Eligibility Criteria for the Use of Bedaquiline [Bdq] in MDR/RR-TB Treatment​

A patient undergoing Multidrug-resistant (MDR)/ Rifampicin-resistant (RR) -TB treatment​ may be eligible for the use of Bedaquiline (Bdq) based on the following inclusion and exclusion criteria:

Inclusion Criteria

1. Adult DR-TB patients ≥ 18 years
2. Children aged 5 years to less than 18 years of age and weighing at least 15 kg; given their special needs, in consultation with a paediatrician
3. Patients with controlled stable arrhythmia can be considered after obtaining cardiac consultation
4. Pregnant and lactating women (though not contraindicated, need to take all precautions)

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Exclusion Criteria

1. Patients currently having an uncontrolled cardiac arrhythmia that requires medication
2. Patients having any of the following QT prolongation (Fredericia’s correction- QTcF) interval characteristics at screening:
   • QTcF >500 at baseline and normal electrolytes, ECG to be repeated after 6 hours and if both ECGs show QTcF >500 then the patient should not be challenged with cardiotoxic drugs.
   • History of additional risk factors for Torsade de Pointes, e.g., heart failure, hypokalemia, family history of long QT syndrome

If the results of the serum chemistry panel, haematology or urinalysis are outside the normal reference range (including the above-listed parameters), the patient may still be considered based on the treating physician's judgement. (Hypokalemia, hypomagnesemia and hypocalcemia should be corrected prior to a patient receiving any QTc prolonging drugs).

Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.
• Consolidated Guidelines on Tuberculosis: Module 4 – Treatment: Drug-resistant TB Treatment, 2020.
• The Use of Bedaquiline in the Treatment of Multidrug-resistant Tuberculosis: Interim Policy Guidance, 2013.

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