By Sharon Atieno

With more than two million children and adolescents lacking preventive treatment for Tuberculosis(TB), which is needed for those living with HIV or exposed to TB within the home, a new paediatric formulation of rifapentine (P) by Lupin Limited, has been approved for use in TB prevention treatment options.

Included under the 3HP prevention treatment option- a short course regimen that combines high-dose Isoniazid (H) and high-dose rifapentine (P) once weekly for three months- the new formulation is water-soluble and raspberry-flavoured, making it easy to administer and more acceptable to children.

“Child formulations are a critical but largely neglected area of child health. Because a fruit-flavoured, dispersible medicine can make the difference between a child taking their medicine or not, it can be transformative in the lives of children and caregivers affected by the disease,” said Dr. Philippe Duneton, executive director of Unitaid.

The Unitaid-funded IMPAACT4TB Consortium, led by the Aurum Institute, has announced that the new formulation will reach the market at US$6,53 – US$15,80, depending on the weight of a child.

The affordable price also means that the 3HP 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.

IMPAACT4TB will catalyse the uptake of the paediatric product through an Early Market Access Vehicle (EMAV) of approximately 85,000 patient courses of the rifapentine 150mg single tablets that need to be coupled with isoniazid to make 3HP.

“Historically, children have been marginalized 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,” said Professor Gavin Churchyard, the group CEO of the Aurum Institute.

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 who are infected with TB, especially those under the age of 5, 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.

“This child-friendly formulation promises to make a significant improvement in access to TB prevention for children. 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 Tendayi Westerhof, director of the Pan African Positive Women’s Coalition, an IMPAACT4TB community partner in Zimbabwe.

“The availability of Rifapentine Dispersible tablets is a testament to Lupin’s unwavering commitment to transforming lives and shaping a healthier future. It signifies our dedication to meeting unmet medical needs and our pursuit of an equitable world. With this novel child-friendly treatment, we aim for a future where innovative solutions close gaps in global health, ensuring no child is left behind in the fight against tuberculosis,” said Mr. Nilesh Gupta, managing director, Lupin.

Currently, the World Health Organization (WHO) recommends the use of 3HP in children two years of age and above. Dosing for younger children will be reviewed by the WHO Technical Advisory Group on dosing in the first quarter of 2024.