15 December 2015

Cherise ScottTB Alliance

Introduction of Child-Friendly TB Medicines

CNS Webinar

2Introduction of Child-Friendly TB Medicines

• TB is a significant cause of death among children; children are susceptible to the most severe and fatal forms of TB

• In 2014, an estimated 1 million children became ill with TB and 140, 000 children died of TB, according to the WHO.

• Children with TB have been historically neglected – many go undiagnosed and untreated

• Child health and survival is improving, with fewer deaths from diseases such as HIV and pneumonia. But TB lingers, and lacks attention and resources dedicated to the problem

Children with TB are the neglected of the neglected

Childhood TB: Hiding in the shadows

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• In 2010, WHO revised dosing guidelines for TB drugs for children based on evidence that children were not receiving enough TB medicine

*depending on setting and type of disease

• The guidance and policy changed, but the products available for treatment of children did not change

• Many providers must crush or chop available tablets to achieve desired dose

Market unresponsive to call for new treatments

New guidelines, old drugs

Drug Previous WHO Guidance Current WHO Guidance

Dose and range (mg/kgbody weight)

Dose and range (mg/kg body weight)

Isoniazid 5 (4-6) 10 (7-15)

Rifampicin 10 (8-12) 15 (10-20)

Pyrazinamide 25 (20-30) 35 (30-40)

Ethambutol* 20 (15-25) 20 (15-25)

4Introduction of Child-Friendly TB Medicines

Delivering current treatment is complex and burdensome

Challenges of administering treatment

Dosing chart for pediatric TB therapy in the Philippines.

Treatment administered via syrups.

Dosing chart for pediatric TB therapy in South Africa. Treatment

administered via pills.

Pharmacist preparing syrups of Rifampicin for pediatric TB treatment

in Thailand.

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• No appropriately-dosed, quality-assured, child-friendly TB medicines

• Many providers must cut or crush tablets, create their own syrups, to achieve desired dose

• Burdensome for the caregiver to give and the child to take; decreases adherence

• Poor tasting medicine can cause vomiting

• Inconsistent administration from country to country means there is no unified response to the problem

Lack of consideration of the unique needs of children

Sub-optimal treatment for children

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The FDCs include:

• Rifampicin 75 mg + Isoniazid 50 mg + Pyrazinamide 150 mg (two-month intensive phase)

• Rifampicin 75 mg + Isoniazid 50 mg (four-month continuation phase)

Product attributes:

• Correct, WHO-recommended doses

• Dispersible in liquid

– No crushing or chopping pills

• Palatable fruit flavors

Milestone: Introduction of child-friendly FDCs

7Introduction of Child-Friendly TB Medicines

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• The right medicines in the right dose improves adherence and will save more lives. This is an important step in improving TB treatment and child survival, and decreasing the development of drug-resistant TB.

• Simple formulations decrease burden on the healthcare system and enable scale up in treatment. Simpler TB medicines for children can allow healthcare systems to scale up treatment. Fewer pills will simplify ordering and storage.

• Child-friendly medicines improve the lives of children with TB and their families. Six months is a long time to take medicine. Medicines designed for children lessen the daily struggle of parents, caregivers, and children alike.

Impact of improved TB treatments for children

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Child-friendly TB medicines in the correct doses are

now available

Improve treatment, save lives

Now that improved treatments are

available, countries must accelerate

adoption to save lives

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• Must scale investment in pediatric research (including accelerating R&D for children)

• Call to Action –increase awareness, political will, resources

How can we avoid repeating the same mistakes?

One day of treatment for a child with MDR-TB/HIV (excluding injections)

Photo credit: Desmond Tutu TB Centre

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We thank the funders who made this possible

Project Funders

Major supporter

Sign the Call to Action:tballiance.org/signthecall