Re-posted from the Vital Strategies blog published on February 4, 2016
Patients diagnosed with multi-drug resistant tuberculosis (MDR-TB) face a daunting treatment regimen – including up to two years of treatment and months of daily injections, which can leave them with terrible side effects, including permanent deafness.
But the evaluation of a standard treatment regimen of anti-tuberculosis drugs for patients with MDR-TB – STREAM – a clinical trial coordinated by Vital Strategies along with The Union and key global partners is giving new hope. The trial aims to reduce the treatment time from 20 to 24 months to just 6 or 9 months, and do away with painful injections.
What has caused the rise of MDR-TB?
According to the WHO, “Inappropriate or incorrect use of antimicrobial drugs, or use of ineffective formulations of drugs (e.g. use of single drugs, poor quality medicines or bad storage conditions), and premature treatment interruption can cause drug resistance”.
The patient can then pass on this MDR strain to other people through the air. About one in 20 cases of TB are now MDR and it is presenting a huge public health problem.
Jan Komrska, a Pharmacist at Vital Strategies, is leading the supply chain management for the STREAM trial.
“One of the objectives is to see if we can cure MDR-TB in a shorter period of time. Another is to check whether we can treat it without daily injections, which the current regimen requires.”
“These injections can have extreme and painful side effects. Some patients lose their hearing while others suffer extreme nausea. It can discourage people from continuing treatment.”
The trial is comparing three different treatment regimens, each with a shorter duration of treatment than the currently recommended regimen.
“Results from Stage 1 of the trial are expected at the end of 2017. Stage 2 will involve more than one thousand patients in countries with a high burden of MDR-TB, across Africa and Asia.”
Jessica Nan, Technical Officer at Vital Strategies, says patients will be monitored for up to two years after completing their treatment.
“Less than half of MDR-TB patients given the current two year regimen are treated successfully. If this trial can demonstrate better results with shorter and more tolerable regimens, then these regimens may become the standard of care for MDR-TB.”
In February 2016 STREAM is initiating four Stage 2 trial sites in Mongolia and Ethiopia and expects them to start recruiting first patients soon after.