Pioneering new MSF-run clinical trial for drug-resistant TB treatment starts
The phase II/III trial, called TB PRACTECAL, aims to find a treatment regime for drug resistant TB that is drastically shorter, at six months long, more effective and has less debilitating side effects than current treatment.
The trial is run and sponsored by the international medical humanitarian organisation Médecins Sans Frontières/ Doctors Without Borders (MSF) and is supported by the London School of Hygiene & Tropical Medicine as well as other leaders in medical research[1].
It is a full phase III clinical trial combining two new anti-TB drugs (bedaquiline and pretomanid). This will maximise the potential of the trial to develop radically improved treatment for people with either multi drug-resistant TB and the even more resistant, extensively drug-resistant TB. The two new drugs will be given in combination with existing drugs for tackling drug-resistant TB (linezolid, clofazimine and moxifloxacin).
Despite killing more people than HIV[2], TB is woefully underfunded. Medicines for TB have barely improved over the last 50 years. And the number of strains of TB resistant to current medicines is increasing at an alarming rate.
Currently patients with drug-resistant TB are on medicine for almost two years during which time they must swallow more than 10,000 pills and have painful daily injections for at least 8 months. Side effects from treatment are often incapacitating, including nausea, joint pains, psychosis and going permanently deaf.
MSF has been calling on politicians, global health bodies and pharmaceutical companies to address this TB crisis, but in the face of insufficient movement has now decided to take action itself. MSF has played a catalytic role in providing TB and drug resistant TB care for 30 years and is now running two clinical trials. The other, end-TB, is due to start in Georgia later this year.
The first patient on the TB PRACTECAL trial is based at the MSF supported hospital in Karakalpakstan, in North West Uzbekistan. They are the first of 630 patients, to be recruited from Uzbekistan, Belarus and South Africa.
The trial will run in two stages. The first stage is a phase II trial finishing in 2018. It will test three different regimes containing new drugs, bedaquiline and pretomanid. The second stage is a phase III trial which will continue to test the two most successful regimes and will end in 2020.
COMMENTS
Dr Bern-Thomas Nyang’wa, MSF’s TB specialist and Chief Investigator on the trial says:
“MSF is one of the biggest non-government providers of TB care in the world and we refuse to wait years or even decades for new treatment, while thousands of our patients continue to suffer long, toxic and failing treatments. Despite aggressive treatment, only half of people with drug resistant TB globally are cured. [3] The current TB regimes are simply inadequate.
“This is an exciting milestone in an important research project that could save hundreds of thousands of lives. The results cannot come sooner.”
Professor David Moore at the London School of Hygiene & Tropical Medicine says:
“We’re thrilled that this crucial large scale clinical trial for the treatment of drug resistant TB has started.
“We know these two new drug classes have shown promising signs of tackling drug resistant TB microbes, and there are emerging signals from other therapeutic regimens that we should be able to safely shorten treatment courses and improve patient outcomes. But until now no one has tested these exciting drug combinations.
“If the findings of this trial fulfil the promise of earlier studies, particularly if we are able to effectively treat drug-resistant TB without the need for the tyrannical daily injections, we are on the path to finding a treatment package that could make a huge difference to the hundreds of thousands of multi drug resistant TB patients, and their families, that need treatment every year.”
Professor Nargiza N Parpieva, Director of the Republican specialised scientific-practical medical centre of physiology and pulmonology in Uzbekistan says:
“Uzbekistan is working hard to address the challenge of drug resistant TB. The Ministry of Health of the Republic of Uzbekistan, the national TB program in partnership with international organizations, including MSF, has cared for, diagnosed and supported thousands of patients over the last 13 years.
“Treatment is long and arduous but if we explain to our patients, their families and medical staff directly involved in the trial the importance of this new approach to treating drug resistant TB we can achieve good results for this complex category of patients.
“It’s invaluable that our patients, doctors and colleagues now have the chance to spearhead better treatment for patients with drug resistant TB in Uzbekistan and around the world.”
Mel Spigelman, Managing Director, President and CEO, TB Alliance says:
“We’re very excited about the launch of TB-PRACTECAL and partnering with MSF. This study will build on the promising results found in two of TB Alliance’s late-stage clinical trials, which have studied bedaquiline and pretomanid in combination with other drugs. Combining novel drugs holds the key to revolutionizing TB treatment in all its forms.”
ENDS
For more information please contact Charlotte Morris, Press Officer at MSF UK on [email protected] or +44 7587 553539
Notes to Editors
Médecins Sans Frontières/ Doctors Without Borders (MSF) is an international medical humanitarian organisation. It has been fighting TB for over 30 years and is now one of the biggest non-government providers of TB care worldwide. It currently treats patients with TB and drug resistant TB in 24 countries including India, the Central African Republic, South Africa and Uzbekistan. MSF also works with Ministries of Health in 12 countries to run courses of treatment that include new drugs and runs two clinical trials, in conjunction with partners, to find new TB treatment regimens. MSF also supports an initiative called the 3P project to find a better way to develop new TB treatments in the future.
For more information on MSF’s TB work please see our recent TB Briefing Paper
For more information on TB PRACTECAL please see our website here
The London School of Hygiene & Tropical Medicine is a world-leading centre for research and postgraduate education in public and global health, with more than 4,000 students and 1,000 staff working in over 100 countries. The School is one of the highest-rated research institutions in the UK, is among the world's leading schools in public and global health, and was named University of the Year in the Times Higher Education Awards 2016. Our mission is to improve health and health equity in the UK and worldwide; working in partnership to achieve excellence in public and global health research, education and translation of knowledge into policy and practice. www.lshtm.ac.uk
TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight tuberculosis (TB) and a partner on the TB-PRACTECAL trial, contributing its expertise in trial design and the drug pretomanid. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia’s Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Germany’s Federal Ministry of Education and Research, Global Health Innovative Technology Fund, Irish Aid, Indonesia Health Fund, National Institute of Allergy and Infectious Disease, Netherlands Ministry of Foreign Affairs, UNITAID, United Kingdom Department for International Development, United States Agency for International Development, and the United States Food and Drug Administration.
[1] The full list of partners is: London School of Hygiene and Tropical Medicine (LSHTM), University College London (UCL), Drugs for Neglected Diseases initiative (DNDi), Swiss Tropical and Public Health Institute (Swiss TPH), World Health Organization’s Special Programme for research & Training in Tropical Diseases (TDR), Global Alliance for TB Drug Development, Ministry of Health in Republic of Uzbekistan, Ministry of Health of the Republic of Belarus and THINK TB and HIV Investigative Network.
[2] Global Tuberculosis Report 2016, WHO, page 5 http://apps.who.int/iris/bitstream/10665/250441/1/9789241565394-eng.pdf?ua=1
[3] See MSF’s TB briefing paper https://www.msf.org.uk/sites/uk/files/TB_briefingpaper.pdf