Tuberculosis (TB)

Public Notice: Guideline Development Group meeting to update the WHO guidelines on drug-resistant tuberculosis

In order to support countries in responding to the challenge of TB, the World Health Organization (WHO) has produced guidelines for the treatment and care of TB, including for multi-drug- /rifampicin-resistant TB (MDR/RR-TB). Access to the most effective and safe medicines and treatment regimens is necessary to optimize treatment outcomes while minimizing adverse events and the acquisition of additional drug resistance. Although for decades, the TB “treatment landscape” was limited, this has been dramatically transformed. The latest evidence-based guidelines for the treatment of MDR/RR-TB were published by WHO in 2018, which were later disseminated as the consolidated WHO guidelines on drug-resistant TB treatment. Since then, new evidence in various areas has become available, prompting WHO to initiate a guideline development process to rapidly and effectively assess these interventions and inform countries on their use and considerations for introduction.

The scope of the upcoming update of the WHO drug-resistant TB guidelines will focus on the use of a modified all-oral shorter MDR/RR-TB regimen (i.e. less than 12-month duration); use of a novel regimen combining pretomanid, bedaquiline and linezolid; use of bedaquiline for more than 6 months and its concurrent use with delamanid.

The sources of available evidence are as follows:

  • Additional programmatic data on the use of all oral shorter regimens for MDR/RR-TB from programmatic cohorts in South Africa;
  • Results from the Nix-TB Trial by TB Alliance on the use of bedaquiline, pretomanid and linezolid in combination for patients with XDR-TB and non-responsive or treatment-intolerant MDR-TB;
  • Additional programmatic data on the use of bedaquiline (including its use beyond six months duration) to treat MDR/RR-TB from programmatic cohorts in high incidence TB countries, end TB observational study sites and elsewhere;
  • New programmatic data on the concurrent use of bedaquiline and delamanid to treat MDR/RR-TB from the endTB observational study sites and elsewhere.

The upcoming update will respond to earlier evidence gaps deemed critical to better understand the use new medicines, including the assessment of a novel compound within a new regimen. The assessment will be conducted by a Guideline Development Group (GDG) composed of external experts who will be evaluating and discussing the evidence to inform the development and formulation of recommendations.

The Group of experts has been selected on an individual capacity and following the rules of the WHO Guideline Review Committee and the WHO Office of Compliance, Risk Management and Ethics. To ensure transparency and neutrality in this guideline development process, the names and brief biographies of experts being considered for participation in this Guideline Development Group meeting are disclosed for public notice. In the event that a member of the public has proof of any competing interests for any of the selected GDG members, this information should be sent to ldr.policies@who.int by no later than 10 October 2019. The list of experts and their biographies are accessible here.