The fact that tuberculosis has been the scrooge of the earth for centuries is not unknown. For years it was the disease that afflicted millions and ultimately resulted in the patient wasting away and dying. TB Alliance, a not-for-profit, partnership—dedicated to the discovery, development, and delivery of new, faster-acting and affordable tuberculosis medicines—is headquartered in New York and has a regional office in Pretoria. Working remotely and entirely virtually, it has a new offering for drug-resistant TB.

Drug resistance is rampant in TB since the length of treatment leads to people falling off the regimen. TB Alliance is now promoting a treatment protocol BPaL, a six-month treatment for what is called extensively drug-resistant TB (XDR). The BPaL regimen includes bedaquiline (B), pretomanid (Pa), and linezolid (L). TB Alliance president and CEO Mel Spigelman says, “Long-drawn program of TB treatment is not only on the burden on the patient but also on the healthcare system. If we had the fund, TB treatment could be brought down to a week instead of months or years.”

“Seven countries have already procured Pretomanid, as part of the three-drug combination recommended by TB Alliance. Seven more are preparing to accept it,” says Sandeep Juneja. In India, Viatris, formerly Mylan, will initially make its Pretomanid available through a donation of 400 treatment courses to the National TB Elimination Program (NTEP). Lupin is the first Indian company to get the rights to manufacture the regimen. It will market it to 140 companies.

The TB Alliance forms non-exclusive contracts with manufacturing companies in different markets so that the market forces regulate pricing. The excitement around this regimen is palpable as the success rate in clinical trials is up to 90% for drug-resistant TB.

India has the highest burden of TB and therefore, has a structured programme to eradicate TB. It is gaining traction since the Prime Minister has announced an ambitious program for TB elimination by 2025—five years ahead of WHO’s Sustainable Development Goals. Technically DCGI does not get marketing approval for any drug unless clinical trials are conducted in India. Like the immunisation programme, surveillance in National TB Elimination Programme is implemented at all levels—community, primary health care level, block level, district level, state level and national level.

The National Strategic Plan (NSP 2017-2025) lays out the road map to end TB by 2025. The four core focuses are build, prevent, detect, and treat. They cover the entire spectrum of activities—from prevention of the spread of infection/disease to early diagnosis; drug susceptibility-based treatment, treatment support along with building the health system; advocacy, communication, and social mobilization.

Nikshay is a website that has real-time and auto-aggregated data at the block, district, state and national level and analytical reports are generated for Programme managers to monitor, track and enable targeted interventions to ensure universal care for TB patients. The site also has an app for patients called TB Arogya Saathi to self-monitor progress in treatment and benefits. “The programme has an online case-based digital surveillance system called Nikshay. This ecosystem enables the programme to track all patients notified from the public and private sector,” says Sudarshan Mandal, deputy director-general, TB, MOHFW.

While the estimate of the disease burden at the national level is provided by the WHO through the annual Global TB Report, based on information reported in Nikshay, locally relevant research studies and secondary data, the Government of India is also implementing a National TB Prevalence Survey through ICMR.

In India, since 2018—to control and prevent tuberculosis—it is mandatory for both public and private health care providers termed as the clinical establishment (medical laboratories and medical practitioners) to notify a case of TB to the local designated public health authority. Including all chemists and druggists, pharmacies dispensing anti TB drugs shall notify the TB patients along with the relevant details of medicines, maintain a copy of the prescription, shall furnish the same either electronically or in hard copy, to the nodal officer of the district.

“Although clinical trials were not conducted in India, data is being made available to DCGI. New trial data from XENEX trial will be presented to the leadership to see what they say, how they would like to proceed based on new data,” adds Spigelman. India started its clinical trials using the 400 doses donated by Viatris.

Excerpts from an interview with Dr Sudarshan Mandal, DDG, TB, MOHFW.

Does India subscribe to the TB Alliance and their suggestions?

The evidence generated through studies on newer anti-TB drugs and regimens conducted and published by TB Alliance were reviewed by a national technical expert group constituted by NTEP for considering the newer scientific evidence grading and recommendations by WHO.

What is the reason that B-PaL studies conducted in other parts of the world are not suitable for India?

National technical expert group on treatment of TB under NTEP reviewed the BPaL study (NixTB trial) results and the related WHO recommendations. They observed that the dose of Linezolid (1200mg) used in the study was too high and patients in India would not be able to tolerate it. Hence, it was recommended to undertake a clinical trial on BPaL in India to compare BPaL regimen containing (1200mg per day) with a regimen containing lower doses of Linezolid (600mg per day for 6 months, 600mg per day for 2 months followed by 300mg per day for 4 months) so that more evidence is available on effectiveness and safety of BPaL with lower doses of Linezolid like ZeNix TB trial.

What is the expected time for the study to begin?

The results of the ZeNix TB trial recently made public by TB Alliance have shown that BPaL with lower doses of Linezolid also has high treatment efficacy and a greater safety profile. Considering this, the initiation of the study in India (expected to begin on July 21), had to be pushed to adjust for the ZeNix TB trial results in the Indian trial protocol and necessary approvals from all ethics research committees/institutional review boards, drug controller general of India and national operational research committee will need to be obtained again.

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