Earlier this week, the World Health Organization (WHO) released a rapid communication which detailed the upcoming changes to the treatment guidance for drug-resistant tuberculosis (DR-TB). These guidelines are used to inform national TB programmes globally on how to treat patients with these difficult-to-treat forms of TB. The new guidance will include 6-month all-oral regimens for the treatment of multidrug- and rifampicin-resistant TB (MDR/RR-TB) with or without additional resistance to fluoroquinolones (pre-XDR-TB). There will be an additional 9-month all-oral regimen for the treatment of MDR/RR-TB.
The WHO goes on to detail that these updated guidelines are in direct response to the results from the TB-PRACTECAL and ZeNix clinical trials, both evaluating novel TB drug regimens to treat drug resistant forms of Tuberculosis, sponsored by MSF and TB Alliance, respectively. The novel regimens include BPaLM and BPAL. The rapid communication states:
The evidence assessment suggested that the 6-month BPaLM regimen – comprising bedaquiline, pretomanid, linezolid (600 mg) and moxifloxacin – may be used programmatically in MDR/RR-TB patients without previous exposure to these medicines in place of the 9-month regimen (described below) or the longer (≥18 months) regimen. The BPaLM regimen showed favourable efficacy and safety when compared with the regimens given in the control arm of the TB-PRACTECAL trial. The evidence assessment also suggested that the BPaL combination (with 600 mg linezolid) retains sufficient efficacy and allows the regimen to be used without moxifloxacin in the case of documented resistance to fluoroquinolones (i.e. in patients with pre-XDR-TB). In this group of patients receiving the BPaL combination, where there is a slow response to therapy, an extension of 3 months (bringing the total regimen to 9 months) is possible.
The reduction of treatment duration while maintaining efficacy and safety is a watershed moment for individuals living with a drug-resistant TB infection. Injectable drugs have effectively been removed from primary guidance and what previously could have taken 9 months to several years can be completed in 6-9 months.
This Rapid Communication is released in advance of updated WHO consolidated guidelines expected later in 2022, to inform national TB programmes and other stakeholders of key changes in the treatment of DR-TB and to allow for rapid transition and planning at the country level. To read more about the rapid communication via the WHO's news release, click here.