Additional Considerations for the Use of Newer Drugs in Longer Oral M/XDR-TB Regimen

Delamanid (Dlm) can be provided to adults and children aged 2 years to <18 years, given their special needs in consultation with a paediatrician.​ Special considerations while using Dlm include:

• Dlm will be considered only for a longer oral Multi (M)/ Extensively Drug-resistant TB (XDR-TB) regimenand not for a shorter oral M/XDR TB regimen.
• It is important that Dlm is taken daily preferably after a standard meal to improve bioavailability.​
• If taking a light meal with Dlm and other anti-TB drugs, patients should not consume milk-containing products at the same time as calcium can decrease the absorption of Fluoroquinolone (FQs).​
• Other second-line drugs that are likely to be administered with  Dlm, notably Bedaquiline (Bdq), Fluoroquinolones (FQs) and Clofazimine (Cfz), may potentially increase the risk of cardiotoxicity; so there is a need to extensive monitor for cardiotoxicity.​

Delamanid Use in People Living with HIV (PLHIV)

Drug-drug interaction studies of Dlm with Tenofovir, Efavirenz and Lopinavir/ Ritonavir, respectively, suggested that no dose adjustments were needed when Dlm was used with any of these Antiretroviral (ARV) agents.​ However, there is still not enough evidence on safety, hence the ART regimen is to be designed in close consultation with an ART specialist for the patient on a Dlm-containing regimen.

Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.
• WHO Consolidated Guidelines on Tuberculosis: Module 4 – Treatment: Drug-resistant TB Treatment, 2020.

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