Final results from Stage 1 of the STREAM randomised clinical trial, presented at the Union World Conference on Lung Health, showed that a nine-to-11-month treatment regimen is as effective in treating MDR-TB, when given under trial conditions, as the 20-24-month treatment regimen recommended in the 2011 WHO guidelines.
The Union’s STREAM trial is the world’s first multi-country randomised phase III clinical trial to test the efficacy, safety and economic impact of shortened MDR-TB treatment regimens. Stage 1 of the trial looked to determine whether a nine to 11-month treatment regimen, that demonstrated cure rates exceeding 85 percent during a pilot programme in Bangladesh, was as effective as the longer regimen under clinical trial conditions. The 20-24-month regimen used in many countries globally is costly, has significant side effects and the length of the regimen makes it hard for both patients and the health system. In addition, the regimen has an average treatment success rate of approximately 50 percent when used in many real-world treatment settings.
Until now there has been a lack of strong supporting evidence to underpin MDR-TB treatment guidelines. The results from STREAM Stage 1 help to fill that gap.
Because of these widely acknowledged challenges, WHO guidelines were updated in 2016 to recommend a shorter, nine-to-12-month regimen for most people with MDR-TB under specific conditions. The guidelines acknowledge that this recommendation is based on very low certainty in the evidence.
Building on the experience of the STREAM trial, TREAT TB has launched a webinar series to strengthen capacity to conduct high-quality MDR-TB trials.
The STREAM trial is the result of a unique collaboration between The Union, Vital Strategies and several key partners, with funding from USAID and Janssen Research & Development.