Two major clinical trials have been initiated to generate clinical evidence on the safety and efficacy of novel, short and all-oral regimens for the most difficult-to-treat strains of tuberculosis (TB).

The trials have been initiated by international humanitarian organisation Médecins Sans Frontières (MSF – Doctors without Borders) in collaboration with the Indian Council for Medical Research (ICMR)- National AIDS Research Institute (NARI) and Maharashtra’s Department of Health Service. The initiative is part of the UNITAID-funded multi-country project called endTB, which aims to speed up and expand access to better treatments for drug-resistant forms of TB, a note from MSF said.

Clinical trials

The two clinical trials, namely endTB and endTB-Q will use the new generation of TB drugs, which were developed after almost 50 years of draught of new anti-TB drug classes — bedaquiline and delamanid — to find radically shorter (6 or 9 months), more tolerable, injection-free treatments for MDR-TB.

In India, the endTB trials will be run at two sites in Maharashtra - Pune and Mumbai. And the first patient has been enrolled yesterday in the trials at Aundh Chest Hospital in Pune – the first trial site activated in India.

Approximately 220 patients are expected to be enrolled in the trials at the two sites by the end of 2021, by a team of over 30 medical and paramedical staff, working under the joint coordination of NARI and MSF.

India accounts for 27 per cent of the 10 million TB cases globally, of which an estimated 130,000 are multi-drug-resistant (MDR-TB). The current treatment of MDR-TB has a duration of 18-24 months for most patients and during the treatment, patients ingest more than 14,000 pills and, in some cases have to endure painful daily injections for six-to-eight months, which also have terrible side effects such as acute psychosis and permanent deafness.

Most Indian MDR-TB patients prefer to visit private practitioners of varying standards in desperate attempts to cure their disease, they find treatment expensive and this results in treatment interruptions, the note said.

The new generation drugs — bedaquiline and delamanid have shown promising results when added to the standard, long and badly-tolerated MDR-TB treatment, said Samiran Panda, Head, Epidemiology and Communicable Disease, ICMR and Coordinating Principal Investigator endTB Trials -India. However, he added, “we know little about how to optimise their use in the management of complex cases. Without further research, we are only scratching the surface and patients continue to suffer.”

Hanif Shaikh, endTB Trials –India Coordinator pointed out that India had a low success rate – 48 percent of treating MDR-TB, compared to 56 percent globally. India is contributing to the global TB elimination efforts by generating more scientific evidence through these trials, he said, adding that “Together, these two trials will revolutionize the treatment by identifying the most effective and less toxic all-oral, shorter (between six and nine months) treatment regimens against the deadliest forms of TB.”

“Adding India into the multi-country trials was a crucial step that will help building robust evidence about the best therapeutic options for the hardest-to-treat TB patients from a high TB burden country,” added Stobdan Kalon, medical Coordinator - MSF, India.

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