Shorter Oral Bedaquiline-containing regimen is recommended for Multidrug-resistant/ Rifampicin-resistant (MDR/RR-TB) patients in whom:

1. Resistance to the component drugs has been excluded; OR
2. No previous treatment for more than one month, with second-line drugs used in shorter oral Bedaquiline-containing MDR/RR-TB regimen, has been given; AND
3. No other exclusion criteria as listed below is present.

Inclusion Criteria

Drug Susceptibility Testing (DST) based inclusion criteria:

The total duration of treatment in this regimen is 9-11 months with Intensive Phase (IP) at least 4 months and Continuation Phase (CP) for 5 months. Treatment extension of IP is done up to 2 months based on follow-up results and is indicated in the algorithm presented in the figure below.

Figure: Treatment Extension/ Regimen Change Based on Follow up Smear/ Culture/ DST Results

Based on the World Health Organization (WHO) treatment guidelines, 2020 recommendations, the National TB Elimination Programme (NTEP) have decided to transition from the current shorter injectable-containing Multi-drug Resistant (MDR)/ Rifampicin-resistant TB (RR-TB) regimen to the shorter oral bedaquiline-containing MDR/RR-TB regimen in the year 2021.​

Salient Features of the Shorter Oral Bedaquiline-containing MDR/RR-TB Regimen

There are five principal ways to prevent Drug-resistant Tuberculosis (DR-TB) as given in the figure below.

Figure: Five Principal Ways to Prevent DR-TB; Source: Guideline for PMDT in India, 2021.

Baseline Second-line Drug-susceptibility Test (SL-DST) means to offer (DST) for Fluoroquinolones (FQ) once Rifampicin (R) and/or Isoniazid (Inh) resistance is diagnosed.

Pre-treatment counselling must serve as an informed decision-making process that enables patients to make a duly informed decision regarding the use of all anti-TB drugs and regimen, including newer drugs. 

Written consent is not needed for any treatment regimen under National TB Elimination Programme (NTEP).

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Figure: Key points to be covered during pre-treatment counselling; Source: PMDT Guidelines India, 2021, p45.

Drug resistance is caused by a genetic mutation that makes the drug ineffective against the mutant bacilli.

The causes of drug-resistant TB can be enumerated as follows: 

1. Providers/ Programme Related Causes:

• Inadequate or poorly administered TB treatment regimen
• Unavailability or poor quality of anti-TB drugs
• Poor monitoring of TB treatment
• Delay in detection and management of DR-TB

2. TB Patient/ Host Related Causes:

There are two main evaluations that must be conducted during pre-treatment evaluation to initiate patients on a shorter oral bedaquiline-containing MDR/RR-TB regimen. These evaluations are:

Clinical Evaluation

• History and physical examination
• Height check
• Weight check
• Psychiatric evaluation, if required

Laboratory-based Evaluation

Delamanid (Dlm) is the first approved drug in the class of nitro-dihydro-imidazo-oxazoles for the treatment of Multi-drug Resistant TB (MDR-TB). 

Figure: Delamanid (DLM) Tablets

Mechanism of Action

It is a bactericidal drug with 36 hours of half-life and acts with two different mechanisms of action.