Moxifloxacin regimens miss Phase III endpoint

The not-for-profit Global Alliance for TB Drug Development said use of moxifloxacin in combination regimens did not shorten treatment time in tuberculosis patients, compared with standard of care (SOC) regimens. In the Phase III REMoxTB trial, the fluoroquinolone antibiotic moxifloxacin substituted for either isoniazid or ethambutol in the SOC TB regimen for four months followed by two months of placebo missed the primary endpoint of non-inferiority to six months of SOC comprising rifampicin/isoniazid/ethambutol/pyrazinamide.

In the 1,931-patient African, Asian and Latin American study, viral load was reduced faster when moxifloxacin was given; however, patients were more likely to relapse. The alliance said the data support continued clinical testing of moxifloxacin as a component of other regimens. ...