DR-TB STAT + TAG brief: Is Shorter Better? Understanding the Shorter Regimen For Treating Drug-Resistant Tuberculosis
“Multidrug-resistant TB (MDR-TB) is a growing problem around the world, and is difficult to treat. In 2016, the World Health Organization (WHO) recommended a shorter regimen for treating MDR-TB. Now, data from a randomized controlled trial are available. The Drug-Resistant TB Treatment Scale-up Action Team (DR-TB STAT) and Treatment Action Group (TAG) released a new brief explaining what the shorter regimen is, who can receive it, and its advantages and disadvantages.”
Read the full brief here.
New trial evaluates whether the efficacy of the BPaL drug regimen can be maintained with reduced toxicity
“TB Alliance has announced the start of a clinical trial of a three-drug regimen to treat extensively drug resistant tuberculosis (XDR-TB)—one of the deadliest forms of tuberculosis (TB)—and those with pre-XDR-TB and multi-drug resident TB (MDR-TB) whose prior treatment has failed or who have not tolerated their treatment.
The trial, called ZeNix, will evaluate whether the efficacy of the BPaL (bedaquiline, pretomanid and linezolid) drug regimen can be maintained, while reducing toxicity by testing a lower dose and shorter duration of the drug linezolid. The first ZeNix patients have been enrolled in Georgia and South Africa, with sites in Russia joining later in 2018.
‘Too few people with XDR-TB are successfully cured with the current treatments,’ said Dr. Mel Spigelman, president and CEO of TB Alliance. ‘The present treatments take far too long and are made up of complex patchworks of drugs, many of which are toxic or ineffective—further contributing to TB drug resistance. With ZeNix, we are attempting to optimize a potentially safer, quicker and less complicated treatment to address this dire situation.’”
Read the full announcement 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.
“The Indian subsidiary of US healthcare giant Johnson & Johnson (NYSE: JNJ) announced a new partnership with the Institute of Microbial Technology (IMTECH), part of the Council of Scientific and Industrial Research (CSIR), to unlock the potential of Indian science and help accelerate the discovery of innovative new tuberculosis (TB) treatments.
Under the Memorandum of Understanding, scientists from J&J’s global public health team will work closely with scientists from CSIR-IMTECH, based in Chandigarh, India, on a research and development program to explore potentially more effective, safer, all-oral treatment regimens to tackle multidrug-resistant TB (MDR-TB), as well as new molecular entities to treat all TB patients.
The new research program will capitalize on the CSIR-IMTECH’s world-class expertise in microbial technology and research and the proven research and development capabilities of J&J’s Janssen Pharmaceutical Companies to strengthen the collective potential of our research efforts.”
Read the Pharma Letter here.
“This study forecasted the percentage of MDR tuberculosis among incident cases of tuberculosis to increase, reaching 12·4% in India, 8·9% in the Philippines, 32·5% in Russia, and 5·7% in South Africa in 2040. It also predicted the percentage of XDR tuberculosis among incident MDR tuberculosis to increase, reaching 8·9% in India, 9·0% in the Philippines, 9·0% in Russia, and 8·5% in South Africa in 2040.
Acquired drug resistance would cause less than 30% of incident MDR tuberculosis during 2000-40. Acquired drug resistance caused 80% of incident XDR tuberculosis in 2000, but this estimate would decrease to less than 50% by 2040.
MDR and XDR tuberculosis were forecast to increase in all four countries despite improvements in acquired drug resistance shown by the Green Light Committee-supported programmatic management of drug-resistant tuberculosis. Additional control efforts beyond improving acquired drug resistance rates are needed to stop the spread of MDR and XDR tuberculosis in countries with a high burden of MDR tuberculosis.”
Read the full article here.
On 7 & 8th July 2017, leaders of the G20 met in Hamburg, Germany, to address major global economic challenges and to contribute to prosperity and well-being. Their Declaration, published on July 8, carries an important section on combatting antimicrobial resistance (AMR):
“AMR represents a growing threat to public health and economic growth. To tackle the spread of AMR in humans, animals and the environment, we aim to have implementation of our National Action Plans, based on a One-Health approach, well under way by the end of 2018.
We will promote the prudent use of antibiotics in all sectors and strive to restrict their use in veterinary medicine to therapeutic uses alone. Responsible and prudent use of antibiotics in food producing animals does not include the use for growth promotion in the absence of risk analysis. We underline that treatments should be available through prescription or the veterinary equivalent only. We will strengthen public awareness, infection prevention and control and improve the understanding of the issue of antimicrobials in the environment.
We will promote access to affordable and quality antimicrobials, vaccines and diagnostics, including through efforts to preserve existing therapeutic options. We highlight the importance of fostering R&D, in particular for priority pathogens as identified by the WHO and tuberculosis.
We call for a new international R&D Collaboration Hub to maximise the impact of existing and new anti-microbial basic and clinical research initiatives as well as product development. We invite all interested countries and partners to join this new initiative. Concurrently, in collaboration with relevant experts including from the OECD and the WHO, we will further examine practical market incentive options.”
Read the full news report from Nature Microbiology here.
The European Medicines Agency, the Japanese Pharmaceuticals and Medical Devices Agency, and the United States’ Food and Drug Administration have agreed to align their data requirements for certain aspects of the clinical development of new antibiotics in order to stimulate the development of new treatments to fight antimicrobial resistance and protect global public health.
Representatives from the three regulatory agencies met in Vienna on 26-27 April 2017 and discussed recommendations for the design of clinical trials that test new treatments for certain types of bacterial infections, including infections caused by multi-drug resistant organisms. They identified a number of areas where the data requirements in the three regions could be streamlined. The three regulatory agencies will be working to update their guidance documents respectively.
Read the full press release here.