GUWAHATI, Aug 27 - In a major policy shift aimed at enhancing effectiveness and minimizing side effects of TB treatment, the World Health Organization (WHO) has put forward a recommendation of injection-free regimens for the treatment of rifampicin- and multidrug-resistant tuberculosis (RR/MDR-TB).
The new WHO recommendation suggests replacing injectable medicines (kanamycin/capreomycin), which have severe side effects and causes distress to patients and are associated with increased risk of failure and relapse.
The new MDR-TB treatment guidelines scheduled for release later in 2018 will replace all previous and current WHO guidelines on treatment of RR/MDR-TB.
According to a WHO Rapid Communication, in the new longer MDR-TB regimen, medicines have been regrouped into three categories and ranked based on the latest evidence about the balance of effectiveness to safety. The injectable agents, which showed high toxicity, will be used only when a regimen with 4-5 effective drugs cannot otherwise be composed.
A source in the Revised National Tuberculosis Control Programme (RNTCP), Assam, told The Assam Tribune that implementation of the WHO proposal on the ground would take some time.
“First, the government will have to take a policy decision to that effect. The transition from injection to tablets will take time – say from months to a year – because it would require finalization of guidelines, training, forecasting, medicine procurement and availability, etc.,” he said, adding that a streamlined phase-out would be effected once a policy decision was made.
The Rapid Communication aims to inform TB programme managers and other stakeholders of WHO Member States about the key implications for MDR-TB treatment regimens arising from the new evidence assessment. It highlights the immediate steps to be taken to ensure that RR/MDR-TB patients receive treatment in accordance with the latest evidence on effectiveness and safety.
For hastening the transition, WHO is establishing a multi-stakeholder task force to coordinate the support to national TB programmes in their rapid transition to the key changes envisaged. As a first priority, the task force will support countries to undertake a rapid situational assessment of their most urgent needs and adjust their medicine and diagnostics procurement plans. Subsequent activities will involve support to countries to update their national guidelines, future programme budgets and monitoring systems to enable the switch to more effective MDR-TB regimens.
The Rapid Communication, while stating that it would not be immediately possible to achieve the new standards of care in every individual MDR-TB patient, asserts that strategic planning should start immediately to enable rapid transition to the upcoming new WHO guidelines.
“Consolidated, updated and more detailed WHO policy guidelines on MDR-TB treatment will be provided by the end of 2018, including the detailed GRADE evidence assessment underpinning the changes according to the requirements of the WHO Guidelines Review Committee,” it added.
Providing evidence-based guidelines to inform public health service delivery for Member States and other stakeholders is one of the core responsibilities of WHO. The most recent WHO evidence-based guidelines for the treatment of multidrug-resistant or rifampicin-resistant tuberculosis were published in October 2016. Subsequently, new evidence prompted a public call for data by WHO in anticipation of a formal review. Anonymized individual data received from clinical trials, cohort/observational studies and programmatic implementation of both longer and shorter MDR-TB regimens were incorporated into an individual RR/MDR-TB patient data base (IPD) hosted by McGill University, Canada, under contract with WHO.