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Optimized First-Line Drugs in Children >5kg

TB Alliance and partners have developed 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 were absent from the market for many years. Those treating children with TB were forced to adapt adult treatments, often by crushing or cutting pills, in order to treat children. This approach institutionalized 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 and partners have developed child-appropriate formulations of the current standard TB treatment to improve the treatment of pediatric TB patients, In this particular program, TB Alliance developed several products, including child-appropriate versions of individual first-line drugs and fixed dose combinations (for children weighing more than 5 kg). 

The following combination products have already reached market.

  • Isoniazid + Rifampicin
  • Ethambutol + Rifampicin + Pyrazinamide

These products can be ordered here

Phase 4

Trial Components