Four-month rifapentine regimen for TB equally effective as 6-month standard regimen: NEJM
USA: The effectiveness of a 4-month rifapentine-based regimen containing moxifloxacin is noninferior to the standard 6-month regimen for the treatment of patients with drug-susceptible pulmonary tuberculosis, finds a recent study. The findings of the study are published in the New England Journal of Medicine.
Regimens based on rifapentine have potent antimycobacterial activity. This may allow for a shorter course in patients with drug-susceptible pulmonary tuberculosis. To determine the same, Susan E. Dorman and colleagues performed an open-label, phase 3, randomized, controlled trial.
The trial included patients with newly diagnosed pulmonary tuberculosis from 13 countries in which the researchers compared two 4-month rifapentine-based regimens with a standard 6-month regimen consisting of rifampin, isoniazid, pyrazinamide, and ethambutol (control) using a noninferiority margin of 6.6 percentage points.
In one 4-month regimen, rifampin was replaced with rifapentine; in the other, rifampin was replaced with rifapentine and ethambutol with moxifloxacin. The primary efficacy outcome was survival free of tuberculosis at 12 months.
Among 2516 participants who had undergone randomization, 2343 had a culture positive for Mycobacterium tuberculosis that was not resistant to isoniazid, rifampin, or fluoroquinolones (microbiologically eligible population; 768 in the control group, 791 in the rifapentine–moxifloxacin group, and 784 in the rifapentine group), of whom 194 were coinfected with human immunodeficiency virus and 1703 had cavitation on chest radiography.
A total of 2234 participants could be assessed for the primary outcome (assessable population; 726 in the control group, 756 in the rifapentine–moxifloxacin group, and 752 in the rifapentine group).
Key findings of the study include:
- Rifapentine with moxifloxacin was noninferior to the control in the microbiologically eligible population (15.5% vs. 14.6% had an unfavorable outcome) and in the assessable population (11.6% vs. 9.6%; difference).
- Noninferiority was shown in the secondary and sensitivity analyses.
- Rifapentine without moxifloxacin was not shown to be noninferior to the control in either population (17.7% vs. 14.6% with an unfavorable outcome in the microbiologically eligible population; and 14.2% vs. 9.6% in the assessable populaTION).
"Our findings show that the efficacy of a 4-month rifapentine-based regimen containing moxifloxacin was noninferior to the standard 6-month regimen in the treatment of tuberculosis.," wrote the authors.
The study titled, "Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis," is published in the New England Journal of Medicine.