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Two new bedaquiline-containing shortened treatment regimens are safe and effective in treating multi-drug resistant tuberculosis (MDR-TB), according to the STREAM (Stage 2) clinical trial published in The Lancet. The shortened treatment would result in lower direct costs to patients, a note on the trial said. The trial was published on Tuesday.
The STREAM trial is the world’s largest MDR-TB trial, with over 1,000 participants recruited from eight countries on three continents, the note said. Stage 2 of the trial was conducted in Ethiopia, Georgia, India, Moldova, Mongolia, South Africa and Uganda.
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The medal is awarded annually to one or more mid-career investigators for distinguished work in tropical medicineMDR-TB is resistant to two key drugs, isoniazid and rifampicin. Stage-2 of the trial evaluated two new regimens—an all-oral 9-month regimen and a 6-month injection-containing regimen (both containing the new anti-tuberculosis drug bedaquiline) compared to a 9-month control regimen studied in Stage-1 (that contained injections, not bedaquiline). Bedaquiline is from Janssen Pharmaceutical Companies (Johnson & Johnson).
Till 2016, the recommended treatment for MDR-TB included 7,200 pills and 240 injections and took up to 24 months to complete, the note pointed out.
In 2017, STREAM Stage-1 confirmed that a 9-month treatment regimen was as effective as the longer regimen.
“Now, STREAM Stage-2 has demonstrated that both a fully-oral 9-month regimen and a 6-month injection-containing regimen have superior efficacy than the control regimen (the regimen evaluated in STREAM Stage-1),” the note said.
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USFDA closes inspection of the facility with Voluntary Action Indicated“A within-trial health economics study led by the Liverpool School of Tropical Medicine found that the fully-oral treatment is more expensive than the control regimen from a health system perspective—largely driven by the cost of the regimen; however, patient direct costs were lower in both study regimens compared to the control regimen,” the note added.
Covid-19 has exacerbated the global threat of TB and the recently released World Health Organization’s Global Tuberculosis Report 2022 said that an estimated 10.6 million people fell ill with TB worldwide in 2021, representing an increase of 4.5 percent from 2020, reversing years of slow decline.
The estimated number of new cases of MDR-TB during the same time period increased by 3.1 percent as access to health services and optimal TB diagnosis and management had been impacted by the pandemic. India aims to end TB by 2025, five years ahead of the global target.
Vital Strategies was sponsor for the trial and other global partners included the Medical Research Council Clinical Trials Unit at University College London (UCL), the International Union Against Tuberculosis and Lung Disease (The Union) and Liverpool School of Tropical Medicine.
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