Union response to STREAM clinical trial preliminary results for nine-month treatment regimen of multidrug-resistant TB

In a response to the preliminary results released today Dr Paula I Fujiwara, Scientific Director, The Union, said:

“The Union is pleased with the performance of the nine-month regimen in the STREAM trial. We believe that this regimen has been shown to be feasible to implement in the field and should continue to result in good treatment outcomes for patients.

“We believe that the results support the current WHO recommendation to change to a shortened regimen for many patients, and that close monitoring remains an important feature of the regimen.

“The nine-month regimen performed in the STREAM trial in a way that was consistent with its use to date within programme settings, such as in the Bangladesh, West Africa and MSF cohort studies. These outcomes were observed despite the high standards of the clinical trial, including stringent definitions of unfavourable outcomes and very long follow-up periods after treatment was completed.

“Observations over many years of supporting programmes in MDR-TB management tells us that the high retention of patients on a 20-24 month regimen in the STREAM trial is very difficult to achieve in the field, and such good treatment outcomes have not to-date and likely will not be replicated in ‘real world’ settings. Nor can patients be expected to tolerate an eight-month period of injections and the huge burden of pills that the 20-24 month regimen requires.

“The STREAM trial demonstrates the importance of evaluating treatment regimens in clinical trials to fully understand their potential. Further research is required to explore ways to make the nine-month regimen even more effective and as safe as possible so its potential can be maximised. STREAM Stage 2 is an important step forward in this process.

“The Union’s Expanded MDR-TB Programme team looks forward to working with our technical partner agencies, including WHO, to fully support programmes as they transition to this shortened treatment regimen.”