The International Union Against Tuberculosis and Lung Disease (The Union) announced plans for new clinical research that will evaluate the effectiveness of two new treatment regimens for multidrug-resistant tuberculosis (MDR-TB). If successful, the study will provide robust new evidence on the effectiveness of both an all-oral and a six-month treatment regimen for MDR-TB.
The current standard treatment regimen for MDR-TB lasts up to 24 months and requires frequent injections, which pose a significant burden both for patients and for health systems tasked with administering treatment. Permanent hearing loss is a serious and tragic side effect of the injected medicines used to treat MDR-TB.
"If these new regimens are demonstrated to be effective, this research will help make MDR-TB treatment substantially less burdensome for everyone involved. I'm optimistic. Undergoing treatment for multidrug-resistant TB currently is one of the most grueling experiences that a person affected by disease can face. It's also extraordinarily challenging for health workers to administer, and it requires a much greater investment of resources from the public health system compared with most other diseases," said I.D. Rusen, Senior Vice President for Research and Development. "The complexity and costs associated with treating MDR-TB have a lot to do with why so few people with MDR-TB today receive successful treatment. MDR-TB patients shouldn't have to choose between deafness and death."
The two regimens to be tested in the study include an all-oral 9-month regimen and a 6-month regimen, which will both include bedaquiline, a new novel anti-TB medicine developed by Janssen Research & Development, LLC (Janssen). The Union and the main trial partner, the UK Medical Research Council, will enroll participants in the study from 2015 through the first quarter of 2018, as needed. Results of the study are expected in 2020.
The evaluation of these new regimens comprises the second stage of a larger ongoing clinical trial called STREAM, which is testing the effectiveness of shortened treatment regimens for MDR-TB. The second stage of STREAM is the result of innovative partnerships between the United States Agency for International Development (USAID), The Union, and Janssen. Such public-private partnerships are relatively rare in clinical research and are essential to developing new treatments for MDR-TB.
"USAID is committed to supporting research that will lead to better treatment outcomes for MDR-TB patients," said Dr. Ariel Pablos-Méndez, USAID Assistant Administrator for Global Health. "Today, treatment for MDR-TB can be long, grueling and toxic. With an injection-free, more tolerable and shorter regimen, we can reduce the suffering associated with MDR-TB treatment and save lives. This collaboration with the Union and Janssen allows us to continue the important work of the STREAM study," he said.
The first stage of STREAM is primarily funded by the USAID with additional funding support from the UK Medical Research Council and the UK Department for International Development (DFID) and is testing a separate 9-month treatment regimen, with results expected in 2017.
According to the World Health Organization, an estimated 480,000 people developed MDR-TB and an estimated 210,000 died from the disease in 2013. MDR-TB is defined as tuberculosis that is resistant to at least isoniazid and rifampicin, two of the most important first-line drugs typically used to treat TB.