New child-friendly formulation of rifapentine for short course tuberculosis prevention treatment

More than 2 million children and adolescents lack preventive treatment for TB, which is needed for those living with HIV or exposed to TB at home.

Johannesburg, 11 December 2023 – A new formulation of rifapentine (P), designed especially for children by Lupin Limited, has been approved for use in tuberculosis (TB) prevention treatment options known as 3HP.* The child-friendly formulation of isoniazid (H) then can be included with rifapentine to make the regimen fully child-friendly.

The Unitaid-funded IMPAACT4TB Consortium, led by the Aurum Institute and comprised of the Clinton Health Access Initiative (CHAI), Johns Hopkins University, KNCV Tuberculosis Foundation and the Treatment Action Group (TAG), which pioneered the introduction of shorter, rifapentine-based TB preventive treatment options, is announcing that the new formulation will reach the market at a price of US$6,53 – US$15,80, depending on the weight of a child. 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.

The IMPAACT4TB Consortium, since its inception in 2017, has worked to overcome barriers to access patient-friendly formulations of rifapentine-based regimens, pushing manufacturers to develop and commercialize these products. This resulted in the procurement of over 4.2 million patient courses of 3HP across 78 countries. The paediatric formulation, now available to governments and global health procurers in more than 135 countries, is water-soluble and raspberry-flavoured, making it easy to administer and more acceptable to children.

An assessment conducted within the project of the paediatric TB preventive treatment (TPT) market estimated that about 2.25 million children and adolescents need TPT every year due to their HIV status or based on exposure to TB within the home. We have not met the targets for TPT in children, placing millions of children at risk of developing TB. The new paediatric formulation is expected to improve access for all children.

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.

“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 TBinfection,” said Tendayi Westerhof, director of the Pan African Positive Women’s Coalition, an IMPAACT4TB community partner in Zimbabwe.

“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,” said Professor Gavin Churchyard, the group CEO of the Aurum Institute.

“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, they can be transformative in the lives of children and caregivers affected by disease. As the leading multilateral funder of child tuberculosis research and development, Unitaid is proud to have supported this work and countless other efforts to ensure children can access the best and most appropriate medicines for TB treatment and prevention,” said Dr. Philippe Duneton, executive director of Unitaid.

“Children deserve access to the same life-saving medicine to prevent TB as adults. Our work with public and private sector organizations through the IMPAACT4TB market shaping partnerships means that today, they are finally getting that access,” said Dr. Neil Buddy Shah, CEO of the Clinton Health Access Initiative.

“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.

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.

Evidence shows that short-course TB preventive treatment regimens are cost-effective; people taking shorter drug regimens are up to three times more likely to complete their course of TPT than those on longer regimens—leading to better outcomes and more lives saved.

*WHO currently recommends the use of 3HP in children 2 years of age and above. Dosing for younger children will be reviewed by the WHO Technical Advisory Group on dosing in Q1 2024.

Read more on IMPAACT4TB

KNCV has been fighting TB since its establishment in 1903. Over the past 120 years, the organization has acquired indispensable knowledge and experience in the field of effective TB prevention and care, resulting in pre-elimination in the Netherlands and significant contributions to global evidence generation, policy development and TB program implementation worldwide.

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