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Recent - Changes - in - Ntep Technical - and - Operational - Guidel
Recent - Changes - in - Ntep Technical - and - Operational - Guidel
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Editorial
steroid should be regularly screened for signs and • All presumptive TB will undergo sputum smear
symptoms of TB. examination (spot–early morning or spot–spot). If the
There is no change in the definition of presumptive first sputum is positive and not at risk for DRTB, it
extra‑pulmonary TB cases. is categorized as microbiologically confirmed TB
• Smear‑positive and presumptive multi‑drug resistance
There are few additions in the definition of presumptive TB (MDR TB): A Cartridge‑Based Nucleic Acid
TB cases in paediatric patients, where loss of body Amplification Test (CBNAAT) will be performed
weight is defined that loss of >5% body weight as to rule out Rifampicin resistance and categorized as
compared to highest weight recorded in the last microbiologically confirmed drug‑sensitive TB or
3 months. The history of unexplained or no weight gain RIF‑resistant TB
in the past 3 months and symptomatic child contact
• If the first smear is negative and chest X‑ray (CXR)
with any form of active TB in the last 2 years may be
is suggestive of TB, 2nd sample will be subjected to
significant.
smear and CBNAAT simultaneously
There have been changes in the definition of presumptive • On the basis of the CBNAAT result, patients will
DRTB cases as follows: be categorized as microbiologically confirmed
• TB patients who have failed treatment with first‑line drug‑sensitive TB or RIF‑resistant TB
anti‑tubercular drugs (ATD) • A RIF indeterminate result will get an additional
• Paediatric TB non‑responder CBNAAT to get a valid result and in case of
• TB patients who are contacts of DRTB indeterminate on second occasion, the specimen
• TB patients who are found positive on any follow‑up will be sent to the Intermediate Reference
sputum smear examination during treatment with Laboratory (IRL) or Culture and Drug Sensitivity
first‑line ATD Test (C and DST) centre for Line Probe Assay (LPA)
• Previously treated TB cases or Liquid Culture and Drug Sensitivity Test
• TB patients with HIV co‑infection. (LC and DST)
Diagnostic algorithm of pulmonary TB has been • Whenever facilities are available, effort should be
completely changed from the previous guidelines made to obtain DST results of all drugs
• If both the sputum smear and CXR are negative, the positive for acid‑fast bacilli, or positive for
patient should be referred to a pulmonologist mycobacterium TB on culture, or positive for
• All key population (PLHIV, children, EPTB, etc.) TB through Quality Assured Rapid Diagnostic
will preferentially get a CBNAAT molecular test.
• All diagnostic health care facilities should have TB
(2) Clinically diagnosed TB case refers to a presumptive
lab that are quality assured by competent authority.
TB patient who is not microbiologically confirmed,
Diagnostic algorithm of extra‑pulmonary TB has but has been diagnosed with active TB by a clinician
been completely changed: on the basis of X‑ray abnormalities, histopathology
Case definition: There are significant changes in the or clinical signs with a decision to treat the patient
definition of cases as per New Guidelines: with a full course of anti‑TB treatment.
(1) Microbiologically confirmed TB case refers to a Microbiologically confirmed or clinically diagnosed
presumptive TB patient with biological specimen cases of TB are classified according to
Drug Dosage for Adult TB Difference of RNTCP regimen between new and
previous guidelines
Weight Number of tablets (FDCs) lnj.
category Intensive phase Continuation phase Streptomycin New guidelines Previous guidelines
HRZE HRE Daily regimen Intermittent regimen
75/150/400/275 75/150/275 gm Ethambutol in CP of both Ethambutol in CP of
25‑39 kg 2 2 0.5 categories I and II regimen category II regimen only
40‑54 kg 3 3 0.75 Fixed dose combination as per No fixed dose, limited
weight band weight band
55‑69 kg 4 4 1
No need of extension of IP Extension of IP for 1 month
>=70 5 5 1
if sputum is positive at the
end of IP
In patients above 50 years of age, maximum dose of
Follow‑up-clinical, laboratory Follow‑up-laboratory only
Streptomycin should be 0.75 g. investigation
Drug Dosage for Pediatric TB Long‑term follow‑up up to 2 years No long‑term follow‑up
(a) Containing two hepatotoxic drugs: INH + • It has no cross‑resistance with first‑ and
Rifampicin + Ethambutol for 9 months second‑line ATD
or • Significant benefit in improving the time to
(b) INH + Rifampicin + Ethambutol + Streptomycin for culture conversion in MDR TB patients
2 months followed by INH and Rifampicin for 7 months • RNTCP introducing BDQ at six sites in the
or country initially
(c) Rifampicin + Ethambutol + Pyrazinamide for • Basic criterion – Adult aged ≥18 years having
6–9 months. pulmonary MDR TB
(d) Containing one hepatotoxic drug: • Female should not be pregnant.
INH + Ethambutol + Streptomycin for 2 months
followed by INH + Ethambutol for 10 months.
(e) Containing no hepatotoxic drugs:
Streptomycin + Ethambutol + FQ for 18–24 months.
Initiation of first‑line ART in relation to ATD
Clinical CD4 cell Timing of ART ART
staging count in relation to Recommendati ons
(cells/ initiation of
mm3) TB treatment
Start ART CD4 Start ATT first Start ART Regimen
irrespective count of Start ART as TLE for patients not
of any any soon as TB on ART.
clinical value treatment Forpatients already
stage is tolerateon 151 line ART,
(between2 ZLN, shift to ZLE
weeks and 2& continue ZLE
months) even after ATT is
stopped.
T = Tenofovir 300MG + L = Lamivudine 300MG + E = Efavirenz
600MG (FDC) Z= Zidovudine + L = Lamivudine 300MG + N =
Nevirapine E = Efavirenz 600MG
Appropriate modification of the treatment regimen can • In case of reported baseline additional resistance to
be done in case of additional resistance. other first‑line drugs (FLD) the regime is – injection
SLD + FQ + Rifampicin + any FLD to which the
If isoniazid resistance is found, the use of isoniazid
patient is sensitive + one of the remaining group four
depends on:
drugs (Ethionamide, Cycloserine, PAS)
1. If high‑level resistance detected by liquid
• In addition, high dose INH is to be added if LPA
culture – omit INH.
shows inhA mutation or culture shows low‑level INH
2. If low‑level resistance detected by LC – add high
resistance
dose INH.
• Total duration of treatment will be 9–12 months
3. If LPA reports INH resistance by Kat G
• IP for 3 months with extension to a maximum
mutation – omit INH.
6 months and CP for 6 months depending on
4. If LPA reports INH resistance by INH A
follow‑up sputum reports
mutation – add high dose INH.
• Treatment initiated at DRTB centre.
There are some new additions
• If RR by CBNAAT, then add INH in the standard Type of TB Case Treatment regimen Treatment
dose till result of LPA or LC and DST. in IP regimen CP
• For new patients diagnosed as TB and RR by Rifampicin Sensitive INH (3‑6) Km Lfx R E Z (6) Lfx R E Z
CBNAAT – repeat CBNAAT and send the sample Resistant1TB & DST of (modify treatment treatment of
SEZ not known based on baseline MDR/RR with
for liquid culture
DST report to E, Z, Additional
• If second CBNAAT shows RR then start KM, CM, Lfx, Mfx) Resistance
standard MDR till result for culture DST
available. Perform DST to INH and SLDST on
liquid culture. Type of TB Case Treatment Treatment
regimen in IP regimen CP
• If second CBNAAT shows R sensitiveness,
MDR or Rifampicin (6‑9) Km Lfx (18) Lfx Eto
continue regimen for new TB cases and wait for Resistant TB Eto Cs Z Cs
LC and DST. As soon as LC result is available, + Ethambutol
modify the regimen as follows: resistance
• If LC shows R sensitiveness – continue MDR or Rifampicin (6‑9) Km Lfx (18) Lfx Eto
regimen for new TB cases Resistant TB + Eto Cs E Cs E
• If LC shows R resistance – refer the patients Pyrazinamide
resistance
to DRTB centre for decision regarding
MDR or Rifampicin (6‑9) Km Lfx (18) Lfx Eto
starting MDR or continuing regimen for Resistant TB + Eto Cs PAS Cs PAS
new TB cases depending on the response to Ethambutol +
treatment given so far. Pyrazinamide
• For mixed resistance pattern, consider oral drug in the resistance
sequence of preference – Pyrazanamide, Ethambutol, MDR or Rifampicin (6‑9) Km Mfx (18) Mfx
Ethionamide, Cycloserine, PAS, Clofazimine, Linezolide, Resistant TB + Eto Cs Z E Eto Cs E
Levofloxacin PAS Cfz PAS Cfz
Coamoxyclave, high dose INH, Clarythromycin
• Regimen designing or modification will be MDR or Rifampicin (6‑9) Km Lfx (18) Lfx Eto
prerogative of the DRTB centre committee only. Resistant TB + Eto Cs Z E Cs E PAS
Moxifloxacin PAS Cfz Cfz
Treatment of mono/poly drug resistance TB MDR or Rifampicin (6‑12) Km (18) Eto Cs
• On receiving reports showing mono/poly Resistant Eto Cs Z E E PAS Cfz
TB+Resistance PAS Cfz Lzd Lzd
DRTB from the quality assured C and DST laboratory, to all
the patients and the family members are counselled Fluoroquinolones
• Pre‑treatment evaluation by the DRTB centre MDR or Rifampicin (6‑9) Cm Lfx (18) Lfx Eto
committee Resistant TB + Eto Cs Z E Cs E
• Mono drugs resistance TB. Resistance
• Injectable second‑line drug (SLD) + FQ + to Km only
Rifampicin + two out of the first‑line drugs MDR or Rifampicin (6‑12) Lfx (18) Lvx
(from H, E, Z) to which the patient is sensitive Resistant TB + Eto Cs Z E Eto Cs E
to make a total five effective drugs given Resistance to all SL PAS Cfz Lzd PAS Cfz
daily. Injectable Lzd
• There are additions of some new chapters on diabetes This is an open access article distributed under the terms of the Creative Commons
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• Clear‑cut guidelines regarding absolute
contraindication of ATD, reintroduction of ATD Access this article online
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following adverse drug reactions, algorithm on liver
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Disease with TB and kidney disease with TB. www.jacpjournal.org
Arunabha D. Chaudhuri
Department of Pulmonary Medicine, R.G. Kar Medical College, DOI:
10.4103/2320-8775.196644
Kolkata, West Bengal, India