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

About IMPAACT4TB

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/

For people starting HIV treatment, combining dolutegravir-containing antiretroviral therapy with 3HP TB preventive treatment is safe and works effectively in tandem

DENVER (March 5, 2023) — New clinical trial results show that the best-in-class treatment for HIV works well with one of the best tuberculosis (TB) preventive treatments. The trial looked at people who had yet to start treatment for HIV, evaluating how dolutegravir (DTG)-based antiretroviral therapy (ART) works when taken together with 3HP, a short, three-month course of isoniazid and rifapentine. The results, showing the safety of starting DTG-based ART and 3HP TB preventive treatment at the same time, were presented today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver, Colorado.

Each year, there are an estimated 670,000 new TB cases among people living with HIV and an estimated 167,000 deaths from TB-related HIV. The findings of the study, funded by Unitaid through the IMPAACT4TB project, show the promise of simultaneous initiation of DTG and 3HP to prevent a major health threat in sub-Saharan Africa and the world.

“An ounce of prevention is worth a pound of cure and, whenever possible, it is best to get that ounce in early,” said Ethel Weld, MD PhD, an assistant professor of medicine at the Johns Hopkins University School of Medicine and the principal investigator in the study. “This study looked at the safety, efficacy, and drug levels of DTG when given together with 3HP from the outset in new HIV patients. Though an expected interaction was seen, DTG still held down HIV viral loads, and the combination was safe and well-tolerated.”

The trial — called “DOLPHIN-TOO” — focused on DTG drug concentrations in blood among people living with HIV who had never previously been treated with ART and who are also taking 3HP or 6 months of isoniazid (6H). At the same time that the patients started DTG, they also started either 3HP or 6H. Studies have shown the 3HP regimen is preferred by patients, has less toxicity and is more achievable for patients to complete than the longer courses of isoniazid (which can last up to a year in some places).

The trial focused on whether the levels of DTG in the blood were impacted by the 3HP regimen. The results showed that, while people in the 3HP group did have lower levels the DTG in their blood stream than people in the 6H group, they were nonetheless able to achieve viral suppression (an undetectable level of HIV virus in blood) by 8 weeks and maintain it for the length of the six-month study. Minimal side effects were seen, none were severe and the majority were resolved with continuation of therapy. Previous research, released at the Union World Conference on Lung Health in November of 2023, had provided information on the safety and efficacy of the use of 3HP and DTG together, without data on the drug levels in the blood.

This study points to the use of short course TB preventive treatment in people who are newly diagnosed with HIV and are at highest risk of active TB disease. The results will inform WHO and country-level policy on the timing of TB preventive treatment in people who are newly initiating DTG based ART in high burden TB countries globally. This study complements previous studies conducted by the Unitaid-funded IMPAACT4TB consortium that determined the safety of use of 3HP in people living with HIV who are already established and virally suppressed on DTG-based ART. Those studies increased the demand for the product, which led to a reduction in the price of the product, fostering widescale access to short course TPT. This is expected to reduce TB mortality by 150,000 by 2035.

“For patients with HIV, the best time to start TB preventive treatment is when they are first starting ART,” said Professor Gavin Churchyard, the group CEO of the Aurum Institute. “This is when patients are most closely monitored and are in regular contact with clinics and healthcare providers, making it easier to monitor them for any potential side effects. Seeing how safe and effective simultaneous initiation of 3HP and DTG-based ART is, this approach needs to be adopted in every country where TB is prevalent. The only way we will end TB is if we systematically prevent new TB cases in people with HIV up front — and we now have the recipe to do so.”

“This research gives programs the green light to fully integrate 3HP into the care of people with HIV right from the very beginning of HIV treatment,” said Mike Frick, co-director of the TB program the Treatment Action Group, a community-based research and policy think tank. “We already knew that it was okay to use 3HP and dolutegravir together in people experienced with HIV treatment. Now we know the same is true for people who are just starting HIV treatment for the first time. National governments should feel confident using 3HP in HIV programs, and donors, including the President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund, should support countries in procuring 3HP as an essential part of the HIV clinical care package."

Note to editors:

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 Unitaid, 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 70 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. 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. www.unitaid.org

About 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. www.auruminstitute.org

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 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.

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. https://www.auruminstitute.org/

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, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

To request an interview, or for more information, please contact:

Kyle Wilkinson: This email address is being protected from spambots. You need JavaScript enabled to view it.  ( +41 79 445 17 45 )

Kanya Ndaki:This email address is being protected from spambots. You need JavaScript enabled to view it. ( +27 832986100 )

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South Africa’s National Research Foundation has released its rating of researchers as part of its goal to develop an internationally competitive scientific research system. Aurum Group CEO Prof Gavin Churchyard has received an A-rating, which is given to researchers who are recognised by their peers as leading international scholars in their field, and for the high quality and impact of their recent research.

The rating system developed by the NRF is a valuable tool for measuring the quality of South African researchers against the best in the world. Individuals are rated according to the quality and impact of their research over the past 8 years.

In the field of medical and health sciences in South Africa, Prof. Churchyard joins an exclusive group of 24 scientists who have earned the NRF A rating.

An A-rating is the highest achievable rating for researchers on the NRF's rating system. Commenting on his A-rating Prof. Churchyard highlighted that it serves as both a recognition of past accomplishments and a reminder of the ongoing work that lies ahead. “I am deeply honoured to receive the NRF A-rating, a recognition that reflects the incredible efforts of our entire team at The Aurum Institute. This milestone is a reminder of the important contribution that African researchers are making in global health.”

Prof Churchyard completed his MBBCh, Master’s in Internal Medicine and PhD in Infectious Diseases at the University of the Witwatersrand and is a Fellow of the College of Physicians in South Africa and the Royal College of Physicians in Edinburgh. He has published 300 peer-reviewed articles over his career, including in high impact journals such as the New England Journal of Medicine, Lancet, and Nature Medicine. Prof Churchyard has published 12 book chapters. His research contributed to changing World Health Organisation (WHO) policy on TB prevention and screening and catalysed the adoption and scale up of short course TB preventive treatment by more than 50 high burden countries.

He has contributed to the development of numerous WHO guidelines in the areas of TB TB/HIV, and COVID-19, and target regimen profiles for treatment of TB disease and infection. Prof Churchyards other research interests include TB vaccines, TB host directed therapy, TB diagnostics and case finding, HIV vaccines, COVID-19, and occupational lung disease.

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. https://www.auruminstitute.org/

To request an interview, or for more information, please contact: 
Group Communications Director, Kanya Ndaki, This email address is being protected from spambots. You need JavaScript enabled to view it. +27 832986100