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Four months of rifampicin monotherapy for latent tuberculosis infection in children

  • Oh, Chi Eun (Department of Pediatrics, Kosin University College of Medicine) ;
  • Menzies, Dick (Respiratory Epidemiology and Clinical Research Unit, McGill International TB Centre, McGill University)
  • Received : 2021.08.11
  • Accepted : 2021.10.14
  • Published : 2022.05.15

Abstract

Diagnosing and treating latent tuberculosis infection (LTBI) is an important part of efforts to combat tuberculosis (TB). The Korean guidelines for TB published in 2020 recommend 2 LTBI regimens for children and adolescents: 9 months of daily isoniazid (9H) and 3 months of daily isoniazid plus rifampicin. Isoniazid for 6-12 months has been used to effectively treat LTBI in children for over 50 years. However, a long treatment period results in poor patient compliance. This review summarizes pediatric data on the treatment completion rate, safety, and efficacy of 4 months of daily rifampicin (4R) and evaluates the pharmacokinetics and pharmacodynamics of rifampicin in children. The 4R regimen has a higher treatment completion rate than the 9H regimen and equivalent safety in children. The efficacy of preventing TB is also consistent with that of 9H when summarizing reports published to date. A shorter treatment period could increase patient compliance and, therefore, prevent TB in more patients. By using an effective, safe, and highly compliant regimen for the treatment of children with LTBI, we would become one step closer to our goal of eradicating TB.

Keywords

References

  1. Houben RM, Dodd PJ. the global burden of latent tuberculosis infection: a re-estimation using mathematical modelling. PLoS Med 2016;13:e1002152. https://doi.org/10.1371/journal.pmed.1002152
  2. Neuenschwander BE, Zwahlen M, Kim SJ, Engel RR, Rieder HL. Trends in the prevalence of infection with mycobacterium tuberculosis in Korea from 1965 to 1995: an analysis of seven surveys by mixture models. Int J Tuberc Lung Dis 2000;4:719-29.
  3. Korean National Tuberculosis Association. 7th Korea National Health and Nutrition Examination Survey: Tuberculin Survey Support and Quality Control. Seoul (Korea): Korea Centers for Disease Control and Prevention, 2017.
  4. Go U, Park M, Kim UN, Lee S, Han S, Lee J, et al. Tuberculosis prevention and care in Korea: evolution of policy and practice. J Clin Tuberc Other Mycobact Dis 2018;11:28-36. https://doi.org/10.1016/j.jctube.2018.04.006
  5. Cho KS. Tuberculosis control in the Republic of Korea. Epidemiol Health 2018;40:e2018036. https://doi.org/10.4178/epih.e2018036
  6. Song JH, Huh K, Chung DR. Modern history of tuberculosis in Korea. Infect Chemother 2019;51:414-26. https://doi.org/10.3947/ic.2019.51.4.414
  7. Korea Centers for Disease Control and Prevention. Korean Guidelines for Tuberculosis. 4th ed. Cheongju (Korea): Joint Committee for the Revision of Korean Guidelines for Tuberculosis and Korea Centers for Disease Control & Prevention, 2020.
  8. Targeted tuberculin testing and treatment of latent tuberculosis infection. American Thoracic Society. MMWR Recomm Rep 2000;49(RR-6):1-51.
  9. Sterling TR, Njie G, Zenner D, Cohn DL, Reves R, Ahmed A, et al. Guidelines for the treatment of latent tuberculosis infection: recommendations from the National Tuberculosis Controllers Association and CDC, 2020. MMWR Recomm Rep 2020;69:1-11.
  10. Lincoln EM. The effect of antimicrobial therapy on the prognosis of primary tuberculosis in children. Am Rev Tuberc 1954;69:682-9.
  11. A double-blind placebo-controlled clinical trial of three antituberculosis chemoprophylaxis regimens in patients with silicosis in Hong Kong. Hong Kong Chest Service/Tuberculosis Research Centre, Madras/British Medical Research Council. Am Rev Respir Dis 1992;145:36-41. https://doi.org/10.1164/ajrccm/145.1.36
  12. Lobue P, Menzies D. Treatment of latent tuberculosis infection: an update. Respirology 2010;15:603-22. https://doi.org/10.1111/j.1440-1843.2010.01751.x
  13. Sensi P. History of the development of rifampin. Rev Infect Dis 1983;5 Suppl 3:S402-6. https://doi.org/10.1093/clinids/5.Supplement_3.S402
  14. Wehrli W. Rifampin: mechanisms of action and resistance. Rev Infect Dis 1983;5 Suppl 3:S407-11. https://doi.org/10.1093/clinids/5.Supplement_3.S407
  15. Maslow MJ, Portal-Celhay C. Rifamycins. In: Bennett JE, Dolin R, editors. Mandell, Douglas, and Bennett's principles and practice of infectious diseases. 9th ed. Philadelphia (PA): Elsevier, Inc., 2020;e4:337-49.
  16. Dickinson JM, Mitchison DA. Experimental models to explain the high sterilizing activity of rifampin in the chemotherapy of tuberculosis. Am Rev Respir Dis 1981;123(4 Pt 1):367-71.
  17. Fox W. Whither short-course chemotherapy? Br J Dis Chest 1981;75:331-57. https://doi.org/10.1016/0007-0971(81)90022-X
  18. Alsayyed B. Rifampin. Pediatr Rev 2004;25:216-7. https://doi.org/10.1542/pir.25-6-216
  19. Gumbo T, Louie A, Deziel MR, Liu W, Parsons LM, Salfinger M, et al. Concentration-dependent Mycobacterium tuberculosis killing and prevention of resistance by rifampin. Antimicrob Agents Chemother 2007;51:3781-8. https://doi.org/10.1128/AAC.01533-06
  20. Schaaf HS, Willemse M, Cilliers K, Labadarios D, Maritz JS, Hussey GD, 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. https://doi.org/10.1186/1741-7015-7-19
  21. Peloquin CA. Therapeutic drug monitoring in the treatment of tuberculosis. Drugs 2002;62:2169-83. https://doi.org/10.2165/00003495-200262150-00001
  22. World Health Organization. Rapid advice: treatment of tuberculosis in children [Internet]. Geneva (Switzerland): World Health Organization; 2010 [cited 2021 Jul 30]. Available from: https://apps.who.int/iris/handle/10665/44444.
  23. Thee S, Seddon JA, Donald PR, Seifart HI, Werely CJ, Hesseling AC, et al. Pharmacokinetics of isoniazid, rifampin, and pyrazinamide in children younger than two years of age with tuberculosis: evidence for implementation of revised World Health Organization recommendations. Antimicrob Agents Chemother 2011;55:5560-7. https://doi.org/10.1128/AAC.05429-11
  24. Hiruy H, Rogers Z, Mbowane C, Adamson J, Ngotho L, Karim F, et al. Subtherapeutic concentrations of first-line anti-TB drugs in South African children treated according to current guidelines: the PHATISA study. J Antimicrob Chemother 2015;70:1115-23. https://doi.org/10.1093/jac/dku478
  25. Bekker A, Schaaf HS, Draper HR, van der Laan L, Murray S, Wiesner L, et al. Pharmacokinetics of rifampin, isoniazid, pyrazinamide, and ethambutol in infants dosed according to revised WHO-recommended treatment guidelines. Antimicrob Agents Chemother 2016;60:2171-9. https://doi.org/10.1128/AAC.02600-15
  26. Kwara A, Enimil A, Gillani FS, Yang H, Sarfo AM, Dompreh A, et al. Pharmacokinetics of first-line antituberculosis drugs using WHO revised dosage in children with tuberculosis with and without hiv coinfection. J Pediatric Infect Dis Soc 2016;5:356-65. https://doi.org/10.1093/jpids/piv035
  27. Aruldhas BW, Hoglund RM, Ranjalkar J, Tarning J, Mathew SK, Verghese VP, et al. Optimization of dosing regimens of isoniazid and rifampicin in children with tuberculosis in India. Br J Clin Pharmacol 2019;85:644-54. https://doi.org/10.1111/bcp.13846
  28. Guiastrennec B, Ramachandran G, Karlsson MO, Kumar AKH, Bhavani PK, Gangadevi NP, et al. Suboptimal antituberculosis drug concentrations and outcomes in small and HIV-coinfected children in India: recommendations for dose modifications. Clin Pharmacol Ther 2018;104:733-41. https://doi.org/10.1002/cpt.987
  29. Antwi S, Yang H, Enimil A, Sarfo AM, Gillani FS, Ansong D, et al. Pharmacokinetics of the first-line antituberculosis drugs in ghanaian children with tuberculosis with or without HIV coinfection. Antimicrob Agents Chemother 2017;61:e01701-16.
  30. World Health Organization. Communicable Diseases Cluster. Fixed-dose combination tablets for the treatment of tuberculosis: report of an informal meeting held in Geneva, Tuesday, 27 April 1999 [Internet]. Geneva (Switzerland): World Health Organization; 1999 [cited 2021 Jul 30]. Available from: https://apps.who.int/iris/handle/10665/65981.
  31. American Academy of Pediatrics. Tuberculosis. In: Kimberlin DW, Brady MT, Jackson MA, Long SS, editors. Red book: 2018 report of the Committee on Infectious Diseases. 31st ed. Itasca: American Academy of Pediatrics, 2018:829-53.
  32. WHO operational handbook on tuberculosis (Module 1 - Prevention): tuberculosis preventive treatment [Internet]. Geneva (Switzerland): World Health Organization; 2020 [cited 2021 Jul 30] Available from:. https://apps.who.int/iris/bitstream/handle/10665/331525/9789240002906-eng.pdf.
  33. Steele MA, Burk RF, DesPrez RM. Toxic hepatitis with isoniazid and rifampin. A meta-analysis. Chest 1991;99:465-71. https://doi.org/10.1378/chest.99.2.465
  34. Sanders WE Jr. Rifampin. Ann Intern Med 1976;85:82-6. https://doi.org/10.7326/0003-4819-85-1-82
  35. LiverTox: Clinical and research information on drug-induced liver injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012- [updated 2018 Jun 10; cited 2021 Jul 30] Available from: https://www.ncbi.nlm.nih.gov/books/NBK548314/.
  36. Girling DJ. Adverse reactions to rifampicin in antituberculosis regimens. J Antimicrob Chemother 1977;3:115-32. https://doi.org/10.1093/jac/3.2.115
  37. Baron DN, Bell JL. Serum enzyme changes in patients receiving antituberculosis therapy with rifampicin or p-aminosalicylic acid, plus isoniazid and streptomycin. Tubercle 1974;55:115-20. https://doi.org/10.1016/0041-3879(74)90004-X
  38. Grosset J, Leventis S. Adverse effects of rifampin. Rev Infect Dis 1983;5 Suppl 3:S440-50. https://doi.org/10.1093/clinids/5.Supplement_3.S440
  39. Villarino ME, Ridzon R, Weismuller PC, Elcock M, Maxwell RM, Meador J, et al. Rifampin preventive therapy for tuberculosis infection: experience with 157 adolescents. Am J Respir Crit Care Med 1997;155:1735-8. https://doi.org/10.1164/ajrccm.155.5.9154885
  40. A controlled clinical trial of daily and intermittent regimens of rifampicin plus ethambutol in the retreatment of patients with pulmonary tuber-culosis in Hong Kong. A Hong Kong Tuberculosis Treatment Services/Brompton Hospital/British Medical Research Council investigation. Tubercle 1974;55:1-27. https://doi.org/10.1016/0041-3879(74)90064-6
  41. Mehta YS, Jijina FF, Badakere SS, Pathare AV, Mohanty D. Rifampicin-induced immune thrombocytopenia. Tuber Lung Dis 1996;77:558-62. https://doi.org/10.1016/S0962-8479(96)90056-8
  42. Semvua HH, Kibiki GS, Kisanga ER, Boeree MJ, Burger DM, Aarnoutse R. Pharmacological interactions between rifampicin and antiretroviral drugs: challenges and research priorities for resource-limited settings. Ther Drug Monit 2015;37:22-32. https://doi.org/10.1097/FTD.0000000000000108
  43. Baciewicz AM, Chrisman CR, Finch CK, Self TH. Update on rifampin, rifabutin, and rifapentine drug interactions. Curr Med Res Opin 2013;29:1-12.
  44. World Health Organization. Updated recommendations on first-line and second-line antiretroviral regimens and post-exposure prophylaxis and recommendations on early infant diagnosis of HIV: interim guidelines: supplement to the 2016 consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection [Internet]. Geneva (Switzerland): World Health Organization; 2008 [cited 2021 Jul 30]. Available from: https://apps.who.int/iris/handle/10665/277395.
  45. U.S. Food and Drug Administration. Drug development and drug interactions | Table of substrates, inhibitors and inducers [Internet]. Silver Spring (MD): U.S. Food and Drug Administration; 2021 [cited 2021 Jul 30]. Available from: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers.
  46. Campbell JR, Al-Jahdali H, Bah B, Belo M, Cook VJ, Long R, et al. Safety and efficacy of rifampin or isoniazid among people with Mycobacterium tuberculosis infection and living with human immunodeficiency virus or other health conditions: post hoc analysis of 2 randomized trials. Clin Infect Dis 2021;73:e3545-54. https://doi.org/10.1093/cid/ciaa1169
  47. Cruz AT, Ahmed A, Mandalakas AM, Starke JR. Treatment of latent tuberculosis infection in children. J Pediatric Infect Dis Soc 2013;2:248-58. https://doi.org/10.1093/jpids/pit030
  48. Powell DA, Perkins L, Wang SH, Hunt G, Ryan-Wenger N. Completion of therapy for latent tuberculosis in children of different nationalities. Pediatr Infect Dis J 2008;27:272-4. https://doi.org/10.1097/INF.0b013e3181609a0a
  49. Cruz AT, Starke JR. Increasing adherence for latent tuberculosis infection therapy with health department-administered therapy. Pediatr Infect Dis J 2012;31:193-5. https://doi.org/10.1097/INF.0b013e318236984f
  50. Taylor EM, Painter J, Posey DL, Zhou W, Shetty S. Latent tuberculosis infection among immigrant and refugee children arriving in the United States: 2010. J Immigr Minor Health 2016;18:966-70. https://doi.org/10.1007/s10903-015-0273-2
  51. Goswami ND, Gadkowski LB, Piedrahita C, Bissette D, Ahearn MA, Blain ML, et al. Predictors of latent tuberculosis treatment initiation and completion at a U.S. public health clinic: a prospective cohort study. BMC Public Health 2012;12:468. https://doi.org/10.1186/1471-2458-12-468
  52. Hirsch-Moverman Y, Shrestha-Kuwahara R, Bethel J, Blumberg HM, Venkatappa TK, Horsburgh CR, et al. Latent tuberculous infection in the United States and Canada: who completes treatment and why? Int J Tuberc Lung Dis 2015;19:31-8. https://doi.org/10.5588/ijtld.14.0373
  53. Hwang WJ, Lee GU, Kim SH, Cho EY. Childhood tuberculosis contact investigation and treatment of latent tuberculosis infection: a single center study, 2014-2017. Pediatr Infect Vaccine 2019;26:32-41. https://doi.org/10.14776/piv.2019.26.e4
  54. Diallo T, Adjobimey M, Ruslami R, Trajman A, Sow O, Obeng Baah J, et al. Safety and side effects of rifampin versus isoniazid in children. N Engl J Med 2018;379:454-63. https://doi.org/10.1056/NEJMoa1714284
  55. Cruz AT, Starke JR. Safety and completion of a 4-month course of rifampicin for latent tuberculous infection in children. Int J Tuberc Lung Dis 2014;18:1057-61. https://doi.org/10.5588/ijtld.14.0286
  56. Cruz AT, Starke JR. Completion rate and safety of tuberculosis infection treatment with shorter regimens. Pediatrics 2018;141:e20172838. https://doi.org/10.1542/peds.2017-2838
  57. Lardizabal A, Passannante M, Kojakali F, Hayden C, Reichman LB. Enhancement of treatment completion for latent tuberculosis infection with 4 months of rifampin. Chest 2006;130:1712-7. https://doi.org/10.1378/chest.130.6.1712
  58. Page KR, Sifakis F, Montes de Oca R, Cronin WA, Doherty MC, Federline L, et al. Improved adherence and less toxicity with rifampin vs isoniazid for treatment of latent tuberculosis: a retrospective study. Arch Intern Med 2006;166:1863-70. https://doi.org/10.1001/archinte.166.17.1863
  59. Ronald LA, FitzGerald JM, Bartlett-Esquilant G, Schwartzman K, Benedetti A, Boivin JF, et al. Treatment with isoniazid or rifampin for latent tuberculosis infection: population-based study of hepatotoxicity, completion and costs. Eur Respir J 2020;55:1902048. https://doi.org/10.1183/13993003.02048-2019
  60. Gaensbauer J, Aiona K, Haas M, Reves R, Young J, Belknap R. Better completion of pediatric latent tuberculosis treatment using 4 months of rifampin in a US-based tuberculosis clinic. Pediatr Infect Dis J 2018;37:224-8. https://doi.org/10.1097/INF.0000000000001721
  61. Jenkins D, Davidson FF. Isoniazid chemoprophylaxis of tuberculosis. Calif Med 1972;116:1-5.
  62. Mount FW, Ferebee SH. Preventive effects of isoniazid in the treatment of primary tuberculosis in children. N Engl J Med 1961;265:713-21. https://doi.org/10.1056/NEJM196110122651501
  63. Comstock GW, Hammes LM, Pio A. Isoniazid prophylaxis in Alaskan Boarding schools. A comparison of two doses. Am Rev Respir Dis 1969;100:773-9.
  64. Menzies D, Adjobimey M, Ruslami R, Trajman A, Sow O, Kim H, et al. Four months of rifampin or nine months of isoniazid for latent tuberculosis in adults. N Engl J Med 2018;379:440-53. https://doi.org/10.1056/NEJMoa1714283
  65. Zenner D, Beer N, Harris RJ, Lipman MC, Stagg HR, van der Werf MJ. Treatment of latent tuberculosis infection: an updated network meta-analysis. Ann Intern Med 2017;167:248-55. https://doi.org/10.7326/m17-0609
  66. Bastos ML, Campbell JR, Oxlade O, Adjobimey M, Trajman A, Ruslami R, et al. Health system costs of treating latent tuberculosis infection with four months of rifampin versus nine months of isoniazid in different settings. Ann Intern Med 2020;173:169-78.
  67. den Boon S, Matteelli A, Getahun H. Rifampicin resistance after treatment for latent tuberculous infection: a systematic review and meta-analysis. Int J Tuberc Lung Dis 2016;20:1065-71. https://doi.org/10.5588/ijtld.15.0908
  68. U.S. Food and Drug Administation. FDA Updates and press announcements on nitrosamines in rifampin and rifapentine [Internet]. Silver Spring (MD): Food and Drug Administation; 2020 [cited 2021 Mar 30]. Available from: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-nitrosamines-rifampin-and-rifapentine.
  69. Adams LV. Latent tuberculosis infection in children [Internet]. Alphen aan den Rijn: Wolters Kluwer; 2021 [cited 2021 Mar 23]. Available from: https://www.uptodate.com/contents/latent-tuberculosis-infection-in-children.
  70. Ministry of Food and Drug Safety of Republic of Korea. Announcement of results of safety investigation of rifampicin-containing drugs [Internet]. Cheongju (Korea): Ministry of Food and Drug Safety; 2021 [cited 2021 Jul 30]. Available from: https://impfood.mfds.go.kr/CFBBB02F02/getCntntsDetail?cntntsSn=358519.