Rifampicin Plus Pyrazinamide versus Isoniazid For Treating Latent Tuberculosis Infection: A Meta-analysis△_Chinese Journal of Evidence-Based Medicine

Authors：

GAO Xiaofeng , WANG Li , LIU Guanjian , WEN Jin , SUN Xin , XIE Yu , LIF Youping

Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China.;

Corresponding author：

Keywords：

Tuberculosis; isoniazid; rifampicin; pyrazinamide; meta-analysis

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Objective 　To evaluate the efficacy and safety of rifampicin plus pyrazinamide versus isoniazid for prevention of tuberculosis among persons with or without HIV-infection respectively.
Methord 　Meta-analysis of randomized controlled trials(RCT) and quasi-randomized controlled trials(quasi RCT) that compared rifampicin plus pyrazinamide for 2-3 months with isoniazid for 6-12 months. Endpoints were development of active tuberculosis, severe adverse effects, and death. Treatment effects were summarized as risk difference (RD) with 95% confidence interval (CI).
Results 　Three trials conducted in HIV-infected patients and 3 trials conducted in HIV-uninfected persons were identified. The rates of tuberculosis in the rifampicin plus pyrazinamide group were similar to that in the isoniazid group, whether the subjects were HIV-infected patients or not (for HIV-infected patients: pooled RD= 0%, 95%CI: -1% to 2%, P=0.89; for HIV-uninfected persons: pooled RD=0%, 95%CI: -2% to 1%, P=0.55). There was no difference in mortality between the two treatment groups (for HIV-infected patients: pooled RD=-1%, 95%CI: -4% to 2%, P=0.53; for HIV-uninfected persons: pooled RD=0%, 95%CI: -1% to 1%, P=1.00). However, both subgroup analyses showed that a higher incidence of all severe adverse events was associated with rifampicin plus pyrazinamide than isoniazid among HIV-uninfected persons (one: RD=29%, 95%CI: 13% to 46%; P=0.000 5; another: RD=7%, 95%CI: 4% to 10%; P lt;0.000 1).
Conclusion 　Rifampicin plus pyrazinamide is equivalent to isoniazid in terms of efficacy and mortality in the treatment of latent tuberculosis infection. However, this regimen increases risk of severe adverse effects compared with isoniazid in HIV-uninfected persons.

Citation： GAO Xiaofeng,WANG Li,LIU Guanjian,WEN Jin,SUN Xin,XIE Yu,LIF Youping. Rifampicin Plus Pyrazinamide versus Isoniazid For Treating Latent Tuberculosis Infection: A Meta-analysis△. Chinese Journal of Evidence-Based Medicine, 2007, 07(1): 27-36. doi: Copy

1.	Fountain FF, Tolley E, Chrisman CR, et al. Isoniazid hepatotoxicity associated with treatment of latent tuberculosis infection: a 7-year evaluation from a public health tuberculosis clinic. Chest, 2005, 128: 116–123.
2.	Kopanoff DE, Snider DE Jr, Caras GJ. Isoniazid-related hepatitis:a U.S.Public Health Service cooperative surveillance study. Am Rev Respir Dis, 1978, 117: 991–1001.
3.	Snider DE Jr, Caras GJ. Isoniazid-associated hepatitis death: a review of available information. Am Rev Respir Dis, 1992, 145: 494–497.
4.	Tulsky JP, Pilote L, Hahn JA, et al. Adherence to isoniazid prophylaxis in the homeless: a randomized controlled trial. Arch Intern Med, 2000, 160: 697–702.
5.	American Thoracic Society, Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med, 2000, 161(Suppl): s221–247.
6.	Fatal and severe hepatitis associated with rifampin and pyrazinamide for the treatment of latent tuberculosis infection: New York and Georgia, 2000. Morb Mortal Wkly Rep, 2001, 50: 289–291.
7.	Update: Fatal and severe liver injuries associated with rifampin and pyrazinamide for latent tuberculosis infection, and revisions in American Thoracic Society/CDC recommendations: United States, 2001. Morb Mortal Wkly Rep, 2001, 50: 733–735.
8.	Update: Fatal and severe liver injuries associated with rifampin and pyrazinamide treatment for latent tuberculosis infection. Morb Mortal Wkly Rep, 2002, 51: 998–999.
9.	Update: Adverse Event Data and Revised American Thoracic Society/CDC Recommendations Against the Use of Rifampin and Pyrazinamide for Treatment of Latent Tuberculosis Infection---United States, 2003. Morb Mortal Wkly Rep, 2003, 52: 735–738.
10.	Jüni P, Altman DG, Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials. BMJ, 2001, 323: 42–46.
11.	Alderson P, Green S, Higgins JPT. Cochrane Reviewers’ Handbook 4.2.2 [updated March 2004]. In: The Cochrane Library, Issue 1, 2004.
12.	Ena J, Valls V. Short-course therapy with rifampin plus isoniazid, compared with standard therapy with isoniazid, for latent tuberculosis infection: a meta-analysis. Clin Infect Dis, 2005, 40: 670–676.
13.	The European Agency for the Evaluation of Medicinal Products. Evaluation of medicines for human use: points to consider on the choice of non-inferiority margin. Available at: http://www.emea.eu.int/pdfs/human/ewp/215899en.pdf.
14.	Higgins JPT, Thompson SG, Deeks JJ, et al. Measuring inconsistency in meta-analysis. BMJ, 2003, 327: 557–560.
15.	Sterne JAC, Egger M, Smith GD. Systematic reviews in health care: investigating and dealing with publication and other biases in meta-analysis. BMJ, 2001, 323: 101–105.
16.	Halsey NA, Coberly JS, Desormeaux J, et al. Randomised trial of isoniazid versus rifampicin and pyrazinamide for prevention of tuberculosis in HIV-1 infection. The Lancet, 1998, l 351: 786–792.
17.	Mwinga A, Hosp M, Godfrey-Faussett P, et al. Twice weekly tuberculosis preventive therapy in HIV infection in Zambia. AIDS, 1998, 12: 2447–2457.
18.	Gordin F, Chaisson RE, Matts JP, et al. Rifampin and pyrazinamide vs isoniazid for prevention of tuberculosis in HIV-infected persons: an international randomized trial. JAMA, 2000, 283: 1445–1450.
19.	Jasmer RM, Saukkonen JJ, Blumberg HM, et al. Short-Course Rifampin and Pyrazinamide Compared with Isoniazid for Latent Tuberculosis Infection: A Multicenter Clinical Trial. Ann Intern Med, 2002, 137: 640–647.
20.	Leung CC, Law WS, Chang KC, et al. Initial experience on rifampin and pyrazinamide vs isoniazid in the treatment of latent tuberculosis infection among patients with silicosis in Hong Kong. Chest, 2003, 124: 2112–2118.
21.	Tortajada C, Martinez-Lacasa J, Sanchez F, et al. Is the combination of pyrazinamide plus rifampicin safe for treating latent tuberculosis infection in persons not infected by the human immunodeficiency virus? Int J Tuberc Lung Dis, 2005, 9: 276–281.
22.	Woldehanna S, Volmink J. Treatment of latent tuberculosis infection in HIV infected persons. The Cochrane library, 2006 issue 1.
23.	Anonymous. Efficacy of various durations of isoniazid preventive therapy for tuberculosis: five years of follow-up in the IUAT trial. International Union Against Tuberculosis Committee on Prophylaxis. Bulletin of the world health organization, 1982, 60: 555–564.
24.	Bock NN, Rogers T, Tapia JR, et al. Acceptability of short-course rifampin and pyrazinamide treatment of latent tuberculosis infection among jail inmates. Chest, 2001, 119: 833–837.
25.	Chaisson RE, Armstrong J, Stafford J, et al. Safety and tolerability of intermittent rifampin/pyrazinamide for the treatment of latent tuberculosis infection in prisoners. JAMA, 2002, 288: 165–166.
26.	Lee AM, Mennone JZ, Jones RC, et al. Risk factors for hepatotoxicity associated with rifampin and pyrazinamide for the treatment of latent tuberculosis infection: experience from three public health tuberculosis clinics. Int J Tuberc Lung Dis, 2002, 6: 995–1000.
27.	McNeill L, Allen M, Estrada C, et al. Pyrazinamide and Rifampin vs Isoniazid for the Treatment of Latent Tuberculosis. Chest, 2003, 123: 102–106.
28.	Stout JE, Engemann JJ, Cheng AC, et al. Safety of 2 Months of Rifampin and Pyrazinamide for Treatment of Latent Tuberculosis. Am J Respir Crit Care Med, 2003, 167: 824–827.
29.	Priest DH, Vossel LF, Sherfy EA, et al. Use of intermittent rifampin and pyrazinamide therapy for latent tuberculosis infection in a targeted tuberculin testing program. Clin Infect Dis, 2004, 39:1764-1771.
30.	Lobato MN, Reves RR, Jasmer RM, et al. 2RZ Study Group. Adverse events and treatment completion for latent tuberculosis in jail inmates and homeless persons. Chest, 2005, 127: 1296–1303.
31.	Saukkonen J. Rifampin and pyrazinamide for latent tuberculosis infection: clinical trials and general practice. Clin Infect Dis, 2004, 39: 566–568.
32.	McElroy PD, Ijaz K, Lambert LA, et al. national survey to measure rates of liver injury, hospitalization, and death associated with rifampin and pyrazinamide for latent tuberculosis infection. Clin Infect Dis, 2005, 41: 1125–1133.
33.	Ijaz K, Jereb JA, Lambert LA, et al. severe or fatal liver injury in 50 patients in the united states taking rifampin and pyrazinamide for latent tuberculosis infection. Clin Infect Dis, 2006: 42: 346–355.
34.	Schulz KF, Chalmers I, Grimes DA, et al. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology. JAMA, 1994, 272: 125–128.
35.	Bucher HC, Griffith LE, Guyatt GH, et al. Isoniazid prophylaxis for tuberculosis in HIV infection:a meta-analysis of randomized controlled trials. AIDS, 1999, 13: 501–507.

1. Fountain FF, Tolley E, Chrisman CR, et al. Isoniazid hepatotoxicity associated with treatment of latent tuberculosis infection: a 7-year evaluation from a public health tuberculosis clinic. Chest, 2005, 128: 116–123.
2. Kopanoff DE, Snider DE Jr, Caras GJ. Isoniazid-related hepatitis:a U.S.Public Health Service cooperative surveillance study. Am Rev Respir Dis, 1978, 117: 991–1001.
3. Snider DE Jr, Caras GJ. Isoniazid-associated hepatitis death: a review of available information. Am Rev Respir Dis, 1992, 145: 494–497.
4. Tulsky JP, Pilote L, Hahn JA, et al. Adherence to isoniazid prophylaxis in the homeless: a randomized controlled trial. Arch Intern Med, 2000, 160: 697–702.
5. American Thoracic Society, Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med, 2000, 161(Suppl): s221–247.
6. Fatal and severe hepatitis associated with rifampin and pyrazinamide for the treatment of latent tuberculosis infection: New York and Georgia, 2000. Morb Mortal Wkly Rep, 2001, 50: 289–291.
7. Update: Fatal and severe liver injuries associated with rifampin and pyrazinamide for latent tuberculosis infection, and revisions in American Thoracic Society/CDC recommendations: United States, 2001. Morb Mortal Wkly Rep, 2001, 50: 733–735.
8. Update: Fatal and severe liver injuries associated with rifampin and pyrazinamide treatment for latent tuberculosis infection. Morb Mortal Wkly Rep, 2002, 51: 998–999.
9. Update: Adverse Event Data and Revised American Thoracic Society/CDC Recommendations Against the Use of Rifampin and Pyrazinamide for Treatment of Latent Tuberculosis Infection---United States, 2003. Morb Mortal Wkly Rep, 2003, 52: 735–738.
10. Jüni P, Altman DG, Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials. BMJ, 2001, 323: 42–46.
11. Alderson P, Green S, Higgins JPT. Cochrane Reviewers’ Handbook 4.2.2 [updated March 2004]. In: The Cochrane Library, Issue 1, 2004.
12. Ena J, Valls V. Short-course therapy with rifampin plus isoniazid, compared with standard therapy with isoniazid, for latent tuberculosis infection: a meta-analysis. Clin Infect Dis, 2005, 40: 670–676.
13. The European Agency for the Evaluation of Medicinal Products. Evaluation of medicines for human use: points to consider on the choice of non-inferiority margin. Available at: http://www.emea.eu.int/pdfs/human/ewp/215899en.pdf.
14. Higgins JPT, Thompson SG, Deeks JJ, et al. Measuring inconsistency in meta-analysis. BMJ, 2003, 327: 557–560.
15. Sterne JAC, Egger M, Smith GD. Systematic reviews in health care: investigating and dealing with publication and other biases in meta-analysis. BMJ, 2001, 323: 101–105.
16. Halsey NA, Coberly JS, Desormeaux J, et al. Randomised trial of isoniazid versus rifampicin and pyrazinamide for prevention of tuberculosis in HIV-1 infection. The Lancet, 1998, l 351: 786–792.
17. Mwinga A, Hosp M, Godfrey-Faussett P, et al. Twice weekly tuberculosis preventive therapy in HIV infection in Zambia. AIDS, 1998, 12: 2447–2457.
18. Gordin F, Chaisson RE, Matts JP, et al. Rifampin and pyrazinamide vs isoniazid for prevention of tuberculosis in HIV-infected persons: an international randomized trial. JAMA, 2000, 283: 1445–1450.
19. Jasmer RM, Saukkonen JJ, Blumberg HM, et al. Short-Course Rifampin and Pyrazinamide Compared with Isoniazid for Latent Tuberculosis Infection: A Multicenter Clinical Trial. Ann Intern Med, 2002, 137: 640–647.
20. Leung CC, Law WS, Chang KC, et al. Initial experience on rifampin and pyrazinamide vs isoniazid in the treatment of latent tuberculosis infection among patients with silicosis in Hong Kong. Chest, 2003, 124: 2112–2118.
21. Tortajada C, Martinez-Lacasa J, Sanchez F, et al. Is the combination of pyrazinamide plus rifampicin safe for treating latent tuberculosis infection in persons not infected by the human immunodeficiency virus? Int J Tuberc Lung Dis, 2005, 9: 276–281.
22. Woldehanna S, Volmink J. Treatment of latent tuberculosis infection in HIV infected persons. The Cochrane library, 2006 issue 1.
23. Anonymous. Efficacy of various durations of isoniazid preventive therapy for tuberculosis: five years of follow-up in the IUAT trial. International Union Against Tuberculosis Committee on Prophylaxis. Bulletin of the world health organization, 1982, 60: 555–564.
24. Bock NN, Rogers T, Tapia JR, et al. Acceptability of short-course rifampin and pyrazinamide treatment of latent tuberculosis infection among jail inmates. Chest, 2001, 119: 833–837.
25. Chaisson RE, Armstrong J, Stafford J, et al. Safety and tolerability of intermittent rifampin/pyrazinamide for the treatment of latent tuberculosis infection in prisoners. JAMA, 2002, 288: 165–166.
26. Lee AM, Mennone JZ, Jones RC, et al. Risk factors for hepatotoxicity associated with rifampin and pyrazinamide for the treatment of latent tuberculosis infection: experience from three public health tuberculosis clinics. Int J Tuberc Lung Dis, 2002, 6: 995–1000.
27. McNeill L, Allen M, Estrada C, et al. Pyrazinamide and Rifampin vs Isoniazid for the Treatment of Latent Tuberculosis. Chest, 2003, 123: 102–106.
28. Stout JE, Engemann JJ, Cheng AC, et al. Safety of 2 Months of Rifampin and Pyrazinamide for Treatment of Latent Tuberculosis. Am J Respir Crit Care Med, 2003, 167: 824–827.
29. Priest DH, Vossel LF, Sherfy EA, et al. Use of intermittent rifampin and pyrazinamide therapy for latent tuberculosis infection in a targeted tuberculin testing program. Clin Infect Dis, 2004, 39:1764-1771.
30. Lobato MN, Reves RR, Jasmer RM, et al. 2RZ Study Group. Adverse events and treatment completion for latent tuberculosis in jail inmates and homeless persons. Chest, 2005, 127: 1296–1303.
31. Saukkonen J. Rifampin and pyrazinamide for latent tuberculosis infection: clinical trials and general practice. Clin Infect Dis, 2004, 39: 566–568.
32. McElroy PD, Ijaz K, Lambert LA, et al. national survey to measure rates of liver injury, hospitalization, and death associated with rifampin and pyrazinamide for latent tuberculosis infection. Clin Infect Dis, 2005, 41: 1125–1133.
33. Ijaz K, Jereb JA, Lambert LA, et al. severe or fatal liver injury in 50 patients in the united states taking rifampin and pyrazinamide for latent tuberculosis infection. Clin Infect Dis, 2006: 42: 346–355.
34. Schulz KF, Chalmers I, Grimes DA, et al. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology. JAMA, 1994, 272: 125–128.
35. Bucher HC, Griffith LE, Guyatt GH, et al. Isoniazid prophylaxis for tuberculosis in HIV infection:a meta-analysis of randomized controlled trials. AIDS, 1999, 13: 501–507.

Chinese Journal of Evidence-Based Medicine

Rifampicin Plus Pyrazinamide versus Isoniazid For Treating Latent Tuberculosis Infection: A Meta-analysis△

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