Children at high risk of contracting tuberculosis, and in need of preventive therapy, could soon be spared the difficulties associated with taking TB drugs meant for adults — thanks to the development of a more palatable and child-friendly regimen that could be a game changer in TB prevention.
A new formulation of first-line TB drug, rifapentine, designed for children by Indian drug manufacturer Lupin Ltd, has been approved for use in short-term TB prevention.
The paediatric formulation, now available to governments and global health procurers in more than 35 countries, is water-soluble and raspberry-flavoured, “making it more easy to administer and more acceptable to children”, noted Prof Gavin Churchyard, group CEO of the Aurum Institute.
The institute, which pioneered the introduction of shorter, rifapentine-based TB preventive treatment options, led the initiative funded by the medicine and diagnostic funder Unitaid. The introduction of the new TB drug means that parents and caregivers will no longer need to crush pills intended for adults to approximate the proper dose for a child.
Churchyard said: “Historically, children have been marginalised in the fight against TB. We have not developed child-appropriate medicines for prevention or treatment until long after the adult versions reach the market. This innovation levels the playing field for our next generation and keeps them healthy.”
Historically, children have been marginalised in the fight against TB ... This innovation levels the playing field for our next generation and keeps them healthy.
— Aurum Institute group CEO,
Prof Gavin Churchyard
At about R125 to R300 per child, dependent on weight, the new formulation forms part of 3HP formulations — a short-term formulation for a combination of two drugs, rifapentine and isoniazid, which are taken once weekly for three months to get rid of latent TB infection.
He said the child-friendly formulation of isoniazid can be included with rifapentine to make the regimen fully child-friendly.
Treatment is recommended for children with latent TB infection, to prevent them from developing the disease. The World Health Organisation (WHO) recommends that children aged two and above who are at risk of TB, through being immunocompromised or in close contact with someone with TB, be considered for the treatment of latent TB.
TB experts say paediatric formulations don’t only ensure that children adhere to their TB regimen, but they ensure they also get proper drug doses — something not guaranteed when parents are forced to crush adult tablets into powder.
Churchyard said the affordable price also means that 3HP treatment in children is now cheaper than alternative TB preventive treatments available for children. “This is the first time low- and middle-income countries will avoid a higher price per tablet for a paediatric TB formulation.”
Tendayi Westerhof, director of the Pan African Positive Women’s Coalition, said the child-friendly formulation promises to significantly improve access to TB prevention for children.
The coalition is part of the IMPAACT4TB consortium, led by the Aurum Institute in Africa, and delivers 3HPs to high-risk groups in 12 countries. The consortium has, since inception in 2017, worked to overcome barriers to access patient-friendly formulations of rifapentine-based regimens, pushing manufacturers to develop and commercialise these products. This resulted in the procurement of more than 4.2-million patient courses of 3HP across 78 countries.
Globally, TB disease killed 1.3-million people in 2022, more than any other infectious disease. Children 0-14 years make up 214,000 of these deaths. Children infected with TB, especially those under the age of five, are at higher risk of progressing from TB infection to active TB disease compared to adults. While children comprised about 12% of TB diagnoses in 2022, they represented an estimated 16% of those killed by TB in the same year. “Parents and caregivers deserve an easier time, keeping children free from the world’s most deadly infection — and children deserve a childhood free from the shadow of TB infection,” said Westerhof.
The development of a shorter preventive TB regimen is expected to help about 2.25-million children and adolescents who need preventive therapy every year due to their HIV status or based on exposure to TB at home.
“We have not met the targets for TB preventive therapy in children, placing millions of children at risk of developing TB. The new paediatric formulation is expected to improve access for all children,” said Churchyard.
Meanwhile, deputy health minister Sibongiseni Dhlomo told delegates attending the Brics TB Research Network Innovation Summit in Durban this week that TB “remains a pressing concern for South Africa”, with about 300,000 people getting infected every year.
“Last year alone, we managed to notify and put 224,000 people on TB treatment regime. Though our infection incidence is declining, we are concerned about the unacceptable death-rate among our TB patients,” he said.
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