Tuberculosis revised guidelines - 2016

INTRODUCTION
•Tuberculosis (TB) - Infectious bacterial disease
caused by Mycobacterium tuberculosis - most
commonly affects the lungs.
•Transmitted from person to person via droplets
from the throat & lungs of people with the active
respiratory disease.
2

HISTORY
• Consumption, phthisis, , Pott's disease, and the White
Plague are all terms used to refer
to tuberculosis throughout history.
• The first references to tuberculosis in non-European
civilization is found in the Vedas. The oldest of them (Rigveda,
1500 BC) calls the disease yaksma. The Atharvaveda calls
it balasa.

Contd….
•The robber of youth , the Captain of
Death , the graveyard cough , and the
King’s-Evil(scrofula).
•The Sushruta Samhita, written around 600
BC, recommends that the disease be treated
with breast milk, various meats, alcohol and
rest.

• Hippocrates in Book , Of the Epidemics (410-400 BC)
described a disease of “weakness of the lung” with fever
and cough which he refers to as phthisis .
• On March 24, 1882, Robert Koch announced to the Berlin
Physiological Society that he had discovered the cause
of tuberculosis.
• 1940 - PAS
• 1943 - Streptomycin
• 1951- isoniazid
• 1959– rifamycins
• 2012 – Delamanid & Bedaquiline

TB is the 9th leading cause of death
worldwide and the leading cause from a
single infectious agent, ranking above
HIV/AIDS.
An estimated 10.4 million people fell ill
with TB in 2016: 90% were adults, 65%
were male, 10% were people living with
HIV (74% in Africa).
60% were in five countries: India,
Indonesia, China, the Philippines and
Pakistan.
9/1

In 2016, there were an
estimated 1.3 million TB
deaths among HIV-negative
people (down from 1.7
million in 2000) and an
additional 0.374 million
deaths among HIV-positive
people

Tuberculosis revised guidelines - 2016

Drug-resistant TB is a continuing
threat.
In 2016, there were 600,000 new cases
with resistance to rifampicin (RRTB),
the most effective first-line drug, of
which 4,90,000 had multidrug-resistant
TB (MDR-TB).
Almost half (47%) of these cases were
in India, China and the Russian
Federation.

Globally, the TB mortality rate is falling at about 3% per year.
TB incidence is falling at about 2% per year but 16% of TB cases
still die from the disease.
By 2020, these figures need to improve to 4–5% per year and
10%, respectively, to reach the first (2020) milestones of the
End TB Strategy.

For TB care and prevention, investments in low- and
middle-income countries will fall almost US$ 2.3 billion
short of the US$ 9.2 billion. This gap will widen by 2020 if
current levels of funding are not increased.

Of the estimated 10.4 million new cases, only
6.3 million were detected and notified in 2016,
leading to a GAP OF 4.1 MILLION CASES.

TOP TEN CAUSES OF DEATH IN INDIA-2016

Worldwide India is the country with the highest burden
of both TB + MDR TB. According to WHO, in India, an
estimated 27.9 lakh patients were suffering from TB in
2016 and up to 4.23 lakh had died during the year.

There are an estimated 79,000 multi-drug resistant TB
patients among the notified cases of pulmonary TB each
year. India is also the country with the second highest
number (after South Africa) of estimated HIV associated TB
cases.

EPIDEMIOLOGICAL
DETERMINANTS
25

AGENT FACTORS
27
Agent
Mycobacterium tuberculosis - facultative intracellular
parasite, ingested by phagocytes & resistant to intracellular
killing
Source of infection
Human - human case positive for tubercle bacilli & who has
either received no treatment or has not been fully treated
Bovine - infected milk
Communicability
Patients are infective as long as they remain untreated

HOST FACTORS
1. Age,
Affects all ages. In India, 0-14 age group – 2% , 15-24 age
group - 20%
2. Sex
More prevalent in males
3. Nutrition,
Malnutrition – predisposes to TB
4. Immunity,
Man has no inherited immunity against TB 28

SOCIAL FACTORS
•TB is a social disease with medical aspects, also known as
barometer of social welfare.
•Social factors include poor quality of life, poor housing,
overcrowding, population explosion, under-nutrition, lack
of education, large families, & lack of awareness of causes
of illness.
•All these factors are interrelated & contribute to the
occurrence & spread of TB 29

MODE OF TRANSMISSION
30
•Transmitted mainly by droplet infection
and droplet nuclei – by sputum-positive
patients with pulmonary TB
•Coughing generates the largest number of
droplets of all sizes
•Frequency & vigour of cough & the
ventilation of the environment influence
transmission of infection

INCUBATION PERIOD
• Time from receipt of infection to the development
of a positive tuberculin test ranges from 3 to 6
weeks
• Development of disease depends upon the
closeness of contact, extent of disease & sputum
positivity of the source
• Incubation period may be weeks, months or years
31

WHY IS INCUBATION
PERIOD SO LONG
???

TYPES OF TB
Pulmonary,
In active cases – most commonly involves the lungs (90% cases)
Symptoms – Chest pain & a prolonged cough producing sputum
About 25% of people - asymptomatic
Extra pulmonary,
In 15–20% of active cases, the infection spreads outside the
lungs, causing other kinds of TB
More commonly in immunosuppressed persons and young
children 35

Extra-pulmonary tuberculosis,
Common sites are
Pleura
Lymph nodes
Bones & joints
Intestine
Genitourinary tract
Meninges
36

A potentially more serious,
widespread form of TB -
"disseminated" TB - commonly known
as Miliary Tuberculosis.
Miliary TB -10% of extra-pulmonary
cases
37

SUSPECT TB CASES
As per the previous guidelines, a pulmonary TB suspect was
defined as:
1. Cough for 2 weeks or more
2. Contacts of smear-positive TB patients having cough
for any duration
3. Suspected/confirmed extra-pulmonary TB having
cough for any duration
4. HIV-positive patient having cough for any duration.39

NEW GUIDELINES
Presumptive pulmonary TB refers to a person
with any of the symptoms or signs :
1. Cough >2 weeks,
2. fever >2 weeks,
3. significant weight loss,
4. hemoptysis,
5. any abnormalities in chest radiography.
40

CLINICAL FEATURES
• Coughing that lasts two or more weeks
• Coughing up blood
• Chest pain, or pain with breathing or coughing
• Unexplained weight loss
• Fatigue
• Fever
• Night sweats
• Chills
• Loss of appetite
Signs and
symptoms
of active
Tuberculosis
41

THE RNTCP IN INDIA
• The RNTCP was then expanded
until the entire nation was
covered in March 2006.
• At this time the RNTCP also
became known as RNTCP II and
was designed to consolidate the
gains achieved in RNTCP I, and to
initiate services to
address TB/HIV, MDR-TB and to
extend RNTCP to the private
sector.

1. Complete geographical coverage
2. Notification by the private sector
3. Banning of sero-diagnostic tests
4. Development of Nikshay
5. Standards for TB Care in India
6. The Joint TB Monitoring Mission .
7. Reaching the private sector
A number of significant improvements were made during
the five years of the plan 2012-17. These included:

RECOMMENDATIONS MADE BY THE JOINT
MONITORING MISSION ,RNTCP INDIA
• The Ministry of Health should ensure that private sector TB patients
receive early TB detection, appropriate treatment, sustained
adherence support and a reduction of their OOP.
• A significant increase in government funding for TB control. RNTCP
will need 1500 crores/year to achieve the targets of the NSP and
achieve the goals of the END TB strategy.
• All patients should receive care based on the “Standards for TB Care
in India”.
• There is a need for a high level sustained national campaign on TB:
“TB Free India/TB Mukt Bharat”.

PRIVATE SECTOR INVOLVEMENT
• You have TB,” my general practitioner said. These three words
changed my life,” writes Deepti Chavan in The BMJ, who was treated
by private practitioners in Mumbai. A year into the treatment, she
was told she had multi-drug resistant TB (MDR-TB) and needed
surgery.
• Charan was 16 when she first started coughing. It was in the middle of
school exams. After months of incessant coughing, a chest x-ray
confirmed TB.
• It took six years of medicines, 400 injections, and two major
surgeries to cure her.

REVISED TECHNICAL & OPERATIONAL
GUIDANCE
• So in 2016 the RNTCP published revised technical and
operational guidance.
• The new guidelines, the RNTCP Technical and
Operational Guidelines for Tuberculosis Control in India
2016, did not replace the previous guidance (the
Standards of TB Care in India), but they provide updated
recommendations.
• They also make it absolutely clear that the guide lines
apply to the private sector as well as the public sector.

Technical and Operational Guidelines
1999 2005 2016

CASE DEFINITION
Case
definition
Microbiologically
confirmed
Clinically diagnosed
Anatomical
site
Pulmonary
Extra pulmonary
History of
ATT
New
Recurrent
(Relapse/reinfection)
Treatment after failure
(Default)
Treatment after lost to
follow up
Other previously treated
patients
Treatment outcome
Cure
Treatment completed
Died
Failure
Lost to follow up
Change of regimen
Not evaluated
TB suspect – Presumptive TB

Diagnostic Algorithm
Pulmonary TB Extra Pulmonary TB
Paediatric TB Drug Resistant TB

Intensified TB Case Finding in Key Population
Clinical Social Geographical
Clients attending HIV Care Settings Prisoners Urban Slums
Substance abuse including smokers Occupations with risk of
developing TB
Hard to reach areas
Co-morbidities like Diabetes Mellitus,
Malignancies, patients on dialysis and
on long term immunosuppressant
therapy
People in Congregated settings
– night shelters, De-addiction
centers, Old age homes
Indigenous and tribal
populations
Health Care Workers
Household & Workplace Contacts
Patients with Past History of TB
Malnourished
Antenatal mothers attending ANC/MCH

Drug Regimen – Drug Sensitive TB
Regimen
HRZE
+
HRE
Daily
FDC
WeightBands
MON
TUE
WED
THU
FRI
SAT
SUN


Weight category
25-39 kg
40-54 kg
55-69 kg
≥70 kg

DR-TB Services Rapid Molecular
Diagnosis
Second line DST
DST Guided
Treatment
Use of newer drug
Pharmacovigilance
628 CBNAAT labs

Treatment Support- Beyond DOTS
Patient
support
Treatment
supporter
ICT
adherence
Pharmacovi
gilance
Nutrition
support
Incentives
and
enablers
Counselling
IP CP 6 12 18 24
Follow up of
treatment
ADR
management and
monitoring

TB-HIV
Single window for delivery of HIV-TB care
Rapid molecular
diagnosis
Daily FDC
ICT based
adherence
support
Pharmacovigilance IPT
ART Centre

TB - Comorbidity
•TB-Tobacco
•TB-Nutrition
•TB-Silicosis

PARTNERSHIPS
• 22 options for engagement with NGOs and private providers; increasing the scope of engagement.
• 26 standards on diagnosis, treatment, public health responsibilities and social inclusions

SURVEILLANCE
Public Sector
• Upfront Notification On
• Treatment
At Diagnosis
Private Sector
• Expand scope of surveillance
TB Notification
TB Notification + Public Healthaction
• Electronic health recording
NIKSHAY e-NIKSHAY

DRAFT Post-2015 TB Strategy at a glance
 A WORLD FREE OF TB
Zero deaths, disease and suffering due to TB
 End the Global TB Epidemic
 95% reduction in TB deaths (compared with 2015)
 90% reduction in TB incidence rate (<10/100,000)
 75% reduction in TB deaths (compared with 2015)
 50% reduction in TB incidence rate (< than 55/100,000)
 No affected families face catastrophic costs due to TB
VISION:
GOAL:
TARGETS FOR 2035:
MILESTONES FOR 2025:

PILLAR 1: INNOVATIVE TB CARE
1. Rapid diagnosis of TB including universal drug
susceptibility testing; systematic screening of contacts
and high-risk groups
2. Treatment of all forms of TB including drug-resistant TB,
with patient support
3. Collaborative TB/HIV activities and management of co-
morbidities
4. Preventive treatment for high-risk groups and vaccination
of children

PILLAR 2: BOLD POLICIES AND
SUPPORTIVE SYSTEMS
1. Government stewardship, commitment, and adequate
resources for TB care and control with monitoring and
evaluation
2. Engagement of communities, civil society organizations,
and all public and private care providers
3. Regulatory framework for vital registration, case
notification, drug quality and rational use, and infection
control.
4. Universal Health Coverage, social protection and other
measures to address social determinants of TB

PILLAR 3: INTENSIFIED RESEARCH
AND INNOVATION
1. Discovery, development and rapid uptake of new
diagnostics, drugs and vaccines
2. Operational research to optimize implementation
and adopt innovations

THE END TB STRATEGY
• India is a signatory to the WHO’s THE END TB STRATEGY ‘’ that calls
for a world free of tuberculosis, with measurable aims of a 50% and
75% reduction in incidence and deaths, respectively by 2025, and
corresponding reductions of 90% and 95% by 2035.
• To meet these targets RNTCP has Revised its strategy (TOG-2016)
adopting newer strategies, such as increasing rapid molecular
diagnostics, Cartridge Based Nucleic Acid Amplification (CBNAAT)
sites provide rapid decentralised diagnosis of MDR-TB, and use of
bedaquiline, a new anti-TB drug through conditional access to treat
drug-resistant TB.

END TB STRATEGY – INDIA WAY FORWARD
Technical &
Operational
Guidelines
Diagnostic
algorithm
Intensified TB
case finding
Daily regimen
Enhanced
adherence
support
Treatment
Monitoring
Single Window
Delivery HIV-
TB
PMDT Scale up
New surveillance
and Monitoring
Extend care to
patients in
private sector

THE SDGS AND THE END TB
STRATEGY
•The first milestones of the End TB Strategy are set for
2020. They are a 35% reduction in TB deaths and a 20%
reduction in TB incidence, compared with levels in 2015; and
that “No TB patients and their households should face
catastrophic costs as a result of TB disease.”
• Monitoring of TB-specific indicators is well established at global
and national levels

Vision:
A TB FREE INDIA
Goal:
Universal Access
to quality TB
diagnosis and
treatment for all
TB patients in
the country
(2,8 million)
(4.8 lakh)
SDGs and End TB Targets
3.3

Tuberculosis revised guidelines - 2016

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