Mycobacterial disease · Shortening drug-susceptible TB treatment
Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis
| Design | International, randomised, open-label, phase 3 non-inferiority trial |
|---|---|
| Treatment | Four-month rifapentine-based regimen with moxifloxacin, or rifapentine without moxifloxacin |
| Control | Standard six-month rifampin-based regimen |
| Population | 2343 microbiologically eligible participants with drug-susceptible tuberculosis; 194 co-infected with HIV and 1703 with cavitation on chest radiography |
| Follow-up | 12 months after randomisation |
| Primary endpoint | Survival free of tuberculosis at 12 months |
| Result | The four-month rifapentine-moxifloxacin regimen was non-inferior to the standard six-month regimen among the 2234 participants assessable for the primary outcome. The rifapentine regimen without moxifloxacin did not meet non-inferiority. Grade 3 or higher adverse events during treatment occurred in 19.3% of the control group, 18.8% of the rifapentine-moxifloxacin group and 14.3% of the rifapentine group. |
| Secondary endpoints | Culture conversion, adverse events, relapse |
The efficacy of a 4-month rifapentine-based regimen containing moxifloxacin was noninferior to the standard 6-month regimen in the treatment of tuberculosis.
The trial authors, in the published abstract
The first successful shortening of drug-susceptible tuberculosis treatment in forty years, and it worked only with moxifloxacin — the rifapentine-alone arm failed non-inferiority, which is why the regimen is specified so precisely. Two months less therapy matters enormously for adherence in a disease where completion is the main determinant of cure. Contrast REMoxTB, which tried the same shortening without rifapentine and failed.
Dorman SE, Nahid P, Kurbatova EV, et al. Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis. N Engl J Med 2021 May 6;384(18):1705-1718.