The World Health Organization (WHO) issued today guidance for the use of delamanid in treating children over 6 years of age and adolescents diagnosed with multidrug-resistant tuberculosis (MDR-TB). This follows on interim guidance released by WHO in 2014 on use of delamanid in treatment of MDR-TB in adults.
Based on new evidence that has become available on the use of delamanid among children with MDR-TB, WHO now recommends that the drug may be used on top of the longer (18-24 months) treatment regimen in children and adolescents (6 – 17 years) with MDR-TB.
The recommendation lists five conditions that must be respected, which are adapted from those applied in the interim guidance for adults. More information on those conditions is available in the current guidance. Included in these conditions is the recommendation that children with MDR-TB who also have resistance to fluoroquinolones or second-line injectable drugs (or both) benefit from this new medicine. Another condition is that the drug not be used on top of the shorter MDR-TB regimen newly recommended by WHO in May 2016.
“In recent years we have witnessed significant advances in TB treatment. However, much more funding and new transformational tools are urgently needed to end TB, especially among vulnerable populations such as children,” said Dr Mario Raviglione, Director of the WHO Global TB Programme. “The new recommendation on delamanid brings us one step closer towards better treatment options for children.”
For a patient to really benefit from the use of a new drug such as delamanid, National TB Programmes must adhere to the principles of designing an effective [longer] regimen for these patients and routinely implement active TB drug safety monitoring and management (aDSM) in patients receiving MDR-TB treatment.
“After decades of neglect, healthcare practitioners started to treat paediatric TB patients with treatments developed for adults, which had suboptimal results,” said Dr Nguyen Viet Nhung, Director of National Lung Hospital and National TB Programme in Vietnam. “There is still a long way to go for developing drugs and regimens for children with TB, but this new recommendation represents a clear opportunity for governments and other key stakeholders to effectively address TB in children.”
Dr Alena Skrahina, Deputy Director on scientific issues at the Republican Scientific and Practical Centre for Pulmonology and TB in Belarus, commends the application of aDSM for the safe introduction of new anti-TB drugs. “We have a responsibility to provide better treatment alternatives for TB patients, especially children, and to do so, we must work together to strengthen all aspects of the programmatic management of drug-resistant TB. This includes ensuring the safe introduction and proper management of new drugs.”
“The introduction of novel TB drugs has been slow,” said Dr Christian Lienhardt, Team Leader of Research for TB Elimination at WHO. “Although delamanid has been introduced at least once in nearly 40 countries, numbers of patients benefiting from it have been very small. While some case reports on the use of delamanid in children have started to surface, there is still a critical gap in involving paediatric patients in clinical research for TB treatments. We must close this gap if we are to prevent children dying of TB.” This guidance is considered interim and will be reviewed within the next two years as new data become available.