Rntcp new guidelines

NEW GUIDELINES
PREPARED
BY:
TAJAMUL
MANZOOR
(INTERN)

INTRODUCTION
 Revised TB Control Programme (RNTCP) was launched in
1993
 It formulated and adopted the internationally recommended
Directly Observed Short Course (DOTS) strategy
 Objectives of RNTPCP were,
1. to achieve atleast 85% cure rate among new smear-positive cases
2. a case detection rate of atleast 70% of cases

CONT….
 The first technical and operational guidelines for RNTCP
were developed during the initial years of implementation
of the programme.
 They were updated in 2005
 Current guidelines on TB care are in line with RNTCP
national strategic plan for TB control 2012–2017

GOALS AND OBJECTIVES
 The goal of the national strategic plan is to achieve
universal access of quality of TB diagnosis and treatment
of all TB patients in the community.
 The objectives are:
1. 90% notification rate for all cases
2.90% success rate for all new and 85% for re-treatment cases
3. To significantly 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

 A key focus area was strengthening the recording and reporting
systems
 In May 2012, a Govt. of India was issued which mandates all health
care providers to notify every TB case and/or treated to the local
authorities
 Web-based TB notification system NIKSHAY was established to
provide platform for notification
 The major change in the organization structure of RNTCP is the
formation of one TB Unit per block/1.5–2.5 lakh population in
urban areas
 previous RNTCP guidelines, where there was one TB Unit per 5
lakh population/1 per 2.5 lakh in tribal, hilly and difficult areas.

CHANGES IN RNTCP GUIDELINES INCLUDES
 DEFINITIONS OF CASES
DIAGNOSTIC ALGORITHMS
DRUG REGIMENS
FOLLOW-UP OF TREATMENT
DEFINITIONS OF TREATMENT
OUTCOMES
DRUG-RESISTANT TUBERCULOSIS

PRESUMPTIVE TB-CASES DEFINITION
 Refers to a person with any of the symptoms or signs
suggestive of TB:
• cough >2 weeks
• fever >2 weeks
• significant weight loss
• hemoptysis
• any abnormalities in chest radiography
 As per the previous guidelines, a pulmonary TB suspect was defined as:
• An individual having cough for 2 weeks or more
• Contacts of smear-positive TB patients having cough for any duration
• Suspected/confirmed extra-pulmonary TB having cough for any duration
• HIV-positive patient having cough for any duration.

PRESUMPTIVE DRTB CASES DEFINITION
 TB patients who have failed treatment with
first-line anti-tubercular drugs (ATD)
 Pediatric TB non-responder
 TB patients who are contacts of DRTB
 TB patients who are found positive on any
follow-up sputum smear examination during
treatment with first-line ATD
 Previously treated TB cases
 TB patients with HIV co-infection

CLASSIFICATION OF TB
On basis of history of previous
treatment
1. New case
2. Previously treated patient
a) Recurrent TB case
b) Treatment after failure
3. Treatment after loss to follow-up

1. New case – A TB patient who has never had treatment for
TB or has taken ATD for <1 month (No change in new
guidelines)
2. Previously treated patients have received one month or
more ATD in the past. This may be:
(a) Recurrent TB case – A TB patient previously declared as
successfully treated (cured/treatment completed) and who
is subsequently found to be microbiologically confirmed
TB case. -Previously called relapse

(b)Treatment after failure – Patients are those who
have previously been treated for TB and whose
treatment failed at the end of their most recent
course of treatment.
-Previously, it was called failure where a TB patient
is sputum-positive at 5 months or more after
initiation of treatment.

3. Treatment after loss to follow-up – A TB patient
previously treated for TB for one month or more
and who was declared lost to follow-up in their
most recent course of treatment and subsequently
found microbiologically confirmed TB cases.
Previously called treatment after default – A patient
who has received treatment for TB for a month or
more from any source and return for treatment
after having defaulted, that is, not taking ATD
consecutively for 2 months or more and found to
have smear-positive

On the basis of drug resistance
1. Mono resistance (MR)
2. Poly resistance (PDR)
3. Multi-drug resistance (MDR)
4. Rifampicin resistance (RR)
5. Extensive drug resistance (XDR

 Mono resistance (MR) – A TB patient whose biological
specimen is resistant to one first-line anti-TB drug only.
 Poly resistance (PDR) – A TB patient whose biological
specimen is resistant to more than one first-line anti-TB
drug, other than both INH and Rifampicin.
 Multi-drug resistance (MDR) – A TB patient whose
biological specimen is resistant to both INH and Rifampicin
with or without resistance other first-line ATD, based on
results from a Quality Assured Laboratory. (No changes)

 Rifampicin resistance (RR) – Resistance to Rifampicin
detected by phenotypic or genotypic methods with or
without resistant to other ATD excluding INH. Patient with
RR should be managed as if they are in MDR TB case.
 Extensive drug resistance (XDR) – MDR TB case whose
biological specimen was resistant to a Fluroquinolone (FQ)
and a second-line injectable ATD from a Quality Assured
Laboratory. (No changes)

 On basis of bacteriological status
1. Microbiologically confirmed TB case
2. Clinically diagnosed TB case

 Microbiologically confirmed TB case- a presumptive
TB patient with biological specimen positive for AFB
or positive for MTB on culture, or positive for TB
through Quality Assured Rapid Diagnostic molecular
test.
 Clinically diagnosed TB case- a presumptive TB patient
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.

DRUG-SENSITIVE TB REGIMEN
Previous guidelines:
• Standard intermittent regimen
• Treatment under direct observation of Dots provider (DP)
• Category decided by MO (category I/II)
• Drugs to be taken 3 times a week under direct observation
of DP,
1. Intensive phase (IP) for 2–3 months – all doses given
under supervision
2. Continuation phase (CP) for 4–5 months – first dose of
the week given under supervision.

New guidelines:
Principle of treatment of TB has been
shifted towards daily regimen with
administration of daily fixed dose
combination of first-line ATD as per
appropriate weight bands.

Daily regimen for new TB cases
 Treatment in IP will consist of 8 weeks of INH, Rifampicin, Pyrazinamide and
Ethambutol in daily dosages as per four weight bands categories
 There will be no need for extension of IP
 Only Pyrazinamide will be stopped in CP
 Other three drugs will be continued for another 16 weeks as daily dosages

DAILY REGIMEN FOR PREVIOUSLY TREATED TB CASES
 IP will be of 12 weeks, where injection Streptomycin will be stopped after 8
weeks
 The remaining four drugs in daily dosages as per weight band for another 4
weeks
 No need of extension of IP
 At the start of CP, Pyrazinamide will be stopped
 Rest of the drugs will be continued for another 20 weeks as daily dosages.

 ACCORDING TO THE NEW GUIDELINES, ATD ARE TO BE GIVEN IN FIXED DOSE
COMBINATION AS DAILY DOSES ACCORDING TO WEIGHT BANDS
In patients with age above 50 years ,maximum dose of
streptomycin to be given is .75gm

WIEGHT BAND AND FDC FOR CHILDREN

MANAGEMENT OF EXTRA-PULMONARY TB
 There is only one change as follows:
• The CP in both new and previously treated cases may be extended 3–
6 months in certain TB such as CNS, skeletal, disseminated TB, and so
on based on clinical decision of the treating physicians
• 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)

FOLLOW-UP OF TREATMENT
 Clinical follow-up( new addition)
 Follow-up laboratory investigation
 Long-term follow-up

CLINICAL FOLLOW-UP
• Should be at least monthly
• Can be in clinical facility/patient’s house
• To observe improvement of chest symptoms, weight-gain
• Control the co-morbid conditions such as HIV and diabetes
• To monitor any adverse reaction to ATD

FOLLOW-UP LABORATORY INVESTIGATION
For PTB cases –
• Sputum smear examination at the end of IP and at the end of treatment (In the
previous guidelines, follow-up sputum smear to be done at 2, 4 and 6 months for
new cases and 3, 5 and 8 months in previously treated cases)
• In case of clinical deterioration, the Medical Office may consider repeat sputum
smear even during CP (New addition)
• At the completion of treatment, sputum smear and culture should be done for
every patient
• CXR – to be offered whenever required and available.

LONG-TERM FOLLOW-UP
• After completion of treatment, the patient should be followed up at the
end of 6, 12, 18 and 24 months
• Any clinical symptoms and/or cough, sputum microscopy and/or culture
should be considered (New addition)
(no provision of long-term follow-up in the previous guidelines)

TREATMENT OUTCOMES
1. Cured- A microbiologically confirmed TB at the beginning of the treatment
who was smear or culture-negative at the end of complete treatment.
(Changed)
2. Treatment success- TB patients either cured or treatment completed are
accounted in the treatment success. (New addition)
3. Failure- A TB patient whose biological specimen is positive by smear or
culture at the end of the treatment. (Changed)

4. Lost to follow-up- A TB patient whose treatment was interrupted for
one consecutive month or more. (New addition)
5. Not evaluated- A TB patient for whom no treatment outcome is
assigned. (known as transfer out previously)
6. Treatment regimen changed- Previously, it was called as
switched over to MDR treatment.

TREATMENT MDR/RR TB CASES (WITHOUT
ADDITIONAL RESISTANCE)
• 6–9 months of IP • IP includes Kanamycin, Levofoxacin,
Ethambutol, Pyrazinamide, Ethionamide and Cycloserine
• 18 months of CP • CP includes Levofoxacin, Ethambutol,
Ethionamide and Cycloserine
(no change)

• If INH resistance is not known or DST result shows sensitivity to INH,
then addition of INH in the above-mentioned regimen of ATD is to be
done (New addition)
• All MDR TB cases would be subjected to Liquid Culture and DST at
baseline for Kanamycin and Levofloxacin

TREATMENT FOR MONO/POLY DRTB
 Mono drugs resistance TB.
Injectable second-line drug (SLD) + FQ + Rifampicin + two out of the first-line drugs
(from H, E, Z) to which the patient is sensitive to make a total five effective drugs given
daily.
 In case of reported baseline additional resistance to other
first-line drugs (FLD) the regime is –
injection SLD + FQ + Rifampicin + any FLD to which the patient is sensitive + one of the
remaining group four drugs (Ethionamide, Cycloserine, PAS)
 In addition, high dose INH is to be added if LPA shows
inhA mutation or culture shows low-level INH resistance
.

 Total duration of treatment will be 9–12 months
 IP for 3 months with extension to a maximum 6 months and CP for 6
months depending on follow-up sputum reportsTreatment initiated at
DRTB centre

NEW ADDITIONS TO DRTB GUIDELINES
 If RR by CBNAAT, then add INH in the standard dose till result of LPA or LC and
DST.
 For new patients diagnosed as TB and RR by CBNAAT – repeat CBNAAT and send
the sample for liquid culture
 If second CBNAAT shows R sensitiveness, continue regimen for new TB cases
and wait for LC and DST.
 As soon as LC result is available, modify the regimen as follows:
 If LC shows R sensitiveness – continue regimen for new TB cases
 If LC shows R resistance – refer the patients to DRTB centre for decision regarding starting
MDR or continuing regimen for new TB cases depending on the response to treatment given so
far.

 For mixed resistance pattern, consider oral drug in the sequence of
preference –
 Pyrazanamide,
 Ethambutol,
 Ethionamide,
 Cycloserine,
 PAS,
 Clofazimine,
 Linezolide,
 Coamoxyclave,
 high dose INH,
 Clarythromycin
 Regimen designing or modification will be prerogative of the DRTB centre
committee only.

INTRODUCTION OF NEW ATD UNDER RNTCP
 Bedaquiline (BDQ):
 New class of drug, diarylquinoline that targets mycobacterial ATP synthase, and enzyme
essential for supply of energy to mycobacterium TB
 Strong bactericidal and sterilizing activities against MTB
 ADVANTAGES;
 It has no cross-resistance with first- and second-line ATD
 Significant benefit in improving the time to culture conversion in MDR TB patients
 Basic criterion –
 Adult aged ≥18 years having pulmonary MDR TB
 Female should not be pregnant.

 Additional requirements
non-pregnant females or females not on hormonal birth control
methods are eligible. They should be willing to continue
practicing birth control methods throughout the treatment period
or have been post-menopausal for past 2 years; and
patients with controlled stable arrhythmia can be considered
after obtaining cardiac consultation.

 Exclusion criteria
currently having uncontrolled cardiac arrhythmia that requires
medication;
having any of the following characteristics at screening: -
 marked prolongation of QT/QTc interval,
 history of additional risk factors for Torsade de Pointes, e.g. heart failure,
hypokalaemia, family history of long QT syndrome;

 DOSE AND ADMINISTRATION
 Week 0–2: Bdq 400 mg (4 tablets of 100 mg) daily (7 days per week)
+ OBR;
 Week 3–24: Bdq 200 mg (2 tablets of 100 mg) 3 times per week
(with at least 48 hours between doses) for a total dose of 600 mg per
week + OBR; and
 Week 25 (start of month 7) to end of treatment:
Continue other second-line anti-TB drugs only as per RNTCP
recommendations.

 DELAMANID
 Chemical class: nitroimidazole
 Mechanism of Action: Bactericidal (Half-life: 36 hours)
 By blocking the synthesis of mycolic acids (i.e., stopping the bacteria
from
creating building blocks important for their cell walls).
 By poisoning them with nitric oxide, which the drugs release when
metabolized
 Each film-coated tablet contains 50 mg Delamanid
.

 APPROVAL
 The Subject Expert Committee (Antimicrobial & Antiviral) under the Ministry of Health
and Family Welfare in its 34th meeting has approved the use of Dlm under RNTCP
PMDT through conditional access (23).
 The approval dated 14 June 2017
 Indication:
 Indicated in adults aged 18 or over 18 years as part of combination therapy
of pulmonary tuberculosis (TB) due to multi-drug tuberculosis (MDR)
Mycobacterium tuberculosis;

 Inclusion criteria:
Adults (≥18 yrs), including people living with HIV (PLHIV), not eligible for a
shorter MDR-TB regimen for reasons of resistance, contraindication or
tolerability
– MDR/RR-TB with resistance to any/all FQ OR any/all SLI
– XDR-TB
– Mixed Pattern DR-TB including patients who are failing any DR-TB regimen or
have drug intolerance or contraindications or who return after interruption or
emergence of any exclusion criteria for shorter MDR-TB regimen or with
extensive or advanced disease and others deemed at higher baseline risk for
poor outcomes.
Special caution: HIV+ (in consultation with ART centres), 65yrs+,
patients with diabetes, hepatic or severe renal impairment, history of
torsades de pointes or cardiac ventricular arrhythmias

 Exclusion Criteria:
Children under 6 years.
Pregnant & breastfeeding women (20).
Patients with repeated demonstration of a QT interval >500 ms,
history of torsades de pointes or cardiac ventricular arrhythmias
Hypersensitivity to the active substance or to any of the
excipients

 D0SE AND ADMINISTRATION
Week 0–24: Delamanid 100 mg (two tablets of 50 mg)
orally twice a day + OBR
Week 25 (start of month 7) to end of treatment:
Continue other second-line anti-TB drugs only as per
RNTCP recommendations

FOLLOW-UP:
 For MDR TB patients
 Schedule for sputum culture examination for MDR TB (no change)
 For mono DR and poly DRTB patients –
 Schedule for sputum culture examination:
Sputum smear and culture at second and third months and then culture
examination at three monthly interval till completion of the treatment.
 IP should given for at least 3 months,After this, the patient will be reviewed
 If after the 3 months the smear result remains positive, the sputum sample
is sent for genotypic DST to Rifampicin for CBNAAT or LPA and
liquid/solid culture and DST to see for resistance amplification

 FOR MDR TB PATIENTS WITH ADDITIONAL DRUGS
RESISTANCE INCLUDING XDR TB PATIENTS
 Change from IP to CP will be done after achievement
of culture conversion, that is, two consecutive
negative cultures taken at least one month apart
 In case of delay in culture conversion, IP can be
extended from 6 months to maximum 12 months.

OUTCOME FOR RR/MDR AND/OR XDR TB
PATIENTS (NEW GUIDELINES)
 Cure – Treatment completed as recommended by the National Policy without
evidence of failure and three or more consecutive cultures taken at least 30
days apart are negative after IP
 Treatment completed – Treatment completed as recommended by the National
Policy without evidence of failure but no record that three or more consecutive
cultures taken at least 30 days apart are negative after IP
 Treatment success – The sum of cured and treatment completed

 Treatment failed – Treatment terminated or need for
permanent regimen change of at least two or more ATD in CP
because of ;
 lack of microbiological conversion by the end of IP or
 microbiological reversion in the CP after conversion to negative or
 evidence of additional acquired resistance FQ or second-line injectable
drugs, or
 adverse drug reaction.

OUTCOMES FOR MONO/POLY DRUG-RESISTANT
TB PATIENTS
 Cure – A microbiologically confirmed TB at the beginning of treatment who was
culture-negative in the last month of treatment and on at least one previous occasion
 Treatment completed – A patient who has completed treatment according
to the guidelines but does not meet the definition for cure or treatment failure due to
lack of microbiological results
 Not evaluated – A DRTB patient for whom no treatment outcome is assigned,
and this included former ‘transfer out’.

 Failure – Treatment terminated or need for permanent regimen change
of at least two or more anti-TB drugs in CP because of:
 Evidence of additional acquired resistance to Rifampicin, Fluroquinolone
or second-line injectable during treatment
 Severe ADR
 Culture-positive during CP or at end of treatment
 Died – A patient who dies for any reason during the course of M/X
DRTB treatment
 Loss to follow-up – A patient whose treatment was interrupted for
one month or more for any reasons

MANAGEMENT OF TB PATIENTS WITH LIVER DISORDER
 If the serum alanine amino transferase level is more than 3
times normal before initiation of treatment, the regime
should be:
 (a) Containing two hepatotoxic drugs-
 HRE for 9 months
 HRE+S for 2 months f/b HR for 7 months
 HEZ for 6–9 months
 (b) Containing one hepatotoxic drug:
 HE+S for 2 months f/b HE for 10 months
 (c) Containing no hepatotoxic drugs:
 HE+ FQ for 18–24 months

INITIATION OF FIRST LINE ART IN RELATION TO ATD

ISONIAZID PREVENTIVE THERAPY (IPT) FOR PLHIVS
 Adult and adolescents living with HIV should be screened for TB and
those who are unlikely to have active TB should be offered IPT
 Children with HIV who have no TB symptoms and who are unlikely to
have active TB on symptom-based screening should be offered IPT
regardless of their age
 All children with HIV who have successfully completed treatment for
TB disease should receive IPT.
 Dosage of INH preventive therapy
 Adult and adolescent: INH 300 mg + Pyridoxine 50 mg per day for 6 months.
 Children above 12 months: INH 10 mg/kg + Pyridoxine 25 mg per day for 6 months.

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