Shorter Treatment Regimen for Drug-Resistant TB is More Effective
Tuberculosis 08/11/2022 •
Healthcare workers treat a patient with drug-resistant TB in Myanmar.

Two shorter treatment regimens for multi-drug resistant (MDR) tuberculosis have proven to be safe and more effective than the current treatment, the Union World Conference on Lung Health heard on Tuesday.

Results from Stage 2 of the STREAM clinical trial, published in The Lancet on the same day, show that a fully-oral nine-month bedaquiline-based regimen and a six-month injection-containing regimen have superior efficacy to the nine-month regimen currently used, which is a combination of pills and injections.

“Until 2016, the recommended treatment for MDR-TB typically included 7,200 pills and 240 injections and took up to 24 months to complete,” according to a media release from Vital Strategies, the organisation that sponsored the trial.

“In 2017, STREAM Stage 1 confirmed that a nine-month treatment regimen was as effective as the longer regimen. Now, STREAM Stage 2 has demonstrated that both a fully-oral nine-month regimen and a six-month injection-containing regimen have superior efficacy than the control regimen.”

Some 82.7% of trial participants had a favourable outcome using the oral nine-month regimen in comparison to 71.1%  on the nine-month regimen that had both injections and pills.

Largest MDR TB trial

The six-month regimen – which comprised of bedaquiline-based injections for two months as well as pills – was also more effective than the nine-month control regimen, with 91.0% of participants having a favourable outcome compared to 68.5% in controls. 

“While we are pleased with the performance of the regimens tested in STREAM and the evidence generated, there is still an urgent need to build upon these results and improve the efficacy and safety of MDR-TB regimens available,”  said I.D. Rusen, Senior Vice President at Vital Strategies. 

The STREAM Clinical Trial is the world’s largest MDR-TB trial ever conducted, with over 1,000 participants from eight countries. It was implemented by a number of global partners, including 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. 

MDR-TB is resistant to two key medicines, isoniazid and rifampicin, and is expensive to treat. Some of the treatments have serious side-effects including permanent deafness.

“It is particularly encouraging to note that the findings in the fully-oral and 6-month regimens are significantly better not only in the combined outcome measure, but also in the TB-associated outcomes, namely significantly fewer failures and relapses,” said Professor Andrew Nunn, STREAM co-chief investigator, at the MRC Clinical Trials Unit at UCL.

Professor Sarah Meredith, co-chief investigator and medical lead for STREAM based at UCL, also noted, “after careful monitoring of all participants in STREAM, we were pleased that no concerning safety signals were identified. In addition, fewer participants experienced severe hearing loss in the all-oral regimen (2%) and the six-month regimen (4%) compared to the control regimen (8%). This is important information, as hearing loss has been a particular concern for patients taking earlier MDR-TB treatments.”

Image Credits: The Global Fund / John Rae.

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