India to roll out new treatment regimen for drug-resistant TB

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India is getting ready to roll out BPaL (bedaquiline, pretomanid, and linezolid) regimen for all multi/extensively drug-resistant tuberculosis patients and the training for this new exercise is scheduled to begin this month.

This is a significant move in the country’s battle against M/XDR-TB with the new regime indicating good results in countries including Pakistan, South Africa, Ukraine, etc. Announcing the move on social media on Friday, Soumya Swaminathan, principal advisor, National Tuberculosis Elimination Programme, said that “the move should improve treatment outcomes and help thousands of patients”.

Dr. Swaminathan said in her post: “India is getting ready to roll out BPaL regimen for all M/XDRTB patients — training to begin this month. This should improve treatment outcomes & help thousands of patients. Scaling up NAAT coverage will be an essential element of the strategy.”

A nucleic acid amplification test, or NAAT, for tuberculosis (TB) is a molecular test used to detect the DNA (deoxyribonucleic acid) of Mycobacterium tuberculosis complex (MTBC) in a sputum or other respiratory sample.

Welcoming the announcement, Leena Menghaney, South Asia head of humanitarian aid organisation Médecins Sans Frontières (MSF) said: “After the availability of generic bedaquiline cost to TB programmes has fallen – (BPaLM price is US$426 (US$130 bedaquiline, US$238 pretomanid, US$31 linezolid and US$27 moxifloxacin). This is a momentous day for people with drug-resistant tuberculosis, because India will finally replace many of the longer, arduous and less-effective treatments by offering better, safer and shorter BPaLM treatment that is much more likely to cure this deadly disease. The next step is to also introduce delamanid-based short oral regimens for children and as an alternative for people who cannot tolerate bedaquiline or linezolid.”

A senior Health Ministry official explained that after the introduction of the new anti-TB drug pretomanid, which is prescribed as part of the BPaL regimen, medical practitioners and researchers noted that the combination drastically cut short the TB treatment duration by half.

From a treatment duration range of 18 to 24 months, BPaL brings down treatment time to around six months. Furthermore, the older all-oral-drug-regimen included nearly 14 different anti-TB drugs for a patient to take every day. With BPaL, it is likely to take just three daily tablets.

Currently, India has a 56% treatment success rate for MDR/RR-TB cases, and 48% for XDR-TB cases, attributable to long and toxic drug regimens. In fact, historically, treatment of such forms of TB anywhere would take 18 months or longer, with reported global success rate of 52% in the past. A shorter regimen, such as BPaL, which is all oral and requires lesser doses per day, will make it easier for a patient to adhere to and complete treatments, he explained.

Also, in a paper titled ‘Savings from the introduction of BPaL and BPaLM regimens at the country level’ published last month, the study notes that in 2022, the World Health Organisation (WHO) recommended the six-month regimens BPaL (bedaquiline + pretomanid + linezolid) and BPaLM (BPaL + moxifloxacin) as treatment options for most forms of drug-resistant TB. The study found that through BPaL/BPaLM regimens, drug-resistant TB treatment has become more effective, shorter, less burdensome for patients, cheaper for both health systems and patients, and saves more lives.

When shorter and longer regimens are replaced with BPaL/BPaLM, the savings per patient treated in Pakistan, the Philippines, South Africa, and Ukraine are $746, $478, $757, and $2,636, respectively for M/XDR-TB.

In its Global TB Report 2023, WHO said India has made tremendous progress in improving case detection and reversed the impact of COVID-19 on the TB programme. The treatment coverage has improved to 80% of the estimated TB cases, an increase of 19% over the previous year. It added that the estimated number of drug-resistant TB in India has reduced by 21% from 1.4 lakh in 2015 to 1.1 lakh in 2022.