250,000 patients to benefit from free access to short-course TB prevention treatment across seven countries
Support from global consortium will expand access to shorter TB prevention options, help advance efforts towards TB elimination.
Johannesburg – The Unitaid-funded IMPAACT4TB Consortium, led by the Aurum Institute, announced today that it will provide 250,000 patient courses of short course rifapentine-based preventive treatment regimens to seven countries to help prevent tuberculosis (TB). The patient courses will include the three-month 3HP regimen, and the even shorter 1HP, that is only taken for 28 days. This contribution is part of the Consortium’s ongoing efforts to end TB and improve global health outcomes.
The seven countries set to benefit from this initiative are Brazil, Haiti, India, the Maldives, Nigeria, Tanzania and Zambia. This supply of rifapentine-based preventive treatment regimens is expected to contribute significantly to the global effort to reduce the incidence of TB, which continues to be a major public health challenge worldwide.
“Despite commitments to end tuberculosis as a global epidemic by 2030, the disease remains the world’s deadliest infectious disease, killing around 4,400 people every day,” said Prof Gavin Churchyard, CEO of Aurum Institute and the principal investigator of the IMPAACT4TB project. “TB prevention is a cornerstone of any effort to eliminate TB, and we hope that these 250,000 patient courses will contribute to countries’ efforts to finally make TB a disease of the past.”
About one quarter of the world’s population is infected with a form of TB that causes no symptoms and is not contagious. Without treatment, 5% to 10% of those infected will develop active TB, which causes severe illness and can be transmitted from person to person through the air. TB preventive treatment regimens lower the risk of progression to TB in people at risk, including children, pregnant women and people living with HIV.
In recent years, new and shorter rifapentine-based TB preventive treatment regimens have been recommended by the World Health Organization (WHO) and are becoming increasingly available. Currently, over four million patient courses are being manufactured annually. These shorter regimens are associated with higher treatment adherence, completion, and outcomes. In fact, people taking shorter regimens are up to three times more likely to complete their course than those on longer regimens—leading to better outcomes and more lives saved.
In many high-burden TB countries, these new short-course TB preventive treatment regimens are modelled to be cost-effective for both people living with HIV and household contacts of all ages, regardless of whether contact investigation is already in place.
“The seven countries receiving these regimens have expressed their readiness not only to identify underserved and at-risk populations and ensure they receive these newer regimens, but also to invest in strengthening systems around contact tracing and learning lessons on how to improve TB preventive treatment uptake and coverage,” said Dr Philippe Duneton, Executive Director of Unitaid.
These patient courses consist of shorter rifapentine-based regimens, including two treatment options: 3HP, a three-month oral treatment taken once weekly, and 1HP, a 28-day oral treatment taken once daily. Access to rifapentine-based regimens has been established in 71 countries, with over three million patient courses purchased to date. However, despite this progress, key groups and areas are still behind target.
The IMPAACT4TB Consortium’s provision of the patient courses, which was made possible due to cost savings achieved over the past five years, is part of the Consortium’s broader strategy to reduce the cost of rifapentine. Among other things, by working with global partners and manufacturers, the Consortium helped significantly reduce the access price of a three-month patient course of weekly rifapentine and isoniazid, from US$72 to US$14.25.
In addition to providing the patient courses, the IMPAACT4TB Consortium will also provide technical assistance to countries in their implementation efforts, including identifying populations that could benefit from TB prevention, and determining the most appropriate regimen for them. The project actively advocates for universal access to TB prevention tools through their #RightToPreventTB campaign to raise awareness within communities about effective prevention regimens.
In 2021 alone, close to 1.6 million people died from TB, while around 10.6 million people fell ill from the disease. Currently, the world is not on track to achieve the TB prevention targets set at the United Nations High-Level Meeting on TB held in 2018. While significant progress has been made in providing TB prevention to people living with HIV, the number of household contacts receiving TB preventive treatment remains unacceptably low. In fact, the current progress towards the target of providing tuberculosis preventive treatment (TPT) to 30 million people by 2022 is only at 42%, indicating a critical need for stronger efforts to scale up TPT for household contacts.
Notes 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 funded by Unitaid and 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 rollout 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 and catalysed orders for these regimens in 58 additional countries to date. 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), improved TPT service delivery as well as community advocacy for improved TPT policy and uptake within project countries. The Consortium will continue to collaborate globally to advance TB research and improve access to life-saving preventive treatments.
About Unitaid
Unitaid is a global health agency engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, cheaply, and effectively, in low- and middle-income countries. Its work includes funding initiatives to address major diseases such as HIV, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities including advanced HIV disease, cervical cancer, and hepatitis C, and cross-cutting areas, such as fever management. Unitaid is now applying its expertise to address challenges in advancing new therapies and diagnostics for the COVID-19 pandemic. Unitaid is hosted by the World Health Organization. For more information, visit 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. https://www.auruminstitute.org
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World TB Day: Unitaid joins WHO’s call to action for shorter and more effective regimens for all people suffering from drug-resistant TB
Geneva – World TB Day, 24 March, marks the day in 1882 when the bacteria that causes tuberculosis was discovered. In 2023, 131 years after that discovery, TB remains a leading cause of death from infectious disease, surpassed only recently by the COVID-19 pandemic.
Today, Unitaid is joining WHO and other leading global health actors in calling for rapid adoption of regimens for drug-resistant strains of TB that more effectively cure patients while drastically reducing the time required for treatment.
TB elimination efforts have long been stymied by insufficient funding, attention, and political will, leaving healthcare systems to rely on ineffective diagnostic methods, outdated treatments, and a critical lack of awareness. These dangerous gaps have created a space in which drug-resistant strains of TB could develop and spread, largely unchecked.
In 2021 alone, 10.6 million people fell ill with TB and half a million of them developed a strain of the disease that does not respond to some, many – and in severe cases, most – of the drugs available to treat it.
Reinvigorated research into new medicines and regimens to treat TB paved the way for the development and testing of several novel regimens over the past decade, helping advance improved treatment options for people suffering from drug-resistant TB.
Photo caption: When Ramaz checked into the hospital with XDR-TB, he didn’t expect to survive. New medicines changed everything. Photo credit: Mzia Lekveishvili/Unitaid
When Ramaz was 34 years old, he checked into a hospital in Georgia with extensively drug-resistant TB (XDR-TB), a strain of the bacteria that had grown resistant to all available medicines used to treat TB. It was 2016. He had been in treatment for multidrug-resistant TB (MDR-TB) since 2010 but had to stop treatment twice because of the severe and toxic side effects it caused him.
Drug-resistant TB takes a heavy toll on patients, communities, and healthcare systems. Conventional treatments used at the time could last up to two years, cause terrible side effects like permanent hearing loss and kidney failure, require thousands of pills and painful injections, and cost several thousands of dollars per person. XDR-TB is particularly severe and, until recently, nearly incurable.
“I never thought I could survive this disease,” said Ramaz, who thought he was saying goodbye to his wife and daughters when he entered the hospital that day.
But new medicines for treating TB – the first to be developed in almost half a century – helped enable Ramaz’s remarkable recovery. He was treated through Unitaid’s endTB program, which is working to develop and advance a number of shorter, more effective, less toxic, injectable-free, and more affordable treatment regimens for drug-resistant TB.
TB treatment requires a combination of antibiotics, so new drugs need to go through rigorous testing to prove their safety and efficacy when used alongside other medicines. The endTB program – Unitaid’s largest investment and longest running initiative to date – began as a commitment to generate gold-standard evidence to back up the use of two novel drugs – bedaquiline and delamanid – and improve treatment options.
As part of the program, a massive observational study conducted across 17 countries helped shape a WHO recommendation for a nine-month, all oral treatment regimen for MDR-TB. These guidelines from the WHO are a critical step in ushering in changes in country-level TB programs, and introduction of the treatments through endTB helped enable rapid uptake. Later this year, endTB clinical trial results will provide critical insight to guide the use of new and repurposed medicines across diverse populations, including people in treatment for HIV, diabetes, and hepatitis C, as well as in pregnant women and children, who are often excluded from studies.
These new developments come at a time of relative progress in TB, after decades of stagnation. The emergence of bedquiline and delamanid were followed by additional drug developments, including pretomanid, which contributed another highly effective treatment option to the fight against TB.
“We have seen a complete revolution in treatment over the past decade,” says Dr Philippe Duneton, Executive Director of Unitaid. “Before this work began, MDR-TB treatment was not only long and difficult – it was largely ineffective. Today, we’re seeing people make complete recoveries in a fraction of the time, even for people infected with severely resistant strains of TB.”
Photo caption: Dr Barbakadze is one of many doctors involved in Unitaid’s endTB program who has witnessed the impact of new TB medicines on severely ill patients. Photo credit: Mzia Lekveishvili/Unitaid
“Nobody thought Ramaz would survive,” says Dr Ketevan Barbakadze, who heads up the MDR/XDR-TB department in Tbilisi where Ramaz received treatment. “And we have plenty of similar stories.”
She says the introduction of these new medicines has had a true “Lazarus effect,” referring to the rare phenomenon when a person who seems to be dead suddenly shows signs of life again.
But despite significant improvements in patient outcomes observed with the new treatments, many people living in countries with the highest rates of TB remain without easy access to these medicines.
The first-ever United Nations High-Level Meeting on TB held in 2018 set bold five-year goals to reduce the burden of disease worldwide. But efforts are falling far short of reaching the target 1.5 million people affected by drug-resistant TB by 2022 and disruptions and delays caused by the COVID-19 pandemic threaten to reverse 20 years of progress made against TB.
New treatments, though significantly more affordable than previous, less effective regimens, remain in the hundreds of dollars per patient – a considerable expense for countries with limited resources. And the cost of treatment goes beyond medicines – people with TB are often so ill they cannot work, making it challenging to cover their living and treatment expenses.
Diagnosing TB and identifying drug-resistance is also complex. A combination of inadequate or unavailable tools, alongside a lack of awareness about the disease, keeps treatment out of reach for millions of people with TB.
The WHO’s Call to Action advocates for investment and attention to urgently roll out improved treatments, with a focus on ensuring efforts are supported by solutions that improve the quality of care and fight against growing TB drug-resistance.
Unitaid remains committed to efforts to end TB, by leveraging US$250 million in investments to improve treatments and support adherence, facilitate detection, enable access to high-quality preventive medicine, and ensure children, pregnant women, people living with HIV, and all those most affected can access care.
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Unitaid to address intellectual property-related barriers for broader access to health technologies with new call for proposals
Submissions are welcomed until 1 February 2023 at 12:00 (noon) CET.
Intellectual property rights are an important incentivizing mechanism to accelerate the development of innovations to respond to global health challenges. But while they can be effective in stimulating and rewarding innovation in global health, they can also contribute to inequitable access to new products, as has been increasingly recognized over the course of the COVID-19 pandemic.
TRIPS flexibilities – legal mechanisms allowing countries to overcome or reduce the potential negative impact of patents in response to specific public health needs – are intended to address equity barriers.
Unitaid seeks to fund projects that will support the use of TRIPS flexibilities and other solutions to prevent or remove unwarranted intellectual property barriers. Unitaid is particularly interested in ensuring the availability and affordability of health products for HIV, tuberculosis, hepatitis C, and other diseases and conditions outlined in the 2023-2027 Strategy.
Without intervention, inequitable access will only widen, and populations that are already vulnerable and marginalized will face increasing risk of disease, poverty, reduced quality of life and even death. This work will contribute to enhancing equity between countries as it benefits low-income and, importantly, middle-income countries that are typically not included in voluntary licensing agreements.
Through this call for proposals, Unitaid aims to improve access to health products of public health importance, with a particular focus on affordability, increased supply and adoption, and a diversification of the supply base in low- and middle-income countries.
Learn more about this latest funding opportunity here
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G20 health ministers appeal for more TB funding and deliver six key actions to strengthen the global health architecture
28 October, Geneva – World health leaders launched a call to action on financing tuberculosis (TB) today in Bali, Indonesia, where they met ahead of the G20 Summit to discuss strengthening global health architecture.
G20 members recognize that lack of adequate financing remains the top obstacle to ending the TB epidemic, and stress that global investments must increase fourfold by 2030 to meet the targets set for ending this preventable and treatable disease.
The call to action coincides with the recent launch of the World Health Organization’s 2022 Global TB Report, which laid bare the devastating consequences of the COVID-19 pandemic on global efforts to control TB.
The report showed an increase for the first time in many years in the number of people falling ill with TB and drug-resistant TB, along with a decline in 2021 in global spending on essential TB services.
At the same time, G20 members underscored the critical role Unitaid plays in the TB response as the world’s largest multilateral donor to TB research and development, striving for equitable access to life-saving diagnostics and treatment.
Unitaid has contributed to the global efforts by supporting research related to multidrug-resistant TB (MDR-TB) treatment, paediatric TB diagnosis, child-friendly formulations of TB and MDR-TB drugs, TB preventive therapy (the 3HP regimen), and digital adherence technologies. The agency is investing an additional US$ 30 million, aiming to increase TB detection and help to find the missing millions of cases.
Following discussions on strengthening the global health architecture and pandemic prevention, preparedness and response , G20 health ministers delivered six key actions for consideration during the G20 Leaders’ Summit in mid-November.
Unitaid, as a key player for equitable access to health innovation, remains committed to help build global health resilience and response capacity against future pandemic threats.
As co-leader of the ACT-Accelerator’s therapeutics pillar, Unitaid has contributed to substantial progress in the COVID-19 response, demonstrating its unique capability to transform markets and help countries and communities achieve an enabling environment for product adoption.
“Responding to the COVID-19 health crisis, Unitaid and partners have improved access to critical oxygen supplies and facilitated adoption of life-saving therapeutics alongside vital diagnostic tests. But this is not the end of it, much work remains to be done,” Unitaid Executive Director Dr Philippe Duneton said. “We must focus on building resilience at the market and country level in light of unpredictable and fast evolving scenarios. COVID-19 has shown us that reaching equitable global access to medical countermeasures requires a continuum between pandemic preparedness and response efforts.”
Access more information on the Call to Action on Financing for TB Response here.
Access the G20 Health Ministers Communiqué here.
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Accelerate access to new TB testing technologies
Unitaid launches major new investment to increase tuberculosis detection and find the missing millions
- New US$30 million investment will improve access to same-day test results to enable more people to quickly access appropriate treatment.
- Two complementary programs will accelerate the introduction of new diagnostic technologies, evaluate alternative sampling approaches, and develop optimal combinations of testing methods to make TB diagnosis available where people first seek care.
- The work targets the four million people with active TB who go undiagnosed and untreated each year, including more than half of all children with TB, by improving access to TB screening and diagnosis.
Geneva – More than 10 million people each year fall ill with tuberculosis (TB), a highly infectious airborne disease that caused approximately 1.5 million deaths in 2020. An estimated four million people with TB – two out of every five – go undiagnosed.
Efforts to reduce the TB burden are greatly hampered by the large number of people who never receive a diagnosis and therefore do not access treatment. For those who do receive a positive diagnosis, the process can be lengthy and sometimes means patients do not start on the correct treatment from the outset, which can lead to drug resistance.
Sputum smear microscopy – a TB testing method that analyses a sample of sputum, or phlegm, under a microscope – remains the primary method of testing in health centers in low- and middle-income countries where TB is most prevalent. While this method is inexpensive and technologically simple, it is limited by low sensitivity, especially in the presence of HIV-coinfection. Additionally, it requires patients to make multiple visits to health centers and is largely ineffective in diagnosing children or people in advanced stages of disease who have difficulty producing sputum. This contributes to a significant gap in care for the youngest and most vulnerable to illness.
The World Health Organization (WHO) recommends using newer, more sensitive molecular diagnostic platforms and alternative sample types to improve TB case detection but high costs, complexity, and the infrastructure required for molecular diagnostics pose considerable challenges to updating testing practices and have kept them largely out of reach at facilities where people first seek care.
With US$30 million invested, Unitaid and its partners will accelerate the introduction of new diagnostic technologies, evaluate alternative sampling approaches, and develop and evaluate combination approaches to TB diagnosis. Implemented by FIND, the global alliance for diagnostics and the Liverpool School of Tropical Medicine (LSTM), the two complementary initiatives aim to improve screening and increase access to testing in lower levels of the health system.
“One person with active TB can infect between 5 and 15 others in a single year. Inadequate diagnostic capacity remains the greatest barrier to treatment and prevention, without which, 45% of otherwise healthy individuals with TB disease die,” said Dr Philippe Duneton, Executive Director of Unitaid. “With this new investment, Unitaid aims to address this inexcusable gap in TB screening and diagnosis that leaves more than 4 million people each year without access to care for a preventable, treatable, and curable disease.”
“TB is one of the deadliest infectious diseases in the world – second only to COVID-19 in recent years – yet we can test for it, treat it, and cure it,” said Bill Rodriguez, CEO of FIND. “Millions of people die from TB simply because they cannot get a diagnosis. Compounding the problem, COVID has made people hesitant to visit a health facility, leaving TB to spread unchecked faster than ever across households and communities. Providing better tests that can help communities test for TB locally, stop its spread, and ensure people can access treatment is the highest priority to tackle the TB burden. This investment from Unitaid will enable us to work with developers and communities to bridge the TB diagnosis gap so that lives can be saved.”
“For too long, we have lagged behind targets to provide accurate, affordable, and equitable diagnosis for TB where it is most needed,” said Dr Peter MacPherson, Principal Investigator of LSTM’s START 4-ALL Project. “The START 4-ALL Project will investigate how we can combine existing and new TB diagnostics together in combinations that are tailored to the needs of people at risk of TB. Our efforts will be focused around the community and primary care, recognizing that people with TB frequently experience multiple missed opportunities for diagnosis, which result in catastrophic health-seeking costs. By developing and evaluating combinations of TB tests that are suitable for near-patient use in these settings, we will ensure that we find solutions to provide the most accurate, feasible, acceptable, and cost-effective solutions to expand coverage to community and primary care settings and provide same-day test results”
The programs will focus efforts in nine countries – Cameroon, Bangladesh, Brazil, India, Kenya, Malawi, Nigeria, South Africa, and Vietnam – which together accounted for approximately 40% of the global TB burden and undiagnosed populations in 2020.
The new commitment builds on Unitaid’s quarter of a billion dollar investment to advance efforts against TB, including tackling drug-resistance, developing child-friendly medicine formulations, and accelerating the introduction of improved TB preventive treatment.
Projects links:
- Accelerate access to new TB diagnostic technologies
- Strengthen TB diagnostics combinations to reach more people with TB prevention, treatment, and care
NOTES FOR EDITORS
DriveDx4TB (Drive Diagnostics for TB), implemented by FIND, aims to accelerate the introduction of new TB diagnostics that can address barriers to access and improve case detection at primary healthcare and community levels.
The project will generate evidence to inform policy recommendations for three technology classes that have advanced significantly as a result of investments made in testing for COVID-19. These include: third-generation lipoaribomannan (LAM) tests, which can identify TB using urine samples with a rapid test format; point-of-care (POC) molecular diagnostics designed to bring the accuracy of gold-standard laboratory tests into community settings; and near-POC molecular tests, which bridge the gap between laboratory and community health services. New sampling approaches for molecular diagnosis are also being explored, such as cheek swabs.
It will be implemented in South Africa, India, Indonesia and Kenya.
START 4-ALL, implemented by LSTM, will develop, and evaluate combination approaches to diagnostic screening and testing to determine the most accurate, feasible, acceptable, and cost-effective solutions to expand coverage to community and primary care settings and provide same-day test results receiving in the health center where patients first seek care.
START 4-ALL will initially focus on improving the use of existing diagnostic technologies through optimized combinations of existing tools, the project will incorporate new products expected to come to market through DriveDx4TB.
START 4-ALL will be implemented in Bangladesh, Brazil, Cameroon, Kenya, Malawi, Nigeria, and Vietnam.
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