New Study 31/A5349 on the treatment of drug-susceptible TB
The World Health Organization’s (WHO) Global TB Programme welcomes the results from a landmark study on the treatment of drug-susceptible TB presented at the 51st virtual Union World Conference on Lung Health. 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.
Study 31/A5349 is a phase 3, open-label randomized controlled clinical trial that examined the efficacy and safety of two four-month 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.
One of the key findings from the study was that the four-month regimen which included a combination of high-dose rifapentine, isoniazid, pyrazinamide and moxifloxacin, was shown to be non-inferior in terms of efficacy to the currently recommended six-month regimen composed of rifampicin, isoniazid, ethambutol and pyrazinamide. In addition, this four-month regimen was safe and well-tolerated by patients.
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 4-month regimen.
Robust and representative scientific data constitute the premise for WHO public health policy recommendations, which are developed using a rigorous, systematic and evidence-based approach. WHO regularly reviews the findings from key studies on TB treatment in order to offer patients the most effective and safe treatment regimens. The results from Study 31/A5349 mark an important step forward in this process and once the final data become available, WHO intends to initiate a policy development process to refine its current policy recommendations on the treatment of drug-susceptible TB.