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The background and rationale for a new fixed-dose combination for first-line treatment of tuberculosis in children

S M Graham1, M Grzemska2, R P Gie3

  • 1Centre for International Child Health, University of Melbourne Department of Paediatrics and Murdoch Children's Research Institute, Royal Children's Hospital, Melbourne, Victoria, Australia.

The International Journal of Tuberculosis and Lung Disease : the Official Journal of the International Union Against Tuberculosis and Lung Disease
|November 14, 2015
PubMed

Insights

The World Health Organization updated tuberculosis treatment for children in 2010, increasing drug dosages. A new fixed-dose combination (FDC) tablet is now available to simplify administering these higher doses for drug-susceptible tuberculosis in children.

Area of Science:

  • Pediatric infectious diseases
  • Pharmacology and pharmacokinetics
  • Global health initiatives

Background:

  • In 2010, the World Health Organization (WHO) revised tuberculosis (TB) treatment guidelines for children.
  • Revised guidelines recommended increased dosages of isoniazid, rifampicin, and pyrazinamide based on body weight.

Purpose of the Study:

  • To explain the background and rationale for developing a new fixed-dose combination (FDC) tablet for pediatric tuberculosis treatment.
  • To address challenges in implementing revised WHO TB treatment recommendations for children.

Main Methods:

  • Review of pharmacokinetic studies indicating higher drug dosage requirements in young children.
  • Analysis of observational studies assessing the safety of higher TB drug dosages in pediatric populations.

Main Results:

  • Pharmacokinetic and observational studies support higher TB drug dosages for children to achieve therapeutic concentrations without increased toxicity.
  • Implementation challenges arose due to the unavailability of appropriate fixed-dose combinations (FDCs) for the revised pediatric TB treatment dosages.

Conclusions:

  • A new FDC tablet has been developed to facilitate the implementation of revised WHO recommendations for treating drug-susceptible TB in children.
  • The new FDC aims to simplify the administration of appropriate TB drug dosages in pediatric patients, with planned implementation in 2015.

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