The Executive Board of Unitaid, the Geneva-based UN agency promoting innovations to end global pandemics, has approved a new grant to the Aurum Institute of South Africa, Johns Hopkins University and other partners to improve the uptake of treatment to prevent tuberculosis (TB), the world’s leading infectious disease killer.
The $59 million grant, called IMPAACT4TB, will support scale-up of a novel antibiotic regimen pioneered by Johns Hopkins investigators to prevent people most vulnerable to developing active TB, including people living with HIV and children under age five. The four-year grant aims to ensure that people with latent tuberculosis infection (LTBI) – who are infected with the TB bacteria, but do not have symptoms – have access to the new, shorter and less toxic TB treatment using rifapentine and isoniazid for 12 weeks. The regimen was developed by JHU Professor Emeritus Jacques Grosset, MD, in an animal model, and then demonstrated to be safe and effective in high-risk patients in a series of studies organized by CFAR Director Richard Chaisson, professor in the Division of Infectious Diseases.
“The detection and treatment of people with latent TB is an important part of controlling this disease and ultimately ending TB,” said Lelio Marmora, Unitaid Executive Director. “The shorter TB preventive therapy regimen has the potential to be the game changer needed to reach the end TB targets.”
The IMPAACT4TB consortium is being spearheaded by Professor Gavin Churchyard of South Africa's Aurum Institute, in partnership with Johns Hopkins, the Clinton HIV/AIDS Access Initiative, KNCV Tuberculosis Foundation, the Global Drug Facility-Stop TB Partnership and the Treatment Action Group. With support from the World Health Organization, the partners will implement the project in 12 countries in Africa, Latin America and Asia with high burdens of TB or TB/HIV. People living with HIV and child contacts of TB cases under five years of age will receive a quality-assured, affordable, short-course TB preventive therapy of isoniazid and rifapentine) given weekly for three months, known as 3HP.
During the first year of the project, the team will evaluate the safety and drug-drug interactions of 3HP combined with the new antiretroviral drug dolutegravir in people living with HIV in South Africa. This study will be led by Kelly Dooley, associate professor in the Division of Infectious Diseases. Following the successful completion of the study, the consortium will provide the treatment to 400,000 people to catalyze an increase in supply and demand for and uptake of 3HP in project countries including South Africa, Brazil, India, Indonesia, Kenya, Tanzania, Ghana, Mozambique, Ethiopia, Cambodia, Zimbabwe and Malawi. Hopkins investigators will also conduct implementation science projects to determine optimal ways to deliver the regimen.
“IMPAACT4TB will help us take the last step in the cycle of medical innovation, going from discovery in the laboratory and proof of efficacy in clinical trials to delivery on a global scale with a measurable impact on the TB epidemic,” said Dr. Chaisson, also Director of the Johns Hopkins Center for TB Research.
Other Hopkins faculty participating in the project include Amita Gupta, deputy director of the Center for Clinical Global Health Education; David Dowdy, associate professor of Epidemiology; Jonathan Golub, associate professor in ID; Nicole Salazar-Austin, instructor in Pediatrics; Christopher Hoffmann, associate professor in ID; Colleen Hanrahan, assistant scientist in Epidemiology and Vidya Mave, assistant professor in ID.
For additional details, please contact Liz Bonomo, project manager for IMPAACT4TB at Johns Hopkins ([email protected]).