New Fixed-Dose Combinations For The Treatment of TB in Children

New fixed-dose combinations
for the treatment of TB in children

NEW HOPE FOR CHILDREN WITH TB
 At least 1 million children become ill with
SIMPLE, CHILD-FRIENDLY TB TREATMENT
tuberculosis (TB) each year. Children represent about
10-11% of all TB cases. NOW AVAILABLE
 In 2015, 170,000 children died of TB, and there were Until recently, there was no appropriate first-line TB
an additional 40,000 TB deaths among children who treatment designed for children. However, after
were HIV-positive. sustained advocacy and new investment, now child-
 TB in children can be treated. Most children tolerate friendly formulations that do not need to be cut or
treatment very well. crushed to achieve an appropriate dose are available,
 Preventive therapy is highly effective in children offering the opportunity to simplify and improve
exposed to TB. treatment for children everywhere.
 Simple, child-friendly fixed-dose formulations are The formulations were developed in line with the
easy to administer and match WHO dosage
revised dosing published in the 2014 WHO Guidance
recommendations for first line treatment.
on childhood TB through a project led by TB Alliance
TREATING TB IN CHILDREN and WHO (Essential Medicines and Health Products
All children treated for TB should be registered with the department and the Global TB Programme), and
National TB programme. funded by UNITAID and USAID.
The following dosages of first-line anti-TB medicines The fixed-dose combinations (FDCs) are not new
should be used daily for the treatment of TB in children: drugs, but rather improved formulations of currently
used medicines recommended for the first line
Isoniazid (H) 10 mg/kg (range 7–15 mg/kg)
treatment of TB.
Rifampicin (R) 15 mg/kg (range 10–20 mg/kg)
Pyrazinamide (Z) 35 mg/kg (range 30–40 mg/kg) The FDCs are recommended to replace previously
Ethambutol (E) 20 mg/kg (range 15–25 mg/kg) used medicines for children weighing less than 25 kg.
As children approach a body weight of 25 kg, adult
dosages can be used BENEFITS OF CHILD-FRIENDLY TB
FORMULATIONS
 First line treatment of drug-sensitive TB consists of a
 The right medicines in the right doses will increase
two-month intensive phase with isoniazid, rifampicin,
adherence and save more lives. This is an
pyrazinamide (and, depending on the setting and type
important step in improving treatment and child
of disease, ethambutol), followed by a continuation
survival from TB, and slowing the spread of drug-
phase with isoniazid and rifampicin for at least four
resistant TB.
months.
 Simple TB medicines for children eases the TB
 HIV-infected children with TB require antiretroviral
burden on healthcare systems. Using fixed-dose
therapy (ART) and co-trimoxazole preventive therapy
combinations for children eases procurement of TB
(CPT) in addition to TB treatment.
medicines. Fewer pills will simplify ordering and
 Isoniazid in the same dosage is recommended as
storage, and facilitate scale-up of pediatric
preventive therapy over six months for children under
treatment.
the age of five as well as HIV-positive children of any
 Child-friendly medicines improve the daily lives of
age.
children and their families struggling with TB. Six
 The support of the child, his/her parents and
months is a long time to take medicine. But the
immediate family is vital to ensure the completion of
availability of treatment that tastes good and is
treatment and a successful outcome. This may include
simple to provide will ease the daily struggles of
nutritional, financial and counselling assistance.
children, parents, and caregivers alike.
ABOUT THE FIXED-DOSE COMBINATIONS HOW CAN COUNTRIES ACCESS THE
FOR CHILDREN NEW FORMULATIONS
The formulations now available are : Following approval by a WHO Expert Review Panel
For the intensive phase of TB treatment: in June 2015, countries can access the new
Rifampicin 75 mg + Isoniazid 50 mg + formulations through the Global TB Drug Facility
Pyrazinamide 150mg (GDF).
For the continuation phase of TB treatment: TB high burden countries can utilize the WHO
Rifampicin 75mg + Isoniazid 50 mg Collaborative Procedure for fast track registration
and can benefit from technical assistance for
The following dosing table provides information on the transitioning from the old to the new formulations.
number of daily tablets needed to reach the proper
dosing, based on the child’s weight:
OTHER PRODUCTS IN THE PIPELINE
Other products under development and likely to be
Numbers of tablets available in 2016 are:
Weight
Intensive phase: Continuation phase:  100 mg ethambutol dispersible tablets;
band
RHZ 75/50/150* RH 75/50  100 mg isoniazid dispersible tablets
4-7 kg 1 1 (recommended for preventive therapy).
8-11 kg 2 2
12-15 kg 3 3 KEY REFERENCES
16-24 kg 4 4  Global TB Report 2016. World Health
25+ kg Adult dosages recommended Organization, 2016.
 Guidance for national tuberculosis programmes
*Ethambutol should be added in the intensive phase for
on the management of tuberculosis in children:
children with extensive disease or living in settings where the
second edition. Geneva, World Health
prevalence of HIV or of isoniazid resistance is high
Organization, 2014
For more information:

Global TB Programme, World Health Organization http://www.who.int/tb/areas-of-work/children/
TB Alliance www.tballiance.org/children
©World Health Organization December 2016

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