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

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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

Drugs Not Included in Groups A - C and Rationale for Non-inclusion

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There are some anti-TB drugs that are not included in the conventional Groups A, B and C of anti-TB medicines.

The table below shows these drugs and the rationale for not including them in longer Multidrug-resistant TB (MDR-TB) regimens.

Rationale for Grouping of Anti-TB Drugs

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The anti-TB drugs recommended for the treatment of Multi-drug Resistant (MDR)/ Rifampicin-resistant Tuberculosis (RR-TB) patients are grouped based on their efficacy, safety, experience of use of the drug and drug class.

Drugs Used in the Management of Adverse Events

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Adverse events may occur during anti-TB treatment and need to be managed using certain drugs.

The table below provides information on specific drugs suggested for managing Adverse Drug Reactions (ADRs) during anti-TB treatment.

Role of the State Drug Store [SDS] in the Constitution of Patient-wise Boxes

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The State Drug Store (SDS) shall constitute drug boxes for:

Shorter oral Bedaquiline (Bdq)-containing Multi-drug resistant (MDR)/ Rifampicin-resistant Tuberculosis (RR-TB) regimen (Type A and B)
Longer oral Multi (M)/ Extensively Drug-resistant Tuberculosis (XDR-TB) regimen
Isoniazid (H) mono/ poly DR-TB regimen

Boxes will be prepared manually only and not through Nikshay Aushadhi software.

From Nikshay Aushadhi drugs will be supplied in loose to districts.

Guidelines for Issuing Bedaquiline and Delamanid to the Patient

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Loose drugs will be supplied to the Nodal (N)/ District DR-TB Centre (DDR-TBC) from the State Drug Stores (SDS)/ District Drug Stores (DDS) as per the consumption pattern of the previous month and requested via Nikshay Aushadhi.

Constituents of Patient-wise Boxes [PWB] for Isoniazid [H] Mono/Poly DR-TB Regimen

Standard Patient-wise Boxes (PWBs) are constituted for TB patients initiated on Isoniazid (H) Mono/ Poly Drug-resistant TB (DR-TB) regimen.

This regimen has no segregation in terms of Intensive Phase (IP) or Continuation Phase (CP), hence drugs are provided in a single type of PWB.

Table: Constituents of standard PWB (6 months) of H mono/ poly DR-TB regimen; Source: Guidelines for PMDT, India 2021, p134

STANDARD PWB

Management of DR-TB Patients: Lost to Follow-up

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Patients who are “lost to follow-up” (interrupt treatment continuously for 2 months or more) and return back for Drug-resistant TB (DR-TB) treatment under National TB Elimination Programme (NTEP):