A0

The shorter or longer oral Multi/ Extremely Drug-resistant TB (M/XDR-TB) regimens can be used in People Living with Human Immunodeficiency Virus (PLHIV), including those who are receiving Anti-retroviral Treatment (ART). 

The presentation of Multidrug-resistant (MDR)/ Rifampicin-resistant TB (RR-TB) in people living with HIV does not differ from that of Drug-sensitive TB (DR-TB).​ 

Clinical monitoring is one of the major components of the follow-up monitoring of Drug Resistant-TB (DR-TB) patients. 

The objective of regular clinical monitoring of patients is to ensure that the patient is adhering to treatment, progressing well and adverse effects are recognized early. 

Genotypic tests rely on amplification of a targeted genetic region of the Mycobacterium tuberculosis (M.tb) complex, typically by Polymerase Chain Reaction (PCR).

In a situation where Drug-resistant TB (DR-TB) patients may have consumed anti-TB drugs for some duration from the private sector, such prior anti-TB treatment is not likely to be uniformly reliable as far as the quality or quantity and duration of drugs consumed is concerned. 

Given that uncertainty, the basic principle is that the duration of the DR-TB regimen under the National Tuberculosis Elimination Programme (NTEP) need not be reduced. 

Many times, Drug-resistant Tuberculosis (DR-TB) patients diagnosed in the private sector will wish to avail services from the public sector. 

The National TB Elimination Programme (NTEP) strongly recommends bacteriological confirmation of any DR-TB patient before initiation of treatment and discourages any empirical treatment. 

Drug Susceptibility Testing (DST) results available from private laboratories for such patients will be considered acceptable under the following situations: 

The National TB Elimination Program (NTEP) makes an effort to provide Tuberculosis (TB) services to each TB patient, including services to Drug-resistant TB (DR-TB) patients notified/ referred from the private sector.

The requirements from institutions for establishing Nodal Drug-resistant Tuberculosis Centres (NDR-TBCs)​ are as follows:

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