10 May 2021 Shortened 4-month TB treatment offers breakthrough in TB control.

10 May 2021 - 11:30


Phase 3 efficacy study finds shortened 4-month TB drug therapy treatment equivalent to 6-months therapy.

The New England Journal of Medicine has just published the results of a clinical study which shows that in a randomised phase 3 clinical trial, a shortened 4-month TB treatment was equivalent to the standard 6-month TB treatment.  
The study, which was conducted between January 2016 and October 2018, found that a 4-month rifapentine-based regimen containing moxifloxacin was equivalent to the standard 6-month regimen in the treatment of tuberculosis. 
The article is accompanied by a supplement, editorial, video and Research Summary.
The current standard treatment of drug-susceptible TB is a 6-month daily regimen, which is associated with poor adherence and loss to follow-up.

According to Professor Mark Hatherill SATVI Director, “These results are a game-changer for shortening treatment of TB patients in developing countries.”

According to Dr Justin Shenje, SATVI Investigator, “These are exciting findings which could have a massive impact on how we manage patients with pulmonary TB. A 33% reduction in the duration of TB treatment could improve adherence and reduce the cost associated with treatment of TB patients.

Image: ACTG 5349 study team

Figure 1: Primary and secondary efficacy analysis.

The study involved 2 154 participants between with newly diagnosed drug susceptible pulmonary TB in three groups. The first group, the control group (Arm 1) received the standard 6-month treatment consisting of rifampicin, isoniazid pyrazinamide and ethambutol. In the other two groups, (Arm 2) one received a 4-month regimen with rifampicin replaced with rifapentine and in the other group (Arm 3), rifampicin was replaced with rifapentine and ethambutol replaced with moxifloxacin. The study included people living with HIV, which was controlled.  

This phase 3 randomised clinical trial was conducted as part of an international, multicentre trial within the International Trials Consortium Study 31/AIDS Clinical Trials Group (ACTG) and funded by the National Institutes of Health (NIH).

Read abstract online.  Click here.

Watch the online NEJM Quick video which explains this research  Click here.