A movement to promote and conduct research on the treatment and prevention of drug-resistant tuberculosis, with a commitment to address the substantial existing gaps in our knowledge and to help provide access to an effective cure and prophylaxis of drug-resistant tuberculosis throughout the world.
Nearly nine million people will develop tuberculosis (TB) in the world this year; at least 500,000 of these cases will have multidrug-resistant tuberculosis (MDR-TB). Some will receive treatment. However, we know little about the best ways of treating drug-resistant TB (DR-TB) and preventing tuberculosis in people who come in contact with DR-TB patients. Lacking a strong scientific basis in prescribing treatment regimens, existing TB treatments are often ineffective. TB control efforts require new evidence-based knowledge about optimal treatment regimens, prophylaxis, and, possibly, regimens involving new TB drugs, in order to address the growing health threats of MDR-TB and extensively drug-resistant (XDR) TB.
This Position Statement by the World Health Organization (WHO) on the use of delamanid in the treatment of multidrug-resistant tuberculosis (MDR-TB) has been developed in response to the final data from the phase III, multicentre, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of delamanid (Trial #242-09-213, hereafter referred to as ‘Trial 213’). The final Trial 213 data were released in late November by the manufacturer (Otsuka Pharmaceutical, Japan) to WHO and to the European Medicines Authority (EMA) in compliance with EMA regulatory requirements. The original trial protocol and subsequent amendments are registered (#NCT0142670) in the US/NIH clinical trials register (https://clinicaltrials.gov/ct2/show/NCT01424670).
WHO conducted an expedited external expert review of the data on Trial 213 data in early December 2017 in order to assess the implications of the results on the 2014 and 2016 interim policy guidance. As data from ongoing observational studies using delamanid are not yet available for review, this document is focused on the results of Trial 213 and its immediate policy implications.
To download and read the position statement, click here.
Recent News and Announcements
On Thursday, January 25th from 08:00 – 09:00 EST (14:00 – 15:00 CET; 15:00 – 16:00 SAST) Dr. Susan van den Hof presented on KNCV’s Patient Triage Approach. KNCV Tuberculosis Foundation developed the Patient Triage Concept to ensure rapid diagnosis of TB and all forms of DR-TB (i.e. using rapid diagnostics) followed by early initiation of the […]
On Thursday, January 11, 2018 by Dr. Dan Everitt, Vice President and Senior Medical Officer at TB Alliance, presented on New XDR-TB Regimens containing Pretomanid. Dr. Dan Everitt, MD, of the Global Alliance presented the results of an important study of a six-month treatment regimen for XDR-TB using bedaquiline, pretomanid and linezolid, the NiX-TB trial. In addition, the […]
“New Delhi: Perturbed by the increasing number of multi-drug resistant (MDR) and extensive drug resistant (XDR) tuberculosis cases in India, the health ministry has approved the use of a new drug in the treatment of such cases. The technical group on tuberculosis in the ministry of health has given approval to Delamanid, which is in […]
Dr. I.D. Rusen, MD, of the MRC presented the preliminary results from Stage 1 of the STREAM randomized clinical trial on Thursday, December 14th from 10:00 – 11:00 EST (16:00 – 17:00 CET; 17:00 – 18:00 SAST). The STREAM Clinical Trial team, including Andrew Nunn and Patrick Philips (Medical Research Council’s Clinical Trials Unit at UCL) and I.D. Rusen […]
Drug-resistant tuberculosis cases are on the rise in Russia, India, the Philippines, and South Africa and expected to increase through 2040. Additional strategies to prevent transmission will be necessary to stop multidrug-resistant or extensively drug-resistant tuberculosis in countries with a high burden of MDR tuberculosis. Watch the video found here to find out more.