WHO announces landmark changes in MDR-TB treatment regimens

17 August 2018, Geneva - Major improvement in treatment outcomes and quality of life of patients with multidrug-resistant tuberculosis (MDR-TB)* are expected, following key changes in MDR-TB treatment announced by WHO today.

The first important change is a new priority ranking of the available medicines for MDR-TB treatment, based on a careful balance between expected benefits and harms. Treatment success for MDR-TB is currently low in many countries. This could be increased by improving access to the highest-ranked medicines for all patients with MDR-TB.

The second important change is a fully oral regimen as one of the preferred options for MDR-TB treatment, with injectable agents proposed to be replaced by more potent alternatives such as bedaquiline (the first-ever medicine to be developed specifically for the treatment of MDR-TB). Injectable agents cause pain and distress to patients, with many experiencing serious adverse effects that often lead to treatment being interrupted.

“The treatment landscape for patients with MDR-TB will be dramatically transformed for the better with the announcement today,” said Dr Soumya Swaminathan, WHO Deputy Director-General for Programmes. “Building on the available new data, and with the involvement of a large number of stakeholders, WHO has moved forward in rapidly reviewing the evidence and communicating the key changes needed to improve the chances of survival of MDRTB patients worldwide. Political momentum now needs to urgently accelerate, if the global crisis of MDR-TB is to be contained.”

The WHO rapid communication aims to encourage and prepare countries to implement the upcoming new consolidated, updated and more detailed WHO policy guidelines on MDR-TB treatment which will be released later this year. WHO is also establishing a multi-stakeholder Task Force to coordinate support to national TB programmes in their rapid transition to the key changes envisaged.

An evidence-driven process

The announcement follows an in-depth assessment of the latest evidence on the efficacy and safety of medicines available to treat MDR-TB by an independent panel of experts convened by WHO. The outcomes of the meeting, held 16-20 July, also have major and immediate implications for countries, donors and technical partners as clinical care, national diagnostic and treatment policies, medicine and diagnostic procurement strategies, and training plans will require rapid review and adaptation.

The meeting was the culmination of an extensive process initiated by WHO in 2017. Following WHO’s public call for data, anonymized individual patient records from clinical trials, observational studies and national TB programmes were incorporated into a global database hosted by McGill University, Canada under contract with WHO. International standards for data analyses by the McGill group ensured high confidence in the findings and enabled WHO to rapidly communicate the key changes.

“Evidence-based interventions are essential for optimal clinical care of patients and effective public health service delivery,” said Professor Holger Schünemann, Director of Cochrane Canada and member of the International GRADE^# Working Group, who chaired the expert panel meeting. “WHO is a leader in ensuring that its policies and guidelines meet the highest scientific standards, which should generate full trust by its member states and other stakeholders.”

MDR-TB – a global public health crisis

TB is among the oldest diseases known to mankind, yet remains one of the top 10 causes of death worldwide today, as well as the leading global infectious disease killer. About 600,000 new cases of MDR-TB (or other rifampicin-resistant TB) emerge each year and about 240,000 people die of these forms of TB each year according to WHO estimates.

MDR-TB is a major driver of antimicrobial resistance worldwide and threatens hard-earned gains made in the global TB response over the past twenty years. Diagnosis and treatment of MDR-TB remain a major challenge, with only one in four affected people currently being detected and even fewer being treated successfully.

Moving forward

“We would like to thank countries, technical partners, donors, civil society and other key TB stakeholders for their contribution that has culminated in these positive changes for MDR-TB patients,” said Dr Tereza Kasaeva, Director of WHO’s Global TB Programme. “We now ask for their urgent support to national TB programmes in their transition to new MDR-TB treatment regimens.”

Accelerated efforts to address the MDR-TB crisis will contribute to accelerating action to end the global TB epidemic. Heads of State, Government and other global leaders are poised to gather at the first-ever United Nations High-level Meeting on TB in New York on 26 September 2018.

Access WHO’s Rapid Communication here

* MDR-TB: Resistance of Mycobacterium tuberculosis against at least isoniazid and rifampicin, the cornerstone medicines for treatment of TB. Rifampicin-resistant disease on its own requires similar clinical management as MDR-TB.

# Grading of Recommendations, Assessment, Development and Evaluation for evidence-based guidelines and policy development

Source: WHO