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

10 May 2021
5349 Study team
10 May 2021
5349 Study team

ACTG 5349 Study Team:  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).The ACTG 5349 Study team, Worcester, 2021

 

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.  

 

“These results are a game-changer for shortening treatment of TB patients in developing countries.”

Professor Mark Hatherill SATVI Director, 

 

 

The study involved 2 154 participants 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).

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.

Dr Justin Shenje, SATVI Investigator,

 

 

 

Diagram Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis
Figure: Primary and Secondary Efficacy Analyses and Time to an Unfavorable Outcome. Source: Dorman et al., 2021. Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis. New England Journal of Medicine, 384(18):1705-171. 
Citation: Dorman SE, Nahid P, Kurbatova EV, Phillips PPJ, Bryant K, Dooley KE, Engle M, Goldberg SV, Phan HTT, Hakim J, Johnson JL, Lourens M, Martinson NA, Muzanyi G, Narunsky K, Nerette S, Nguyen NV, Pham TH, Pierre S, Purfield AE, Samaneka W, Savic RM, Sanne I, Scott NA, Shenje J, Sizemore E, Vernon A, Waja Z, Weiner M, Swindells S, Chaisson RE; AIDS Clinical Trials Group; Tuberculosis Trials Consortium. 2021. Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis. New England Journal of Medicine, 384(18):1705-1718.Click here. 
 
Additional resources: 

Download Research Summary. Click here