Research: Shortened 4-month TB treatment offers breakthrough in TB control.

10 May 2021
5349 Study team
10 May 2021

The New England Journal of Medicine has 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.  

Four-Month Rifapentine Regimens with or without Moxifloxacin for Tuberculosis
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 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.
 
“These results are a game-changer for shortening treatment of TB patients in developing countries.”

Professor Mark Hatherill SATVI Director,

 

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

Figure: Primary and secondary efficacy analysis

Extra resources

The article is accompanied by a supplement, editorial, video and Research Summary

 

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. 

 

Funding: Supported by the CDC; the Division of Tuberculosis Elimination, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (contracts 200-2009-32582, 200-2009-32593, 200-2009-32594, 200-2009-32589, 200-2009-32597, 200-2009-32598, 75D30119C06702, 75D30119C06701, 75D30119C06703, 75D30119C06222, 75D30119C06225, and 75D30119C06010); and the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under award numbers UM1 AI068634, UM1 AI068636, and UM1 AI106701. Sanofi donated rifapentine and all other trial drugs, supported the shipment of the trial drugs to all sites, and provided funding support for pharmacokinetic testing and preparation of the final clinical study report