Redefining Pediatric TB Care: Delamanid's Impact

Young children have faced considerable challenges in the ongoing war against drug-resistant tuberculosis (TB) as a result of unpleasant injectable drugs used in treatment regimens. These medications, recognized for their severe adverse effects, have largely caused the difficulties experienced by babies and children receiving tuberculosis therapy. However, a breakthrough in India shows hope for reducing this burden.

Delamanid was approved for children under the age of five in India in March, representing a significant advancement in pediatric tuberculosis therapy. The Central TB Division revised its treatment recommendations, increasing the use of Delamanid for younger patients. Previously confined to children over six years old, Delamanid is now recommended for use in infants and children as part of the initial oral regimen for treating multidrug-resistant (MDR-TB) and extensively drug-resistant TB (XDR-TB). This approval allows for the administration of Delamanid by dosage recommendations for children weighing at least 10 kilograms. Until 25mg tablets become available under the national program, centers are advised to utilize 50mg dispersible tablets.

This approval, although arriving two years after global approval for young children, represents a significant advancement in pediatric TB treatment. It enables doctors to offer young patients an all-oral regimen, eliminating the discomfort and potential harm associated with injectables. Previously, treatment regimens for infants with XDR-TB often included injectables like amikacin, which can cause hearing loss in both children and adults.

Dr. Sushant Mane, a national expert in the National Tuberculosis Elimination Programme (NTEP) at JJ Hospital, describes this breakthrough as revolutionary, benefiting not just children but also their families. Children with drug-resistant tuberculosis are subjected to an exhausting 18-month treatment program that includes daily injections for six months. Dr. Mane emphasizes not just the discomfort of injections, but also the ongoing risk of abscesses and subsequent infections at the injection site.

Dr. Vikas Oswal, a chest physician and TB expert, highlights the importance of this judgment for Mumbai, where a significant share of patients are pre-XDR and XDR. Patients often experience hearing difficulties shortly after starting injectables, making this approval a welcome relief.

However, it’s important to note that Bedaquiline, a key component of the 9-month, all-oral regimen and the preferred treatment for children and young adolescents, is still awaiting approval for younger infants. Currently, this drug is only available in selected centers, such as JJ Hospital, under conditional access.

According to the latest India TB report from 2023, there were 1.35 lakh TB cases among children aged 0-14 years in 2022. This underscores the importance of continued advancements in pediatric TB treatment to improve outcomes for young patients across the country.

Source: Inputs from various media Sources