The Use of Delamanid in the Treatment of Multidrug-resistant Tuberculosis in Children and Adolescents

In October 2014, the World Health Organization (WHO) issued an interim policy guidance on the use of delamanid in the treatment of patients with multidrug-resistant tuberculosis (MDR-TB), a recommending that delamanid may be added to a WHO-recommended regimen in adult patients with pulmonary MDR-TB (conditional recommendation; very low confidence in estimates of effect), under five conditions: proper patient inclusion, adherence to the principles of designing a WHO-recommended MDR-TB regimen, close treatment monitoring, active pharmacovigilance and proper management of adverse drug reactions, and informed patient consent. This interim policy did not include children, because of the absence of data in this population. However, data describing safety, tolerability and pharmacokinetics (PK) of delamanid in children with MDR-TB aged 6–17 years recently became available hence, WHO convened a Guideline Development Group (GDG) meeting on 29 June 2016 to review this evidence.