Results of a clinical trial of a new tuberculosis drug regimen in nine countries including India didn't quite meet the goal of shortening the treatment from six months to four months and further study may be required.The Phase 3 clinical trial called REMoxTB trial, however, confirmed the safety of daily moxifloxacin over four months of therapy.Researchers concluded that the safety of moxifloxacin, combined with its activity against TB, supports the continued clinical testing of moxifloxacin as a component of other novel regimens, according to a media release.The results were presented here Sunday at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and published in the New England Journal of Medicine."Shorter and simpler TB cures are urgently needed - the present first-line treatment is nearly 50 years old, too complicated and interacts with common HIV medications," said Mel Spigelman, MD, president and CEO of TB Alliance, the sponsor of the trial."REMoxTB paved the way for future progress by showing us that effective, markedly shorter and safer treatments will most likely require developing novel regimens that combine multiple novel agents."
The trial enrolled 1,931 patients at 50 sites in nine countries, including 376 or almost one fifth from India. Other patients were from Kenya, Mexico, Tanzania, South Africa, China, Thailand, Malaysia and Zambia.The three-arm study substituted moxifloxacin for either isoniazid or ethambutol in the first-line treatment for drug-sensitive TB (first-line treatment consists of isoniazid, rifampicin, pyrazinamide and ethambutol).The study found that, while the experimental regimens initially killed more TB bacteria than the standard regimen, patients receiving those shortened regimens were more likely to relapse than those taking the standard treatment."The REMox trial was among the most rigorous TB drug trials ever conducted in the modern era of TB treatment and among the largest ever conducted for a new TB treatment," said Professor Stephen Gillespie, the Sir James Black Chair of Medicine at the University of St. Andrews (Britain) and the REMox study's chief investigator.
"Although the regimen we studied wasn't quite sufficient to reduce TB treatment time by our two month target, the trial brought us a significant step closer," he added."REMoxTB succeeded in showing that high-quality clinical trials with clear, unequivocal results can be conducted in resource-poor regions where TB is endemic and also in paving the way for future TB trials, especially those that might include moxifloxacin as part of the regimen," Gillespie said.TB killed 1.3 million people in 2012 - one person every 25 seconds. The length of today's TB treatment makes it difficult for many patients to complete therapy, leading to the emergence of multi-drug resistant TB (MDR-TB).The REMoxTB study was a collaboration between the TB Alliance, Bayer HealthCare AG, the University College London (UCL) Centre for Clinical Microbiology, the Medical Research Council Clinical Trials Unit at UCL and the University of St. Andrews.