Two major clinical trials have been initiated with an aim to generate clinical evidence on the safety and efficacy of novel, short and all-oral regimens for strains of tuberculosis (TB) that are most difficult to treat.
These trials have been initiated by the Indian Council of Medical Research (ICMR) – National AIDS Research Institute (NARI), Department of Health Service, Government of Maharashtra, and Doctors without Borders/Medecins Sans Frontieres (MSF).
The trials are part of a UNITAID-funded transformative (multi-country) project called endTB, which aims to speed up and expand access to better treatment for drug-resistant forms of TB, said Dr Samiran Panda, head of epidemiology and communicable diseases at ICMR, and the coordinating principal investigator of the endTB trials. The first patient in India (500th in the multi-country trial) was enrolled at Aundh Chest Hospital, Pune, on Wednesday.
The endTB trials will run at two sites in Maharashtra – Pune and Mumbai. Aundh Chest Hospital is the first trial site to be activated in the country. Approximately 220 patients are expected to be enrolled at both sites by the end of 2021, by a team of over 30 medical and paramedical staff, working under joint coordination of NARI and MSF. At least 100 people will be enrolled at Aundh Chest Hospital, said Dr Sandip Patil, NARI scientists and principal investigator at the hospital.
India accounts for 27 per cent of the 10 million TB cases globally, of which approximately 1,30,000 are multi-drug-resistant (MDR-TB). The current treatment for this has a duration of 18-24 months for most patients. During treatment, patients ingest more than 14,000 pills and, in some cases, have to endure painful injections every day for six to eight months. These injections have side-effects including acute psychosis and permanent deafness.
Most Indian MDR-TB patients prefer private practitioners, and often find the treatment expensive, leading to interruptions in the same.
The two clinical trials, namely endTB and endTB-Q, will use new generation TB drugs – bedaquiline and delamanid – to find radically shorter (six to nine months) ways of treatment, which are more tolerable for patients and are injection-free.
“These drugs represent a unique opportunity to improve MDR-TB treatment,” Dr Panda said. “They’ve shown promising results when added to the standard and long MDR-TB treatment. However, we know little about how to optimise their use in complex cases. Without further research, we’re only scratching the surface, and patients will continue to suffer.”
“Adding India, which has a high burden of TB patients, to the multi-country trial was a crucial step in helping build robust evidence about the best therapeutic options for patients that are the hardest to treat,” said Dr Stobdan Kalon, medical coordinator, MSF, India. “With its support to public healthcare, MSF remains committed to offer better treatment to all MDR-TB patients, bringing innovation through research and contributing to India’s goal to eliminate TB by 2025.”
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