Latent tuberculosis infection treatment for prison inmates: a randomised controlled trial
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
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: 01 May 2012
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