TB Diagnosis and Treatment Guidelines

Technical and Operational
Guidelines for TB Control in India
2016 -
with Focus on Recent Change in the
Programme
Junior Resident: Dr. Tanveer Rehman
Faculty Moderator: Dr. Palanivel C

CONTENTS
1. Introduction
2. Changes/Additions in Recent Programme
3. Presumptive TB case
4. Diagnostic Tools
5. Diagnosis strategy
6. Specimen Collection & Transport
7. PMDT
8. Treatment
9. Follow up
10. Treatment support program
11. Treatment outcomes
12. Puducherry
13. Summary
229-01-2018 Dr Tanveer Rehman PSM JIPMER

INTRODUCTION
• Brief History of TB Control in India
The objectives of the National Strategic Plan (2012-2017) are:
1. achieve 90% notification rate for all cases
2. To achieve 90% success rate for all new and 85% for re-treatment cases
3. To improve the successful outcome of treatment for DRTB cases
4. To achieve decreased morbidity and mortality for HIV-associated TB cases
5. To improve the outcome of TB care in the private sectors

Changes/Additions in Recent Programme
1. Sub District Level 2. Presumptive TB & DR-TB case
3. Diagnostic algorithm 4. Case definitions
5. Principle of TB Treatment 6. Enhanced enables and incentives
7. Introduction of BDQ 8. New treatment Card
9. ICT enabled adherence support 10. Follow up
11. Treatment outcomes 12. Special situations
29-01-2018 4Dr Tanveer Rehman PSM JIPMER

Presumptive TB case: Previous guideline
1. An individual having persistent cough for 2 weeks or more, with or without - fever, weight
loss, night sweat, haemoptysis
2. Cough of any duration for special groups like
1. Contacts of smear-positive TB patients
2. Suspected/confirmed extra-pulmonary TB
3. HIV-positive patient

Presumptive TB case
• New Guideline (any of the following)
1. Cough >2 weeks, or
2. Fever >2 weeks, or
3. Significant weight loss, or
4. Haemoptysis, or
5. Any abnormalities in chest radiography, or
6. Contact of microbiologically confirmed TB patients, PL HIV, diabetics, malnourished,
cancer patients, patients on immunosuppressive therapy or steroid should be regularly
screened for signs and symptoms of TB

Diagnostic Tools available in the program
1. Sputum Smear Microscopy (for AFB) : ZN, Fluorescence
2. Culture :
Solid (LJ) media
Automated Liquid culture systems eg. BACTEC MGIT 960, BactiAlert
Drug Sensitivity Testing (DST)
3. Rapid molecular diagnostic testing:
Line Probe Assay for MTB complex and detection of RIF & INH Resistance
NAAT Xpert MTB/Rif testing using the GeneXpert system

DIAGNOSIS STRATEGY
1. Diagnostic algorithm of TB has been completely changed from the
previous guideline
2. All TB cases diagnosed must be offered testing for HIV
3. All key population (PLHIV, children, EPTB, etc.) will preferentially get a
CBNAAT : upfront CBNAAT
4. “order to DO” – “order of consideration”

Case scenario 1
A patient with H/O cough for >2 weeks is unwilling to come to give sputum
sample next day morning as he lives far away from the PHC. How to collect
his sputum ?

Case scenario 2
If the first sputum smear is positive of a patient with H/O significant weight
loss, and the second smear not available; how to diagnose TB in this
patient?

Case scenario 3
If the first sputum smear is negative and the CXR (done a week back)
suggestive of TB, what is the next step?

Case scenario 3: Answer
1. 2nd sample – smear and CBNAAT both
2. If both positive – diagnosed
3. If both negative – physician call
4. If CBNAAT positive, smear negative – MTB +/-
5. If CBNAAT negative, smear positive – physician call

Pooled sensitivity and specificity of different screening
tools for TB, using culture-confirmed pulmonary TB as
the gold standard

Specimen Collection & Transport
A good quality sputum specimen:
1. Open air room
2. Rinse
3. Inhale
4. Cough out bronchial secretions
5. Volume 3-5 mL
• Result within a day (if delay: 1 week - refrigerate)
• Disinfect – 5% phenol

Programmatic Management of Drug Resistant TB
(PMDT)
1. DOTS Plus
2. Once the MO PHI confirms presumptive DR-TB – 2 sputum specimen
3. Presumptive DR-TB:
• TB patients who have failed treatment with first-line ATD
• Paediatric TB non-responder
• TB patients who are contacts of DRTB
• TB patients who are found positive on any follow-up sputum smear examination
• Previously treated TB cases
• TB patients with HIV co-infection

Integrated DR-TB diagnostic algorithm

Case scenario 4
4.2 Patient X had taken TB treatment three years back in RNTCP and declared
cured. Now he is having cough with sputum for three weeks duration? As per the
new guideline, what steps to be followed for management of TB?
29-01-2018 19
4.1 Patient X is having cough with sputum for three weeks duration. He is coming
from a high MDR-TB setting (MDR TB rate > 5% among new case or >20 % among
re-treatment cases). As per the new guideline, what steps to be followed for
management of TB?
Dr Tanveer Rehman PSM JIPMER

Paediatric Algorithm

TREATMENT
Case definition : significant changes
1. Microbiologically confirmed TB case
2. Clinically diagnosed TB case
3. Microbiologically confirmed or clinically diagnosed cases of TB are
classified according to
i. Anatomical site of disease
ii. History of previous TB
iii. Drug resistance

CASE DEFINITION
Previous guidelines New guidelines
New case: Never had treatment, or
has taken ATD for <1 month
New case: No change
Relapse Recurrent TB case: Declared as successfully treated -
subsequently found to be
microbiologically confirmed TB case

CASE DEFINITION
Previous guidelines New guidelines
Failure: Previously received one month/more
ATD - sputum-positive at 5 months or more
Treatment after failure: Previously received
one month/more ATD - treatment failed at the
end of treatment
Default : Received treatment for TB for a
month/more - not taking ATD consecutively
for
2 months or more and found to have
smear-positive
Treatment after loss to follow-up: Previously
treated for TB for one month/more -
declared lost to follow-up in treatment and
subsequently found microbiologically
confirmed TB

TREATMENT
Case definition : significant changes
Drug resistance
1. Mono resistance (MR)
2. Poly resistance (PDR)
3. Multi-drug resistance (MDR)
4. Rifampicin resistance (RR)
5. Extensive drug resistance (XDR)

TREATMENT
Principle of treatment of TB has been shifted
1. Daily regimen
2. Fixed dose combination
3. Weight bands for adult: (Y,B,G,P)
4. No need for extension of IP
5. In the previous guidelines, extension of ATD in case of CNS and skeletal
TB was maximum 3 months

TREATMENT REGIMEN
Type Intensive Phase Continuation Phase
CAT I (2) HRZE (4) HR
CAT II (2) HRZES + (1) HRZE (5) HRE
New Guidelines
CAT I (8 weeks) 4FDC (16 weeks) 3FDC
CAT II (8 weeks) 4FDC + S + (4 weeks) 4FDC (20 weeks) 3FDC

TREATMENT

New Treatment Card

Old Treatment Card

Additions in the Treatment Card
FRONT BACK
1. NIKSHAY ID 1. Frequency
2. Aadhar No. 2. Formulation
3. Treatment adherence 3. Packaging
4. Source of treatment 4. Weight Bands
5. Number Screened 5. Height
6. Addiction 6. Adverse events
7. Follow up & findings
8. Nutrition support

Drug Resistant TB in Pregnancy

Intensified TB Case Finding (ICF)
1. Provider initiated activity
2. Early identification - high probability of having active TB
3. Screening & diagnosing – appropriate tests and strategies
4. Vulnerable groups to be offered upfront CBNAAT
5. Vulnerable group is any group of people in which the prevalence or incidence of TB is
significantly higher than in the general population.
6. Enhanced outreach – detect more cases
7. Passive screening – missed or delayed diagnosis

Classification of Vulnerable groups

ICT enabled adherence support - 99DOTS
1. Low-cost approach for monitoring and improving TB medication
adherence
2. First used under RNTCP - 2015 in high-burden ART TB-HIV – FDC
3. In 2016 - expanded to all ART Centres in India
4. Registered over 75,408 patients all over India. In Puducherry : IGMC&RI
5. Three key benefits: It reduces patients’ burden - improves the efficiency
of care providers - enables differentiated care

Each ATD pack is wrapped in a custom envelope, which includes hidden
phone numbers that are visible only when doses are dispensed

After taking daily medication, patients make a free call to the hidden toll-free
phone number, yielding high confidence that the dose was “in-hand” and has
been taken

Program staff can login into www.99dots.org from their computer / mobile
(using Nikshay username and password) to see the patient adherence

Treatment support program
1. Principle of direct observation
2. Short messaging service (SMS) gateway: Patient can report events like
pill consumption, S/E – incoming services in pre-recorded Interactive
voice response (IVR)
3. Innovatively designed cards: Doctors will give these - patient SMS to
CCC- reminders medication - incentives - follow up calls health tips
4. Patient compliance toolkit: Mobile app for reporting compliance using
audio/video/SMS

FOLLOW UP
Clinical Long-term
1. Should be at least monthly
2. Patient may visit the clinical facility, or
3. The medical officer may conduct the
review when she/he visits the house of
the patient
4. To observe improvement of chest
symptoms, weight gain, control the
co-morbid conditions such as HIV and
diabetes and to monitor any adverse
reaction to ATD
1. After completion of treatment, the patient
should be followed up at the end of 6,
12, 18 and 24 months
2. Any clinical symptoms and/or cough,
sputum microscopy and/or culture
should be considered

Treatment outcomes for drug susceptible TB patients
1. Cured : A microbiologically confirmed TB – smear or culture negative at the end of
complete treatment (Changed)
2. Treatment completed
3. Treatment success: TB patients either cured or treatment completed are accounted in
the treatment success (New addition)
4. Failure: A TB patient whose biological specimen is positive by smear or culture at the
end of the treatment (Changed)
5. Lost to follow-up: Treatment interrupted for one consecutive month or more
(New addition)

Treatment outcomes for drug susceptible TB patients
6. Failure to respond: Paediatric TB – fails microbiological conversion / response clinically/
deteriorates after 12 weeks of compliant intensive phase; alternate diagnosis ruled out
(New addition)
7. Not evaluated : No treatment outcome is assigned (Former transfer out)
8. Treatment regimen changed : Previously, it was called as switched over to MDR
treatment
9. Died

PUDUCHERRY STC & SDS

PUDUCHERRY STDC, IRL, C&DST

PUDUCHERRY
1. TU: Total 7 - 4 in Pondicherry, Rest 3 districts
2. DMC: Total 28 - Puducherry 22, Karaikal 3, Mahe 2, Yanam 1
3. Daily Dose started
4. Other than GHCD, JIPMER also performs CBNAAT/LPA
5. 1421 TB patients notified
6. ICT : Only ‘99 DOTS’ started : IGMC&RI
7. Incentives not given
8. BDQ not started

SUMMARY
New guidelines
1. Daily regimen
2. Ethambutol in CP of both
categories I and II regimen
3. Fixed dose combination as per
weight band
4. No need of extension of IP
5. Follow-up-clinical, laboratory
investigation
6. Long-term follow-up up to 2
years
Previous guidelines
1. Intermittent regimen
2. Ethambutol in CP of category II
regimen only
3. No fixed dose, limited weight
band
4. Extension of IP for 1 month if
sputum is positive at the end of
IP
5. Follow-up-laboratory only
6. No long-term follow-up

THANK YOU

TB Diagnosis and Treatment Guidelines

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