee B, et al. Early and extended early bactericidal activity of linezolid in pulmonary tuberculosis. Am J Respir Crit Care Med 2008; 178(11): 1180-5.
83. Lee M, Lee J, Carroll MW, et al. Linezolid for treatment of chronic extensively drug-resistant tuberculosis. N Engl J Med 2012; 367(16): 1508-18.
84. Shaw KJ, Barbachyn MR. The oxazolidinones: past, present, and future. Ann N Y Acad Sci 2011; 1241: 48-70.
85. Protopopova M, Hanrahan C, Nikonenko B, et al. Identification of a new antitubercular drug candidate, SQ109, from a combinatorial library of 1, 2-ethylenediamines. J Antimicrob Chemother 2005; 56(5): 968-74.
86. Nikonenko BV, Protopopova M, Samala R, Einck L, Nacy CA. Drug therapy of experimental tuberculosis (TB): improved outcome by combining SQ109, a new diamine antibiotic, with existing TB drugs. Antimicrob Agents Chemother 2007; 51(4): 1563-5.
87. Reddy VM, Einck L, Andries K, Nacy CA. In vitro interactions between new antitubercular drug candidates SQ109 and TMC207. Antimicrob Agents Chemother 2010; 54(7): 2840-6.
88. Chambers HF, Kocagöz T, Sipit T, Turner J, Hopewell PC. Activity of amoxicillin/clavulanate in patients with tuberculosis. Clin Infect Dis 1998; 26(4): 874-7.
89. Donald PR, Sirgel FA, Venter A, et al. Early bactericidal activity of amoxicillin in combination with clavulanic acid in patients with sputum smear-positive pulmonary tuberculosis. Scand J Infect Dis 2001; 33(6): 466-9.
90. Payen MC, De Wit S, Martin C, et al. Clinical use of the meropenem-clavulanate combination for extensively drug-resistant tuberculosis. Int J Tuberc Lung Dis 2012; 16(4): 558-60.
91. Grosset JH, Singer TG, Bishai WR. New drugs for the treatment of tuberculosis: hope and reality. Int J Tuberc Lung Dis 2012; 16(8): 1005-14.
92. Martineau AR, Honecker FU, Wilkinson RJ, Griffiths CJ. Vitamin D in the treatment of pulmonary tuberculosis. J Steroid Biochem Mol Biol 2007; 103(3-5): 793-8.
93. Martineau AR, Timms PM, Bothamley GH, et al. High-dose vitamin D(3) during intensive-phase antimicrobial treatment of pulmonary tuberculosis: a double-blind randomised controlled trial. Lancet 2011; 377(9761): 242-50.
94. Ruslami R, Ganiem AR, Dian S, et al. Intensified regimen containing rifampicin and moxifloxacin for tuberculous meningitis: an open-label, randomised controlled phase 2 trial. Lancet Infect Dis 2013; 13(1): 27-35.
95. Sloan DJ and GR Davies. Anti-tuberculous chemotherapy: Serial Sputum Colony Counting in development, in Progress in Respiratory Research. 2011; Karger: Basel.