Optimized First-Line Drugs in Children >5kg

TB Alliance is working to develop appropriate child-friendly formulations of the current standard TB treatment. The first wave of these new products has already reached market.

Background:

Overview

The current standard TB treatment is Isoniazid + Rifampin + Pyrazinamide + Ethambutol (HRZE). This treatment is used to treat both adults and children, however appropriate doses of child-friendly formulations of these drugs simply do not exist in today's market. Those treating children with TB are forced to adapt adult treatments, often by crushing or cutting pills, in order to treat children. This approach institutionalizes poor outcomes and the development of drug resistance. Additionally, the dosing of TB medicines for newborns and infants weighing 5 kg or less have not been adequately studied either as single drug entities or in combination (including as FDCs).

TB Alliance is working to develop child-appropriate formulations of the current standard TB treatment to improve the treatment of pediatric TB patients, in line with WHO's recommendations, and streamline the development of child appropriate forms of new TB drugs currently in development for adults. In this particular program, TB Alliance is working to develop several products, including child-appropriate versions of individual first-line drugs and fixed dose combinations. Products in development include:

  • Ethambutol
  • Isoniazid
  • Pyrazinamide

 

The following combination products have already reached market.

  • Isoniazid + Rifampicin
  • Ethambutol + Rifampicin + Pyrazinamide

 

More information on these products can be found here

Phase 4

Trial Components