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The principles of designing Drug-resistant TB (DR-TB) treatment regimens (Shorter or longer oral Multi (M)/ Extensively Drug-resistant TB (XDR-TB), and H mono/ poly DR-TB regimens in children are similar to adults:

 

  • Children, aged 5 years to less than 18 years of age and weighing at least 15 kg, are eligible for both longer oral and shorter oral Bedaquiline-containing Multidrug-resistant (MDR)/ Rifampicin-resistant TB (RR-TB) regimens.​
  • Management of H mono/ poly DR-TB in children will be the same as in adults and child-friendly formulations can be used.
  • The drug doses should be used as per paediatric weight bands.
  • Bedaquiline (Bdq) tablets suspended in water have been shown to have the same bioavailability as tablets swallowed whole and therefore, should be used to treat DR-TB in children until a child-friendly formulation becomes available.​
  • Delamanid (Dlm) is already approved for treating M/XDR-TB under the National TB Elimination Programme (NTEP) for children from 6 years onwards.​
  • As in adults, the extension of Bdq beyond 6 months and concomitant use of Bdq and Dlm in special situations will apply to children as well. ​
  • Treatment can be directly extended to 9 months in certain conditions like extensive disease, extrapulmonary TB, uncontrolled comorbidity, bacteriologically positive children at the end of the 4th month and when the regimen is modified.
  • Shortening the total treatment duration to less than 18 months may be considered in children without the extensive disease.​
  • For children under 5 years of age, where neither Bdq nor Dlm is approved yet, the longer oral M/XDR-TB regimen should be suitably modified as per the replacement drug. A suitable regimen can be designed considering child-friendly formulations where Bdq can be replaced with Amikacin (Am), Pyrazinamide (Z) or Ethionamide (Eto) in the initial phase.​
  • Children below 5 years are not excluded from short-course regimens, instead receive short course injectables till further evidence on the use of Bdq is available.
  • The use of injectable agents in children should be exceptional and limited to salvage treatment and be monitored for early detection of ototoxicity. 
  • Meropenem is the preferred drug over imipenem in TB meningitis considering the risk of seizures in children due to Imipenem.

 

Additional Information

 

  • Achieving an appropriate dose in children aged 3-5 years will be easier when the special formulation dispersible 25 mg tablet used in trials in these age groups becomes available.​
  • The recent data review for the World Health Organization (WHO) guidelines suggested that there are no additional safety concerns for concurrent use of Dlm with Bdq.​
  • For treatment and management of adverse drug reactions in children, there should be provision for treatment in consultation with a specialist. 

 

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