New Delhi: TB Alliance, a global not-for-profit organization, today applauded rapid communication regarding new guidelines for treating drug-resistant tuberculosis (DR-TB) released by the World Health Organization. For the first time, almost all patients with DR-TB can be treated in six months with an all-oral regimen.
Based on new clinical evidence presented and published over the past year, the new guidelines allow for the programmatic implementation of treating almost all forms of DR-TB with either BPaLM (a combination of bedaquiline, pretomanid, linezolid and moxifloxacin) or BPaL (bedaquiline, pretomanid and linezolid).
Dr. Mel Spigelman, President, and CEO TB Alliance, which developed pretomanid and first demonstrated the benefits of the BPaL regimen, said, “The WHO has just delivered excellent news for patients. This is a testament to what can be accomplished through long-term, sustained investments in TB research and development. We now have a path forward for handling the vast majority of cases of DR-TB with only six months of all oral treatment, with simplified drug regimens that have manageable side effects, and with cure rates on the same order of magnitude as the treatment for drug-sensitive TB.”
The rapid communication allows implementation of BPaLM and BPaL regimens under programmatic conditions, stating:
“The 6-month BPaLM regimen, comprising bedaquiline, pretomanid, linezolid (600 mg) and moxifloxacin, may be used programmatically in place of 9-month or longer (>18 months) regimens, in patients (aged ≥15 years) with MDR/RR-TB who have not had previous exposure to bedaquiline, pretomanid and linezolid (defined as >1 month exposure). This regimen may be used without moxifloxacin (BPaL) in the case of documented resistance to fluoroquinolones (in patients with pre-XDR-TB). Drug susceptibility testing (DST) to fluoroquinolones is strongly encouraged, but DST should not delay treatment initiation.”
The rapid communication also notes that:
“The data from the ZeNix study made it possible to identify the linezolid dose that offers the best balance in terms of efficacy and safety in patients aged above 14 years. The assessment of evidence from this study suggested that the optimal dosing of linezolid is 600 mg daily and that programmes should strive to maintain this dose throughout the treatment regimen to ensure optimal efficacy, with the possibility of dose reduction in the event of toxicity or poor tolerability.”