New drugs approved by regulatory authorities, notably bedaquiline and delamanid, as well as re-purposed drugs classified as Group 5 in the WHO Companion Handbook to the 2011 Guidelines for Programmatic Management of Drug-resistant Tuberculosis (PMDT) are increasingly being introduced in the treatment regimens for MDR-TB and XDR-TB patients. The WHO's Global TB Programme issued interim policy guidance on the use of bedaquiline in the treatment of MDR-TB in mid-2013 and on the use of Delamanid in October 2014. However limited data, particularly on safety, are currently available on these new drugs, and also on the safety and efficacy of the re-purposed drugs listed under Group 5. It is therefore imperative that adequate provisions for safe, rational and effective use of these drugs be put in place, specifically ensuring appropriate selection of eligible patients, informed consent, design of effective regimens, and close patient monitoring and evaluation. Both drug stock-outs and overstocking should be avoided and orders aligned to treatment regimens recommended by WHO. Furthermore, WHO/GTB is recommending that countries introducing new and re-purposed Group 5 drugs establish active pharmacovigilance to rapidly detect potential drug adverse events.
Given the essential role of the regional Green Light Committees (rGLCs) as the primary point of contact for country guidance and advice on PMDT, it is very important that rGLC members and PMDT consultants are fully au fait with current WHO policy recommendations on the use of new drugs, as well as those in Group 5. Therefore a series of workshops have been planned by the WHO for the rGLC members and their respective rGLC Secretariat Focal Points, whilst encouraging countries and partners to make use of the rGLC mechanism to ensure that treatment principles and drug orders are aligned with WHO guidelines.
Workshops held as yet are as follows:
- For the members of the rGLC for the European Region, the rGLC Secretariat Focal Point, and representatives of partner organizations - Copenhagen, Denmark, 22-23 September 2015.
- For the members of the rGLCs for the African and Eastern Mediterranean Regions, the rGLC Secretariat Focal Points, and representatives of partner organizations - Nairobi, Kenya, 4-5 November 2015.
- For the members of the rGLCs for the South East Asia and Western Pacific Regions, and representatives of partner organizations - Bangkok, Thailand, 24-25 February, 2016
- For the members of the rGLCs for the Americas Region, the rGLC Secretariat Focal Points, and representatives of partner organizations - Panama City, Panama, 18-19 April 2016.
The reports of these workshops are available here
The second Core Group (CG) meeting of the Global Drug-resistant TB Initiative (GDI) was held on 27 October 2014 in Barcelona, Spain. All members of the CG, except for the SEA rGLC chair, attended the meeting, along with observers from the Global Laboratory Initiative (GLI), Global TB Drugs Facility (GDF), Global Fund (GF), Infection Prevention and Control (IC) sub-group and the USAID. The objectives of the meeting were:
- To follow up on recommendations and action points agreed upon during 1st GDI CG meeting and subsequent monthly teleconferences
- To provide an update on progress in global scale up of MDR-TB services and care
- To provide an update on the progress of the respective GDI Task Forces, and the request of the Infection Control (IC) sub-group
- To strengthen communication within GDI, and between the GDI and partners including the GF
- To discuss the GDI "Business Plan" and the work plan for 2014-15.
The participants were briefed about the activities of the GDI Secretariat since the first CG meeting in May 2014, as well as the progress made by the three taskforces formed after the first CG meeting.
A joint session of the GDI and GLI CGs discussed the ways forward to narrow the gap between the diagnosis and enrolment of MDR-TB cases globally. Further discussions will be held to finalise a number of joint GDI and GLI activities for 2015. The joint session was also addressed by Dr Mario Raviglione, Director GTB/WHO
The GDI CG members unanimously agreed to the movement of the IC sub-group under the GDI "umbrella".
Initial discussions on the contents of the GDI "Business Plan" were held. The CG members agreed that scope of the plan should be global in nature, and that the plan should build on the earlier transition framework developed in 2011. A tentative plan was made for a meeting of a small group of CG members early next year to draft the GDI document, which will include budget estimates for the global scale-up of MDR-TB services and care.