Source: DGNews  |  Posted 2 years ago

NEW YORK -- April 6, 2009 -- A phase 2 study has shown that moxifloxacin, in combination with other drugs, could shorten the time needed to cure tuberculosis by several months. The findings are reported in the April 4 issue of The Lancet.

Richard E Chaisson, MD, Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, Maryland, and colleagues assessed 170 tuberculosis-positive patients at 1 hospital in Rio de Janeiro, Brazil.

All were receiving a standard of combination of first line tuberculosis drugs, and were then randomised to receive as the fourth drug in their regimen either moxifloxacin 400mg with an ethambutol placebo (n = 85), or ethambutol 15-20 mg/kg plus moxifloxacin placebo (n = 85) five days per week for 8 weeks. Ethambutol was used as a control.

The endpoint of the study was the proportion of patients whose sputum culture tested negative by week 8.

The researchers found that, at week eight, 80% of moxifloxacin patients tested negative, compared with 63% in the ethambutol group. A total of 16 adverse events (8 in each group) were reported in 12 patients, with only 1 being deemed as related to the study drug.

"The results of our trial have substantial implications for future trials," the authors wrote. "First, the improved culture conversion rates found after 8 weeks in the experimental group suggest that moxifloxacin, in combination with other first-line antituberculosis drugs, could shorten the time needed to cure tuberculosis by several months. Because treatment default is directly related to the duration of treatment, a reduction in the duration of tuberculosis therapy would substantially improve outcomes."

"Additionally, shorter regimens for tuberculosis treatment would reduce workloads for overburdened tuberculosis control programmes, especially in high-incidence countries," they continued. "Second, the demonstration of moxifloxacin's antimycobacterial activity shows that this agent can be used to treat tuberculosis caused by organisms with resistance to first-line antituberculosis agents, such as isoniazid and rifampicin."

They concluded that clinical trials are now underway to assess whether shorter courses of moxifloxacin-containing regimens can cure tuberculosis as well or better than the current 6-month regimen.

SOURCE: The Lancet