Treatment Algorithm for MDR/RR-TB

The treatment algorithm for Multidrug-resistant/ Rifampicin-resistant TB (MDR/ RR-TB) patients is a part of an integrated diagnostic and treatment algorithm under Programmatic Management of Drug-resistant Tuberculosis (PMDT).

A shorter oral Bedaquiline (Bdq)-containing MDR/ RR-TB regimen is recommended for those MDR/ RR-TB patients in whom resistance to the component drugs has been excluded or those who have not been previously treated for more than one month with second-line drugs used in shorter oral Bdq - containing MDR/ RR-TB regimen and have no other exclusion criteria. 

All those MDR/ RR-TB patients who are not eligible for a shorter Bdq - containing regimen, after careful evaluation, are considered for a longer M/ XDR-TB regimen. 

The treatment algorithm for MDR/ RR-TB patients is shown below.

Figure: Treatment Algorithm for MDR/RR-TB; Source: PMDT Guidelines India, March 2021, p46.

Footnotes for the Algorithm

⁴ As per mutation pattern, includes resistance inferred. 

⁵ Discordance in RR results between Nucleic Acid Amplification Tests (NAAT) & First-line Line Probe Assay (FL-LPA) to be resolved with a repeat NAAT at Culture and Drug Susceptibility Testing (C&DST) lab and microbiologists will provide the final decision. InhA mutation is associated with Eto resistance. Use other exclusion criteria to decide regimen if FL-LPA is done on culture isolates for patients with smear-negative specimens. 

⁶ To assess Levofloxacin (Lfx), Moxifloxacin (Mfx) and Amikacin (Am) resistance. 

⁷ Start treatment based on Line Probe Assay (LPA) results and modify based on Liquid Culture (LC) and DST results later.

⁸ Whenever DST is available.​

⁹ Other exclusion criteria for shorter oral Bdq-containing MDR/ RR-TB regimen includes:

• History of exposure for > 1 month to Bdq, Lfx, Ethionamide (Eto), or Clofazimine (Cfz), if the result for DST (Bdq, Fluoroquinolone (FQ), Inh A mutation, Cfz & Pyrazinamide (Z)) is not available.
• Intolerance to any drug or risk of toxicity from a drug in the shorter oral Bdq-containing MDR/ RR-TB regimen (e.g. drug-drug interactions).
• Extensive TB disease – the presence of bilateral cavitary disease or extensive parenchymal damage on chest radiography. In children aged under 15 years, presence of cavities or bilateral disease on chest radiography.
• Severe Extrapulmonary TB (EP-TB) disease - the presence of miliary TB or TB meningitis or Central Nervous System (CNS) TB. In children aged under 15 years, extra-pulmonary forms of disease other than lymphadenopathy (peripheral nodes or isolated mediastinal mass without compression).
• Pregnant and lactating women (with conditional exceptions).
• Children below 5 years.​

¹⁰ This portion applies as states move to a shorter oral Bdq-containing MDR/ RR-TB regimen under the guidance of the National TB Elimination Programme (NTEP).

¹¹ Patients who were on a longer oral M/ XDR-TB regimen based on the history of exposure for >1 month and in whom resistance is not detected to Isoniazid (H) or FQ may be switched to shorter oral Bedaquiline containing MDR/ RR-TB regimen based on the FL and Second-line LPA (SL-LPA) results if the duration of longer oral M/ XDR-TB regimen drugs consumed is <1 month.

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Resources

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

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