A study examining the efficacy and safety of two four-month treatments for drug susceptible pulmonary TB found that the regimen was not inferior to the current standard six-month regimen, according to the World Health Organization (WHO). The study also found that the four-month regimen was safe and well tolerated by patients.
The study, named Study 31/A5349, was led by the U.S. Centers for Disease Control and Prevention’s (CDC) Tuberculosis Trials Consortium (TBTC) in collaboration with the AIDS Clinical Trials Group (ACTG) and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
The four-month regimen included a combination of high-dose rifapentine, isoniazid, pyrazinamide and moxifloxacin, while the six-month regimen was composed of rifampicin, isoniazid, ethambutol and pyrazinamide. The study’s results were presented at the 51st virtual Union World Conference on Lung Health, the WHO said.
Study 31/A5349 is a phase 3, open-label randomized controlled clinical trial that examined treatment regimens with high-dose rifapentine with or without moxifloxacin for the treatment of drug susceptible pulmonary TB, compared to the currently recommended six-month regimen composed of rifampicin, isoniazid, pyrazinamide and ethambutol (2RHZE/4RH). Thirteen countries contributed data to the study, from 34 clinical sites. Approximately 2,500 people aged 12 years and older participated in the study, including 214 people living with HIV infection.
“New, shorter and effective treatment regimens for both drug-susceptible and drug-resistant TB are urgently needed to treat all patients with TB and achieve the WHO’s End TB Strategy targets. Therefore, the findings from this study have the potential to complement current options for the treatment of drug-susceptible TB with a new effective and safe four-month regimen,” the WHO said in a press release.
