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Community Statement: Safeguarding Children against Tuberculosis Takes Center Stage with Introduction of Child-Friendly Formulation of Rifapentine for Short-Course Tuberculosis Preventive Treatment

Community Statement: Safeguarding Children against Tuberculosis Takes Center Stage with Introduction of Child-Friendly Formulation of Rifapentine for Short-Course Tuberculosis Preventive Treatment

As community and civil society leaders who have worked determinedly to prevent tuberculosis (TB) in our communities, we herald the introduction of the world’s first child-friendly formulation of rifapentine as an essential innovation to save children from TB. We call on our governments to move quickly to procure this life-saving product without delay.

Lupin manufactures the new formulation, which is water-dispersible and raspberry-mint flavored, making it easy to administer and more appealing to children. Depending on the child's weight, it costs between US$6.53 and US$15.80, making 3HP the most affordable TB preventive treatment (TPT) regimen for children and cheaper than the longer alternatives—3HR and IPT—that our countries are more accustomed to using.

With support from the Unitaid-funded IMPAACT4TB project, communities and civil society have spent the past seven years creating demand and advocating for the introduction and scale-up of rifapentine-based short-course TB preventive treatment (TPT) regimens 3HP and 1HP. Our persistent efforts, spanning from grassroots to global levels, aimed at ensuring equitable and affordable access to the best available standard of TPT for people at risk of TB. The 3HP and 1HP regimens – consisting of rifapentine taken together with isoniazid either once weekly for 12 weeks (3HP) or daily for one month (1HP) – are becoming the preferred options for preventing the development of TB disease in individuals with TB infection. We have seen how 3HP has changed the game for TB prevention, particularly for adults, with over 8 million patient courses of 3HP procured over the past three years.

"These regimens have demonstrated effectiveness comparable to traditional monotherapy with isoniazid preventive therapy (IPT),” said Edna Tembo, the Director of the Coalition of Women Living with HIV (COWLHA) in Malawi. “3HP has resulted in higher completion rates, reduced pill burden, and fewer side effects. At a national level in Malawi, this has led to improved access to preventive TB treatment, particularly for high-risk communities. Still, one group has lagged: children."

In 2022 alone, TB claimed the lives of 1.3 million individuals, and among these fatalities, 214,000 were children aged 0–14 years. While children face multifaceted challenges when it comes to TB—including underdiagnosis leading to under-notification—they are also in desperate need of child-friendly prevention services.

“Adults are responsible for safeguarding the rights of children. We need to prevent TB among children by treating them with the new pediatric rifapentine formulation, as they face huge challenges in taking oral pills. The Indian TB program should place procurement orders for the new child-friendly formulation. This way, TB can be prevented among children," averred Ketho Angami, from Ark Foundation—a local organization in Nagaland that has been advocating for short-course TPT in India.

Community-led movements supported by IMPAACT4TB are heralding the introduction of a child-friendly formulation of rifapentine as a chance to close the prevention gap between adults and children.

Judith Mkandawire, an expert client, mother, and advocate with COWLHA, called on the Malawi government to act expeditiously in promoting this child-friendly formulation. “I lost my child, and it's now that I refer to it that it was due to TB. Going through this experience, I am now a great advocate for children of TB patients’ household contacts to receive TPT. My plea is for the government to ensure TPT for children is improved to short regimens as for adults because INH is too long and has side effects that most of us fear to give our children with the experience we had.”

A child-friendly version of rifapentine-based 3HP is a crucial step in the work to promote community-led, decentralised, and family-based approaches to TB preventive treatment – but it will only benefit children if governments use it. We call on our governments and others to take advantage of an Early Market Access Vehicle through which IMPAACT4TB will offer enough of the new rifapentine formulation for 85,000 children to receive 3HP this year. This initiative aims to increase access to short-course TB preventive treatments and reach more young children, addressing the unmet medical need for preventing pediatric TB, especially in resource-limited and TB-endemic settings.

A webinar on 17 April 2024, held by the IMPAACT4TB project and the World Health Organization (WHO) addressed the key concerns children face regarding TB. It also discussed how this project collaborated with manufacturers to produce child-friendly dispersible, flavored tablets. The webinar recording can be found here including an animation on how to administer 3HP to a child here.

Mkandawire spoke to the unbearable challenges faced by mothers where TB is concerned. “It is heartbreaking that so many children succumb to TB. As young mothers, we have struggled to crush tablets for our children and lived in fear of exposing them to TB,” stated Mkandawire. “It is time for the world to prioritize children, who are often overlooked in the TB space. Childhood TB prevention, diagnosis, and treatment are a significant breakthrough."

“We urge our National TB Programmes to move quickly to place orders via the Early Market Access Vehicle and work closely with communities to provide 3HP to children in TB-affected households. This is a way to build experience with a new product that, moving forward, should be an essential part of every national TB program,” said Tendayi Westerhof, the Director of PAPWC, Zimbabwe.

Notes for Editor


The IMPAACT4TB (Increasing Market and Public Health Outcomes Through Scaling Up Affordable Access Models of Short Course Preventive Therapy for TB) Consortium led by the Aurum Institute funded by Unitaid and partnered by CHAI, Johns Hopkins University, KNCV, and TAG, focuses on scaling up access to preventive therapy for TB. It targets PLHIV and child contacts, who face the highest risk of TB. Initially investigating the safety of combining 3HP and DTG, the project expanded to introduce 3HP as a preventive option across 12 low-middle income countries. Efforts extended beyond these countries, resulting in over 70 additional countries procuring 3HP. The grant is also supporting studies on 3HP in ART-naive patients, dosing in children aged 0-2, and enhanced service delivery and advocacy for improved policy and uptake. Learn more at www.impaact4tb.org

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. https://unitaid.org/#en 

About Treatment Action Group (TAG)

TAG, headquartered in New York, is an advocacy organization dedicated to advancing research and policies to combat HIV/AIDS, tuberculosis (TB), and hepatitis C. With a focus on promoting access to innovative treatments and advocating for the rights of affected communities, TAG plays a pivotal role in shaping global health agendas. Through collaboration with researchers, policymakers, and grassroots organizations, TAG strives to ensure that life-saving medications and interventions reach those most in need. Their relentless efforts continue to drive progress towards ending the epidemics of HIV/AIDS, TB, and hepatitis C worldwide. https://www.treatmentactiongroup.org/

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