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Union response to release of final results from Stage 1 of the STREAM trial

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In response to the publication of final results from Stage 1 of the STREAM trial, Dr Paula I Fujiwara, Scientific Director, The Union, made the following statement:

“Results from randomised clinical trials (RCT) are a vital component for being able to provide patients the best quality of care, and the final results from Stage 1 published recently are the first time that we have ever had evidence on a shortened treatment for multidrug-resistant tuberculosis (MDR-TB) from a phase III RCT. The STREAM study provides good quality data on a shortened, standardised regimen for drug-resistant TB.

“The results support the programmatic evidence that the STREAM Stage 1 9-11-month shorter regimen is as good as the longer 20-24-month regimen, recommended in the 2011 WHO guidelines, in terms of efficacy. Observational studies and individual patient data show that the regimen performs similarly in the RCT as in programmatic conditions. This cannot be said for the previous longer regimen.  

“For the new all oral regimen, recommended by the World Health Organization (WHO) in 2018, its efficacy in programmatic conditions is unknown and no RCT trial is planned to examine the outcomes for this regimen.

“In line with the updated WHO MDR-TB treatment guidelines published in December 2018, The Union will continue to support the appropriate use of a shorter regimen in conditions where patients are monitored closely throughout treatment, particularly with regards to hearing loss—a potential adverse effect.

“The shorter duration of the shorter regimen is a clear advantage to the patient and increases the likelihood that the treatment is completed, with an earlier return of the patient to work and social activity. We look forward to the analysis of the health economic data exploring the potential cost savings of the 9-11-month regimen to both patient and health systems compared to the 20-24-month regimen. 

“The STREAM Stage 1 results come at a time when TB science is progressing quickly; we are very keen to keep this momentum going. There is still a very real and urgent need to improve the efficacy and safety of MDR-TB treatment and trials like STREAM and STREAM Stage 2, as well as other ongoing trials are a vital part of this work.

“The Union recognises the challenges, including the risk of permanent hearing loss, that people undergoing treatment for MDR-TB face in the course of receiving injectable medicines and will continue to strive towards a shorter, all-oral regimen.

“The Union supports the studies on the removal of the injectables in the STR as long as it is done in appropriate operational research conditions (ideally in line with the GDI recommendations) and would like to discuss with countries and partners regarding the role of other drugs as the replacement for second line injectables (SLI) with the aim of any modified short treatment regimen obtaining the same high cure rates as the original one, with fewer side effects and avoid any amplification of resistance to the key drugs. Countries must ensure active TB drug safety monitoring and management (aDSM) and adequate patient information materials to ensure informed decision making for all patients enrolled in MDR-TB treatment.

“The Union supports and promotes high quality science generating evidence to ensure the new tools required to ensure the End TB/UN HLM declaration targets are developed and made available to all who need them.”