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Treatment of MDR-TB TRC Experience (1980-2005)

Treatment of MDR-TB TRC Experience (1980-2005). Tuberculosis Research Centre (ICMR) Chennai. TRC ICMR. Tuberculosis Research Centre Chennai. Established in 1956

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Treatment of MDR-TB TRC Experience (1980-2005)

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  1. Treatment of MDR-TB TRC Experience (1980-2005) Tuberculosis Research Centre (ICMR) Chennai

  2. TRC ICMR Tuberculosis Research CentreChennai • Established in 1956 • Randomised clinical trials in pulmonary & EPTB • Rifampicin containing regimens used since 1974 • Supranational reference lab. for mycobacteriology • Culture sensitivity available for all patients • Monitoring DOTS programme in a rural area since 1999

  3. TRC ICMR Principles of management of MDR TB at TRC • When patients were failing/relapsing, regimen was chosen based on the last susceptibility results available • Rx was changed according to patient response & susceptibility results • Choice of the regimen was based on the available drugs for managing MDR TB at the time • Rx was supervised for the first 6-month of injection phase thrice weekly • Subsequently, drugs were supplied once-a- week/fortnight and intake monitored by home visits • Patients were seen every month with clinical and bacteriological monitoring and X-ray once in 6-months

  4. TRC ICMR Drugs for MDRTB Drug Dose (mgm) • Kanamycin 1000 • Ofloxacin 400 – 600 • Ethionamide 500 • Cycloserine 500 • Amikacin 500 • Ethambutol 600 – 1200 • PAS 10 gms • Thioacetazone 150 • Isoniazid 600

  5. TRC ICMR Contents TRC experience in managing MDR TB • Pre-quinolone era • Quinolone era • Field experience

  6. TRC ICMR Pre-quinolone era

  7. TRC ICMR Response of H/SH resistant pts. to re-treatment regimens

  8. TRC ICMR Response of pts. to re-treatment regimens according to resistance pattern

  9. TRC ICMR Response of MDR-TB pts. to re-treatment/ Salvage regimens

  10. TRC ICMR Quinolone era

  11. TRC ICMR Total pts. 218 Age 15 – 64 yrs ( Median 34 ) Sex - males 159 ( 73 % ) Weight range 24 – 69.5 kg (Mean 41.6) MDR management TRC experience 1980 – 2002 (RCTs)

  12. TRC ICMR Drug susceptibility profile among MDR pts (n=218) Initial res.to HR 121 Acquired res.to HR 97 Initial res. to H 65 Initial res. to R 4

  13. TRC ICMR Details of radiological findings (n=218)

  14. TRC ICMR Details of previous anti-tuberculosis therapy 149

  15. TRC ICMR Drug regimens Used

  16. TRC ICMR Treatment outcome with SCC regimens

  17. TRC ICMR Response to first Rx regimen for MDR TB

  18. TRC ICMR Treatment outcome based on initial & further change of regimens

  19. TRC ICMR Month of smear conversion among cured patients

  20. TRC ICMR MDRTB at TRC: Outcome of Treatment1980-2002 (n=184)

  21. TRC ICMR Adverse reactions in TRC studies

  22. TRC ICMR Field experience

  23. TRC ICMR When to evaluate for MDR TB ? • Patients not showing any reduction in bacillary population after 3-months of regular treatment with Cat II regimen • Sputum positive patients who are contacts of a known MDR TB patient

  24. TRC ICMR How to evaluate MDR TB ? • MDR TB is only a laboratory proved HR resistance • Clinical suspicion should be followed by lab. Confirmation • Laboratories should be quality controlled

  25. TRC ICMR Drug Resistance in TB When to suspect drug resistance? • Persistent sputum positivity • Fall and rise phenomenon of sputum AFB • Clinical or radiological deterioration in the presence of positive sputum Provided patient has been regular in drug intake

  26. TRC ICMR Drug susceptibility profile at the time of failure (Cat I: N=74) 16 18 10

  27. TRC ICMR Susceptibility profile at the time of relapse (Cat I) : N 43

  28. TRC ICMR Management of MDR TB in the field • Basically 3 new drugs, S/K Eth O Z E • Initial hospitalisation at least for one month • Monthly supply of drugs given to respective PHI • DOT provider identified • TRC staff visits once a month • Pt attends TRC once a month for review • Clinical & bacteriological evaluation monthly

  29. TRC ICMR Results • Patients admitted from May 2000 – Dec’2003 • No. of MDR-TB patients : 51 • Males : 33 (65%) • Mean age in yrs : 38 (14-75) • Mean wt. In Kg : 41.7 ( 23.2-60.5)

  30. TRC ICMR Pattern of drug resistance (N=51)

  31. TRC ICMR Drug regimens used Duration of Rx 18-24 months

  32. TRC ICMR Smear & culture conversion at 6-m

  33. TRC ICMR Status at 6-m according to resistance pattern

  34. TRC ICMR Measures to improve Rx outcome for MDR-TB • Standardised / Individualised treatment • Supervision • Hospitalisation

  35. TRC ICMR Individualised Regimen for MDR-TB

  36. TRC ICMR Standardised Regimen for MDR-TB

  37. TRC ICMR To conclude • Availability of 2nd line drugs, including quinolone, alone was not adequate for managing MDR TB • Early detection, individually tailored regimen did not help to improve the Rx outcome • Directly observed treatment has given better results • Hospitalisation for the entire period of treatment has given better outcome

  38. TRC ICMR Recommendations • MDR TB should be always laboratory proved & Clinical suspicion should be followed by lab. Confirmation • Labs should be established in all states • Hospitalisation & supervision of Rx for the initial 3-6 mths of period is recommended for better outcome

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