On Thursday, October 21st, 2020, the U.S. Center for Disease Control and Prevention's (CDC) TB Trials Consortium (TBTC) announced results from their Phase 3, open-label trial: Study 31/A5349. The clinical trial identified a 4-month drug regimen composed of high-dose rifapentine, moxyifloxacin, pyrazinamide, and isoniazid that they concluded was non-inferior to the standard 6-month HRZE course of therapy for drug-sensitive TB patients. Study 31 was an international, randomized, controlled trial funded by the National Institute of Allergy and Infectious Diseases (NIAID) and was conducted in collaboration with the AIDS Clinical Trials Group (ACTG). The trial contained over 2,500 participants, including 214 individuals with HIV, in 34 clinical sites in over 13 countries.
Study 31/A5349 examined the efficacy and safety of two four-month regimens with high-dose rifapentine with or without moxifloxacin for the treatment of drug-susceptible TB disease. These were compared with the existing six-month regimen (2RHZE/4RH), which includes eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol and 18 weeks of daily treatment with rifampin and isoniazid.
For more information, view the press release on the CDC website.