Tuberculosis (TB)

Guideline Development Group (GDG) Meetings: Revision of the interim policy on bedaquiline for MDR-TB treatment and special session on delamanid use in children

During the last years, the addition of two new drugs – bedaquiline and delamanid – for treatment of drug-resistant TB cases has been promising for a population of cases in which treatment success rates have remain consistently low.

After an accelerated approval process by the United States Food and Drug Administration in December (FDA) 2012 for bedaquiline and a conditional approval by the European Medicine Agency (EMA) in December 2013 for delamanid, the World Health Organization issued conditional recommendations for the use of these drugs in two interim policy guidance documents published in 2013 and 2014, respectively. Although phase III trial data are not yet available, additional data on safety and effectiveness of bedaquiline have become available since these recommendations were widely circulated. Similarly, results from two studies assessing the pharmacokinetics, safety, and tolerability of delamanid in paediatric MDR-TB patients have also been made available.

In view of these, the World Health Organization (WHO) has decided to convene two consecutive Guideline Development Group (GDG) meetings in Geneva, Switzerland from 28 – 29 June 2016. The first meeting will focused on the revision to the interim recommendation on the use of bedaquiline for treatment of multidrug-resistant TB; the second meeting aims at updating the interim policy guidance on delamanid, with a focus on treatment of MDR-TB in children aged 6 years and above.

The objectives for these GDG meetings are as follows:

  • To revise the WHO interim guidance on bedaquiline issued in June 2013, as appropriate, in view of updated evidence on its use in conjunction with WHO-recommended MDR-TB treatment regimens;
  • To update the interim guidance on the use of delamanid as part of WHO-recommended MDR-TB treatment regimens, as appropriate, in view of recent data on its use in children aged 6 years and above.

The names and brief biographies of experts being considered for participation in these WHO- GDG meetings are disclosed for public notice. In the event that a member of the public has proof of any competing interests for any of the GDG candidates, this information should be sent to gonzalezangulol@who.int and research.tb@who.int. The list of participants and their biographies are accessible here.