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.
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 Alliance expects to launch the ZeNix trial in late 2017. This clinical trial, to optimize the use of linezolid with bedaquiline and pretomanid, is expected to be conducted across 10 trial sites in South Africa, Georgia, Belarus, and Russia. Study design and current status was presented on the Webinar.
A copy of the presentation slides will be made available shortly.
“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 its phase 3 clinical trials.
“We are losing a lot of patients to XDR and MDR tuberculosis. We need more than one drug for treating patients in the backdrop of increasing drug resistance in patients. Delmanid proved to be a good alternative. We will initially conduct a trial with this drug on over 400 patients in a controlled manner,” said Jagdish Prasad, director general of health services in the ministry.
“Currently, around 50% of patients don’t respond to tuberculosis treatment. Delamanid has proved effective in many clinical trials in South Africa and Japan. Taking a cue from this, we are expecting that over 70-80% patients will respond to tuberculosis treatment,” he said.”
To read the full article click here.
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.
“The start of 2017 saw concern over a sharp increase in the rise of drug-resistant TB in South Africa. TB is killing millions each year. Last week, Médecins Sans Frontières published promising early data on the use of two new TB drugs, delamanid and bedaquiline, among patients living with drug-resistant TB in Khayelitsha, Cape Town. But availability remains the biggest concern.”
Read the full article here.
“Preliminary results – released at the 48th Union Conference on Lung Health – from Stage 1 of the STREAM randomized clinical trial show that the nine-month treatment regimen being tested achieved favorable outcomes in almost 80 percent of those treated.The results suggest the nine-month regimen is very close to the effectiveness of the 20-24 month regimen recommended in the 2011 WHO guidelines, when both regimens are given under trial conditions.
The STREAM trial – initiated by The Union in 2012 with its main partner, the Medical Research Council Clinical Trials Unit at UCL, is the world’s first multi-country randomised clinical trial to test the efficacy, safety and economic impact of shortened multidrug-resistant tuberculosis (MDR-TB) treatment regimens.”
Read the full announcement here.
Click here for a full schedule of MDR-TB related events at the Union Meeting
“Saint Louis University is leading a multi-national clinical trial of what could become a regimen for drug resistant tuberculosis that does not require injectable medications. The project is funded by a $6.4 million task order from the National Institute of Allergy and Infectious Diseases , part of the National Institutes of Health.
Saint Louis University, a member of NIAID’s network of Vaccine and Treatment Evaluation Units (VTEUs), is partnering with Aurum Institute in Johannesburg, South Africa, the University of Maryland VTEU and Makerere University in Kampala, Uganda, for the phase 4 clinical trial.
Study participants will be recruited in South Africa and Uganda, where MDR-TB is prevalent and clinical data will be analyzed by Saint Louis University and University of Maryland. Researchers will study two groups of volunteers — those who receive the standard therapy for MDR-TB and those who receive a regimen that substitutes an oral medication named delamanid for the shot. In both groups, the efficacy and safety of the tested medications will be analyzed.”
To learn more about the vaccine research being conducted at Saint Louis University, visit vaccine.slu.edu.