Recent trend in country

1. RNTCP
Current Trends
Dr. Ganesh Patel
Resident (3rd)
MD (Pulmonary Medicine)
Dept. of Pulmonary Medicine, GMC Kota
Guided by
Dr Suman Khangarot
(Professor )GMC Kota

3. In our country…

4. Evolution of TB Control In
India
• 1962 National TB Programme (NTP)
• 1992 Programme Review (GOI, WHO and SIDA)
» only 30% of patients diagnosed;
» of these, only 30% treated successfully
• 1993 RNTCP pilot began
• 1998 RNTCP scale-up ( 2% of the total population coverage by
RNTCP)
• 2001 450 million population covered
• 2004 >80% of country covered
• 2006 Entire country covered by RNTCP

5. OVER EMPHASIS ON X-RAYS FOR DIAGNOSIS
-INADEQUATE FUNDING,POOR QUALITY MICROSCOPY
-NON-STANDARD TREATMENT REGIMENS
-LOW RATES OF TREATMENT COMPLETION
-LACK OF SYSTEMATIC INFORMATION ON TREATMENT
OUTCOME
-ONLY 30% OF ESTIMATED TB PATIENTS WERE DIAGONOSED
-ONLY 30% OF THE DIAGONOSED CASES WERE TREATED
SUCCESSFULLY
Revised National Tuberculosis Control
Programm (RNTCP) was needed.

6. GOAL
TO REDUCE MORTALITY AND MORBIDITY FROM TB
TO INTERRUPT CHAIN OF TRANSMISSSION
OBJECTIVES
ACHIEVEMENT OF AT LEAST 85%CURE RATE OF INFECTIOUS CASES
DETECTION OF ATLEAST 70%OF ESTIMATED CASES
INFORMATION, EDUCATION, COMMUNICATION AND IMPROVED
OPERATIONAL RESEARCH ACTIVITIES.
COMPONENTS
POLITICAL COMMITMENT
GOOD QUALITY SPUTUM MICROSCOPY
UNINTERRUPTED SUPPLY OF GOOD QUALITY DRUGS
DIRECTLY OBSERVED TREATMENT
ACCOUNTABILITY

7. Introduction
• TB was declared as a global health
emergency in 1993
• RNTCP as a Pilot project: 1993
• RNTCP Phase-1: 1999–2006
• RNTCP Phase-II: 2006-2011
• Five year plan of “TB Free India”

8. Difference in NTP and
RNTCP
8
NTP RNTP
Case detection and treatment 70% case detection and 85% cure rate
Case finding was active by the health
worker
Case finding is passive by quality
microscopy
Only one sputum smear examination
used to be done
2 sputum examination ( spot, morning)
Patients not categorised for treatment
Patient categorised into two types for
treatment purpose
Chemotherapy was not supervised
Chemotherapy is supervised by DOTs-
agent
Case detection rate and success rate
less than 50%
Case detection rate is more than 85% and
success rate is more than 85%

9. • Goal 6: “Combat HIV/AIDS, malaria and
other diseases”
– Target 8: “By 2015, to have halted and begun
to reverse the incidence of malaria and other
major diseases…”
• Indicator 23: between 1990 and 2015 to halve
prevalence of TB disease and deaths due to TB
• Indicator 24: to detect 70% of new infectious
cases and to successfully treat 85% of detected
sputum positive patients
Millennium Development Goals

10. By 2005:
◦ At least 70% people with sputum smear positive TB will be
diagnosed.
◦ At least 85% cured.
By 2015:
◦ Global burden of TB (prevalence and death rates) will be
reduced by 50% relative to 1990 levels.
 Reduce prevalence to <150 per lakh population
 Reduce deaths to <15 per lakh population
◦ Number of people dying from TB in 2015 should be less than
1 million, including those co-infected with HIV
By 2050:
◦ Global incidence of TB disease will be less than or equal to 1
case per million population per year
Stop TB Partnership Targets

11. • Vision: A world free of TB
• Goal: To dramatically reduce the global
burden of TB by 2015 in line with
Millennium Development Goals and the
Stop TB Partnership targets
Stop TB Strategy, 2006

12. Global TB report
• Globally, TB incidence has fallen by an
average of 1.5% per year since 2000 and
is now 18% lower than the level of 2000.
• In 2014, TB killed 1.5 million people (1.1
million HIV-negative and 0.4 million HIV-
positive).

13. • Of the 9.6 million new TB cases in 2014,
58% were in the South-East Asia (SEAR)
and Western Pacific regions.
• From 2016, the Goal is to end the global
TB epidemic by implementing the End TB
Strategy.
Global TB report

14. • The Target of Halving the TB Mortality
rate by 2015 (compared with 1990) met in
4 WHO regions
- The Region of the Americas,
- The Eastern Mediterranean Region,
- The South-East Asia Region,
- The Western Pacific Region &
Global TB report

15. • All three of the 2015 targets (for incidence,
prevalence and mortality) were met in:
Brazil, Cambodia, China, Ethiopia, India,
Myanmar, the Philippines, Uganda and
Viet Nam.
Global TB report

16. Population Coverage and Patients
Registered
A brief history of tuberculosis control in India. Geneva, Switzerland: World
Health Organisation; 2010.

17. India
• India: 2nd most populous country
• Accounts for a Quarter of the world's annual
incidence of TB.
• Every year in India:
2 million- Develop TB in India &
300,000- Die of TB.
• Treated: Over 15 million patients and
• Lives saved: 3 million,
by the Revised National TB Control Programme
(RNTCP) over the last decade.

18. India Accounts for Nearly
One-third of the Global TB Burden

19. TB is a Leading Killer of
Women
48,000
101,000
493,000
538,000
605,000
Tropical
Diseases
STD Maternal
Mortality
Malaria TB
Deaths among
women
Source: World Health Report, 1999.

20. 0
5000
10000
15000
20000
25000
30000
0-14 15-24 25-34 35-44 45-54 55-64 >65
Male
Female
Age (years)
New Smear-positive Case Detection by Age and Sex—2001
More than 80% of the patients are in the economically productive (15-54 years) age group
Data Source:1.8 lakh new smear-positive patients detected during 2001

22. Statistics-2014
• In 2014, RNTCP covered a population of
12,656 lakh.
• TB suspects examined by sputum smear
microscopy: 87.83 lakh
• Cases Registered for treatment: 14.44 lakh
• Registered TB cases Knowing their HIV
status: 72%
• HIV infected TB patients were initiated on
CPT: 94%
• Initiated on ART: 91%

23. TB and AIDS
10%
60%
0%
10%
20%
30%
40%
50%
60%
70%
PPD+/HIV-negative PPD+/HIV-positive
Lifetime risk
of TB

24. Making TB a notifiable
disease in India
With the aim of improving the collection of
patient care information, in 7 May 2012 India
declared TB to be a notifiable disease.

25. Indicators

26. Burden of Tuberculosis

27. Case finding activities & Notification rates

30. 12th Five year Plan (2012-17)
• Budget: 4500 Crore
• Theme: Universal Access for Quality Diagnosis &
Treatment for all TB patients in the community
• Target “Reaching the Unreached”.
• Goal: “Universal access to TB care and treatment
for all”
• Vision 2020: To significantly reduce TB burden in
India by ensuring universal access to quality
assured TB care as per Standards for TB Care in
India (STCI).

31.  Early detection & Rx of 90% cases (DR-TB & HIV-TB)
 Rx 90% of new TB patients, 85% of previously-treated
 Reduce default rate : new TB cases to < 5%
re-treatment TB cases to < 10%
 Extend RNTCP services to patients in private sector
 To ensure Notification of all TB cases in Nikshay
(incremental step to close the gap of missing TB
cases in India)
 13,000 microscopy centers for sputum smear
microscopy and Culture and DST laboratories.
Objectives
31

32. Contd…
• 62 RNTCP certified Culture and DST laboratories in
the country which includes laboratories from Public
sector (IRL, Medical College), Private and NGO
laboratories.
• Currently 89 Cartridge Based Nucleic Acid
Amplification Test (CBNAAT)
• First National anti TB Drug Resistance Survey
(NDRS) is being conducted across 120 TB Units in the
country and will test drug resistance to drugs other
than Rifampicin and Isoniazid.

33. • More than 330 Medical Colleges are
involved with RNTCP through the task
force mechanism and are contributing in
diagnosis, management and formulating
policies for the program.

34. Successful Partnerships
• Indian Medial Association (IMA),
• Catholic Bishops’ Conference of India
(CBCI),
• Foundation for Innovative New Diagnostics
(FIND),
• World Vision, The International Union
against Tuberculosis and Lung Diseases
(The UNION) &
• The Clinton Health Access Initiative (CHAI)

36. oThe objectives of RNTCP
are to achieve and
maintain a cure rate of at
least 85% among new
sputum smear-positive
cases and to achieve and
maintain detection of
atleast 70% of such cases
in the population.

37. NTCP

38. RNTCP

39. 1.Political
and
administra
tive
commitme
nt
2.Good
quality
diagnosis,
primarily
by sputum
smear
microscop
y
3.Uninterr
upted
supply of
good
quality
drugs
4.Directly
observed
treatment
(DOT)
5.Systemat
ic
monitoring
and
accountabi
lity
Components of DOTS

40. 40
Structure of RNTCP

41. Microscopy vs X-ray
Sputu
m AFB
X-ray
0
10
20
30
40
50
60
70
80
90
100
X-ray
40%
FalsePositiveTruePositive
60%
Specificity
NTI, Bangalore, 1974
98%
50%

42. Directly observed
treatment (DOT) is
one element of the
DOTS strategy
An observer watches
and helps the patient
swallow the tablets
Direct observation
ensures treatment for
the entire course
• with the right drugs
• in the right doses
• at the right
intervals
Directly Observed Treatment

43. DOT is Necessary Even When
Drug Supply Ensured
88%
61%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100% Treatment Success
DOT No DOT
Source: Chaulk CP, Kazandjian VA. Directly observed therapy for treatment
completion of pulmonary tuberculosis: Consensus Statement of the Public Health
Tuberculosis Guidelines Panel. JAMA 1998;279:943-8.

44. Risk of Failure or Relapse was 15 Times Higher among
Patients Taking Treatment Without Observation Compared to
Patients Receiving Treatment Under Observation
0%
10%
20%
30%
40%
50%
Observed treatment Unobserved treatment
Data Source: Pathanamthitta District, Kerala, IJTLD, 2000
3%
44%

45. Unique features of RNTCP
• District TB Control Society
• Modular training
• Patient wise boxes
• Sub-district level supervisory staff (STS, STLS)
for treatment & microscopy
• Robust reporting and recording system

46. o A pulmonary TB suspect is defined as:
An individual having cough of 2 weeks or more
Contacts of smear-positive TB patients having cough of any duration
Suspected/confirmed extra-pulmonary TB having cough of any
duration
HIV positive patient having cough of any duration

47. Diagnostic Algorithm for PTB

48. What is New in RNTCP, effective April 2009
EARLIER NOW
3 weeks cough 2 weeks cough
3 sputum specimens
required
2 sputum specimens
At least 2specimens
should be positive
1 positive is enough

49. 49
Definitions: Revised definitions as per WHO
• Presumptive case: Patient who present with symptoms or signs suggestive of TB ( earlier
known as TB suspect)
• Case Definitions
• A bacteriologically confirmed TB case (BCTB): Biological specimen positive by
microscopy, culture or Xpert MTB/RIF.
• A clinically diagnosed TB case (CDTB): Clinically diagnosed by the practitioner but not
bacteriologically confirmed.
• Both the above case can be classified according to
• Anatomical site of disease
• History of Previous treatment
• Drug resistance
• HIV resistance

50. • PTB:Any BCTB or CDTB case involving the lung parenchyma or tracheobronchial tree. A person with both
PTB and EPTB should be classified as PTB
• EPTB:Any BCTB or CDTB involving organs other than lungs.
50
Classification based on anatomical site of
disease
Classification based on history of previous TB treatment. ( Patient
registration group)
• New patients:Never been treated or taken ATT for less than one month.
• Previously treated patients: Patients who received 01 month or more of ATT in the past;
• Relapse
• Treatment after failure
• Treatment after loss to follow up
• Other previously treated patients
• Patients with unknown previous TB treatment history

51. 51
Previously treated patients
Declared cured or treatment completed
diagnosed with recurrent episodes of TB
treatment failed at the end of treatment
earlier called as Treatment after default
declared lost to follow up at the end of treatment
outcome not known or undocumented
Previously treated patients but does not fit in any above category
Relapse
Previously treated patients
Previously treated patients
Previously treated patients
Treatment after Failure
Treatment after loss to follow up
Other previously treated patients
Patients with unknown previous TB treatment history

52. Classification based on Drug Resistance
52
resistance to one 1st line Anti-TB drug only
Monoresistance
resistance to more than one 1st line Anti-TB drug only
Polydrug resistance
resistance to at least both H and R
Multi drug resistance
resistance to any fluoroquinolone and at least 3 second line injectables (
Capreomycin, Kanamycin and amikacin) in addition to MDR
Extensively drug resistance
resistance to Rifampicin with or without resistance to other drugs
RR-TB

53. Classification based on HIV status
53
BCTB or CDTB
HIV positive result
HIV - Positive TB patients
HIV negative result
HIV - Negative TB patients
No result of HIV testing
HIV - status unknown TB
patients

54. Scientific Basis of DOTS
• Domiciliary Treatment
• Diagnosis by Microscopy
• Short course chemotherapy
• Intermittent chemotherapy
• Directly observed treatment

55. Basis for Domiciliary Treatment
Smear-positive TB patients can be treated effectively
at home with no added risk to contacts
Series Total
Patients
Favorable
Response
(%)
Relapse
(%)
Total
contacts
Attack
rate
(%)
Home 82 86 14 245 10.5
Sanat-
orium
81 92 12 264 11.5
TRC, 1959

56. Which bacilli are acted upon by the ATT drugs?

57. Treatment Regimens
Category of
Treatment
Type of Patient Regimen*
Category I All new pulmonary (smear-positive
and negative), extra pulmonary and
‘others’ TB patients.
2H3R3Z3E3+
4H3R3
Category II TB patients who have had more than
one month anti-tuberculosis
treatment previously
Relapse , Failure, Treatment After Default,
Others
2H3R3Z3E3S3 +
1H3R3Z3E3 +
5H3R3E3

58. Basis for Regimens
CAT I: New sputum smear Positive patients,
high bacillary population, chances for
naturally occurring resistant mutants
higher,therefore 4 drugs in intensive phase
CAT II: Because of previous treatment,
chances of harboring resistant bacilli
are higher; hence 5 drugs in IP and total
duration of treatment is 8 months.In
continuation phase lower bacterial
population;hence less chance of resistant
organisms, therefore 3 drugs are enough.
Best way to Prevent MDR/XDR TB is cure TB patients
with DOTS
Famous saying is "FIRST HIT IS BEST HIT"

59. Regimen for Non-DOTS treatment in RNTCP Areas
o Self administered non
rifampicin containing regimen
o Needed in few cases of
adverse reaction to rifampicin
and pyrazinamide
o Upto a maximum of 1% of
patients may get Non-DOTS
treatment in an RNTCP area.
o Tuberculosis treatment card
to be filled for these patients
as well

60. Regimen for Non-DOTS treatment in RNTCP Areas
Treatment Regimen
Non-DOTS Regimen 2HSE+10 HE

61. Remember the correct doses of anti TB
Drugs!

62. Basis for Intermittent Therapy
Growth of M. tuberculosis during and after exposure to INH
Log Viable
Units of
M TB
Days
INH added
INH washed
All anti-tuberculosis drugs except
Thioacetazone, have a lag phase

63. Comparing the Daily Versus the Intermittent Regimens of the Anti-
Tubercular Chemotherapy in the Initial Intensive Phase in Non-HIV,
Sputum Positive, Pulmonary Tuberculosis Patients
Pranab Kumar Mandal,1 Abhijit Mandal,2 and Sujit Kumar Bhattacharyya3
J Clin Diagn Res. 2013 Feb; 7(2): 292–295.
• Conclusion: Both the intermittent and the
daily regimens showed equal sputum
conversion rates and the drug default
cases were found more in the intermittent
group. However, the adverse reactions
were found more in the daily regimen
category.

64. Drug doses in RNTCP

65. THE CODE AND DOSAGE
Patients who weigh 60kg or more receive
additional Rifampicin 150mg.
Patients who are more than 50 years old
,receive streptomycin 500mg
Patients who weigh less than 30 kg, receive
drug as per body weight.

66. Pediatric weight bands

67. Monitoring of Treatment
o Follow up sputum
microscopy
determines
o Conversion rate
o Cure rate
o Sputum smear
microscopy schedule
o Initial sputum
examination
o End of Intensive phase
of treatment
o 2 months into
Continuation phase of
treatment
o End of treatment

68. Cat.
of Rx
Pre–Rx
Sputu
m
Test at
month
If:
result
Then
Cat–1
+ 2 - C.P. – Sputum at 4 & 6 m
+ I.P. for 1month, Sp. At 3, 5 & 7
- 2
- C.P. Sputum at 6 months
+ I.P. for 1 month, SP. at 3, 5 & 7
Cat–II + 3 - C.P. Sputum at 5 & months
+ I.P. for 1 month, Sp. at 4, 6 & 9
Schedule of follow-up sputum
smear examination

69. Treatment outcome definition
69

70. Advanced RNTCP Regimes
Drug Resistant TB (PMDT)
o MDR TB – Resistant to
INH & Rifampicin

71. CAT V- XDR TB
o XDR TB- MDR TB+ Resistant to Second
line injectable Anti TB drug &
Fluroquinolone

72. Public Health Concern
• The decline in TB incidence: Slow
• Mortality- Unacceptably High and
• Emergence of Drug-Resistant TB: Major public
health concern.
Challenges:
• Prompt, accurate diagnosis and effective
treatment of TB.
• Uninterrupted supply of Drugs
• Engaging the private sector effectively.

73. Private sector health care
A source of mismanagement of TB
and hence of drug resistance.
- Use of incorrect Diagnostics
- Incorrect regimes
- Lack of supervision
- Lack of regulation for over the counter
drugs for TB

74. • why people in India seek care
from the private sector
- poor knowledge about TB
- poor knowledge about services available
through the national programme
- the convenience of services
- a desire for confidentiality
- a desire for personalized care.
Private sector health care

75. “Many people are unaware that all the
medicines needed to treat TB patients are
available free of cost at Indian government
hospitals. Most people tend to spend huge
amounts in private hospitals.”
-Bhalchandra Chorghade (Sr Correspondent
DNA)

77. Why are correct doses
important?
Ref: Mishra G, Mulani J. Tuberculosis Prescription Practices In
Private And Public Sector In India. NJIRM. 2013; 4(2): 71-78.

78. Why are correct doses
important?
Ref: Mishra G, Mulani J. Tuberculosis Prescription Practices In
Private And Public Sector In India. NJIRM. 2013; 4(2): 71-78.

81. World TB Day 2015: Gear up to end TB

82. Some practical points
o 1. TB is a notifiable disease.
o 2. If you are not sure of individualized treatment regime, please do
not start it. Instead you may register the patient under RNTCP.
o 3. Do not start a fluroquinolone to a TB suspect.
o 4.Please do simple sputum microscopy for afb smear for all TB
suspects, rather than directly starting from higher investigations like
CT scan.
o 5. Serological TB tests are banned in India eg. TB IgG and TB IgM.
o 5. Do not even attempt to treat drug resistant TB, in absence of
requisite training. Refer to specialist/ RNTCP /PMDT.

83. References
• National Strategic Plan for Tuberculosis
Control 2012–2017; RNTCP
• TBFACTS.ORG; Information about
Tuberculosis
• TB India 2015; Annual Status Report
• Global Tuberculosis Report 2015 by WHO
• Standards for TB Care in India Manual by
WHO.

84. Thanks a lot for
your cooperation