New Child-Friendly Formulation of Rifapentine for Short-Course Tuberculosis Prevention Treatment(TPT) Now Available as Unitaid and IMPAACT4TB Launch an Early Market Access Vehicle (EMAV)

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, 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. 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 TB infection,” 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.


Notes to editors:

About Unitaid: Unitaid saves lives by making new health products available and affordable for people in low- and middle-income countries. Unitaid works with partners to identify innovative treatments, tests and tools; helps tackle the market barriers that are holding them back; and gets them to the people who need them most—fast. Since it was created in 2006, Unitaid has unlocked access to more than 100 groundbreaking health products to help address the world’s greatest health challenges, including
HIV, TB and malaria; women’s and children’s health; and pandemic prevention, preparedness and response. Every year, these products benefit more than 170 million people. Unitaid is a hosted partnership of the World Health Organization.

About the Aurum Institute: The Aurum Institute is a proudly African organisation working to advance health, science and innovation to create a healthier world for future generations. We partner with governments, the private sector and civil society to design and deliver high-quality care and treatment to people in developing communities.

About IMPAACT4TB: The Increasing Market and Public Health Outcomes Through Scaling Up Affordable Access Models of Short Course Preventive Therapy For TB (IMPAACT4TB) Consortium is led by the Aurum Institute and comprised of the Clinton Health Access Initiative (CHAI), Johns Hopkins University, KNCV the Dutch TB Foundation and the Treatment Action Group (TAG). People living with HIV (PLHIV) and child contacts are at highest risk of contracting TB. The initial IMPAACT4TB grant looked at the safety of co-administering and dosing of 3HP and DTG and, once that was ascertained, the project moved on to introduce and roll out 3HP as an additional TPT option among PLHIV and household contacts of TB patients in 12 low-middle income countries, namely: Brazil, Ethiopia, Cambodia, Indonesia, South Africa, India, Zimbabwe, Kenya, Malawi, Mozambique, Ghana and Tanzania. Although the project was focused in these 12 countries, efforts were also made to ensure wider access to 3HP. These efforts saw over 60 additional countries procuring 3HP for use among eligible populations. The grant also funded studies on the use of 3HP in ART-naive patients on DTG-based regimens (DOLPHIN TOO), dosing of 3HP in children from 0-2 years (TBTC Study 35) and improved TPT service delivery, as well as community advocacy for improved TPT policy and uptake within project countries. Note: 3HP is currently recommended for children who are HIV-negative and children living with HIV on Efavirenz-based regimens. Evidence is currently being generated for use in children on DTG-based regimens.

About Lupin: Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India and South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe and Middle East regions. Lupin has 15 manufacturing sites, seven research centres, and more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology and pharmaceuticals sector.

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Paediatric-friendly rifapentine and isoniazid for 3HP TB preventive treatment

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Early Market Access Vehicle for 150 mg functionally scored (FS), dispersible tablet (DT) paediatric formulation of Rifapentine for TB prevention

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