Volume 12, Number 5—May 2006
Tuberculosis Special Section
Isoniazid Preventive Therapy and Risk for Resistant Tuberculosis
|Author, country, dates||Population||Intervention/ comparison; blinding||Enrolled (n) INH/control||Follow up; loss to follow-up; overall or INH vs. control||TB cases: culture positive/total (%)
||Definition of INH resistance||Resistant cases/total tested (% culture positive tested)
||Risk for resistant TB/1,000
|INH||Controls||INH||Controls||INH||Controls||RR (95% CI)|
|Randomized controlled trials|
|Gordin, USA, 1991–1996 (30)||Clinic attendees; med. CD4 233/247||6 mo INH 300 mg daily vs. placebo; double blind||260/257||34 mo/33 mo; 6.2% vs. 7%||NS/3||NS/6||NS||0/3 (NS)||0/5 (NS)||1.92†||1.94†||0.99 (0.06–6,298.19)|
|Hawken, Kenya, 1992–1997 (31)||Clinic or VCT attendees; med. CD4 321.5/346||6 mo INH 300 mg daily/placebo; double blind||342/342||Med. 1.83 y (range 0–3.41); 32% vs. 27.3% not seen in final 6 m||19/25 (76)||22/23 (95.7)||Growth on 0.2 μg/mL INH >1% growth on control medium||2/17 (90)||0/21 (96)||10.05†||1.46†||6.88 (0.01–3,882.85)|
|Mwinga, Zambia, 1992–1996 (33)||VCT attendees||6 mo INH 900 mg twice weekly/placebo; double blind||350/352||Med. 1.8 y; 32.4% vs. 30.3% not seen in final 6 m||NS/27||NS/44||NS||0/3 (NS)||1/5 (NS)||1.43†||26.38†||0.05 (0.00–30.47)|
|Johnson, Uganda, 1993–NS (34)||Clinic or counseling attendees||6 mo INH 300 mg daily/placebo; partially double blind‡||931/787||Mean 2 y/1.6 y (PPD+/anergic); 16.1% vs. 30.6%||36/51 (70.6)||46/64 (71.9)||Growth on 0.1 μg/mL INH (BACTEC radiometric method) >1% growth on control medium||5/20 (56)||1/24 (52)||13.69||3.39||4.04 (0.50–32.80)|
|Rivero, Spain, 1994–2000 (35)
||Clinic attendees; med. CD4 193/215
||6 mo INH 300 mg daily/no treatment; not blind
||24 mo; 26.8% vs. 7.8%
|Moreno, Spain, 1985–1994 (32)||Clinic attendees; med. CD4 689/648||9–12 mo INH (dose NS)/no treatment; not blind||29/92||89 mo vs. 60 mo; NS||3/3 (100)||39/43 (90.7)||Growth on 0.2 μg/mL INH >1% growth on control medium||2/2 (67)||0/12 (31)||118.64†||5.41†||21.95 (0.04–11,582.31)|
*INH, isoniazid; TB, tuberculosis; RR, relative risk; CI, confidence interval; med., median; NS, not stated; Rx, treatment; VCT, voluntary counseling and testing; PPD, purified protein derivative.
†Calculated by adding 0.5 to numerator and denominator of both groups.
‡Unclear whether isoniazid and placebo group received the same number of tablets.
- Corbett EL, Watt CJ, Walker N, Maher D, Williams BG, Raviglione MC, The growing burden of tuberculosis: global trends and interactions with the HIV epidemic. Arch Intern Med. 2003;163:1009–21.
- Selwyn PA, Hartel D, Lewis VA, Schoenbaum EE, Vermund SH, Klein RS, A prospective study of the risk of tuberculosis among intravenous drug users with human immunodeficiency virus infection. N Engl J Med. 1989;320:545–50.
- Daley CL, Small PM, Schecter GF, Schoolnik GK, McAdam RA, Jacobs WR Jr, An outbreak of tuberculosis with accelerated progression among persons infected with the human immunodeficiency virus. An analysis using restriction-fragment-length polymorphisms. N Engl J Med. 1992;326:231–5.
- Di Perri G, Cruciani M, Danzi MC, Luzzati R, De CG, Malena M, Nosocomial epidemic of active tuberculosis among HIV-infected patients. Lancet. 1989;2:1502–4.
- Mukadi YD, Maher D, Harries A. Tuberculosis case fatality rates in high HIV prevalence populations in sub-Saharan Africa. AIDS. 2001;15:143–52.
- De Cock KM, Chaisson RE. Will DOTS do it? A reappraisal of tuberculosis control in countries with high rates of HIV infection. Int J Tuberc Lung Dis. 1999;3:457–65.
- Woldehanna S, Volmink J. Treatment of latent tuberculosis infection in HIV infected persons (Cochrane Review). The Cochrane Library, Issue 3. Chichester (UK): John Wiley & Sons; 2004.
- World Health Organization Global Tuberculosis Programme, Joint United Nations Programme on HIV/AIDS. Policy statement on preventive therapy against tuberculosis in people living with HIV [cited 2006 Mar 20]. Geneva: The Organization; 1998. WHO/TB/98.255. Available from http://www.who.int/docstore/gtb/publications/TB_HIV_polstmnt/index.html
- Ferebee S. Controlled chemoprophylaxis trials in tuberculosis: a general review. Adv Tuberc Res. 1970;17:28–106.
- Smieja MJ, Marchetti CA, Cook DJ, Smaill FM. Isoniazid for preventing tuberculosis in non-HIV infected persons (Cochrane Review). The Cochrane Library, Issue 4. Chichester (UK): John Wiley & Sons; 2003.
- Wilkinson D, Squire SB, Garner P. Effect of preventive treatment for tuberculosis in adults infected with HIV: systematic review of randomised placebo controlled trials. BMJ. 1998;317:625–9.
- Bucher HC, Griffith LE, Guyatt GH, Sudre P, Naef M, Sendi P, Isoniazid prophylaxis for tuberculosis in HIV infection: a meta-analysis of randomized controlled trials. AIDS. 1999;13:501–7.
- Sankey SS, Weissfeld LA, Fine MJ, Kapoor WN. An assessment of the use of the continuity correction for sparse data in meta-analysis. Comm Statist Simulation Comput. 1996;25:1031–56.
- DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7:177–88.
- Gomez JE, McKinney JD. M. tuberculosis persistence, latency, and drug tolerance. Tuberculosis (Edinb). 2004;84:29–44.
- David HL. Probability distribution of drug-resistant mutants in unselected populations of Mycobacterium tuberculosis. Appl Microbiol. 1970;20:810–4.
- Begg CB, Mazumdar M. Operating characteristics of a rank correlation test for publication bias. Biometrics. 1994;50:1088–101.
- Ferebee SH, Mount FW. Tuberculosis morbidity in a controlled trial of the prophylactic use of isoniazid among household contacts. Am Rev Respir Dis. 1962;85:490–510.
- Katz J, Kunofsky S, Damijonaitis V, Lafleur A, Caron T. Effect of isoniazid upon the reactivation of inactive tuberculosis; final report. Am Rev Respir Dis. 1965;91:345–50.
- Horwitz O, Payne PG, Wilbek E. Epidemiological basis of tuberculosis eradication. 4. The isoniazid trial in Greenland. Bull World Health Organ. 1966;35:509–26.
- Comstock GW, Ferebee SH, Hammes LM. A controlled trial of community-wide isoniazid prophylaxis in Alaska. Am Rev Respir Dis. 1967;95:935–43.
- Pamra SP, Mathur GP. Effects of chemoprophylaxis on minimal pulmonary tuberculosis lesions of doubtful activity. Bull World Health Organ. 1971;45:593–602.
- Debre R, Perdrizet S, Lotte A, Naveau M, Lert F. Isoniazid chemoprophylaxis of latent primary tuberculosis: in five trial centres in France from 1959 to 1969. Int J Epidemiol. 1973;2:153–60.
- Grzybowski S, Ashley MJ, Pinkus G. Chemoprophylaxis in inactive tuberculosis: long-term evaluation of a Canadian trial. Can Med Assoc J. 1976;114:607–11.
- Krebs A. The IUAT trial on isoniazid preventive treatment in persons with fibrotic lung lesions. Bull Int Union Tuberc. 1976;51:193–201.
- Nolan CM, Aitken ML, Elarth AM, Anderson KM, Miller WT. Active tuberculosis after isoniazid chemoprophylaxis of Southeast Asian refugees. Am Rev Respir Dis. 1986;133:431–6.
- British Medical Research Council. A double-blind placebo-controlled clinical trial of three antituberculosis chemoprophylaxis regimens in patients with silicosis in Hong Kong. Am Rev Respir Dis. 1992;145:36–41.
- Pape JW, Jean SS, Ho JL, Hafner A, Johnson WD Jr. Effect of isoniazid prophylaxis on incidence of active tuberculosis and progression of HIV infection. Lancet. 1993;342:268–72.
- Guelar A, Gatell JM, Verdejo J, Podzamczer D, Lozano L, Aznar E, A prospective study of the risk of tuberculosis among HIV-infected patients. AIDS. 1993;7:1345–9.
- Gordin FM, Matts JP, Miller C, Brown LS, Hafner R, John SL, A controlled trial of isoniazid in persons with anergy and human immunodeficiency virus infection who are at high risk for tuberculosis. N Engl J Med. 1997;337:315–20.
- Hawken MP, Meme HK, Elliott LC, Chakaya JM, Morris JS, Githui WA, Isoniazid preventive therapy for tuberculosis in HIV-1-infected adults: results of a randomized controlled trial. AIDS. 1997;11:875–82.
- Moreno S, Miralles P, Diaz MD, Baraia J, Padilla B, Berenguer J, Isoniazid preventive therapy in human immunodeficiency virus-infected persons. Long-term effect on development of tuberculosis and survival. Arch Intern Med. 1997;157:1729–34.
- Mwinga A, Hosp M, Godfrey-Faussett P, Quigley M, Mwaba P, Mugala BN, Twice weekly tuberculosis preventive therapy in HIV infection in Zambia. AIDS. 1998;12:2447–57.
- Johnson JL, Okwera A, Hom DL, Mayanja H, Kityo CM, Nsubuga P, Duration of efficacy of treatment of latent tuberculosis infection in HIV-infected adults. AIDS. 2001;15:2137–47.
- Rivero A, Lopez-Cortes L, Castillo R, Lozano F, Garcia MA, Diez F, Randomized trial of three regimens to prevent tuberculosis in HIV-infected patients with anergy [in Spanish]. Enferm Infecc Microbiol Clin. 2003;21:287–92.
- Rieder HL, Chonde MT, Myking H, Urbaniczik R, Laszlo A, Kim SJ, The public health service national tuberculosis reference laboratory and the national laboratory network: minimum requirements, role and operation in a low-income country. Paris: International Union against Tuberculosis and Lung Disease; 1998.
- Sonnenberg P, Murray J, Glynn JR, Shearer S, Kambashi B, Godfrey-Faussett P. HIV-1 and recurrence, relapse and reinfection of tuberculosis after cure: a cohort study in South African mineworkers. Lancet. 2001;358:1687–93.
- van Rie A, Warren R, Richardson M, Victor TC, Gie RP, Enarson DA, Exogenous reinfection as a cause of recurrent tuberculosis after curative treatment. N Engl J Med. 1999;341:1174–9.
- Centers for Disease Control and Prevention. 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. MMWR Morb Mortal Wkly Rep. 2003;52:735–9.
- World Health Organization. Interim policy on collaborative TB/HIV activities. Geneva: The Organization; 2004. WHO/HTM/TB/2004.330. Available from http://www.who.int/hiv/pub/tb/tbhiv/en/index.html
1Current affiliation: Department of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile