This document was prepared by Christian Lienhardt, Ernesto Jaramillo, Dennis Falzon, Fraser Wares, Karin Weyer, Diana Weil and Mario Raviglione (WHO Global TB Programme), on the basis of the recommendations of an international Expert Group Meeting convened by WHO in Geneva on 15–16 April 2014.
WHO gratefully acknowledges the contributions made by the Chair of the Expert Group (Holger Schünemann); the members of the Expert Group (Mauricio Barreto, Erlina Burhan, Lucy Chesire, Kelly Dooley, Erica Lessem, Dick Menzies, Norbert Ndjeka, Viet Nhung Nguyen, James Seddon, Alena Skrahina, Piret Viiklepp) who developed the recommendations; consultants working on background analyses (Bernard Fourie, Anna Vassall, Ekaterina Kurbatova); and technical resource persons in the meeting (Frank Cobelens, Michael L. Rich, Francis Varaine).
WHO also acknowledges the contributions of the members of the External Review Panel (Jose A. Caminero, Richard E. Chaisson, Gavin Churchyard, Anna Marie Celina Garfin, Giovanni Battista Migliori, Rohit Sarin, Maarten van Cleeff, Andrew Vernon), as well as members of the WHO Strategic and Technical Advisory Group for Tuberculosis (STAG-TB) 2014 (Draurio Barreira, Amy Bloom, Gavin Churchyard, Daniela Cirillo, Frank Cobelens, Elizabeth Corbett, Michel Gasana, Stephen Graham, Akramul Islam, Michael Kimerling, Wang Lixia, Anshu Prakash, Ejaz Qadeer, Joseph Sitienei, Alena Skrahina, Soumya Swaminanthan, Maarten van Cleeff, Irina Vasilyeva).
This document was finalized following consideration of all comments and suggestions from the participants of the Expert Group, the External Review Panel and STAG-TB.
USAID is acknowledged for its support in the development of these guidelines through a sub-agreement under Cooperative Agreement (CA) No. AID-OAA-A-10–00020 for the TB CARE I project awarded to KNCV by the USAID Office of Health. The US Center for Disease Control and Prevention (CDC) provided work pro bono on the use of sputum culture conversion as a surrogate marker of MDR-TB treatment outcome (carried out by Ekaterina Kurbatova and colleagues).
Declarations of interest
All Expert Group members, consultants, technical resource persons, members of the External Review Panel and STAG-TB members submitted completed Declaration of Interest (DoI) forms. These were reviewed by the WHO Legal Department prior to the Expert Group meeting and preparation of the draft interim policy guidance, in keeping with WHO rules.
Two Expert Group members (Daniela Cirillo, Erica Lessem) declared having received support from pharmaceutical companies for work not related to the present guideline; and Dalene van Delft declared receiving compassionate use access to bedaquiline – all of these declarations were deemed to be insignificant. Three members (Frank Cobelens, Michael L. Rich, Francis Varaine) declared current discussions with the company (Otsuka) on potential access to delamanid for future studies on roll-out of new drugs under programmatic conditions (FC, MR) or for future clinical trial of new regimens for MDR-TB Treatment (FV). These declarations were deemed to be significant for a possible conflict of interest, and experts were requested not to contribute to deliberations on the recommendations. The other members of the Expert Group as well as the consultants and the members of the Expert Review Panel declared no interest.
With respect to the STAG-TB review, Chuck Daley declared serving as chair of the data monitoring board for Otsuka delamanid trials, and Francis Varaine declared participation in discussions between MSF and Otsuka to receive supplies of Delamanid for use in clinical trials along with other drugs. These two declarations were deemed significant for a possible conflict of interest and these STAG members did not participate in external review. Frank Cobelens, as a member of STAG-TB, had a revised declaration of interest noting no current or future planned work with Otsuka; he participated in the external review.
