AUGUST 11, 2016
In many parts of the world, tuberculosis is considered a disease of the past—a treatable, preventable condition. Unfortunately, this is untrue for the majority of the world’s population, who live in places where tuberculosis is still not just a fact of life, but a persistent threat.
Vital Strategies recently facilitated the STREAM tuberculosis treatment Investigators Meeting in New York.
The meeting was a gathering of researchers from across the world, working towards a better treatment for one of the humanity’s oldest afflictions.
In 2014, an estimated 9.6 million people became ill with TB, with most of these patients coming from low- and middle-income countries. Of those cases, there were an estimated 480,000 new cases of multi-drug resistant tuberculosis (MDR-TB), a particularly complicated form of TB characterized by resistance to two important drugs of the standard four-drug, anti-TB treatment regimen. MDR-TB is estimated to have killed 190,000 people worldwide in 2014, but one economic analysis projects that it could claim a further 2.6 million lives per year by 2050 if left unchecked.
Among the most difficult challenges is the grueling drug regimen that patients must endure to overcome the disease. Treating MDR-TB can take up to 24-months and requires over 14,000 pills. Under ideal conditions, the task is daunting. It’s far more complicated when a patient has to balance treatment with family and work obligations. Too often, patients give up on the treatment, unable to cope with grueling side-effects and financial hardship.
That’s why Vital Strategies and our partners have been working to implement the STREAM clinical trial.
The 4th annual meeting was attended by USAID and Janssen as funders; the Clinical Trials Unit of the Medical Research Council as the main trial implementer; the Institute of Tropical Medicine, Liverpool School of Tropical Medicine, Quintiles, and Clearwater Clinical as technical organizations to support proper implementation and monitoring of the trial; and researchers from the four Stage 1 countries as well as new Stage 2 investigators from Georgia, India, Moldova, Uganda, and Zimbabwe.
Over the course of the trial, Stage 1 tests a 9-month treatment regimen for MDR-TB, with results expected in early 2018. Between 2012 and 2018, more than 400 patients in Ethiopia, South Africa, Viet Nam and Mongolia are participating in the first stage.
The second stage will test an all-oral 9-month regimen and a 6-month regimen, which will both include Bedaquiline, a new and novel anti-TB medicine developed by Janssen Research & Development, LLC (Janssen).
The Investigators Meeting is an opportunity for these experts to come together to assess progress, challenges and opportunities within the trial. Among these topics were the potential impacts of the new World Health Organization recommendation to change the 24-month drug regimen to 9-months.
In addition, investigators discussed the possibility of lowering the minimum age for trial participation from 18 to 15.
While providing support and oversight for this clinical trial, Vital Strategies is also helping participating countries build the capacity to conduct clinical trials under stringent standards – including proper management of trial supplies. Additionally, Vital Strategies is working with partners such as REDE TB to strengthen engagement with affected communities. To this end, a new Community Engagement Plan was presented to help participating countries involve relevant stakeholders in the process.
Overall, the meeting made one thing clear: progress is being made, and we are moving closer towards our goal of a shorter, safer treatment regimen accessible to those who need it most.