A 4-month daily regimen containing high-dose rifapentine with moxifloxacin for the treatment of pulmonary tuberculosis (TB) was found to be as safe and effective as the existing standard 6-month daily regimen, according to findings from a phase 3 study conducted by the US Centers for Disease Control and Prevention’s Tuberculosis Trials Consortium, in collaboration with the AIDS Clinical Trials Group funded by the National Institutes of Allergy and Infectious Diseases (NIAID).
The randomized, open-label, controlled trial (Study 31/A5349) had more than 2500 participants ages 12 years and older and included 214 people with HIV. The study compared the efficacy and safety of the standard 6-month TB regimen, which consists of isoniazid, rifampin, ethambutol, and pyrazinamide for 2 months followed by 4 months of isoniazid and rifampin to 1 of the following treatment regimens:
- Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin and 9 weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin; or
- Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol and 9 weeks of daily treatment with rifapentine and isoniazid.
Results showed that the 4-month regimen containing high-dose rifapentine and moxifloxacin met the noninferiority criteria for efficacy in all of the several planned analyses, while the second 4-month regimen, which did not include moxifloxacin, failed to meet the noninferiority criteria for efficacy. As for safety, the proportion of patients who experienced adverse events was found to be similar across the 3 groups.
“These robust findings have the potential to change clinical practice by offering people with drug-susceptible TB an additional, shorter-course treatment option that is safe, effective and potentially more convenient,” said Carl W. Dieffenbach, PhD, director of the NIAID Division of AIDS.
For more information visit nih.gov.
Landmark TB trial identifies shorter-course treatment regimen. [press release]. Bethesda, MD: National Institute of Allergy and Infectious Diseases; October 21, 2020.