PAHO and Unitaid strengthen partnership to eliminate communicable diseases from the Americas
Ahead of World TB Day, Unitaid and FIND welcome WHO resources to accelerate access to faster, more accurate tests for drug-resistant tuberculosis
- A novel class of diagnostic technology could help hundreds of thousands of people affected with forms of TB that do not respond to first-line drugs quickly access appropriate treatment, if adequately scaled up
- Targeted next-generation sequencing (tNGS) is a World Health Organization (WHO)-recommended diagnostic technology that can identify resistance to multiple TB drugs in a matter of days, compared with eight weeks required with conventional culture methods
- The availability of NGS technologies, which can be used for many applications including monitoring and detection of several diseases, rapidly expanded during the COVID-19 pandemic – infrastructure that TB programs can now build on to improve care and reduce the spread of drug-resistant TB
- Two WHO resources launched this week – new recommendations and a TB sequencing portal – will help drive implementation of tNGS for TB in low- and middle-income countries. The resources were developed based on evidence generated through the Unitaid-funded FIND-led Seq&Treat project
Geneva – Launched in advance of World Tuberculosis (TB) Day, 24 March, new World Health Organization (WHO) resources, underpinned by evidence generated through a Unitaid-FIND project, will help countries implement new technologies that can quickly identify resistance to a range of TB drugs and ensure that patients get the correct treatment with minimum delay.
Drug-resistance is a growing threat to TB care. Each year, close to half a million people become newly infected with strains of TB that are resistant to one or more of the drugs used to treat it. Only about 2 in 5 people access treatment, allowing drug-resistant TB (DR-TB) to spread. Of those who do reach care, a lack of insight into drug-resistance can impede their access to appropriate treatment.
A novel class of diagnostic technologies called targeted next generation sequencing (tNGS) can analyze the genes of the TB bacteria infecting a person and determine, in just a few days, which drugs are likely to work best. Compared with conventional culture-based tests that require up to eight weeks to identify resistance, these tools could significantly improve diagnosis and treatment success if implemented widely.
Targeted NGS is essential to supporting the rollout of new, shorter DR-TB regimens containing the drug bedaquiline, which alternative rapid diagnostic platforms do not have the capacity to identify. Moreover, tNGS can detect resistance to multiple drugs simultaneously and has the potential to integrate new resistance profiles as they become known – critical to staying ahead of TB mutations.
“The COVID-19 pandemic triggered rapid uptake of sequencing technology around the world, including in most, if not all, low- and middle-income countries,” said Dr Philippe Duneton, Executive Director of Unitaid. “When Unitaid first invested in this technology we never expected capacity to take off so quickly – if we act now, we can piggyback off these improvements in infrastructure to help countless people with drug-resistant tuberculosis get connected with the right treatment without delay.”
The new WHO tools provide critical guidance so countries can make use of sequencing capacity for TB diagnosis. WHO guidelines and the accompanying operational handbook will help operationalize the July 2023 recommendation, supported by the new TB sequencing portal, which serves as the knowledgebase to understand the association between mutations in the genes and resistance to TB medicines. The portal, developed in partnership with Unitaid and FIND, will help ensure that countries have the latest data on TB drug-resistance and that emerging resistance profiles can be quickly added to tNGS platforms.
“The endorsement by WHO of next-generation sequencing marks a pivotal moment, with the potential to significantly advance progress toward achieving the 2030 end TB goals,” said Dr Sergio Carmona, acting CEO and Chief Medical Officer at FIND. “Collaborating with Unitaid and partners to validate this technology has revealed its transformative power, enabling precise and rapid identification of optimal TB treatments, thereby potentially saving countless lives”
Countries and researchers are encouraged to contribute their DR-TB datasets to the sequencing portal to continue to strengthen the associations of TB mutations with drug-resistance.
The Unitaid-funded Seq&Treat project, led by FIND, has piloted sequencing technology for DR-TB diagnosis, informing the WHO’s recommendation for its use and laying the groundwork for scale-up in support of endTB targets.
Contacts for the media:
Hervé Verhoosel
Head of Communications and Spokesperson, Unitaid
M: +33 6 22 59 73 54
Sarah-Jane Loveday
Director, Communications, UNFPA
M: +41 79 431 62 44
About Unitaid
We save lives by making critical health products available and affordable for people in low- and middle-income countries. We work with partners to identify innovative treatments, tests and tools, help tackle the market barriers that are holding them back, and get them to the people who need them most – fast. Since we were created in 2006, we have unlocked access to more than 100 groundbreaking health products to help address the world’s biggest health challenges, including HIV, TB, and malaria; women’s and children’s health; and pandemic prevention, preparedness and response. Every year, more than 300 million people benefit from the products we’ve helped roll out. https://unitaid.org
About FIND
FIND accelerates equitable access to reliable diagnosis around the world. We are working to close critical testing gaps that leave people at risk from preventable and treatable illnesses, enable effective disease surveillance, and build sustainable, resilient health systems. In partnership with countries, WHO and other global health agencies, we are driving progress towards global health security and universal health coverage. We are a WHO Collaborating Centre for Laboratory Strengthening and Diagnostic Technology Evaluation. For more information, please visit https://www.unfpa.org
Overlooked no more: Access to TB innovations for children and pregnant women is a must
Unitaid-backed research underpins WHO recommendation for first-ever multidrug-resistant TB prevention regimen for children
Geneva, 21 February 2024 – There is new hope for both children and adults who have been exposed to multidrug-resistant tuberculosis (MDR-TB), following a World Health Organization (WHO) communication recommending breakthrough preventive treatments for both populations. Research from Unitaid’s BENEFIT Kids project, led by Stellenbosch University and presented at the Union World Conference in November, underpinned the recommendation for the pediatric regimen.
MDR-TB is a form of the disease that has developed resistance to two or more of the first-line drugs used against it. Because so few people access appropriate treatment and even fewer get cured, the disease continues to spread. Children are at particular risk – their weaker immune systems make them more vulnerable to infection and difficulties with diagnosis and arduous treatments mean they are more likely to suffer serious outcomes if the infection progresses to disease.
“Pediatric regimens are typically adapted from adult treatments, meaning the development of child treatments can lag years behind adult interventions. With children at such high risk from multidrug-resistant TB infection, we knew we couldn’t afford to wait,” said Dr Philippe Duneton, Executive Director of Unitaid. “I’m delighted to see the Unitaid-Stellenbosch University commitment to prioritizing children in the TB response has resulted in a life-saving preventive treatment for kids at the same time as the first-ever adult regimen.”
In addition, the Unitaid-Stellenbosch University program worked concurrently to develop properly dosed, palatable, and easy to swallow formulations of levofloxacin, the key medicine used, which is already available for purchase.
The WHO’s recommendation paves the way for optimal MDR-TB prevention for children to be rolled out without delay – though funding is urgently needed to support the contact tracing necessary to find children at risk and connect them with care.
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 300 million people. Unitaid is a hosted partnership of the World Health Organization.
Media contacts:
For more information and media requests:
Hervé Verhoosel
Head of Communications and Spokesperson
M: +33 6 22 59 73 54
Kyle Wilkinson
Communications Officer
+41 79 445 17 45
Unitaid to support access to monoclonal antibodies in low- and middle-income countries with new call for proposals
The deadline for proposal submission is 1 March 2024.
Monoclonal antibodies are manufactured versions of proteins that mimic those generated by the immune system to defend ourselves from diseases. They can be developed to treat or prevent a range of diseases and are already transforming modern medicine in high income countries. With their potential to provide faster, more tolerable and highly efficacious protection, they also hold great promise for addressing public health needs in low- and middle-income countries – but there is a stark global inequity in access to these products.
Very high prices, insufficient production capacity and limited visibility on demand and users’ perspectives are amongst the key barriers that limit the use of monoclonal antibodies in low- and middle-income countries. This perpetuates the lack of interest in infectious disease markets and does not incentivize innovation to simplify and reduce the cost of production and delivery.
Unitaid seeks to support efforts to demonstrate the feasibility and viability of business models that could reduce the cost of production and delivery and enable sufficient production capacity of monoclonal antibodies, to render the most promising products – including those already approved or in the development pipeline – accessible in LMICs.
The ultimate goal is to establish models for widespread and equitable access to monoclonal antibodies so they can deliver the greatest impact as they emerge from the pipeline, to complement other tools and improve the global health response to major public health needs in low- and middle-income countries.
Read more about this latest call for proposals and how to apply here.
Unitaid and KNCV Tuberculosis Foundation seek partner to improve drug-resistant TB care pathways in low- and middle-income countries
The World Health Organization issued landmark updates to multidrug-resistant tuberculosis (MDR-TB) treatment options last year that include recommendations for the use of a novel, all-oral six-month regimen that offers better outcomes with significantly shorter treatment time. The results of the endTB clinical trial offered evidence into additional regimens that, if recommended, could enable effective, shorter MDR-TB treatment for additional populations not currently covered by six-month regimens, such as pregnant women and children.
These advances promise to radically alter outcomes for millions of people. However, new medicines and other tools are often slow to be adopted in the countries that need them most, and even when they do, most people with drug-resistant TB never get diagnosed because access to testing that can accurately identify resistance is limited.
To support rapid implementation of newer, shorter treatment regimens, Unitaid and KNCV are seeking a market access partner with a proven record of developing and executing market strategies to secure adequate, equitable access conditions for vital tools relevant to drug-resistant TB care in low- and middle-income countries.
The partner will work as a sub-grantee in the Unitaid-funded ASCENT project, led by KNCV. The partner will be responsible for mapping health technologies and identifying market inefficiencies that prevent equitable access to shorter MDR-TB regimens, conducting market analysis on an agreed set of screening, treatment and support tools, and designing and implementing a scalable and sustainable access strategy. The partner will work in close collaboration with Unitaid and KNCV, as well as other partners and international donors.
The deadline to submit a proposal is 1st February 2024. Find out more about how to apply here:
On 15 January 2024, Unitaid and KNCV TB Plus hosted a webinar to present the scope and content of the RfP and answer any process-related questions. A recording of the session can be found here: https://youtu.be/dbvlA-WU4-w
Media contacts:
For more information and media requests:
Hervé Verhoosel
Head of Communications and Spokesperson
M: +33 6 22 59 73 54
Kyle Wilkinson,
Communications Officer
+41 79 445 17 45
New child-friendly formulation of rifapentine for short course tuberculosis prevention treatment now available as Unitaid and IMPAACT4TB launch an early market access vehicle
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 – 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 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 300 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.
Media contacts:
For more information and media requests:
Hervé Verhoosel
Head of Communications and Spokesperson
M: +33 6 22 59 73 54
Kyle Wilkinson,
Communications Officer
+41 79 445 17 45