Via MSF.org: Access: MSF reports on use of the new tuberculosis drugs bedaquiline and delamanid. Excerpt:
Liverpool - At the annual Union World Conference on Lung Health which starts in Liverpool today, Médecins Sans Frontières (MSF) will share its experience using the new TB drugs, bedaquiline and delamanid, to treat people with drug-resistant TB in programme settings.
MSF is also involved in two clinical trials to test new TB treatments, both of which will start to enrol patients soon. The trials aim to find new, more effective, shorter, and more user-friendly treatments for drug-resistant forms of TB.
“The lack of solid data and evidence on the safety and efficacy of the new TB drugs means that only the sickest people can receive them under current guidelines, and that governments are reluctant to introduce them into their national TB treatment programmes for routine use,” said Dr Catherine Hewison, MSF TB advisor.
“Furthermore, very few of those eligible patients have accessed them to date. In fact, through MSF’s effort to accelerate access to and research for the new TB drugs, we now have some of the largest cohorts of patients on bedaquiline and delamanid.”
Bedaquiline and delamanid, which were approved by the US Food and Drug Administration and European Medicines Agency in 2012 and 2014, are the first two new TB drugs developed in nearly 50 years. They represent a new hope for patients sick with the most resistant forms of TB, for whom most existing drugs do not work. Yet, as of October 2016, only 5,700 patients have been able to receive bedaquiline globally, and a mere 405 have had access to delamanid. According to the latest World Health Organization (WHO) estimates, 580,000 people were eligible for multi-drug resistant TB treatment in 2015.
Among the many reasons for this massive gap, one is the limited knowledge on how to use these drugs in combination with existing drugs, as multiple medicines are required to kill the bacteria. Early clinical research and programmatic use have shown promising results, which have led the WHO to recommend use of the drugs for some of the sickest patients.
However, far more clinical research should be conducted and published, particularly on their use in new combination treatments, their use in specific categories of patients (such as pregnant women, children, and HIV-positive patients); and their use beyond the six months of treatment currently recommended in WHO interim guidelines.