New Delhi, India, May 4 (Bureau) TB Alliance on Tuesday applauded the World Health Organization for releasing a new guidelines for treating the drug-resistant tuberculosis (DR-TB). The global body for finding affordable drug based solution for tuberculosis said that for the first time, almost all patients with DR-TB can be treated in six months with an all-oral regimen. It also said the new guidelines could have significant implications on the decision-making of many high-TB-burden countries who are implementing efforts to control drug-resistant TB. According to TB Alliance, the WHO’s new guidelines based on new clinical evidence presented and published over the past year 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).
Mel Spigelman, President & CEO, TB Alliance, 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,” he added. The organisation has developed pretomanid and first demonstrated the benefits of the BPaL regimen. “The 6-month BPaLM regimen, comprising of drugs such as 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 DR TB,” the WHO’s guidelines state. Pretomanid received its first regulatory approval in August 2019 for the treatment of people with certain forms of highly drug-resistant TB.
BPaL was most recently evaluated in TB Alliance’s ZeNix trial that took place in 11 sites across Georgia, Moldova, Russia, and South Africa, the alliance said. India has the world’s highest TB burden, with 26 lakh cases and close to 4,50,000 deaths each year. India accounts for a quarter of the world’s DR-TB and fewer than 50 per cent of patients put on treatment are having successful treatment outcomes. The organisation also said that Made in India Pretomanid is part of a six-month treatment regimen with reported efficacy of 90 per cent and has the potential to contribute to India’s ‘TB Elimination program by 2025. In July 2020, the Drug Controller General of India (DCGI) had approved the TB drug Pretomanid for conditional access under the National Tuberculosis Elimination Program (NTEP), making India the second country in the world to provide regulatory approval for this product.