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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

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

Tuberculosis Research Centre (ICMR)

Chennai


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


Principles of management of mdr tb at trc

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


Drugs for mdrtb

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


Contents

TRC ICMR

Contents

TRC experience in managing MDR TB

  • Pre-quinolone era

  • Quinolone era

  • Field experience


Pre quinolone era

TRC ICMR

Pre-quinolone era


Response of h sh resistant pts to re treatment regimens

TRC ICMR

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


Response of pts to re treatment regimens according to resistance pattern

TRC ICMR

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


Response of mdr tb pts to re treatment salvage regimens

TRC ICMR

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


Quinolone era

TRC ICMR

Quinolone era


Mdr management trc experience 1980 2002 rcts

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)


Drug susceptibility profile among mdr pts n 218

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


Details of radiological findings n 218

TRC ICMR

Details of radiological findings (n=218)


Details of previous anti tuberculosis therapy

TRC ICMR

Details of previous anti-tuberculosis therapy

149


Drug regimens used

TRC ICMR

Drug regimens Used


Treatment outcome with scc regimens

TRC ICMR

Treatment outcome with SCC regimens


Response to first rx regimen for mdr tb

TRC ICMR

Response to first Rx regimen for MDR TB


Treatment outcome based on initial further change of regimens

TRC ICMR

Treatment outcome based on initial & further change of regimens


Month of smear conversion among cured patients

TRC ICMR

Month of smear conversion among cured patients


Mdrtb at trc outcome of treatment 1980 2002 n 184

TRC ICMR

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


Adverse reactions in trc studies

TRC ICMR

Adverse reactions in TRC studies


Field experience

TRC ICMR

Field experience


When to evaluate for mdr tb

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


How to evaluate mdr tb

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


Drug resistance in tb

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


Drug susceptibility profile at the time of failure cat i n 74

TRC ICMR

Drug susceptibility profile at the time of failure (Cat I: N=74)

16

18

10


Susceptibility profile at the time of relapse cat i n 43

TRC ICMR

Susceptibility profile at the time of relapse (Cat I) : N 43


Management of mdr tb in the field

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


Results

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)


Pattern of drug resistance n 51

TRC ICMR

Pattern of drug resistance (N=51)


Drug regimens used duration of rx 18 24 months

TRC ICMR

Drug regimens used Duration of Rx 18-24 months


Smear culture conversion at 6 m

TRC ICMR

Smear & culture conversion at 6-m


Status at 6 m according to resistance pattern

TRC ICMR

Status at 6-m according to resistance pattern


TRC ICMR

Measures to improve Rx outcome

for MDR-TB

  • Standardised / Individualised treatment

  • Supervision

  • Hospitalisation


Individualised regimen for mdr tb

TRC ICMR

Individualised Regimen for MDR-TB


Standardised regimen for mdr tb

TRC ICMR

Standardised Regimen for MDR-TB


To conclude

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


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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