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 1 . 8 million new cases annually ( 0 .

8
million new infectious cases ). Highest
in the world .
 About 370 , 000 deaths .
 Substantial socio - economic impact
since incidence highest in
economically productive age groups .


REVISED
NATIONAL
TUBERCULOSIS
CONTROL PROGRAMME
GROUP MEMBERS
Dr . Abhay Dahiya
Dr . Amit Murarka
Mr . Anant Kumar
Mr . Anup Lakra
Ms . Doyir eshi
Ms . Neha Asthana
Mr . Netra Risal
Dr . Raj Rishi Meena
Dr . Ranvir Singh Saluja
Mr . Renthungo Patton
OVERVIEW
Tuberculosis has been present in
humans since antiquity .
Was known as “ Consumption ” in the
past .
Tuberculosis is an infectious
disease caused by Mycobacterium
tuberculosis .
The bacteria was discovered by
Sir Robert Koch , hence T . B also
known as Koch ’ s disease .
Tuberculosis is the world's
greatest infectious killer of
women of reproductive age and the
leading cause of death among
people with HIV / AIDS
India is the highest TB burden country
globally
accounting for one fifth of the global
incidence
Globally ~9
million new TB India
cases occur 20%
Non-HBCs
annually 20%

China
15%
Other 13 HBCs
18%

Indonesia
South Africa
6%
4%
Nigeria
Philippines 4%
3% Bangladesh
Ethiopia Pakistan
4%
3% 3%

Source: WHO Geneva; WHO Report 2006: Global Tuberculosis Control; Surveillance, Planning and Financing
STATISTICS
One third of the world population infected
with TB bacilli.
75 % of which are pulmonary cases
90% of the infected population
asymptomatic
50 % mortality Rate in rest 10% if
untreated
Most common mode of transmission via
aerosol droplets
22% infection rate
10-15 secondary cases from a active but
untreated pt./year
Aetiology
Problem of TB in India
Incidence of TB disease: 1.8 million new TB cases annually
(0.8 million new infectious cases).Highest in the world.
2 peaks in incidence are observed
o1-4 yr age group

oAdolescents &Young adults

3-5 times more common in males


Prevalence of TB disease : 3.8 million bacteriologically
positive (2000)
Deaths : about 370,000 deaths due to TB each year
TB / HIV : ~2.5 million people with HIV & ~1 million co
infected with TB
oAbout 5% of TB patients estimated to be HIV positive
MDR - TB in new TB cases ≤3%
Substantial socio - economic impact since incidence highest
in economically productive age groups
Estimated Incidence of TB in India*
(No. of New Smear Positive Cases per 100,000 population,
per year)

North
West East
National 75
North Zone 95
East Zone 75
West Zone 80
South Zone 75
South
NATIONAL TUBERCULOSIS
CONTROL PROGRAMME
 NTCP started by the Indian government
in 1962
 No change in prevalence of disease
 Mortality declined from 80 lakh in
1971 to 53 lakh in 1993

Achievements
Shortfalls
Shift in age trends from an Drastic rise in Multi drug
extensive disease among the resistant tuberculosis .
young to a more chronic and As per a WHO surveillance .
less severe disease in the 3 to 5 % new case and 12 %
elderly . of the treated patients had
Marked reduction in MDR - TB
complications e . g . Only 30 % of existing cases
Tubercular being diagnosed with
enteritis , laryngitis , amyloid accuracy , of which only 30
disease etc . % completed their
Shift in age at first treatment .
infection to later decades . Mortality rate 29 % amongst
infectious patients
Re vie w
WasDone in 1992
Key problems identified were :

1 . Overemphasis on the X - rays rather than


sputum microscopy for case detection
2 . Poor quality of microscopes
3 . More emphasis on case detection then cure
4 . Inadequate budgetary outlays
5 . Shortage of drugs
6 . Poor organisational setup
7 . Poor patient compliance
REVISED NATIONAL TB CONTROL
PROGRAMME
In 1993 , a revised strategy called DOTS
( Directly observed treatment short
course ) to control TB was pilot tested .
As a result of its tremendous success RNTCP
was launched in the country in 1997 with
WHO recommended DOTS strategy .
The programme was expanded in phased manner
and by march 2006 , entire country has been
covered under the programme .
For the management of MDR - TB DOTS - plus has
been started in selected sites .
By 2010 DOTS - plus sites throughout the
country with facilities to enroll atleast
5000 pt ’ s / year .
V ES
T CP CT I
RN OBJE
S &
OA L
G
qGoal :
 The goal of TB control Programme is to decrease
mortality and morbidity due to TB and cut
transmission of infection until TB ceases to be
a major public health problem in India .
qObjectives :
 To achieve and maintain a cure rate of at least
85 % amongst new smear positive cases
 To achieve and maintain a case detection of at
least 70 % of the estimated new sputum positive
TB patients

qDirectly observed treatment short course


( DOTS )


 Is a systemic strategy having 5 components :


1 . 1 . Political and administrative commitment .
2 . 2 . Good quality Diagnosis , primarily by sputum
smear
3. microscopy .
4 . 3 . Uninterrupted supply of quality drugs
ORGANIZATION

Central TB division DDG (TB)

TB training and demonstration centre


State TB cell STO

l centre for TB control in the district DTO


District TB cell

5 lakh population ( CHC/Block/taluka hospital) Tuberculosis unit MO-TC, STS,STLS

er 1 lakh population (CHC/PHC/dispensary) Microscopy centre MO,LT

DOT centre
Team at district Tuberculosis
centre
1 . District Tuberculosis officer
2 . Medical officer
3 . Laboratory Technician
4 . X - ray technician
5 . Treatment organiser
6 . Statistical assistant
7 . Data entry operator
Fu n ct ion s of D ist r ict
t ub e r cu losis of f ice r

1 . Responsible for smooth implementation


of RNTCP and for achieving the
programme objective
2 . Planning and coordinating TB
activities .
3 . Identification of microscopy centre
, DOT centre and staff responsible
4 . Arranging , maintaining supply of
drugs , laboratory reagent and sputum
containers
5 . Organizing training of staff of the
TU ’ s
6 . Inspection of TU ’ s , CHC ’ s , block PHC ’ s
7 . Review meetings with MOTC , STS , STLS
atleast once a month
8 . Organizing health education campaigns
9 . Establish linkage with pvt .
Practitioners , NGO ’ s and community
leaders
10 . Function as member secretary of
district society
11 . Keep the CDHO and chairman district
Tuberculosis society , inform on the
progress of RNTCP activities
12 . Ensure maintenance of financial
records
13 . Evaluate pt . referred by other centres
S IS
GN O
DIA
DIAGNOSTIC ALGORITHM FOR PULMONARY TB
Diagnosis by Microscopy of
Patients Presenting to Health
Facilities
qMicroscopy is more accurate
S p ecificity
than x - ray , and correlates 100
with infectiousness as well

%
as with risk of death from 80
TB
60

qVirtually all patients with 40


multiple positive direct
AFB smears have TB 20

qAt least half of persons 0

with x - rays suggestive of A FB


m icr o s co p y
X-r ay

TB do not have TBCA


Acid Fast Stain Tubercle Bacilli
Problems with Over-Reliance on X-ray for
TB Diagnosis

1.Misclassificationof non-TB as TB, resulting in unwarranted


treatment and avoidable expenditure
2.
3.Inability
to distinguish between smear positive and smear
negative patients, resulting in inadequate priority to true
smear positive patients
4.
5.Failure to give appropriate treatment
6.
7.Inability to monitor progress accurately

q
Ø Lower cure rates and increased spread of TB
qA systematic evaluation of 100
well-functioning District TB

%
centres by the National TB
Institute, Bangalore found 80
that nearly 70% of the cases
diagnosed and put on
treatment on the basis of x- 60
ray, did not have
tuberculosis at all
q 40
qThe proportion of cases
diagnosed on the basis of x-
ray alone and put on 20
treatment unnecessarily is
likely to be even higher in
many centres 0
D ia g n o s e d Abcyt u a l c a s e
x - r a y a lo n e
NTI, IJT, 1974
Three sputum Samples collected - SPOT –
Early Morning – SPOT
Three sputum smears are
optimal
100%
100% 93%
81%
Cumulative Positivity

50%

0%
First Second Third
Diagnosis of
tuberculosis
Tools
Tuberculin test Merits
Can identify infection Demerits
Cannot differentiate
Good epidemiological tool infection & disease

X-ray Sensitive Not specific


Sputum Sm. Definitive diagnosis Sensitivity 60-80%
Microscopy Easy to perform at the periphery
Replicability
Less costly

Culture for MTB Highly sensitive & specific Costly, not freely available
long waiting period
E NT
AT M
TRE
Objectives of
Chemotherapy
qTo achieve a cure rate of atleast 85 %
in all new smear positive cases .
qTo achieve at least 90 % treatment
completion rate of all retreatment
case and sputum negative cases
qTo decrease mortality , long - term
morbidity and transmission
qTo effect a permanent cure , prevent
relapses and decrease transmission
qTo minimize development of drug
resistance
qTo achieve the above while minimizing
drug side effects
Need for standardized
treatment
qTo treat smear positive TB patients as
priority
qTo prevent under - treatment of smear
positive cases
o prevent spread of TB in the
community
o prevent acquired drug resistance
qTo avoid over - treatment
qTo minimize side effects
qTo be able to monitor and compare
treatment outcomes
Smear positive Case Smear negative case

A patient with at least 2 A patient having symptoms


initial sputum smear suggestive of TB with at least
examination ( direct smear 3 sputum examinations negative
microscopy ) positive for acid - for AFB and radiographic
fast bacilli ( AFB ). abnormalities consistent with
Or active pulmonary TB .
A patient with one sputum Or
A patient whose diagnosis is
examination positive for AFB
and radiographic abnormalities based on culture positive for
consistent with active M . tuberculosis but sputum
pulmonary TB . smear examinations negative
for AFB .
Or
A patient with one sputum
specimen positive for AFB and
culture positive for M
tuberculosis .
Types of Tuberculosis
Patients
qNew :
A TB patient who has never had treatment for TB or
one who has taken
anti TB drugs for less than one month .

qRelapse :
A TB patient who was declared cured or treatment
completed by a physician , but who reports back to the
health service and is now found to be sputum smear -
positive .

qTransferred in :
A TB patient who has been received for treatment in
one Tuberculosis
unit , after starting treatment in another unit ( TU )
where ( s ) he has been
registered .
qTreatment after default :
A TB patient who received anti TB treatment for
one month or
more from any source and returns to treatment
after having
defaulted , i . e ., not taken anti TB drugs
consecutively for two
months or more , and who is found to be sputum
smear positive .

qFailure :
Any TB patient who is smear positive at 5
months or more after starting treatment . Failure
also includes a patient who was treated with
category III regimen but who becomes smear
positive during treatment .

qChronic :
A TB patient who remains smear positive after
completing a re -
treatment regimen .
In t e nsive Ph a se
Aims for a rapid killing of bacilli
A state of non-infectiousness within 2 weeks
Quick relief of symptoms
Smear negativity by 2 months
Prevent development of drug resistance
Multi-drug regimens and DOT
Continuation Phase
Aims to eliminate remaining bacilli
Killing of “persisters” prevents relapses
Multi-drug regimens and DOT necessary even
though risk of emergence of drug resistance is
less as fewer bacilli remain
Treatment Regimens
Cat I New smear positive; seriously ill 2H3R3Z3E3 /
smear negative; seriously ill extra-
4H3R3
pulmonary

Cat II Previously treated smear positive 2H3R3Z3E3S3 /


(relapse, failure,
1H3R3Z3E3 /
treatment after default)
5H3R3E3

Cat III New smear negative and extra- 2H3R3Z3 /


pulmonary, not seriously ill 4H3R3
 Treatment Outcomes
qCured :
 Initially sputum smear positive patient who has
completed
 treatment and had negative sputum smears , on at
least two
 occasions , one of which was at the end of
treatment .
qTreatment Completed :
 A sputum smear positive patient who has completed
treatment ,
 with negative smears at the end of IP and CP .
 or
 A sputum smear negative patient who has received a
full course of treatment and has not become smear
positive during or at the end of treatment .
 or
 Extra - pulmonary patient who had received full course
of treatment and has not become smear positive during or
at the end of treatment .
qDied :
 Patient who died during the course of treatment ,
regardless of the cause of death .
qFailure :
 Any TB patient who is smear positive at 5 months or more
after starting treatment or
 A patient who was treated with category III but who
becomes smear positive during treatment .
qDefaulted :
 A patient who has not taken anti TB drugs for 2 months
or more consecutively after starting treatment .
qTransferred out :
 A patient who has been transferred to another TB unit
or district and for whom the treatment result ( outcome ) is
not known .
DIRECTLY OBSERVED
TREATMENT
qDOT ensures the best possible results in
treatment of TB .
qHere an observer watches and supports the
patient in taking their drugs , thereby
ensuring that the patient receives the
medication .
qDirect observation ensures treatment for the
entire course
qwith the right drugs
qin the right doses
qat the right intervals
Patients swallows drugs in presence of
observer
Why is it necessary to directly
observe treatment?
qAt least 1 / 3 of patients on self -
administered Rx fail to adhere to Rx
qImpossible to predict which patients will
take medicines
qDOT necessary at least in the IP of Rx to
ensure adherence and smear conversion
qTB patient missing 1 attendance can be
traced immediately and counseled
“ This use of supervised treatment ( now
known as directly observed treatment) in
which patients are observed taking their
anti - TB medications , was shown to be
essential in India ”
Fox W . 1961
Based on studies from TRC
Directly Observed Treatment is the
Standard of Care
“ Every patient with TB in this country should
receive DOT ”
(Iseman, NEJM, 1993)
“ DOT has emerged as the standard of care ”
(Bayer, Lancet, 1995)
“ DOT seems imperative … where the disease
has become epidemic ”
(Chaulk, JAMA, 1996)
DOTS- Plus
qThe WHO working group on DOTS - Plus for
MDR - TB was established in 1999 to lead the
global effort to control MDR - TB ( Cat . IV )
( Whose sputum culture isolates are
resistant to at least isoniazid and
rifampicin ).
qTreatment is for a minimum duration of 18
months beyond sputum conversion ( At least
to sets of consecutive negative smears and
cultures taken 30 days apart ).
qRegimens should consist of at least four
drugs with either certain , or almost
certain , effectiveness .
q
qDrugs are administered at least six days a
week .
q In most cases , an injectable agent and a
fluoroquinolone form the core of the
regimen .
qAn injectable agent ( an aminoglycoside or
capreomycin ) is used for a minimum of 6
months .
 XDR- TB:

 XDR – TB is defined as ……..


 MDR
 Plus resistance to any fluoroquinolone ,
 And at least one of the second line
injectable drugs , capreomycin , kanamycin or
amikacin .

qSuch extensive resistance markedly limits


treatment options because few effective
and reasonably well tolerated alternative
drugs are available .
Tuberculosis in Children
qTB in children represents 5 - 15 % of all
TB cases .
qDiagnosis
 Younger children with pulmonary TB rarely
cough out sputum as they usually swallow
it .
 Diagnosis of pulmonary TB by sputum
microscopy is therefore very unlikely
among smaller children .
 Gastric lavage or laryngeal swabs are
difficult to carry out .
 Bacteriological confirmation is not
possible in most cases .
 Children will be suspected of having
pulmonary TB if they present with fever
and / or cough for more than 3 weeks , with
or without weight loss or no weight gain .

 TB should also be suspected if there is a


history of contact with a suspected or
diagnosed case of active TB disease in the
last 2 yrs .

 Diagnosis of TB in children should be based


on a combination of clinical presentation ,
sputum examination ( wherever possible ),
chest X - ray , mantoux test and history of
contact .
Chemoprophylaxis
qAsymptomatic children under 6 yrs of
age , exposed to a patient with
infectious ( smear positive ) TB from the
same household , need to be given 6
months of daily isoniazid ( 5 mg / kg ) as
chemoprphylaxis against the disease .
TB treatment in HIV
infected patients
qAll new TB cases known to be HIV
positive are classified as seriously
ill and treated with category I
regimen . The retreatment cases are to
be treated with category II regimen .
qThe HIV positive status should not be
mentioned in any RNTCP records .
qRoutine HIV testing of all TB suspected
patients is NOT the national policy .
qTreatment interruption , due to higher
occurrence of adverse drug reactions
or inter - current opportunistic
infections , could also lead to an
increased risk of relapse of TB .
qThe current recommendations on ART are to
use a triple drug combination . A
combination of stavudine / zidovudine plus
lamivudine plus Efavirenz / Nevirapine is
usually used .

qCo - administration of Rifampicin with any of


the protease inhibitors or non - nucleoside
reverse transcriptase inhibitors should be
avoided .

qIn TB patients co - infected with HIV , TB


treatment should be completed prior to
starting ART , unless there is a high risk
of HIV disease progression and death during
the period of TB treatment ( i . e . a CD4 count
< 200 / cmm or the presence of disseminated
TB )
Public private partnership
 Involvement of pvt . Sector and NGO ’ s
improves case detection and compliance .
 Patients get services from the providers of
their choice
 Central govt . provides 100 % grant in aid to
states and UT ’ s besides free drugs
 The central budget allocation has increased
from 1 . 8 crore in 1981 to 186 crore in
2005 - 06
 Second phase of World bank project has
commenced from October 2005 for a period
of 5 years
 Total cost of the budget is US$ 256
million .
 RNTCP is also being financially
supported by

1 . DFID
2 . Global TB drug facility ( GDF )
3 . Global fund to fight AIDS ,
Tuberculosis and malaria ( GFATM )
4 . United states agency for international
development ( USAID )
Con clusion

qRNTCP diagnosis and treatment strategies


are based on scientific evidence
qIn addition
◦It is consistent with international WHO
guidelines
◦It is consistent with International Standards
of TB Care
◦Well documented and good RNTCP treatment
outcomes in millions of patients supports
the soundness of the treatment strategies
◦Has already resulted in savings of 13 , 000
crores

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