Multi-country trial ups hope of recovering from TB in 6 months

In the light of India’s ambitious goals to eliminate tuberculosis by 2025, patients cured from clinical trials of combination therapy including crucial drugs Bedaquiline and Delamanid holds promise. Majority of the drug-resistant patients subjected to this combination regimen became negative for TB within six months, a study published in The Lancet stated.

Multi-national trials were conducted by Medecins Sans Frontières (Doctors without Borders) in three countries – South Africa, India and Armenia. While 14 patients were enrolled in SA, seven each hailed from Mumbai in India and Armenia. While half of the cohort had multi-drug resistance (MDR) another half had extensively drug-resistant TB (XDR)

Of 28 patients that were enrolled, it was possible to carry out trials till the end in 23 patients. 17 (74%) of these patients converted to TB negative by the end of six months. . “The proportion of patients with culture conversion in our study (74%) was considerably higher than those previously reported in patients with XDR tuberculosis in South Africa (55–58%),”stated the study.

For close to 50 years, the treatment landscape for TB has largely remained unchanged.

MDR-TB patients have to consume 14,000 pills for two years plus daily injections for six months at the moment. This is a path-breaking finding as MDR-TB and XDR-TB treatments usually stretch beyond two years and are extremely painful.

16 adverse events were reported in seven patients including gastrointestinal, nervous system and psychiatric troubles. Of seven patients who had serious adverse events, one patient died. The patient who died was also HIV positive.

“Although the number of patients treated in the cohort was quite small, our preliminary results show that the use of the combination of bedaquiline and delamanid appears to be safe and can lead to high rates of culture conversion in patients who have historically had very little treatment success,”the study said.

In India, patients are in dire need of these life saving drugs and innovative therapies such as the combination of Bedaquiline and Delamanid. Inspite of National Strategic Plan of India aiming to make Bedaquiline, a drug used to treat MDR-TB available at 140 sites, it is currently given to only a handful, only 728 people in all of India, in six sites are receiving the life saving drug. The gap in availibility of drug to needy patients is huge.

The WHO TB report 2017 estimates that 1,47,000 patients in India were grappling with Multi-drug resistant TB – that in which the first line drugs of Rifampacin, Isoniazid, Ethambutol and Pyrazinamide do not work. However, the Indian government has records of only 37, 258 MDR-TB patients, which means that over a lakh drug-resistant patients are going untreated.


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