WHO releases new guideline for treating drug-resistant TB; India has the globe’s highest burden

The World Health Organization has released a new guideline for treating drug-resistant tuberculosis in almost all such patients in six months with an all-oral regimen with close to 90% cure rates as against the current success rate of 59%.

The new regimen is undergoing clinical trials in India which has the world’s biggest TB burden with 2.6 million cases and close to 450,000 deaths each year. While this is more than a quarter of the global burden, there is no clarity on when India would be able to adopt the new regimen in its government-funded programme as that would require provisioning of additional resources.

India accounts for a quarter of the world's drug resistant-TB cases, and fewer than 50% of patients put on treatment have successful treatment outcomes. This is an area where innovation in treatment can make a big difference.

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The six-month regimen, comprising bedaquiline, pretomanid, linezolid (600 mg) and moxifloxacin, may be used programmatically in place of nine-month or longer (more than 18 months) regimens, in multi-drug resistant TB patients aged 15 years and above, who have not had previous exposure to such medicines.

Such a regimen may also be used without moxifloxacin in the case of documented resistance to fluoroquinolones in patients with extremely drug-resistant TB.

“The WHO has just delivered excellent news for patients. We now have a path forward for handling the vast majority of cases of drug-resistant TB with only six months of all-oral treatment, with simplified drug regimens that have manageable side effects,” Mel Spigelman, president and CEO, of TB Alliance, which developed pretomanid, said in a statement.

Asked about the pretomanid price and availability in India, Spigelman told DH, “Pretomanid is accessible in India and in approximately 150 other countries at a price of $ 364 (nearly Rs 28,000) for a full treatment course. The treatment costs a fraction of alternative treatment options for this deadly infectious disease.”

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“The Drugs Controller General of India approved the medicine in 2020. We have engaged with multiple India-based manufacturers and the product is currently manufactured in India by Viatris. In India, the government is currently enrolling patients in a national clinical trial.”

The multi-centre trial, led by the National Institute for Research on Tuberculosis, Chennai, would continue till December 2023 during which the new and shorter regimen’s efficacy and tolerability would be examined in Indian patients.

The WHO updated its guidelines for the treatment of drug-resistant TB on the basis of new scientific evidence that emerged after the previous guideline that came in June 2020.

“The two regimens (with and without moxifloxacin) showed high treatment success. The evidence from the available studies suggests that these regimens may be used in eligible patients with MDR (or rifampicin-resistant) TB and pre-XDR TB regardless of their HIV status,” the WHO says in its rapid communication.

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