Research from The International Union Against Tuberculosis and Lung Disease; Damien Foundation and Institute of Tropical Medicine in Antwerp proves decisive in ground breaking announcement
12 May 2016 (Paris, France) – Today the World Health Organization (WHO) in Geneva announced new recommendations for a shortened treatment regimen for multi-drug resistant tuberculosis (MDR-TB) patients – just nine months compared to the current 24-month treatment standard used worldwide.
The announcement is in response to the pressing need to improve treatment outcomes for MDR-TB – a public health emergency - and based on programmatic studies involving 1200 patients with uncomplicated MDR-TB in 10 countries. These studies were conducted by The Union, Damien Foundation, Medecins Sans Frontieres (MSF) and the Antwerp Institute of Tropical Medicine in Belgium.
“This is a historic moment for the tuberculosis (TB) community and an endorsement of the tireless work completed by our researchers who have surmounted challenges of finance and logistics to deliver a shortened treatment regimen that has the potential to revolutionise how we care for patients in communities worldwide,” said José Luis Castro, Executive Director, The Union.
He added, “However this is the start of a process – not the end. Annually, 480,000 people contract MDR-TB – and the number is rising. The onus is on us all to ensure that access to correct treatments, both for patients and health care providers, increases exponentially. That is why our on-going studies into even shorter regimens will continue. Research and evidence is fundamental to beating this disease.”
The studies referenced by WHO started with the Bangladesh Regimen, a Damien Foundation study based on the pioneering work of Dr Armand Van Deun. This used a nine-month treatment regimen to treat 515 patients between 2005-2011. The success rate was 84.5%, compared with the 24-month standard treatment of around 50%.
“We had hoped to save the life of a few patients, but now it seems we found the treatment regimen needed to control the growing MDR-TB epidemic, as long as the bacilli remain sensitive to its core drugs,” said Dr Armand Van Deun, The Union’s Bacteriology Consultant and Senior Scientific Fellow at the Institute of Tropical Medicine, Antwerp.
This was followed by the Union-coordinated West and Central Africa Francophone study. This was the first multi-country MDR-TB patient cohort treated using the nine-month regimen in nine countries (Benin, Burkina-Faso, Burundi, Cameroon, Côte d’Ivoire, Central African Republic, Niger, Democratic Republic of Congo and Rwanda). The study was funded by the French 5% Initiative, through the national agency Expertise France, and had similarly high success rates – 82.1% (preliminary data – final analysis will be completed end 2016).
“This study demonstrates that the nine-month regimen can be recommended in other environments than Bangladesh, and in settings with high HIV prevalence,” said Dr Arnaud Trébucq, Senior Consultant, The Union.
Currently on-going is the STREAM trial (Standardised Treatment Regimen of Anti-Tuberculosis Drugs for Patients with MDR-TB). Supported by US Agency for International Development (USAID), this is a Union-sponsored multi-centre international randomized control trial to evaluate shortened regimens for patients with MDR-TB. The first trial has been on-going in Ethiopia, South Africa, Vietnam and Mongolia and has recently expanded to test two additional shortened treatment regimens using bedaquiline, a new medicine from Janssen Pharmaceuticals. This stage will evaluate a nine-month all–oral regimen, that does not require painful injections, and a simplified six-month regimen.
“WHO’s announcement has profound implications for those countries dealing with an on-going epidemic of drug-resistant TB. The adoption of a shortened regimen will reduce the burden on patients, on healthcare systems and on the resources of low- and middle-income countries. There is no doubt that without this endorsement, many of those countries would not take the step to move from 24 months to nine – now they can,” said Dr I.D. Rusen, Senior Vice President, Research & Development, The Union.
“The problem with 24 months of treatment is the very real possibility that a patient may not be able to finish that treatment. If they don’t take the medications as prescribed, they are not cured, they may die. The difference – 13 months – between the standard and shortened treatment is absolutely huge,” said Dr Paula Fujiwara, Scientific Director, The Union.
Dr. Aung Kya Jai Maug, Medical Director, Damien Foundation Bangladesh, said “Ensuring prompt and comprehensive access to the highly effective nine months Bangladesh regimen for multidrug resistant tuberculosis will lead to a true paradigm shift on multidrug resistant care”.
“Thanks to the relentless efforts of Armand Van Deun and colleagues from the Damien Foundation and The Union, hundreds of thousands of patients with MDR-TB each year will benefit from this shorter, less toxic, and more effective regimen. From a disease worse than most malignancies, MDR-TB now has become a manageable disease from which cure is likely,” said Prof. Dr. Bouke De Jong, Head of the Mycobacteriology Unit at the Antwerp Institute of Tropical Medicine.
José Luis Castro added, “While this is good news, statistics clearly show that MDR-TB is an increasing burden and much of this is due to a failure of basic TB control. The international TB community must advocate for investment in the expansion of quality basic services and preventative care on the frontline where it matters most. Only then can we stop this disease in its tracks.”