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New Child-Friendly Formulation of Rifapentine for Short Course Tuberculosis Prevention Treatment.

New Child-Friendly Formulation of Rifapentine for Short Course Tuberculosis Prevention Treatment.

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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Prof. Gavin Churchyard receives A-rating from National Research Foundation

Prof. Gavin Churchyard receives A-rating from National Research Foundation

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 


PanTB-HM Clinical Trial Begins Recruitment in South Africa

PanTB-HM Clinical Trial Begins Recruitment in South Africa

The panTB-HM clinical trial has begun patient recruitment in South Africa, with first patient dosed on 28 July 2023. This trial is a historic milestone in the quest to revolutionise tuberculosis (TB) treatment and improve outcomes for all TB patients.

The panTB-HM trial addresses the World Health Organisation (WHO) target profile for new TB regimens that can be administered without prior knowledge of rifampicin susceptibility, the marker for multi-drug resistant TB. The panTB-HM trial is designed as a phase 2c trial, aligning with WHO recommendations for TB regimen development.

The trial's primary objective is to assess the proportion of patients with durable, non-relapsing cure, representing a pivotal step in advancing TB treatment paradigms. The goal is a more effective, shorter-duration TB treatment that protects lung function during and after treatment.

The innovative regimen contains new TB drugs bedaquiline and pretomanid and the experimental new oxazolidinone sutezolid. Extensive preclinical studies and phase 1 and 2 clinical trials of sutezolid demonstrated excellent safety over up to three months of daily oral dosing, a substantially better safety profile than other oxazolidinones used in TB regimens (i.e., linezolid).

Even after successful treatment with standard drug regimens, many TB survivors endure persistent lung conditions, such as bronchiectasis and fibrosis, that gradually erode lung function. The panTB-HM trial incorporates N-acetylcysteine (NAC), a repurposed host-directed WHO essential medicine. NAC is used to protect both the liver and lung from oxidative damage, preserving lung function and accelerating the eradication of MTB infection by replenishing glutathione (GSH).

Tuberculosis remains a formidable global health challenge, causing significant morbidity, mortality, and socio-economic consequences. In 2021, WHO estimated 10.6 million cases of TB worldwide and >500,000 of these patients had multi-drug resistant TB. TB continues to be the global infectious disease with the highest mortality rate, with 1.6 million deaths in 2021, topped only by pandemic COVID.

The panTB-HM trial is a collaboration led by The Aurum Institute, with Prof Robert Wallis as Aurum Institute Chief Scientific Officer and Principal Investigator of the trial. The consortium includes academic institutions Ludwig-Maximilians-Universitaet Muenchen (Germany) Stellenbosch University (South Africa), and Stichting Katholieke Universiteit-Radboudumc (Netherlands); clinical trial sites include Wits Health Consortium`s Clinical HIV Research Unit (South Africa) and National Institute for Medical Research in Mbeya (Tanzania, United Republic of); the consortium also includes a corporate collaborator, Sequella Inc (United States).

The trial is funded by the European & Developing Countries Clinical Trials Partnership (EDCTP), grant number RIA2019AMR-264.

Clinical Trial Registration Information Sites:

Pan African Clinical Trials Registry: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=24206

South African Clinical Trials Registry: https://sanctr.samrc.ac.za/TrialDisplay.aspx?TrialID=6986

ClinicalTrials.gov:https://www.clinicaltrials.gov/study/NCT05686356?term=panTBHM&rank=1

 

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/

For the latest information and updates on the panTB-HM trial, please visit our official website at https://pantb-hm.org/.

For media inquiries and additional details, please contact:

Don Mudzengi Email: This email address is being protected from spambots. You need JavaScript enabled to view it.


Lancet Commission Calls for Renewed Global Response on TB

Lancet Commission Calls for Renewed Global Response on TB

As the United Nations High-Level Meeting (UNHLM) on TB approaches, a new report from the Lancet Commission on tuberculosis releases recommendations, providing a path forward to turn the tide on this preventable, treatable and curable disease.

For the first time in 20 years there has been an increase in TB deaths — rising from 1.4 million in 2019 to 1.6 million in 2021 — as COVID-19 erased years of reduction in TB mortality rates. Moreover, there has been a troubling decline in the number of people diagnosed with TB, estimating that one-third of people were undiagnosed and untreated in 2022. The COVID pandemic had a significant impact on the ability of global health systems to prevent, screen and treat TB. COVID-19 quickly and substantially disrupted TB response efforts as diagnostic infrastructure was diverted away from TB programs and shutdowns led to reduced access to TB treatment services. In almost all high TB burden countries, COVID-19 resulted in health worker shortages and burnout, further diminishing health systems’ capacity to provide essential TB services. COVID-19 also had a negative effect on many countries’ abilities to invest in health, with precious resources for health programs being diverted to respond to COVID and economic disruptions impacting governments’ abilities to prioritize health moving forward.

“Progress on fighting TB has been stalled, but we can and must get back on track. As this new critical report states, we must focus on a new menu of tools that have the potential to revolutionize TB prevention, diagnosis and treatment.” stated Dr. Eric Goosby, Commission co-Chair, UCSF Professor of Medicine and former UN Special Envoy on Tuberculosis.

Lancet Commission Report Endorses New Menu of Tools New treatment regimens and several late-stage vaccine candidates present an incredible opportunity to make major inroads in preventing TB deaths. Recommendations put forth by the Commission include:

  • Immediate scale-up in access to molecular diagnostics and AI-assisted chest x-ray technology.
  • Sustained investments in research and development to accelerate progress on new tools including non-sputum-based tests such as tongue swabs, urine-based antigen tests and improved screening tools, all of which are faster and more accurate than sputum tests, which can take one to eight weeks to provide results.
  • Addressing malnutrition as a major risk factor for TB with more than a third of annual TB incidence attributable to undernutrition — especially in Southeast Asia. Recent research illustrates the positive impact of giving food baskets to patients with TB and their closest contacts. In a large study in India, better nutrition in patients with TB reduced incidence of infection by nearly 50 percent while reducing mortality among those treated for TB by nearly 60 percent.
  • Endorsement of the 1/4/6x24 campaign, an effort to bring new, shorter, safe and effective TB regimens to as many countries as possible by 2024. Specifically, the report outlines recommendations for ensuring access to one-month regimen or once-weekly for TB prevention, four months for drug-sensitive TB, and six months treatment regimen for drug-resistant TB.

“The newer, shorter 1/4/6 TB treatment regimens can have a huge impact on adherence and efficacy,” said Soumya Swaminathan, Commission Co-chair and former World Health Organization Chief Scientist. “To maximize the impact of these significant treatment breakthroughs, we need more countries adopting the new treatment paths faster. Adjunct therapies like nutritional support can also go a long way in reducing deaths due to TB.”

Economic Cost of Inaction - Recommendations for The Global Fund to Fight AIDS, TB and Malaria

The cost of inaction on TB is massive. More than 27 million lives and over $13 trillion in economic losses will result if there is a business-as-usual trajectory between now and 2050. A recent estimate commissioned by the STOP TB Partnership proposes a near-term target of US$15 billion a year, rising to US$20 billion in 2025, to end TB by 2030. This estimate takes into account lost ground due to COVID-19 and acceleration in the development of new tools.

Donor financing plays a significant role in funding TB resources in many low- and middle-income countries. TB receives less funding from the Global Fund compared to HIV and malaria even though TB accounts for 61 percent of global deaths caused by the three diseases. The report recommends that the Global Fund allocate more money to TB based on disease burden and cost-effectiveness. It also suggests prioritising the increase in TB support for low-income countries with higher TB mortality.

This new report is a follow-up to the 2019 Lancet Commission on tuberculosis. The first report outlined a blueprint for reaching the goals set by the first UNHLM in 2018. While progress has been made in some areas, the targets of the UNHLM have not yet been achieved. Some African countries have sustained declines in TB mortality, but more than seven million people have died from TB in the past five years, emphasizing the urgency to accelerate efforts.

This year’s UNHLM on TB is taking place on September 22 and presents a critical opportunity to mobilise political will and resources to scale up new technology, emphasising affordability and availability.

“TB advocates and survivors like me know there aren’t a lot of opportunities to shed light on this disease despite its impact on so many people across the world. We are demanding that countries step up and prioritize the funding and technology that will get us to a TB-free world,” said Nandita Venkatesan, TB survivor champion and journalist.

 In addition to holding a High-Level Meeting on TB, additional meetings will focus on Pandemic Preparedness and Response (PPR) and Universal Health Coverage (UHC). The Commission highlights several areas where aligning global TB efforts with the PPR and UHC agendas would be mutually beneficial, emphasising that investing in PPR should be synergistic with efforts to end TB.

The Lancet Commission received support from the United States Agency for International Development through Supporting, Mobilising, and Accelerating Research for Tuberculosis Elimination, a five-year cooperative agreement that aims to transform TB prevention and care.


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