The TB Alliance commends WHO’s rapid communication on significant changes in the treatment of drug-resistant tuberculosis.

The TB Alliance praised the World Health Organization (WHO)’s rapid communication on new guidelines for the treatment of drug-resistant tuberculosis (DR-TB) on Tuesday. First, almost all patients with DR-TB can be treated with a total oral regimen for 6 months. Based on new clinical evidence presented and published over the past year, the new guidelines indicate that almost all forms of DR-TB are either BPalM (a combination of bedaquiline, pretomanid, linezolid, and moxifloxacin) or BPaL. It can be carried out by a program to treat with. (Bedaquiline, pretomanid, and linezolid).

“WHO has just delivered great news to patients. This is proof that it can be achieved through long-term and sustainable investment in tuberculosis research and development. We now have the majority of cases of DR-TB. In just 6 months of all oral treatments, we are on the road to coping with simplified drug therapy with manageable side effects, and with a cure rate comparable to treatment. Dr. Mel Spigelman, President and CEO of the TB Alliance, who first demonstrated the benefits of the BPaL regimen, said in a statement.

Rapid communication allows you to implement BPaLM and BPaL regimens under programmatic conditions.

“A 6-month BPaLM regimen containing bedaquiline, pretomanid, linezolid (600 mg), and moxifloxacin is a program for patients aged 15 years and older instead of a 9-month and longer (> 18-month) regimen. Can be used. MDR / RR-TB (defined as 1 month or longer exposure) without previous exposure to bedaquiline, pretomanid, linezolid. This regimen has proven resistance to fluoroquinolone (XDR-TB). Previous patients), can be used without moxifloxacin (BPaL). Drug susceptibility testing (DST) for fluoroquinolone is highly recommended, but DST should not delay the start of treatment. “1

Rapid communication also states:

“Data from the ZeNix trial have made it possible to identify doses of linezolid that provide the best balance between efficacy and safety in patients age 14 years and older. The optimal dose of linezolid is 600 mg daily, and the program may reduce the dose if it is toxic or poorly tolerated, and this dose throughout the treatment regimen to ensure optimal efficacy. Suggested that efforts should be made to maintain. “

Pretomanid received first regulatory approval in August 2019 for the treatment of certain forms of drug-resistant tuberculosis patients. iiBPaL was recently evaluated in the TB Alliance’s ZeNix trial, a phase 3 clinical trial conducted in 11 locations in Georgia. Moldova, Russia, South Africa. The BPaLM regimen was evaluated in the TB-PRACTECAL trial sponsored by Doctors Without Borders (MSF). The study compared three BPaL-based regimens with standard of care in the regions of the three countries where the study was conducted (Belarus, South Africa and Uzbekistan). Key safety and efficacy results for both ZeNix and TBPARCTECAL have been submitted to peer-reviewed journals.

India, with 2.6 million cases each year and nearly 450,000 deaths, is the country with the highest burden of tuberculosis in the world. The country accounts for one-quarter of the world’s DR-TB, and less than 50% of treated patients are successful.prime minister Narendra Modi Prior to the Sustainable Development Goals of 2030, we have set ambitious goals for the eradication of tuberculosis in India by 2025. Pretomanid is a “Made in India” product used as part of a 6-month treatment regimen that has been reported to be 90% effective and could contribute to India’s “TB eradication program” by 2025. There is sex.

Last July, the Drugs Controller General of India (DCGI) approved the tuberculosis drug pretomanid (specially developed for certain drug-resistant diseases) for conditional access under the Tuberculosis Eradication Program (NTEP). The countries of the world that provide regulatory approval for this product, making India second.

According to the organization, the new guidelines can have a significant impact on the decision-making of many TB-bearing countries that are implementing efforts to manage drug-resistant tuberculosis.