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Mumbal: Eight children, including a 10-month-old baby, are among the youngest in the country to receive two of the newest anti-tuberculosis drugs-bedaquiline and de lamanid-at Byculla’s JJ Hospital under a special project to assess their safety in infants and young kids. The World Health Organization paved the way for the drugs to be used in children of all ages last March, but India has been slow to adopt the change due to lack of paediatric data.

The state-run JJ Hospital was selected last October as a nodal centre with conditional access to dispense bedaquiline and delamanid on compassionate grounds to children under five, primarily with an aim to evaluate outcomes and adverse ef fects. The Byculla hospital has since administered the drugs to eight children two suffering from multi-drug resistant TB and six from pre-extensively drug-resis tuberculosis (Pre XDRTB) Barring a fivemonth-old infant who suc cumbed due to multiple complications of tuberculo sis, the remaining seven are responding well to the new drugs, JJ doctors confirmed.

“Seven of the eight children have no untoward medical events recorded. We are closely monitoring their health,” said Dr Sushant Mane, JJ’s nodal officer for paedatrics at the National Centre for Excellence for TB, adding they have been provided with childfriendly formulations that can be dispersed in water The only kid who passed away in the cohort had an extensive spread of tuberculosis involving the lungs, heart and brain. The hospital plans to submit an interim report to the DCGI once the children complete six months of treatment.

Bedaquiline, considered one of the biggest breakthroughs in tuberculosis drug de velopment, is given only to children above five in India.

Even delamanid is approved for children from six years onwards in the country’s official document, although DCGI has, in principle, allowed its use in children above five.

“The inclusion of bedaquiline for young kids will be a paradigm shift. DCGI is just waiting for more data be fore granting approval for young babies, which institutes like JJ are collating,” said New Delhi-based Dr Sangeeta Sharma, a member of the national drug-resistant TB committee. Sharma added that her own institute, the National Institute of Tuberculosis and Respiratory Diseases, is conducting trials to assess the safety of giving bedaquiline and delamanid In younger children.

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