Dr. Daniel Meressa, Principal Investigator for the STREAM trial site at St. Peter’s Tuberculosis Specialized Hospital in Addis Ababa, Ethiopia, speaks about his experience treating patients with MDR-TB, and why the STREAM trial continues to be vital to ending the epidemic.
“In 2012, I had the opportunity to face the challenges of MDR-TB treatment when STREAM first started in Ethiopia. We had doubts about the effectiveness of the WHO 2011 recommended regimen, mainly the long duration, and adverse drug effects. The regimen was very difficult for patients to tolerate due to its drug toxicity. Patients who developed severe disturbances died as a result of treatment complications.
“STREAM Stage 1 provided important evidence that a shorter 9–11-month treatment regimen is as effective for the treatment of MDR-TB as the longer 20-month treatment recommended by the WHO in 2011.
“When recommending guidelines for the shorter regimen, the WHO clearly mentioned evidence from STREAM Stage 1. The Ethiopian NTP (National Tuberculosis Program) also asked about our experience with the shorter regimen evaluated in STREAM. We shared our experiences and were actively involved in the design and revision of the national guidelines when Ethiopia adopted the shorter regimen in April 2018.
“Policy change impacts the lives of people and has major budget implications, especially in resource constrained settings such as Ethiopia. We must be sure the MDR-TB regimen we are recommending is safe and effective…The evidence should be strong and high-quality, and we can only get that evidence from clinical trials. We need multi-site, multi-country clinical trial evidence because that’s the only way we can know if the regimen is applicable across different settings.
“STREAM Stage 2 is trying to address these issues by comparing the efficacy and safety of the shorter regimen to a fully oral regimen that includes the new drug, bedaquiline. This regimen is potentially as effective and more tolerable than the injectable-containing regimens currently in use. The injectable-containing regimen has drawbacks and can have serious toxicities like severe hearing loss and kidney injury.
When other countries made the decision to move to the all oral shorter regimen, the Ethiopian NTP discussed this as well. But the final agreement was that the evidence is not adequate, and we need additional clinical trial evidence before shifting to this fully oral regimen.Dr. Daniel Meressa, Principal Investigator for the STREAM trial site at St. Peter’s Tuberculosis Specialized Hospital in Addis Ababa, Ethiopia
“We need to complete STREAM Stage 2 while reviewing observational study reports, but these reports cannot replace the evidence we will generate from this randomized controlled trial.
“STREAM not only brings important evidence; it is also the first-ever MDR-TB clinical trial to be conducted in our setting in close collaboration with the NTP and the community. We had the opportunity to communicate with world-class consultants and research experts, which really improved our clinical knowledge. Additionally, we hope community engagement will have a bigger role in routine TB control activities. Community engagement is worth the effort to raise awareness about clinical trials in communities.
“STREAM has been an exciting and inspiring experience. I remember a young girl who interrupted her college education due to MDR-TB. She started on STREAM and was treated with the shorter regimen. Once her treatment was completed, she managed to return to school to become a pharmacist because of the shorter duration of treatment.
“Our TB burden in Ethiopia is high, and we need to be supported by research studies like STREAM to give us the hope many more patients, like the young girl I remember, will be able to carry on with their lives.”