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Free Content Latent tuberculosis infection treatment for prison inmates: a randomised controlled trial

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Abstract:

SETTING: A prison in northern Taiwan.

OBJECTIVE: To compare safety and the completion rate of the 4-month daily rifampicin regimen (4R) vs. the standard 6-month daily isoniazid regimen (6H) for latent tuberculosis infection (LTBI) in prison inmates.

DESIGN: This was an open-label randomised trial among human immunodeficiency virus negative male inmates. Inmates without active tuberculosis (TB) who tested positive for both the tuberculin skin test and QuantiFERON®-TB Gold In-Tube were eligible, but those with baseline glutamic pyruvic transaminase (GPT) levels ≥ 120 U/l, bilirubin levels ≥ 2.4 U/l or a platelet count < 150 k/mm3 were excluded. The primary endpoint was any adverse event that resulted in discontinuation of LTBI treatment.

RESULTS: Participants (n = 373; 14% hepatitis B surface antigen positive, 21% anti-hepatitis C virus [HCV] positive) were randomised (stratified by hepatitis B virus, HCV status and 2-year prison term) to receive either 4R or 6H under directly observed treatment. The 4R group (n = 190) was less likely to experience an adverse event leading to discontinuation of treatment (2% vs. 12%, P < 0.001 for all adverse events; 0% vs. 8%, P < 0.001 for hepatotoxicity), and more likely to complete LTBI treatment (86% vs. 78%, P = 0.041), compared with the 6H group (n = 183).

CONCLUSIONS: 4R is safer and has a higher completion rate than 6H as treatment for LTBI among male prison inmates.

Keywords: hepatotoxicity; isoniazid; rifampicin

Document Type: Research Article

DOI: https://doi.org/10.5588/ijtld.11.0504

Affiliations: 1: Centers for Disease Control, Taipei, Taiwan; Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan; Department of Pediatrics, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan 2: Centers for Disease Control, Taipei, Taiwan 3: Department of Pediatrics, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan 4: Department of Internal Medicine, and Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan 5: Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan

Publication date: 2012-05-01

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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