RNTCP NEW GUIDELINES

2017
Dr.K.GANESH KUMAR MBBS.,DTCD,
MEDICAL OFFICER – DTC
SALEM.
 Pulmonary Tuberculosis diagnostic algorithm

Presumptive TB patient
PLHIV
*status Not known/HIV Negative

Smear Examination CXR

Smear Positive and Smear Positive but Smear Negative but Smear Negative /NA &
CXR suggestive of TB Clinical
CXR suggestive of TB CXR Not suggestive of TB CXR not suggestive of Suspicion High
CBNAAT TB/NA

MTB Positive MTB Negative Consider

alternative
Rif Rif Rif Follow diagnosis and
sensitive Indeterminate Resistant PMDT refer to the
guidelines specialist
Repeat CBNAAT
Microbiologically on 2ndsample
Confirmed MTB *All presumptive TB cases should be offered HIV
Indeterminate on 2ndsample collect
counseling and testing :however diagnostic work
fresh sample for LC/LPA
up for TB must not be delayed.
 TB CLASSIFICATION
• Microbiologically confirmed TB Case - Presumptive TB Patient with biological
specimen
Positive for AFB
Positive for MTB on culture
Positive for TB through quality assured rapid
diagnostic Molecular Tests

• Clinically Diagnosed TB Case- Presumptive TB Patient not Micro.confirmed

Diagnosed as active TB by clinician based on
CXR abnormality/HPE /Clinical signs
with a decision to treat the patient with full course of ATT
 TB AFFECTS ALL ORGANS IN BODY EXCEPT HAIR AND NAILS
1.LYMPH NODES (LYMPHADENITIS/COLD ABSCESS)-CERVICAL,HILAR

2.BRAIN (MENINGITIS/ENCEPHALITIS/TUBERCULOMA/HYDROCEPHALUS)

3.SPINE

4.EYE(CONJUCTIVITIS/EPISCLERITIS/CORNEAL ULCER/CHOROIDITIS/EALES )

5.HEART(PERICARDITIS)

6.PLEURA(PLEURAL EFFUSION)

7.ABDOMEN( ASCITES,ILEOCAECAL ,MESENTERIC NODES)

8.GENITAL ORGANS( MALE-EPIDIDYMIS, FEMALE- SALPHINGITIS,ENDOMETRITIS)

9.URINARY SYSTEM( RENAL ,BLADDER)

10.SKIN

11.JOINTS (ARTHRITIS,SYNOVITIS)

12.BONE(OSTEOMYELITIS)

13.ENT ( OTITS/LARNYNGITIS)
 TYPE OF PATIENT
TREATMENT GROUPS

MICROBIOLOGICALLY CONFIRMED TB CASE

(DEFINITIVE TB CASE)
NEW
CLINICALLY DIAGNOSED TB CASE (PROBABLE TB)

RECURRENT TB
PREVIOUSLY
TREATED TREATMENT AFTER FAILURE

TREATMENT AFTER LOSS TO FOLLOWUP

OTHER PREVIOUSLY TREATED PATIENT

 Type of TB Patients
A TB patient who has received one month or more of
Previously Treated
anti‐TB drugs in the past

A TB Patient declared as successfully treated (cured/treatment completed)

i Recurrent as is subsequently found to be microbiologically confirmed TB case

Treatment after A TB patient who has previously been treated for TB and his treatment
ii failed at the end of their most recent course of treatment
Failure

Treatment after A TB patient previously treated for TB for 1 month or more and was
iii declared LFU in the end of their most recent course of treatment and
LFU subsequently found microbiologically Positive

Other previously TB patients who have been previously treated for TB but whose outcome
iv after their most recent course of treatment is unknown or documented
Treated patients
 Treatment Outcome
Microbiologically confirmed TB patients at the beginning of treatment who
Cured
was smear or culture negative at the end of the complete treatment

A TB patient who completed treatment without evidence of failure or

Treatment clinical deterioration BUT with no record to show that the smear or culture
Completed results of biological specimen in the last month of treatment was negative,
either because test was not done or because result is unavailable

A TB patient whose biological specimen is positive by smear or culture at

end of treatment

Failure Failure to Respond: A case of paediatric TB who fails to have

bacteriological conversion to negative status or fails to respond
clinically / or deteriorates after 12 weeks of compliant intensive phase
shall be deemed to have failed response provided alternative
diagnoses / reasons for non‐response have been ruled out
 Treatment Outcome

A TB patient whose treatment was interrupted for 1 consecutive

Lost to follow up
month or more

A TB Patient for whom no treatment outcome is assigned. This

Not Evaluated
includes former “transfer-out”

A TB patient who is on first line regimen and has been diagnosed

Treatment
as having DRTB and switched to drug resistant TB regimen prior
Regimen Changed to being declared as failed

Died A patient who has died during the course of anti-TB treatment
 DAILY REGIMEN GUIDELINES
• Daily treatment to be rolled out before 25th of October 2017

• All patients who are already on intermittent treatment will

continue the same till completion of their course.

• Daily treatment to be initiated only to those cases for whom

fresh treatment course is initiated (New as well as RT)

• All paediatric cases will continue intermittent treatment, until

paediatric FDC strips are received.
 DRUG STOCK

• All FDC stock to be entered as number of strips in all the

stock registers & not as PWBs

• Both 4 FDC & 3 FDC to be entered separately

 DISPENSING FDC STRIPS
• All issue of FDC to Treatment Supporters shall be in
complete strips of 28 tablets.

• Strips should NOT be cut when dispensing to patients or

Treatment supporters. Whole strips of 28 tablets per strip
should be used.

• Partially used Strips of patients lost to follow up or patients

who have died, must be returned to the district drug store
until further directions.
 DISPENSING FDC STRIPS
• CAT I ATT – Issue drugs for a month and verify empty blister
packs while coming for next month Drug collection.

• CAT II ATT- Issue 1 Strip & Streptomycin for 10 days

pending culture reports (LPA/CBNAAT) and then issue
monthly drugs
 DOSAGE
• Frequency of Dosage: DAILY (7 day/week)

• Single daily dosage

• 4 weeks per month, i.e.: 28 doses

 OLD DRUG BOXES & HIV TB CASES
• All the balance stocks of Cat I Cat II boxes of Intermittent
regimen to be sent to District stores(DTC)

• Treatment for co-infected cases will continue from ART

centres. Drugs for TBHIV co-infected cases also will be
supplied from FDCs received for the district.

• 99 dots will continue only for all TBHIV co-infected cases for
the time being.
 Anti TB Treatment (Daily)
Type of TB Case Treatment Regimen

New
A TB patient who has never had 2H7R7Z7E7 + 4H7R7E7
Treatment with anti‐TB drugs or
has taken it for less than one month

2H7R7Z7E7S7
Previously Treated +
A TB patient who has received one 1H7R7Z7E7
month or more of anti‐TB drugs in the +
past
5H7R7E7

4 FDC will be used in IP 3 FDC will be used in CP

 FDC DRUGS

4 FDC- R150 H75 Z400 E275mg 3FDC - R150 H75 E275mg

 Inj. Streptomycin
• 15 mg/kg (12–18 mg/kg) daily

• Maximum daily dose 1000 mg

• Patients aged over 50 years may not tolerate the daily dose of
Streptomycin more than 750 mg

• Similarly, patients weighing less than 50 kg may not tolerate

doses above 500-750 mg daily

30
 Daily Dose Schedule for Adults
(as per weight bands)
Number of tablets
Inj. Streptomycin
Continuation
Intensive phase (Intensive Phase
Weight band phase
only)
HRZE [4FDC] HRE [3FDC]
75/150/400/275 mg 75/150/275 mg gm
25-39 kg 2 2 0.5 gm

40-54 kg 3 3 0.75 gm

55-69 kg 4 4 1 gm

≥70 5 5 1 gm
 TB: New case treatment (adults)
Intensive phase Total Number of Total No. of Strips
Patient body weight (kg) strip per month
(2 months) RHZE tablets required required
30-39 2 112 4 2
40-54 3 168 6 3
55-69 4 224 8 4
≥70 5 280 10 5

Total Number of Total No. of Strips

Continuation phase
Patient body weight (kg) tablets required required strip per month
(4 months) HRE

30-39 2 224 8 2
40-54 3 336 12 3
55-69 4 448 16 4
≥70 5 560 20 5
 TB: Retreatment case treatment (adults)

Patient body weight IP (3 months) Total Number of Total No. of strip per Inj.STREPTOMYCIN No.of SM
(kg) RHZE tablets required Strips required month (2 Months) Injections

30-39 2 168 6 2 0.5g 56

40-54 3 252 9 3 0.75g 56
55-70 4 336 12 4 1g 56
≥70 5 420 15 5 1g 56
Inj.Streptomycin daily for 2 months (56 days)

Continuation phase Total Number of Total No. of

Patient body weight (kg) strip per month
(5 months) HRE tablets required Strips required

30-39 2 280 10 2
40-54 3 420 15 3
55-70 4 560 20 4
≥70 5 700 25 5
 Key Product Information (Paediatric)
(Dispersible FDC)

• Rifampicin 75 mg + Isoniazid 50 mg + Pyrazinamide 150 mg

• Rifampicin 75 mg + Isoniazid 50 mg
• Formulation: Dispersible; flavor

• Ethambutol 100 mg
• Isoniazid 100 mg
• Formulation: Dispersible
Daily dispersible FDCs Paediatric Anti-TB drugs

WT BAND COMBI

4 TO 7 C+E
8TO 11 2C+2E
12 TO 15 3C+3E

16TO 24 4C+4E

25TO 29 A+3C+3E

30 TO 39 2A+2C+2E

C: HRZ paediatric base dose (dispersible) H 50mg R 75 mg Z 150 mg

A: Adult 4FDC base dose
E: Ethambutol 100mg (dispersible)
 Daily dispersible FDCs Paediatric Anti-TB drugs
(will be available under RNTCP for TBHIV patients 2016)

WT BAND COMBI INH RIF PZA EMB

4 TO 7 C+E 50 75 150 100

8TO 11 2C+2E 100 150 300 200
12 TO 15 3C+3E 150 225 450 300

16TO 24 4C+4E 200 300 600 400

25TO 29 A+3C+3E 225 375 850 575

30 TO 39 2A+2C+2E 250 450 1100 750

C: HRZ paediatric base dose (dispersible)

A: Adult 4FDC base dose
E: Ethambutol 100mg (dispersible)
 Situations where LOOSE DRUGS to be used
for anti tb treatment as Daily regimen
• Adult weighing below 25 kg

• Children weighing above 39 kg

• NEW Cases of Neurological TB(MENINGITIS/ENCEPHALITIS/TUBERCULOMA/HYDROCEPHALUS) requiring CAT I

ATT

• HIV TB Coinfection cases on II Line ART/ Protease Inhibitor based regimen

• Drug Allergy

• ADR’s (Adverse Drug Reactions) Due to ATT –example-Jaundice

 Recommended Daily Dosage of
Essential first-line anti-TB drugs
Daily Dose (mg/kg body wt.)
Name of Drug
Adult Paediatrics

Isoniazid 5 mg/kg (4–6 mg/kg) daily 10 mg/kg (7–15 mg/kg) daily

Rifampicin 10 mg/kg (8–12 mg/kg) daily 15 mg/kg (10-20 mg/kg) daily

Streptomycin 15 mg/kg (12–18 mg/kg) daily 15 mg/kg (12–18 mg/kg) daily

Ethambutol 15 mg/kg (15–20 mg/kg) daily 20 mg/kg (15–25 mg/kg) daily

Pyrazinamide 25 mg/kg (20–30 mg/kg) daily 35 mg/kg (30–40mg/kg) daily

 HIV TB

All HIV-TB coinfection cases to be initiated on ATT ,CPT

Followed by ART irrespective of CD4 count.
 Adjustments to Regimen
TB-HIV patients on I line ART(ZLN/TLN)- ART Regimen
modified (ZLE/TLE)

 Nevirapine should be replaced by Efavirenz

TB HIV patients On II line ART or Alternative First line ART

(containing PI/NNRTI)- ATT Regimen modified
 Rifampicin should be replaced by Rifabutin 150 mg

 BUT IN PAEDIATRIC CASES- NO NEED OF CHANGE IN ATT

REGIMEN . ART SUPER BOOSTING WILL BE DONE IN ART
CENTRE
 Schedule of Follow up Sputum Smear Examination
Cat. Pre–Rx Test at If: Then
of Rx Sputum month result
C.P. – Sputum at 6 Months
-
+ 2
Send LPA Culture to rule out Drug resistance
Cat–I +
C.P. – Sputum at 6 Months
C.P. Sputum at 6 Months
-
- 2
Send LPA Culture to rule out Drug resistance
+
C.P. – Sputum at 6 Months
C.P. Sputum 8 Months
Cat–II -
+ 3
Send LPA Culture to rule out Drug resistance
+
C.P - Sputum 8 Months

 NO IP EXTENSION IN DAILY REGIMEN

 EXTEND IP

NO IP EXTENSION IN DAILY REGIMEN

EXTEND CP
3 MONTHS--- IN NEUROLOGICAL TB
TB SPINE WITH NEUROLOGICAL
INVOLVEMENT
OSTEO ARTICULAR TB
DISSEMINATED TB/MILIARY TB
 ISONIAZID CHEMOPROPHYLAXIS

< 6 yrs child

contacts of smear positive TB
After ruling out active TB disease
Irrespective of BCG status

Isoniazid 10 mg/kg/day daily for 6 months

 Paediatric Dosing Chart
Number of 100 mg tablets of INH to
Weight range (kg) be administered per dose (total dose Dose (mg)
10 mg/kg/day)

<5 ½ tablet 50

5.1–9.9 1 tablet 100

10–13.9 1 ½ tablet 150

14–19.9 2 tablets 200

20–24.9 2 ½ tablets 250

3 tablets or
>25 300
one adult tablet
 IPT regimen Plan

Adult and Adolescent: Isoniazid 300mg +Pyridoxine 50mg

(Vitamin B6) per day for 6 months

Children above 12 months: Isoniazid 10mg/kg +Pyridoxine25

mg (Vitamin B6) per day for 6 months
 IPT in special circumstances..1
Scenario Action
Patients previously • Initiate IPT for another 6 months in CLHIV / PLHIV who successfully complete their first line TB
treated for TB treatment earlier./just successfully completed should also receive INH for an additional six months
(Secondary
prophylaxis)

IPT with ART • Combined use of IPT with ART for all CLHIV / PLHIV irrespective of
(Secondary prophylaxis) 1. the degree of immune suppression 2.previously been treated for TB
3. pregnancy
• ART should not be delayed while starting or completing a course of IPT.

Patient on IPT develops

Develop TB symptoms during IPT treatment
TB during IPT treatment

Evaluate patient for TB. Do DST for drugs H,R, O and K. Treat according to resistance pattern.

Sensitive to all the drugs then based on history and duration of IPT decide following.
Taken ATT in past OR taken IPT for > 30 days -Cat-II
No ATT or had IPT for < 30 days - CAT-I
 IPT in special circumstances..2
Scenario Action
Develop TB after IPT Treat TB episode as per previous TB treatment history and Rif resistance pattern (whenever available)
treatment

IPT and Pregnancy • Pregnant woman living with HIV should not exclude from symptom-based TB screening and receiving IPT
• Isoniazid is safe in pregnancy & breast feeding

Start IPT irrespective of their gestation period & Advise to complete even if becomes pregnant while taking .

IPT and MDR-TB • Contacts of MDRTB and PLHIV who have completed DRTB treatment are not eligible for IPT.

Strict clinical observation and close monitoring for the development of active TB disease for at least two years is
preferred over the provision of preventive treatment for contacts with MDR-TB cases.

IPT in children born • Assess the newborn for TB.Non-specific features suggestive of neonatal TB include: Fever, low birth weight,
to microbiologically hepato-splenomegally, irritability, feeding intolerance.
confirmed TB mothers:
• If the child has none of the above, give IPT for 6 months. Administer BCG at birth.
 Restarting IPT after interruption
Scenario Action
Taken INH for < 1 month in total and discontinued Adherence counseling, Address reasons
Conduct ICF and if asymptomatic

Restart INH afresh &Ensure complete 6 month course

Taken INH for > 1 month: Adherence counseling,

Discontinued INH for <1 month Conduct ICF and if asymptomatic

Continue from where they left off & Ensure complete 6 month

Taken INH for > 1 month: Adherence counseling,

Discontinued INH for > 1 month < 3 months Conduct ICF and if asymptomatic

Restart INH & Ensure complete 6 month within a 9 month period

Discontinued for > 3 months, or Do not re-initiate IPT

Discontinued more than once
THANK YOU