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The Aurum Institute and its partners also announced the launch of the next phase of work to improve access to shorter TB prevention treatments for children and pregnant women
The IMPAACT4TB Consortium, led by the Aurum Institute, welcomed this week’s announcement by Unitaid and MedAccess of two new pricing agreements that will drastically lower the price of tuberculosis (TB) prevention treatments in 138 low- and middle-income countries. The new agreements aim to make rifapentine-based TB prevention treatment regimens more widely available and affordable by bringing in a second generic manufacturer of a fixed dose combination of 3HP (a three-month, once-weekly oral treatment), as well as single tablets of rifapentine, which are used in combination with isoniazid 300 mg for 1HP (a one-month, once-daily oral treatment).
“In recent years, we’ve come a long way towards improving access, at an affordable cost, to tuberculosis-prevention treatments that are shorter and easier to take, but supply has remained a constraint,” said Dr Matteo Zignol, WHO Global Tuberculosis Programme. “This announcement will help us prevent TB among more people by ensuring that there is enough supply to meet the needs of eligible countries. Ultimately, preventing TB is critical to our ability to finally end this deadly disease.”
In 2020 alone, more than 1.5 million people died from TB, while around 10 million people fell ill from the disease. About one quarter of the world’s population is infected with a latent 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 prevention treatment regimens like 1HP and 3HP lower the risk of progression to TB in people at risk, including children, pregnant women and people living with HIV.
The IMPAACT4TB Consortium will also be provided with additional funding from Unitaid—to the tune of US$20 million to support the continued introduction of short course, rifapentine-based TB prevention treatment regimens around the globe. The funding, awarded to the Aurum Institute, will build on the momentum created by the IMPAACT4TB Consortium over the past five years, focusing specifically on evidence required to ensure that children and pregnant women, including those living with HIV, and household contacts have access to the latest TB prevention regimens.
“To date, the world has fallen behind in reaching children with short-course, rifapentine-based TB prevention regimens,” said Prof Gavin Churchyard, IMPAACT4TB Principal Investigator and Aurum Group CEO. “This new funding will build on the successes of the IMPAACT4TB program, and allow us to fill the major evidence gaps that exist when it comes to preventing TB in children living with HIV, as well as in HIV positive pregnant women.”
The additional funding will help identify the correct dosing and drug-to-drug interactions when children and pregnant women living with HIV take three months of weekly isoniazid and rifapentine—or 3HP—combined with dolutegravir (DTG) based Anti-Retroviral Therapy. The costed extension will fund three studies to help fill these evidence gaps: one in HIV positive pregnant women in South Africa (DOLPHIN MOMS); one in children living with HIV in South Africa who are taking DTG (DOLPHIN KIDS); and one comparing the use of comparing 1HP to 3HP in South Africa, Mozambique, India and Indonesia (One to Three).
“Since 2018, the World Health Organization has recommended a shorter rifapentine based TB prevention treatment regimen, known as 1HP, but we’ve seen little uptake,” said Prof Gavin Churchyard, IMPAACT4TB Principal Investigator and Aurum Group CEO. “The 1HP regimen consists of only one month of daily isoniazid and rifapentine, but is slightly more expensive. This new funding will allow us to understand patient acceptability, tolerance and preference of 1HP in comparison to 3HP.”
Alongside evidence generation, the project will invest in ensuring countries are aware of the need for medicines for children for TB prevention that are easier to swallow and with the appropriate dose. Currently, 3HP tablets need to be swallowed whole, which is difficult for some children, and need to be broken into pieces to dose children appropriately, limiting access to TB prevention for children. Once new formulations are ready, governments will, in turn, need to be ready to introduce them.
“We expect this desperately needed child-friendly formulation to be ready for distribution by no later than the end of 2024,” said Mike Frick from the Treatment Action Group (TAG). “To ensure countries are prepared to order these new regimens once they are ready, we’re already starting to raise awareness among communities and eligible populations that currently do not have access to optimal TPT regimens.”
Launched in 2017, the IMPAACT4TB project has focused on the introduction of shorter, rifapentine-based TB prevention treatment options that are associated with higher treatment adherence, completion, and outcomes. Since it was launched, the project has supported the introduction of these regimens in 12 countries around the globe, catalyzing orders for rifapentine-based TB prevention treatment regimens in an additional 47 countries. Working with global partners and manufacturers, the project also helped to significantly reduce the access price of a three-month patient course of weekly rifapentine and isoniazid, from US$72 to below US$15.
“We would like to thank Ministries of Health across our 12 project countries and Unitaid for their ongoing support for this extension that allows us to generate evidence for expanded use of shorter TB prevention treatment regimens across all eligible populations,” added Prof Churchyard.
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 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. These efforts saw 23 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), improved TPT service delivery as well as community advocacy for improved TPT policy and uptake within project countries.
About Unitaid
Unitaid is a global health agency engaged in finding innovative solutions to prevent, diagnose, and treat diseases more quickly, affordably, 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, serving as a key member of the Access to COVID-19 Tools (ACT) Accelerator, co-leading with Wellcome the Therapeutics Pillar and participating in the Diagnostics Pillar. Unitaid is hosted by the World Health Organization. For more information, please 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/