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

Int J Tuberc Lung Dis. 2012 May;16(5):633-8. doi: 10.5588/ijtld.11.0504. Epub 2012 Mar 8.


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/mm(3) 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.

Trial registration: NCT00767975.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antitubercular Agents / administration & dosage
  • Antitubercular Agents / adverse effects
  • Antitubercular Agents / therapeutic use*
  • Follow-Up Studies
  • Humans
  • Interferon-gamma Release Tests
  • Isoniazid / therapeutic use*
  • Latent Tuberculosis / drug therapy*
  • Male
  • Medication Adherence
  • Middle Aged
  • Prisoners
  • Rifampin / administration & dosage
  • Rifampin / adverse effects
  • Rifampin / therapeutic use*
  • Taiwan
  • Treatment Outcome
  • Tuberculin Test
  • Young Adult


  • Antitubercular Agents
  • Isoniazid
  • Rifampin

Associated data