REMoxTB: Moxifloxacin safe, active, but failed to shorten TB treatment

Issue: October 2014

WASHINGTON, D.C. — Results of the REMoxTB trial showed that a regimen containing moxifloxacin was safe and demonstrated activity against tuberculosis, but it did not allow the standard 6-month treatment course to be shortened, according to new data presented here at ICAAC 2014. The data were also published simultaneously in The New England Journal of Medicine.

“The most important clinical implication is that we’ve shown that moxifloxacin is safe for the treatment of tuberculosis,” study researcher Stephen H. Gillespie MD, DSc, Sir James Black Chair of Medicine at the University of St. Andrews in Scotland told Infectious Disease News. “We’ve also now established the clinical trials network and facilities to move forward with a treatment-shortening regimen, and the results show that our experimental regimens are active… we can expect to see a 4-month regimen in clinical practice in the near future.”

Stephen H. Gillespie

Gillespie and colleagues conducted a randomized, placebo controlled, double-blind trial to test the noninferiority of a moxifloxacin-containing TB regimen. The three arms of the trial included 17 weeks of isoniazid, rifampicin and moxifloxacin supplemented by pyrazinamide for the first 8 weeks of therapy; 17 weeks of rifampicin and moxifloxacin supplemented by pyrazinamide and ethambutol for the first 8 weeks; and a control group that received 26 weeks isoniazid and rifampicin supplemented by ethambutol and pyrazinamide in the first 8 weeks.

A total of 1,931 patients at 50 sites in nine resource-poor countries participated in the trial.

Neither experimental treatment met noninferiority criteria, the researchers said. However, patients who received treatment with moxifloxacin achieved a culture-negative status more quickly than the control group (P<.01). As for safety, there was no difference between the incidence of grade 3 and 4 adverse events across all three treatment groups.

Mel Spigelman

“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,” Mel Spigelman, MD, president and CEO of TB Alliance, which sponsored the trial, said in a press release. “REMoxTB paved the way for future progress by showing us that effective, markedly shorter and safer treatment will most likely require developing novel regimens that combine multiple novel agents.”

According to the researchers, REMoxTB was the most rigorous TB trial ever conducted, and although the experimental regimen wasn’t sufficient to reduce TB treatment time by 2 months, the results bring them closer to achieving that goal. — by John Schoen

Stephen H. Gillespie MD, DSc, can be reached at shg3@st-andrews.ac.uk.

For more information:

Gillespie SH. Abstract L-1062. Presented at: Interscience Conference on Antimicrobial Agents and Chemotherapy; Sept. 5-9, 2014; Washington, D.C.

Gillespie SH. N Engl J Med. 2014;doi:10.1056/NEJMoa1407426.

Disclosure: Gillespie reports no relevant financial disclosures.