Revised definitions of TB cases

and management as per NTEP

Dept. of Community
Medicine
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 LEARNING OBJECTIVES

• Introduction to the program

• Problem statement
• Revised case definition
• Management
– Diagnostic tools
– Diagnostic algorithms
• New paradigm of TB treatment
• Management of TB in special situations
• Summary

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 INTRODUCTION
• 2020: RNTCP renamed as NTEP
• National Strategic Plan for Tuberculosis Elimination 2017-2025

• National Strategic Plan for Tuberculosis Control 2012-2017

• 2006-11: 2nd phase of RNTCP with improved quality and reach of services

• 1997: DOTS - launched as the RNTCP strategy

• 1993: NTP was revitalised as Revised National Tuberculosis Control

Program (RNTCP).

• 1962: The National Tuberculosis Control Programme (NTP) of India was

launched.
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 NTEP
• Key activities
– active TB case finding
– use of newer and shorter regimen
– private sector engagement
– financial/nutritional support to TB patients
– IT enabled surveillance
– preventive and awareness measures.

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 Table showing the estimated figures for TB burden
globally and for India by WHO for 2018
Estimates of TB Global (Million) India % of Global
Burden (2018)

Incidence TB cases 10 2.69 million 27%

Moratlity of TB 1.2 440,000 31%

Incidence HIVTB 0.86 92,000 9%

Mortality of HIV-TB 0.25 9,700 4%

MDR-TB 0.5 130,000 24%

Children with TB 1.12 342,000 31%

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 CASE DEFINITIONS
• Bacteriologically confirmed TB
• refers to a presumptive TB case from whom a biological specimen is
positive for acid fast bacilli, or positive for Mycobacterium tuberculosis on
culture, or positive for tuberculosis through Rapid Diagnostic molecular
test
• Clinically Diagnosed TB
• refers to a presumptive TB case who is not microbiologically confirmed,
but has been diagnosed with active TB by a clinician on the basis of X-ray
abnormalities, histopathology or clinical signs with a decision to treat the
patient with a full course of Anti-TB treatment.

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 Presumptive TB definitions
new guidelines Previous guidelines
• refers to a person with any of the • pulmonary TB suspect was defined as:
symptoms and signs suggestive – any individual having cough >
of TB 2weeks
– cough >2 weeks – contacts of smear positive TB
patients having cough for any
– fever >2 weeks duration
– significant weight loss – suspected/confirmed EPTB having
– haemoptysis cough for any duration
– any abnormality in chest – HIV positive patient having cough
for any duration
radiograph.

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 Presumptive DR TB cases
New guidelines
– refers to the patient who is eligible for
Rifampicin resistant screening at the
time of diagnosis or/and during the
course of treatment for DS TB or H
mono/poly & includes following
patients:
• All Notified TB patients (Public and
private)
• Follow-up positive on microscopy
including treatment failures on
standard first line treatment and all
oral H mono/poly regimen
• Any clinical non-responder including
paediatric (if specimen available)
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Previous guidelines
• TB patients who have failed
treatment with 1st line ATD
• Pediatric TB non responders
• TB patients who are contacts of
DRTB
• TB patients who are found positive
on any follow up sputum smear
examination during t/t with 1st line
ATD
• previously treated TB cases
• TB patients with HIV coinfection
8
 Presumptive Paediatric TB
• refers to children:
– persistent fever >2weeks
– cough >2 weeks
– loss of weight/ no weight gain and/ or
history of contact with infectious TB
cases.
– In a symptomatic child, contact with
a person with any form of active TB
within last 2 years may be significant.
–History of unexplained weight loss or no
weight gain in past 3 months
–loss of weight - defined as loss of more
than 5% body weight as compared to
highest weight recorded in last 3 months.
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Presumptive Extra Pulmonary TB
– refers to the presence of organ-
specific symptoms and signs:
– swelling of lymph node, pain
– swelling in joints, neck stiffness,
disorientation, etc.,
– constitutional symptoms like
significant weight loss, persistent
fever for 2 weeks or more, night
sweats.
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 Classification based on history of previous TB treatment
New guideline Previous guideline
• New TB patient • same as the new guideline
– A TB patient who has never had treatment
for TB or has taken anti-TB drugs for less
than one month is considered as a new
TB patient.
• Previously treated TB
– A patient who has received one month or
more of anti-TB drugs from any source in
the past.
• Recurrent TB patient - A TB Patient
previously declared as successfully • previously called relapse
treated (cured/treatment completed) and
is subsequently found to be
microbiologically confirmed TB is a
recurrent TB patient.
• Treatment after failure patients - those
who have previously been treated for TB • called failure where a TB patient is sputum
3/9/2021 and whose treatment failed at the end of positive at 5 months or more after initiation 10
their most recent course of treatment.
of treatment
 New guidelines Previous guidelines
• Treatment after lost to follow-up • Treatment after default: patient
A TB patient previously treated for TB who has received treatment for TB
for one month or more and was
for a month or more from any source
declared lost to follow-up (LFU) in their
most recent course of treatment and and return for treatment after having
subsequently found to be defaulted i.e not taking ATD
microbiologically confirmed TB consecutively for 2 months or more
• Other previously treated patients are
and found to have smear positive
those who have previously been
treated, who cannot be classified into
any of the above.
• Transfer in a TB patient who has been
received for treatment in a Tuberculosis Unit,
after starting treatment in another TB unit where
s/he has been registered is considered as
transferred in.

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 • Classification based on anatomical site of disease
a. Pulmonary tuberculosis (PTB)
b. Extra Pulmonary tuberculosis (EPTB)
c. Miliary TB is classified as PTB because there are lesions in the lungs.
A patient with both pulmonary and extra-pulmonary TB should be
classified as a case of Pulmonary TB.
• Classification based on drug resistance
a. Mono-resistant (MR)
b. Poly-Drug Resistant (PDR)
c. Multi Drug Resistant (MDR)
d. Extensively Drug Resistant (XDR)
e. Rifampicin Resistant (RR)
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• Classification based on HIV status
a. HIV - positive TB
b. HIV - negative TB
c. HIV status unknown TB

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 MANAGEMENT AS PER NTEP

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 Diagnostic Tools

Tools for microbiological confirmation of TB

A. Sputum Smear Microscopy (for AFB):
– Zeihl-Neelsen Staining
– Fluorescence staining
B. Culture:
– Solid (Lowenstein Jensen) media
– Automated Liquid culture systems e.g. BACTEC MGIT 960, BacT
Alert or Versatrek etc.
C. Drug Sensitivity Testing:
– Modified Proportionate Sensitivity Testing (PST) for MGIT 960
system
–
3/9/2021 Economic variant of Proportion sensitivity testing (1%) using LJ 15
medium
 D. Rapid molecular diagnostic tests:
– Line Probe Assay (LPA) for MTB complex and detection of RIF & INH
resistance (FL LPA) and FQ and SLI resistance (SL LPA)
– Nucleic Acid Amplification Test (NAAT) (CBNAAT/TrueNat)
Other diagnostic tools:
• Radiography
• serological tests, tuberculin tests, IGRA- not to be used for diagnosis of TB

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 Diagnostic Algorithm for Drug Sensitive TB

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 Diagnostic algorithm for Paediatric Pulmonary TB

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 Anti TB Drugs
• Anti-TB drugs have the following three actions:
a. Early bactericidal activity
b. Sterilizing activity
c. Ability to prevent emergence of drug resistance
Drugs Early bactericidal Sterilizing activity Prevention of
emergence of drug
resistance
Isoniazid (H) ++++ ++ ++++

Rifampicin (R) +++ ++++ +++

Streptomycin (Z) +++ - ++

Pyrazinamide (E) ++ +++ +

Ethambutol (S) + - ++
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 DRUG-SENSITIVE TB REGIMEN
Previous Guidelines: New guidelines:
• Standard intermittent regimen • Principle of treatment of TB has
• Treatment under direct observation been shifted towards daily regimen
of DOTS provider (DP) with administration of daily fixed
• Category decided by MO (cat I/II) dose combinations (FDCs) of 1st
line ATD as per appropriate weight
• Drugs to be taken 3 times a week
bands.
under direct observation of DP
• No need of extension of IP
1. Intensive phase (IP) for 2 – 3
• Only pyrazinamide will be stopped
months: all doses given under
in CP
supervision
2. Continuation phase (CP) for 4 – 5
months: 1st dose of the week
given under supervision
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 Treatment Regimen
• Intensive phase (IP) - 8 weeks (56 doses) of isoniazid (H), rifampicin (R),
pyrazinamide (Z) and ethambutol (E) given under direct observation in daily
dosages as per weight band categories.

• Continuation phase (CP) - 16 weeks (112 doses) of isoniazid, rifampicin and

ethambutol in daily dosages. Only pyrazinamide will be stopped in the
continuation phase. The CP may be extended by 12-24 weeks in certain
forms of TB like CNS TB, Skeletal TB, Disseminated TB etc. based on clinical
decision of the treating physician on case to case basis. Extension beyond 12
weeks should only be on recommendation of specialists.
Type of TB case Treatment Regimen in IP Treatment Regimen in CP
(Weeks) (Weeks)
New and previously treated 2 HRZE 4 HRE
cases (H and R Sensitive / (8 weeks) (16 weeks)
unknown)
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 Drug dosages for first line anti-TB drugs
Drugs Adults Children Maximum in
children
Isoniazid 5mg/kg daily 10 mg/kg daily 300 mg
(4 - 6 mg/kg) (7 – 15 mg/kg)
Rifampicin 10 mg/kg daily 15 mg/kg daily 600 mg
(8 - 12 mg/kg) (10 - 20 mg/kg)
Pyrazinamide 25 mg/kg daily 35 mg/kg daily 2000 mg
(20 – 30 mg) (30 – 40 mg/kg)
Ethambutol* 15 mg/kg daily 20 mg/kg daily 1500 mg
(12 – 18 mg/kg) (15 – 25 mg/kg)
Streptomycin** 15 mg/kg daily 20 mg/kg daily 1000 mg
(15 – 20 mg/kg) (15 – 20 mg/kg)

**Streptomycin is administered only in certain situations, like TB meningitis or if any first line drug need
to be replaced due to ADR as per weight of the patient.
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 FDCs IN NTEP

• Adults
• 4-FDC
• given in IP
• consists of HRZE

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 FDCs IN NTEP
• Adults
• 3-FDC
• given in CP
• consists of
HRE

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 Daily dose schedule for adults (as per weight
bands)
Old dose schedule revised dose schedule
Weight Numbers of tablets (FDCs)
Categor
y Intensive phase Continuation
HRZE phase
HRE
75/150/400/275 75/150/275
25 – 34 2 2
kg

35 – 49 3 3
kg
50 – 64 4 4
kg
65 – 75 5 5
kg
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 Drug dosage for pediatric TB

• Dispersible FDC,
flavoured
– Rifampicin 75 mg +
Isoniazid 50 mg +
Pyrazinamide 150 mg
– Rifampicin 75 mg +
Isoniazid 50 mg

• Dispersible Loose drugs

– Ethambutol 100 mg
– Isoniazid 100 mg
A=Adult FDC (HRZE = 75/150/400/275; HRE = 75/150/275). It is added in higher weight band
categories i.e. > 25 kg as these children may be able to swallow tablets.
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 FDC for
pediatric TB
• Paediatric
patient

• Dispersible 3
FDC consists of
HRZ

• Dispersible 2
FDC consists of
HR.

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 Management of Hospitalized patients
• Usual mode of TB treatment - domiciliary, but patients require
hospitalization in the following conditions:
– pneumothorax or
– large accumulations of pleural fluid leading to breathlessness
– massive hemoptysis
– In case of severe adverse reactions
– Severe malnutrition
• If the hospitalized patient is newly diagnosed, he/she should be notified.
Once back, home visits to be conducted.
• In case of transfer for t/t: follow up results and treatment outcome should
be sent back to the referring PHI/TU and updated in Nikshay
• On discharge, patients may be given a maximum of 1-week drug supply
to cover the transit period prior to their resumption of treatment at their
respective DOT Centre, ensuring uninterrupted treatment.
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 Management of Extrapulmonary TB
• The treatment regimen and schedule for EP TB cases will remain
the same as for pulmonary TB.
• The duration of continuation phase in EPTB may be extended by 3
to 6 months in special situations like TB meningitis, Bone & Joint TB,
Spinal TB with neurological involvement and neuro- tuberculosis.
• Extension beyond 3 months will only be on recommendation of
experts of concerned field.

(In the previous guidelines, extension of ATD in case of CNS

and skeletal TB was maximum 3 months)

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 MANAGEMENT OF DR-TB

INTEGRATED DR TB ALGORITHM
• Main objective of this algorithm is to segregate people based on
risk assessment for DR TB and offer DST guided treatment based
on drug resistance status at least for R resistance at the time of
diagnosis of TB

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Standard regimen for initiating treatment of MDR/RR
TB or H mono-poly DR TB
Regimen class Intensive phase Continuation phase

H mono/poly DR TB (R resistance not detected and H resistance)

All oral H mono-poly DR TB regimen@ (6) Lfx R E Z

MDR / RR TB

Shorter MDR TB regimen@ (4-6) Mfxh Km / Am* EtoCfz Z Hh (5) MfxhCfz Z E

E
All oral longer MDR TB (18-20) Bdq(6) LfxLzd#Cfz Cs
regimen@

*If the intensive phase is prolonged, the injectable agent is only given three times a week in the
extended intensive phase.
# Reduce Lzd to 300 mg/day after 6 to 8 months.
@ Pyridoxin to be given to all DR TB patients as per weight band.
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• All oral H mono/ poly DR TB regimen is of 6 months with no separate IP/CP
• Shorter MDR TB regimen : 9 – 11 months
– 4 – 6 months IP containing injectables
– 5 months CP
• If IP prolonged: injectables given 3 times/ week in the extended IP
• All oral longer MDR TB regimen : 18-20 months with no separate IP/CP
• Newer drugs like Bdq & Dlm would be given for 6 months duration; dose of
Lzd will be tapered to 300mg after the initial 6-8 months of t/t
• This regimen will also be used for t/t of XDR TB patients with 20 months
duration

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 Management of TB patients in special situations
• TB in Pregnant and Lactating women
• TB and Contraceptive pills usage
• TB in patients with liver disorders
• TB patient with renal failure and severe renal insufficiency
• TB in patients with seizure disorders
• Anti-TB Treatment of HIV infected TB patients
• TB and Diabetes
• TB and Nutrition

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 SUMMARY

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 Thank you

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 REFERENCES
• Training Modules (1-4) for Programme Managers And Medical Officers;
New Delhi, India: Central TB Division, MoHFW, Government of India;
July 2020., www.tbcindia.gov.in (accessed )
• Park, K., n.d. Park's textbook of preventive and social medicine. 25th
ed.
• https://www.nhp.gov.in/revised-national-tuberculosis-control-
programme_pg. (last accessed on 16.08.2021)
• Kishore J. National health programs of India. 12th ed. New Delhi; 2017.
• Kadri A. IAPSM’s Textbook of Community Medicine. 2nd ed. [S.l.]:
Jaypee Brothers Medical P; 2021.

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