First study to evaluate bedaquiline, a game changing TB treatment drug, as a shorter, safer regimen for TB prevention

NEW YORK CITY, September 19, 2023 — In the lead up to the second United Nations (UN) High-Level Meeting on Tuberculosis, Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB) announced plans to conduct a transformational multinational study of a one-month treatment regimen to prevent all forms of tuberculosis (TB), including drug-resistant TB.

BREACH-TB (Bedaquiline Roll-Out Evidence in TB Contacts and People Living with HIV to Prevent Tuberculosis) will test whether one month of oral bedaquiline, a potent drug that has revolutionized the treatment of drug-resistant TB, can prevent both drug-resistant (DR) and drug-susceptible (DS) TB in people exposed to either form of TB in their households and in people with HIV infection, including pregnant women and children.

“Developing a short regimen that can prevent both DR- and DS-TB infections from advancing to active TB disease will greatly simplify options for TB preventive treatment (TPT) and ensure that more people exposed to TB in high-burden countries will get and complete treatment, helping to achieve the UN’s goal of Ending the TB Epidemic by 2030,” said SMART4TB chief of party, Dr. Richard Chaisson, professor of medicine at Johns Hopkins University School of Medicine.

TB is a leading infectious killer globally, with an estimated 1.6 million deaths in 2021. In 2018, the first-ever UN High-Level Meeting on TB made ending the disease a global priority and set the target of preventing 30 million new cases between 2018 and 2022. However, less than half of the target was reached. The World Health Organization has prioritized preventive therapy as a key strategy for ending TB.

“The study design of BREACH will allow us to boldly investigate a promising preventive pan-TB regimen—meaning that household contacts, people living with HIV and other key members of TB-affected communities, will be part of a global effort to get us closer to a safe and effective preventive treatment for all,” said Dr. Payam Nahid, SMART4TB’s senior scientific advisor and professor of medicine at the University of California, San Francisco.

Preventive therapy is only successful if the person with latent TB completes the course of medication. However, people with latent TB infections don’t show symptoms of the disease, making it more difficult to keep them on a long, arduous medication schedule solely for prevention. Providers know this and would prefer to offer shorter regimens as a first-line option to ensure they are fully completed. While short-course regimens for DS-TB have been available for several years, individuals exposed to DR-TB can only be treated with longer courses of unproven regimens to prevent development of TB disease.

Approved by the United States Food & Drug Administration in 2012, bedaquiline was the first new drug to be developed for TB in 40 years. It has since become a game-changer in the treatment of DR-TB. The BREACH Study will be the first to evaluate bedaquiline for TB prevention.
SMART4TB is a cooperative agreement with the United States Agency for International Development (USAID), made possible by the generosity of the American people.

“A shorter regimen that fights both drug-resistant and drug-susceptible TB would be a game-changer for those living with TB and get us closer to our shared goal of ending the epidemic by 2030. This clinical trial will lay the foundation for a remarkable innovation in our fight against TB: a single-dose, long-acting injectable medicine,” said Dr. Atul Gawande, USAID assistant administrator for Global Health.

The study is being led by researchers Drs Eric Nuermberger and Sonya Krishnan at Johns Hopkins University. It is slated to begin enrollment in 2024.

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The SMART4TB Consortium brings together experts in TB tools development, implementation science, capacity strengthening, civil society engagement, and policy translation. Led by Johns Hopkins University, consortium members include University of California, San Francisco, Elizabeth Glaser Pediatric AIDS Foundation, KNCV Tuberculosis Foundation, and Treatment Action Group. SMART4TB is a cooperative agreement with the United States Agency for International Development (USAID), made possible by the generosity of the American people.The findings in this publication do not necessarily represent the views of the U.S. Agency for International Development or the U.S. Government.

Community Advisory Boards representing Africa, Asia-Pacific and Eastern Europe and Central Asia will ensure research is needs-driven and new tools are accessible  

BALTIMORE, June 15, 2023 — Supporting, Mobilizing, and Accelerating Research for Tuberculosis Elimination (SMART4TB) is a five-year cooperative agreement made possible by the United States Agency for International Development (USAID), with the assistance of the American people, that aims to transform tuberculosis (TB) prevention and care. The consortium is excited to announce Afrocab Treatment Access Partnership (Afrocab), APCASO and Eurasian Community for Access to Treatment (ECAT) as community partners in the project.

“Engaging TB-affected communities in all parts of the research process is essential for developing locally relevant and translatable evidence,” said SMART4TB Chief of Party, Dr. Richard Chaisson, professor of medicine, epidemiology and international health at the Johns Hopkins University School of Medicine. “SMART4TB is delighted to partner with Afrocab, APCASO and ECAT to enable community engagement and leadership on the consortium’s research and policy activities.”

Engagement with local, national, regional and global community partners is integral to the SMART4TB project. With support from SMART4TB Consortium member Treatment Action Group (TAG), these Community Advisory Boards (CABs) will help shape the research agenda and protocols to ensure alignment with community needs and priorities; support trial sensitization and when available, results dissemination with the broader TB community and other key stakeholders; and drive the translation of SMART4TB research into evidence-based, progressive policy and programming. This will include support for generating community demand for access to the benefits of scientific progress.

“Afrocab Treatment Access Partnership is excited to leverage our experience engaging with researchers, normative bodies, regulatory agencies and other decision makers to support the SMART4TB project. We look forward to utilizing our longstanding network of advocates across the region and ability to mobilize community voices to demonstrate demand for change in TB programs worldwide,” said Kenly Sikwese, executive director of the Afrocab.

“APCASO is pleased to partner with SMART4TB to ensure a people-centered approach to TB treatment, care and research and to prioritize the voices of affected communities in these efforts,” said RD Marte, executive director of APCASO. “We are looking forward to connecting TB-affected communities with researchers and policymakers and to holding governments accountable to ensuring communities needs are met.”

“The time is now for new approaches to removing barriers to TB prevention, treatment and diagnostics innovations. SMART4TB provides an opportunity to push for more equitable research and access for all,” said Denis Godlevsky, director of International Treatment Preparedness Coalition Eastern Europe and Central Asia (ITPC EECA) and ECAT coordinator.

CABs were selected by a panel of seven which included community advocates, SMART4TB representatives and community engagement experts. The panel reviewed over 30 applications, weighing each applicant’s governance structure and experience with TB, advocacy and research against the eligibility criteria published in the call for expressions of interest.

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The SMART4TB Consortium brings together experts in TB tools development, implementation science, capacity strengthening, civil society engagement, and policy translation. Led by Johns Hopkins University, consortium members include University of California, San Francisco, Elizabeth Glaser Pediatric AIDS Foundation, KNCV Tuberculosis Foundation, and Treatment Action Group. SMART4TB is a cooperative agreement with the United States Agency for International Development (USAID), made possible by the generosity of the American people.The findings in this publication do not necessarily represent the views of the U.S. Agency for International Development or the U.S. Government.

Founded in 2011, Afrocab is a regional advocacy network focused on increasing access to effective diagnostics and therapeutics for HIV, TB and other co-morbidities such as Advanced HIV Disease (AHD). With members from 25 Sub-Saharan African nations, Afrocab has a storied history navigating the research to policy processes and fostering links between communities, industry and researchers. Best known for its impressive track record in HIV, the Afrocab has also led advocacy efforts to tackle TB, a major cause of morbidity and mortality among people living with HIV. Afrocab co-chairs the Long-Acting Technology (LAT) CAB, focused on the research and development of long-acting formulations for TB prevention, and hepatitis C and malaria cures. And members of the Afrocab have also led work to improve access to a urine-based test for TB and TB preventive therapy (TPT), tools critical to preventing TB-related sickness and death among people with AIDS.

APCASO has served the Asia-Pacific region for three decades as a network of civil society organizations governed by an elected council of national representatives from APCASO’s member organizations. In 2016, APCASO established ACT! AP, a group dedicated to building the capacity of civil society organizations and communities to advocate for well-funded, people-centered national TB programs. APCASO and ACT! AP have partnered with critical TB stakeholders including the WHO Civil Society Task Force; Global Fund Community, Rights, and Gender Communication and Coordination Platform for Asia-Pacific; Stop TB Partnership; and country level TB advocacy networks to support capacitation and expand advocacy opportunities. APCASO’s work to develop and implement a TB accountability framework and scorecard is used across the region to drive investments in TB programs and research.

Founded in 2016, the ECAT brings together over 50 community advocates and experts from countries across the Eastern Europe and Central Asia region to push for timely and comprehensive access to diagnostics and treatments for HIV, TB and hepatitis C. The ECAT has a reputation of holding policymakers and drug sponsors and their commercial partners accountable for ensuring equitable access to innovations in the region, where TB medicines and other tools are often marketed at much higher prices than are available globally. ECAT is backed by the International Treatment Preparedness Coalition in Eastern Europe and Central Asia (ITPC EECA), which brings additional experience tracking research and development, engaging with research and product sponsors, and fighting intellectual property related barriers to access. Members of the ECAT have won price reductions and increased access to modern HIV, HCV and TB medicines in the region. The ECAT has led successful negotiations and advocacy campaigns targeting dolutegravir, sofosbuvir, bedaquiline and other essential medications to ensure both price reductions and increase generic competition on the market.

Consortium is working with global partners on diagnostic, therapeutic, vaccine, and operational research to improve TB care and outcomes for affected communities 

BALTIMORE, March 24, 2023 — Supporting, Mobilizing, and Accelerating Research to Eliminate Tuberculosis (SMART4TB), an initiative made possible by the generosity of the American people through the United States Agency for International Development (USAID), commemorates World TB Day by calling for renewed commitments to ending the tuberculosis epidemic. Over 1.6 million people die across the globe each year from this preventable, curable disease.

 “The global SMART4TB consortium aims to transform tuberculosis (TB) prevention and care, thanks to a historic multi-year investment from the U.S. Agency for International Development,” said Dr. Richard Chaisson, Chief of Party for SMART4TB and Professor of Medicine, Epidemiology, and International Health at Johns Hopkins School of Medicine. “Through innovative, person-centered research geared toward changing TB policy, we aspire to reverse the setbacks the COVID-19 pandemic made to progress against TB and catalyze the end to TB.”

SMART4TB will spend the next five years engaged in community-informed diagnostic and therapeutic clinical research, vaccine preparedness, and other operational research, as well as policy translation to transform the TB response. Dr. Payam Nahid, Senior Research Advisor at SMART4TB, Professor of Medicine at University of California San Francisco, and Director of the UCSF Center for Tuberculosis, stressed the significance of research in meeting global TB targets, “Each year, nearly 4 million people with TB go undiagnosed. Developing new tests that are fast and accurate and can effectively diagnose patients quickly and at their point of care, can get patients diagnosed and treated faster, and help programs stop transmission earlier.”

Investing in and developing a comprehensive approach to TB pediatric studies and treatment for pregnant people is a key area of focus across SMART4TB research. “Due to lack of research, children and pregnant people are often still subjected to more toxic, longer, and less effective TB treatment. We must close the gaps in care, starting with ensuring that these populations are included in treatment, prevention, and diagnostic research from the outset,” said Nilesh Bhatt, SMART4TB Partner Lead and Global Clinical Research Director at the Elizabeth Glaser Pediatric AIDS Foundation.

As SMART4TB evolves, collaboration with partners in high-burden countries on capacity strengthening and operational research is central to the consortium’s approach. “SMART4TB wants to produce research and policy guidance that is driven by local leadership,” said Dr. Mustapha Gidado, Executive Director of KNCV Tuberculosis Foundation. “By developing operational goals and research plans in partnership with health ministries, and community leaders, we intend to sustain the impact of our research far beyond the life of this project.”

SMART4TB will also work at the global level, infusing the perspective of TB-affected communities, to leverage critical moments such as the G20 Summit and the United Nations High Level Meeting on Tuberculosis in September for the resources and political will needed to end TB. “The commitments that nations make now can give us the kind of profound change that TB-affected communities are demanding,” said Lindsay McKenna, SMART4TB Partner Lead and TB Project Co-Director at Treatment Action Group. “This includes investments in developing and implementing shorter, more effective treatment regimens; new diagnostic tools; and a new, more efficacious vaccine, and provisions to ensure they are affordable and equitably accessible.”

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The SMART4TB Consortium brings together experts in TB tools development, implementation science, capacity strengthening, civil society engagement, and policy translation. Led by Johns Hopkins University, consortium members include University of California, San Francisco, Elizabeth Glaser Pediatric AIDS Foundation, KNCV Tuberculosis Foundation, and Treatment Action Group. SMART4TB is a cooperative agreement with the United States Agency for International Development (USAID), made possible by the generosity of the American people.The findings in this publication do not necessarily represent the views of the U.S. Agency for International Development or the U.S. Government.