Drug Resistance Tuberculosis (DR-TB)

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It is a laboratory diagnosis confirmed after testing Mycobacterium tuberculosis strains for resistance  using WHO recommended rapid genotypic tests like gene-expert or conventional phenotypic culture  and DST. 

Clinical presentation 

The features are the same as susceptible tuberculosis but patient shows resistance to the first line  treatments.  Signs  and  symptoms  of  DR-TB  are  like  those  of  drug-susceptible  TB  (cough,  bloody  stained sputum, fever, night sweats and weight loss).  Patients with the following features have high DR-TB risk (presumptive DR-TB patients):

  • History of previous TB treatment 
    • Treatment failure after using first-line anti-TB medicines 
    • Relapse and return after loss to follow-up, without recent treatment failure 
    • Patients  who  remain  sputum  smear-positive  at  month  two  or  later  during treatment of TB using first-line anti TB medicines  
  • Close contact of a known DR-TB case 
  • Healthcare workers presenting with TB symptoms
  • Vulnerable groups in congregate settings (prisoners, urban poor, miners, PWIDs) 

All presumptive DR-TB cases adults and children must receive the Xpert MTB/RIF test as the initial  diagnostic test to ensure universal coverage of DST. 

Pharmacological Treatment 

When you diagnose RR/MDR TB communicate with DTLC for initiation of treatment. 

Table 7.4  Proposed MDR TB treatment regimens

 Age Group  Patient Condition Proposed Regimens

Intensive Phase

--------------------

Continuation Phase*

If any of the medicines cannot be used, consult the DR-TB consillium to consider replacement if needed using one or more of the following based on DST prior use and likelihood of efficacy (in order of priority)

Adults and children >12 yrs

MDR/RR-TB susceptible to fluoroquinolone

6 Lfx - Bdq - Lzd - Cfz – Cs

12 Lfx - Cfz - Cs

E, Z, Pto, PAS

MDR/RR-TB with resistance to fluoroquinolone (pre- XDR) or extensive drug resistance (XDR-TB)

6 Bdq - Lzd - Cfz - Cs – Dlm

14 Lzd - Cfz - Cs

E, Z, Pto, PAS

Central nervous system disease

6 Lfx - Lzd - Cs – Pto – Z

14 Lfx - Lzd – Cs - Z

INHHD (if low-level H resistance - inhA mutation)1
Pregnant RR/MDR-TB

20 Lfx - Cs -E -Cfz- Z

Consult consillium on all pregnant
cases. Consider strengthening the regimen post-partum with the addition of  Bdq and Lzd (for 6 months; to replace Class C medicines if possible).

Table 7.5: Paediatric treatment regimens for children <12 years with non-severe disease 

 Age Group  Patient Condition Proposed Regimens

Intensive Phase

---------------

Continuation Phase*

If any of the medicines cannot be used, consult the DR-TB consillium to consider replacement if needed using one or more of the following based on DST prior use and likelihood of efficacy (in order of priority)

Children 6 – 12 yrs

RR/MDR TB
susceptible to
fluoroquinolone

6 Lfx – Bdq – Lzd – Cs 

3 Lfx – Lzd – Cs 

Cfz, Dlm1 (E if documented sensitivity), Z (Cfz preferred over Cs if 50mg capsule
available)

RR/MDR-TB with  resistance to  fluoroquinolone (pre- XDR) or extensive  drug resistance (XDR- TB)

6 Bdq - Lzd - Cs - PAS 

3 Lzd - Cs - PAS

Cfz, Dlm1(E if documented sensitivity), Z (Cfz preferred over PAS if 50mg capsule available)

3 – 6 yrs

RR/MDR TB susceptible to fluoroquinolone

9 Lfx/Mfx - Lzd - Cs - Eto

 Cfz, Dlm1, PAS (E if documented sensitivity), Z; Eto should not be used if inhA mutation
(Cfz preferred over Eto if 50mg capsule available)
RR/MDR-TB with  resistance to  fluoroquinolone

6 Lzd - Cs – Dlm1- Eto

3 Lzd – Cs - Eto

  

Cfz, PAS (E if documented sensitivity), Z; 
Eto should not be used if inhA mutation 
(Cfz preferred over Eto if 50mg capsule available)
< 3 yrs 

RR/MDR-TB susceptible to fluoroquinolone

9 Lfx/Mfx - Lzd - Cs - Eto

 Cfz, PAS (E if documented sensitivity), Z;  Eto should not be used if inhA mutation  (Cfz preferred over Eto if 50mg capsule  available) 
RR/MDR-TB with  resistance to  fluoroquinolone 

6 Lzd - Cs – PAS – Eto

3 Lzd- Cs - PAS 

  

Cfz, Dlm1 (E or Z if documented sensitivity) 
(Cfz preferred over Eto if 50mg capsule available) 

Table 7.6: Modified Short Treatment Regimen 

 Age Group  Patient Condition Proposed Regimens

Intensive Phase

Continuation Phase

15 yrs and above

Patient eligible for short treatment  regimen

6 Bdq – Lzd – Lfx – Cfz – Cs  – Z

3-5 Lfx – Cfz –  Cs – Z

Patient eligible for short treatment  regimen but cannot tolerate  linezolid (Haemoglobin (Hb) < 8 g/dL, neutrophils <0.75 x109/L or  platelets <50 x109/L or severe  peripheral neuropathy grade ≥2 or  optic neuritis grade ≥2 at baseline) 

6 Bdq – Dlm– Lfx – Cfz – Cs  – Z

3-5 Lfx – Cfz –  Cs – Z