Understanding pharmacokinetics to improve tuberculosis treatment outcome

Expert Opinion on Drug Metabolism and Toxicology

Volumn 10, Issue 6, 2014, Pages 813-823

  Reynolds, Jonathan ^a   Heysell, Scott K ^b  

^a UNIVERSITY OF VIRGINIA   (United States)

^b UNIVERSITY OF VIRGINIA   (United States)

Author keywords

Dried blood spot; Minimum inhibitory concentration; Multidrug resistant tuberculosis; Pharmacokinetics; Therapeutic drug monitoring; Tuberculosis

Indexed keywords

AMIKACIN; AMINOGLYCOSIDE; AMINOSALICYLIC ACID; AMOXICILLIN PLUS CLAVULANIC ACID; BEDAQUILINE; CARBAPENEM DERIVATIVE; CLARITHROMYCIN; CLOFAZIMINE; CYCLOSERINE; ETHAMBUTOL; ETHIONAMIDE; IMIPENEM; ISONIAZID; KANAMYCIN; LEVOFLOXACIN; LINEZOLID; MEROPENEM; MOXIFLOXACIN; OFLOXACIN; PROTIONAMIDE; PYRAZINAMIDE; QUINOLONE DERIVATIVE; RIFABUTIN; RIFAMPICIN; RIFAMYCIN; SERINE DERIVATIVE; STREPTOMYCIN; TERIZIDONE; THIOAMIDE; UNINDEXED DRUG; TUBERCULOSTATIC AGENT;

AREA UNDER THE CURVE; BACTERICIDAL ACTIVITY; CLINICAL PRACTICE; COMORBIDITY; DIABETES MELLITUS; DRIED BLOOD SPOT TESTING; DRUG DOSE ESCALATION; DRUG MONITORING; DRUG SENSITIVITY; EXTRAPULMONARY TUBERCULOSIS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LUNG TUBERCULOSIS; MAXIMUM PLASMA CONCENTRATION; MINIMUM INHIBITORY CONCENTRATION; MULTIDRUG RESISTANCE; NONHUMAN; PEDIATRICS; PHARMACODYNAMICS; REVIEW; TREATMENT OUTCOME; COMPLICATION; MICROBIAL SENSITIVITY TEST; TUBERCULOSIS; TUBERCULOSIS, PULMONARY;

ANTITUBERCULAR AGENTS; DIABETES MELLITUS; DRUG MONITORING; ETHAMBUTOL; HIV INFECTIONS; HUMANS; ISONIAZID; MICROBIAL SENSITIVITY TESTS; PYRAZINAMIDE; RIFAMYCINS; TREATMENT OUTCOME; TUBERCULOSIS; TUBERCULOSIS, PULMONARY;

EID: 84901066156     PISSN: 17425255     EISSN: 17447607     Source Type: Journal    
DOI: 10.1517/17425255.2014.895813     Document Type: Review

References (107)

1. World Health Organization. Global tuberculosis report 2012. 2012. Available from: http://www.who. int/tb/publications/globalreport/en/ index.html
2. American Thoracic Society, Centers for Disease Control and Prevention, and Infectious Disease Society of America. Treatment of tuberculosis. MMWR Recomm Rep 2003;52:1203
3. Weis SE, Slocum PC, Blais FX, et al. The effect of Directly Observed Therapy on the rates of drug resistance and relapse in tuberculosis. N Engl J Med 1994;330:1179-84
4. Burman WJ, Dalton CB, Cohn DL, et al. A cost-effectiveness analysis of directly observed therapy vs self-administered therapy for treatment of tuberculosis. Chest 1997;112:63-70
5. Srivastava S, Pasipanodya JG, Meek C, et al. Multidrug-resistant tuberculosis not due to noncompliance but to between-patient pharmacokinetic variability. J Infect Dis 2011;204:1951-9
6. Weiner M, Burman W, Vernon A, et al.; Tuberculosis Trials Consortium. Low isoniazid concentrations and outcome of tuberculosis treatment with once-weekly isoniazid and rifapentine. Am J Respir Crit Care Med 2003;167(10):1341-7
7. Pasipanodya J, McIlleron H, Burger A, et al. Serum drug concentrations predictive of pulmonary tuberculosis outcomes. J Infect Dis 2013;208:1564-73
8. Chideya S, Winston CA, Peloquin CA, et al. Isoniazid, rifampin, ethambutol, and pyrazinamide pharmacokinetics and treatment outcomes among predominately HIV-infected cohort of adults with tuberculosis from Botswana. Clin Infect Dis 2009;48:1685-94
9. Falzon D, Jaramillo E, Wares F, et al. Universal access to care for multidrug-resistant tuberculosis: an analysis of surveillance data. Lancet Infect Dis 2013;13:690-7
10. Shenoi S, Heysell SK, Moll AP, Friedland G. Multidrug-resistant and extensively drug-resistant tuberculosis: consequences for the global HIV community. Curr Opin Infect Dis 2009;22:11-17
11. Diel R, Vandeputte J, de Vries G, et al. Costs of tuberculosis disease in the EU - a systematic analysis and cost calculation. Euro Respir J 2014;43(2):554-65
12. Eagle H, Fleischman R, Musselman AD. The effective concentrations of penicillin in vitro and in vivo for streptococci, pneumococci, and Treponema pallidum. J Bacteriol 1950;59:625-43
13. Eagle H, Fleischman R, Musselman AD. Effect of schedule of administration on the therapeutic efficacy of penicillin; importance of the aggregate time penicillin remains at effectively bactericidal levels. Am J Med 1950;9:280-99
14. Ambrose PG, Bhavani SM, Rubino A, et al. Pharmacokinetics- Pharmacodynamics of Antimicrobial Therapy: it?s Not Just for Mice Anymore. Clin Infect Dis 2007;44:79-86
15. NCCLS. Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically. 6th edition. NCCLS, Wayne, PA, USA; 2003
16. Kim SJ. Drug-susceptibility testing in tuberculosis: methods and reliability of results. Eur Respir J 2005;25(3):564-9
17. Heysell SK, Houpt ER. The future of molecular diagnostics for drug-resistant tuberculosis. Expert Rev Mol Diagn 2012;12(4):395-405
18. Heifets LB, Cangelosi GA. Drug susceptibility testing of Mycobacterium: a neglected problem at the turn of the century. Int J Tuberc Lung Dis 1999;3(7):564-81
19. Hall L, Jude KP, Clark SL, et al. Evaluation of the sensititre™ MYCOTB plate for the susceptibility testing of mycobacterium tuberculosis complex against first and second line agents. J Clin Microbiol 2012;50(11):3732-4
20. Mpagama S, Houpt ER, Stroup S, et al. Application of quantitative second-line drug susceptibility testing at a multidrug-resistant tuberculosis hospital in Tanzania. BMC Infect Dis 2013;13:432
21. Lee JS, Armstrong DT, Ssengooba W, et al. The Sensititre MYCOTB MIC plate for susceptibility testing of Mycobacterium tuberculosis to 1st and 2nd line drugs. Antimicrob Agents Chemother 2014;58(1):11-18
22. Pasipanodya J, Gumbo T. An Oracle: antituberculosis pharmacokineticpharmacodynamics, clinical correlation, and clinical trial simulations to predict the future. Antimicrob Agents Chemother 2011;55(1):24-34
23. Bratton DJ, Phillips PP, Parmar MK, et al. A multi-arm multi-stage clinical trial design for binary outcomes with application to tuberculosis. BMC Med Res Methodol 2013;13:139
24. Burki T. PanACEA: a new approach to tuberculosis research. Lancet Infect Dis 2012;12(3):184-5
25. Srivastava S, Musaka S, Sherman C, et al. Efflux-pump-derived multiple drug resistance to ethambutol monotherapy in Mycobacterium tuberculosis and the pharmacokinetics and pharmacodynamics of ethambutol. J Infect Dis 2010;201:1225-31
26. Gumbo T, Dona CS, Meek C, Leff R. Pharmacokinetics-pharmacodynamics of pyrazinamide in a novel in vitro model of tuberculosis for sterilizing effect: a paradigm for faster assessment of new antituberculosis drugs. Antimicrob Agents Chemother 2009;53:3197-204
27. Anonymous. Ethambutol plus isoniazid for the treatment of pulmonary tuberculosis - a controlled trial of our regiments. Tubercle 1981;62:13-29
28. British Medical Research Council. A controlled comparison of four regimens of streptomycin plus pyrazinamide in the retreatment of pulmonary tuberculosis. Tubercle 1969;50:81-114
29. Dickinson JM, Ellard GA, Mitchison DA. Suitability of isoniazid and ethambutol for intermittent administration in the treatment of tuberculosis. Tubercle 1968;49:351-66
30. Jayaram R, Shandil RK, Gaonkar S, et al. Isoniazid pharmacokineticspharmacodynamics in an aerosol infection model of tuberculosis. Antimicrob Agents Chemother 2004;48:2951-7
31. Gumbo T, Louie A, Liu W, et al. Isoniazid bactericidal activity and resistance emergence: integrating pharmacodynamics and pharmacogenomics to predict efficacy in different ethnic populations. Antimicrob Agents Chemother 2007;51:2329-36
32. Mitchison DA, Dickinson JM. Laboratory aspects of intermittent drug therapy. Postgrad Med J 1971;47:737-41
33. Verbist L. Rifampicin activity ?in vitro? and in established tuberculosis in mice. Acta Tuberc Pneumol Belg 1969;60:397-412
34. Jayaram R, Gaonkar S, Kaur P, et al. Pharmacokinetics-pharmacodynamics of rifampin in an aerosol infection model of tuberculosis. Antimicrob Agents Chemother 2003;47:2118-24
35. Gumbo T, Louie A, Deziel MR, et al. Concentration-dependent Mycobacterium tuberculosis killing and prevention of resistance by rifampin. Antimicrob Agnets Chemother 2007;51:3781-8
36. Hall R, Leff GRD, Gumbo T. Treatment of active pulmonary tuberculosis in adults: current standards and recent advances. Pharmacotherapy 2009;29:1468-81
37. Boeree M. What Is the ?Right? Dose of Rifampin? Oral abstract and paper 148LB. 20th Conference on Retroviruses and Opportunistic Infections; 3 - 6 March 2013; Atlanta
38. Shandil RK, Jayaram R, Kaur P, et al. Moxifloxacin, ofloxacin, sparfloxacin, and ciprofloxacin against Mycobacterium tuberculosis: evaluation of in vitro and pharmacodynamics indices that best predict in vivo efficacy. Antimicrob Agents Chemother 2007;51:576-82
39. Gumbo T, Louie A, Dezeil MR, Drusano GL. Pharmacodynamic evidence that ciprofloxacin failure against tuberculosis is not due to poor microbial kill but to rapid emergence of resistance. Antimicrob Agents Chemother 2005;49:3178-81
40. Gumbo T, Louie A, Deziel MR, et al. Selection of a moxifloxacin dose that suppresses drug resistance in Mycobacterium tuberculosis, by use of an in vitro pharmacodynamics infection model and mathematical modeling. J Infect Dis 2004;190:1642-51
41. Peloquin CA, Hadad DJ, Molino LP, et al. Population pharmacokinetics of levofloxacin, gatifloxacin, and moxifloxacin in adults with pulmonary tuberculosis. Antimicrob Agents Chemother 2008;52:852-7
42. Mpagama SG, Ndusilo N, Stroup S, et al. Plasma drug activity in patients on treatment for multidrug-resistant tuberculosis. Antimicrob Agent Chemother 2014;58(2):782-8
43. Chigutsa E, Meredith S, Wiesner L, et al. Population pharmacokinetics and pharmacodynamics of ofloxacin in south African patients with multidrug-resistant tuberculosis. Antimicrob Agents Chemother 2012;56(7):3857-63
44. Jacobson KR, Tierny B, Jeon CY, et al. Treatment outcomes among patients with extensively drug-resistant tuberculosis: systematic review and meta-analysis. Clin Infect Dis 2010;51(1):6-14
45. van Deun A, Maug AKJ, Salim MAH, et al. Short, highly effective, and inexpensive standardized treatment of multidrug-resistant tuberculosis. Am J Respir Crit Care Med 2010;182:684-92
46. Mandell GL, Bennett JE, Dolin R. Mandell, douglas, and Bennett?s principles and practice of infectious diseases. Volume 1. 7th edition. Churchill Livingstone, Philadelphia; 2010. p. 300-6
47. Lee M, Lee J, Carroll MW, et al. Linezolid for treatment of chronic extensively drug-resistant tuberculosis. N Engl J Med 2012;367:1508-18
48. Fox G, Menzies D. A review of the evidence for using bedaquiline (TMC207) to treat multi-drug resistant tuberculosis. Infect Dis Ther 2013, doi: 10.1007/s40121-013-0009-3
49. Dietze R, Hadad DJ, McGee B, et al. Early and extended bactericidal activity of linezolid in pulmonary tuberculosis. Am J Respir Crit Care Med 2008;178(11):1180-5
50. 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
51. Peloquin CA. Therapeutic drug monitoring in the treatment of tuberculosis. Drugs 2002;62:2169-83
52. Chang KC, Leung CC, Yew WW, et al. Peak plasma rifampicin level in tuberculosis patients with slow culture conversion. Eur J Clin Microbiol Infect Dis 2008;27:467-72
53. Rowland M. Plasma protein binding and therapeutic drug monitoring. Ther Drug Monit 1980;2(1):29-37; Review
54. Edelbroek PM, van der Heijden J, Stolk LM. Dried blood spot methods in therapeutic drug monitoring: methods, assays, and pitfalls. Ther Drug Monit 2009;31(3):327-36
55. Harmelink IM, Alffenaar JW, Wessels AM, et al. A rapid and simple liquid chromatography-tandem mass spectrom- etry method for the determination of linezolid in human serum. EJHP Sci 2008;14:3-7
56. Vu DH, Blhuis MS, Koster RA, et al. Dried blood spot analysis for therapeutic drug monitoring of linezolid in patients with multidrug-resistant tuberculosis. Antimicrob Agents Chemother 2012;56(11):5758-63
57. Wallis RS, Palaci M, Vinhas S, et al. A whole blood bactericidal assay for tuberculosis. J Infect Dis 2001;183:1300-3
58. Wallis RS, Vinhas SA, Johnson JL, et al. Whole blood bactericidal activity during treatment of pulmonary tuberculosis. J Infect Dis 2003;187:270-8
59. Wallis RS, Kim P, Cole S, et al. Tuberculosis biomarkers discovery: developments, needs, and challenges. Lancet Infect Dis 2013;13:362-72
60. Wallis RS, Jakubiec WM, Kumar V, et al. Pharmacokinetics and whole-blood bactericidal activity against Mycobacterium tuberculosis of single doses of PNU-100480 in healthy volunteers. J Infect Dis 2010;202(5):745-51
61. Heysell SK, Mtabho C, Mpagama SG, et al. A plasma drug activity assay for treatment optimization in tuberculosis patients. Antimicrob Agents Chemother 2011;55(12):5819-25
62. Rao SP, et al. Indolcarboxamide is a preclinical candidate for treating multidrug-resistant tuberculosis. Sci Transl Med 2013;5:214
63. Wallis RS. Immune activation, allergic drug toxicity and mortality in HIV-positive tuberculosis. Tuber Lung Dis 1996;77:516-23
64. Hawken M, Nunn P, Gathua S, et al. Increased recurrence of tuberculosis in HIV-1-infected patients in Kenya. Lancet 1993;342:332-8
65. Perriens JH, Colebunders RL, Karahunga C, et al. Increased mortality and tuberculosis treatment failure rate among human immunodeficiency virus (HIV) seropositive compared with HIV seronegative patients with pulmonary tuberculosis in Kinshasa, Zaire. Am Rev Respir Dis 1991;122:750-5
66. Abdool Karim SS, Naidoo K, Grobler A, et al. Timing of initiation of antiretroviral drugs during tuberculosis therapy. N Eng J Med 2010;362(8):697-706
67. Abdool Karim SS, Naidoo K, Grobler A. Integration of antiretroviral therapy with tuberculosis treatment. N Engl J Med 2011;365(16):1492-501
68. 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
69. Havlir DV, Kendall MA, Kumwenda J, et al. Timing of antiretroviral therapy for HIV-1 infection and tuberculosis. N Engl J Med 2011;352(16):1482-91
70. Kotler DP, Gaetz HP, Lange M, et al. Enteropathy associated with the acquired immunodeficiency syndrome. Ann Intern Med 1984;101:421-8
71. Gillin JS, Shike M, Alcock N, et al. Malabsorption and mucosal abnormalities of the small intestine in the acquired immunodeficiency syndrome. Ann Intern Med 1985;102:619-22
72. Bartlett JG, Belitsos PC, Sears CL. AIDS enteropathy. Clin Infect Dis 1992;15:726-35
73. Ashokraj Y, Kaur KJ, Singh I, et al. In vivo dissolution: predominant factor affecting the bioavailability of rifampicin in its solid oral dosage forms. Clin Res Reg Aff 2008;25(1):1-12
74. 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
75. Weiner M, Benator D, Burman W, et al. Association between acquired rifamycin resistance and the pharmacokinetics of rifabutin and isoniazid among patients with HIV and tuberculosis. Clin Infect Dis 2005;40(10):1481-91
76. Centers for Disease Control and Prevention (CDC). Updated guidelines for the use of rifabutin or rifampin for the treatment and prevention of tuberculosis among HIV-infected patients taking protease inhibitors or nonnucleoside reverse transcriptase inhibitors. MMWR Morb Mortal Wkly Rep 2000;49(9):185-9
77. Okwera A, Whalen C, Byekwaso F, et al. Randomized trial of thiacetazone and rifampicin-containing regimens for pulmonary tuberculosis in HIV infected Ugandans. Makere University-Case Western Reserve University Research Collaboration. Lancet 1994;344:1323-8
78. Boulle A, van Custsem G, Cohen K, et al. Outcomes of nevirapine- and efavirenz-based antiretroviral therapy when coadministered with rifampicin-based antitubercular therapy. JAMA 2008;300(5):530-9
79. Manosuthi W, Sungkanuparph S, Tantanathip P, et al. A randomized trial comparing plasma drug concentrations and efficacies between 2 nonnucleoside reverse-transcriptase inhibitor-based regimens in HIV-infected patients receiving rifampicin: the N2R study. Clin Infect Dis 2009;8(12):1752-9
80. Ramachandran G, Ramesh K, Hemanth Kumar AK, et al. Association of high T allele frequency of CYP2B6 G516T polymorphism among ethnic south Indian HIV-infected patients with elevated plasma efavirenz and nevirapine. J Antimicrob Chemother 2009;63:841-84
81. McIlleron HM, Schomaker M, Ren Y, et al. Effects of rifampin-based antituberculosis therapy on plasma efavirenz oncentrations in children vary by CYP2B6 genotype. AIDS 2013;27:1933-40
82. Lan NT, Thu NT, Varrail-Tran A, et al. Randomised pharmacokinetic trial of rifabutin with lopinavir/ritonavirantiretroviral therapy in patients with HIV-associated tuberculosis in Vietnam. PLoS One 2014, doi:10.1371/journal.pone. 0084866
83. Loeliger A, Suthar AB, Ripin D, et al. Protease inhibitor-containing antiretroviral treatment and tuberculosis: can rifabutin fill the breach? Int J Tuberc Lung Dis 2012;16:6-15
84. Baciewicz AM, Chrisman CR, Finch CK, Self TH. Update on rifampin and rifabutin drug interactions. Am J Med Sci 2008;335:126-36
85. Shetty N, Shemko M, Vaz M, D?Souza G. An epidemiological evaluation of risk factors for tuberculosis in South India: a matched case control study. Int J Tuberc Lung Dis 2006;10:80-6
86. Coker R, McKee M, Atun R, et al. Risk factors for pulmonary tuberculosis in Russia: case-control study. BMJ 2006;332:85-7
87. Stevenson CR, Forouhi NG, Roglic G, et al. Diabetes and tuberculosis: the impact of the diabetes epidemic on tuberculosis incidence. BMC Public Health 2007;7:234
88. Jeon CY, Murray MB. Diabetes mellitus increases the risk of active tuberculosis: a systematic review of 13 observational studies. PLoS Med 2008;5:e152
89. Mboussa J, Monabeka H, Kombo M, et al. Course of pulmonary tuberculosis in diabetics. Rev Pneumol Clin 2003;59:39-44
90. Oursler KK, Moore RD, Bishai WR, et al. Survival of patients with pulmonary tuberculosis: clinical and molecular epidemiologic factors. Clin Infect Dis 2002;34:752-9
91. Alisjahbana B, Sahiratmadja E, Nelwan EJ, et al. The effect of type 2 diabetes mellitus on the presentation and treatment response of pulmonary tuberculosis. Clin Infect Dis 2007;45:428-35
92. Nijland HM, Ruslami R, Stalenhoef JE, et al. Exposure to rifampicin is strongly reduced in patients with tuberculosis and type 2 diabetes. Clin Infect Dis 2006;43:848-54
93. Heysell SK, Moore JL, Keller SJ, Houpt ER. Therapeutic drug monitoring for slow response to tuberculosis treatment in a state control program, Virginia, USA. Emerg Infect Dis 2010;16(101):1546-53
94. Heysell SK, Moore JL, Staley D, et al. Early therapeutic drug monitoring for isoniazid and rifampin among diabetics with newly diagnosed tuberculosis in Virginia, U.S.A. Tuberc Res Treat 2013, doi: 10.1155/2013/129723
95. Dooley KE, Chaisson RE. Tuberculosis and diabetes mellitus: convergence of two epidemics. Lancet Infect Dis 2009;9:737-46
96. McIlleron H, Willemse M, Werely CJ, et al. Isoniazid plasma concentrations in a cohort of South African children with tuberculosis: implications for international pediatric dosing guidelines. Clin Infect Dis 2009;48:1547-53
97. Ramachandran G, Hemanth Kumar AK, Bhavani PK, et al. Age, nutritional status and INH acetylator status affect pharmacokinetics of anti-tuberculosis drugs in children. Int J Tuberc Lung Dis 2013;17(6):800-6
98. Schaaf HS, Willemse M, Cilliers K, et al. Rifampin pharmacokinetics in children, with and without human immunodeficiency virus infection, hospitalized for the management of severe forms of tuberculosis. BMC Med 2009;7:19
99. Seddon JA, Hesseling AC, Schaaf HS. Retooling existing tuberculosis drugs for children. Clin Infect Dis 2013;56(1):167-8
100. United States Congress. Food and drug administration amendments act of 2007. HR3580. 110th congress; 2007
101. European Medicines Agency 2007. The EU paediatric regulation. Available from: http://www.emea.europa.eu/htms/human/ paediatrics/regulation.htm
102. Golden MP, Vikram HR. Extrapulmonary tuberculosis: an overview. Am Fam Physician 2005;72(9):1761-8
103. World Health Organization. Guidelines for treatment of tuberculosis. 4th edition. World Health Organization, Geneva; 2010
104. Donald PR. Cerebrospinal fluid concentrations of antituberculosis agents in adults and children. Tuberculosis 2010;90(5):279-92
105. 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
106. Akkerman OW, van Altena R, Klinkenberg T, et al. Drug concentration in lung tissue in multidrug-resistant tuberculosis. Eur Respir J 2013;42:1750-2
107. Srivastava S, Peloquin CA, Sotgiu G, Migliori GB. Therapeutic drug management: is it the future of multidrug-resistant tuberculosis treatment? Eur Respir J 2013;42:1449-53