NTEP

Dr. Harpreet Kaur
PG student
Community Medicine
Guru Gobind Singh Medical College, Faridkot

Learning Objective
• To know the basic structure of National Tuberculosis Elimination
Programme.

Lesson Plan
• Evolution of RNTCP
• STOP TB Strategy
• End TB Strategy
• National Strategic Plan 2017-25
• Treatment regimen
• Nikshay

Evolution of RNTCP
• In 1959
The National TB Institute (NTI), Bengaluru, was established to devise strategies for TB
control in India.
• In 1962
The National Tuberculosis Control Programme of India was initiated.
Despite the NTP being in existence, since no appreciable change in epidemiological
situation of TB in the country had been observed.
• In 1992
GOI, with WHO and SIDA reviewed the TB situation and the performance of the NTP.
• In 1993
The Revised National TB Control Programme was piloted.
• In 1997
RNTCP was launched as a national programme with a plan to scale up in a phased manner.

RNTCP
• Adopted the internationally recommended DOTS strategy as the most
systematic and cost-effective approach to revitalise the TB control
programme in India.
• 5 components of DOTS strategy:
• The entire country was covered by March 2006.

STOP TB Strategy
In 2006
• The WHO released STOP TB Strategy with six principal
components-
• Pursuing high quality DOTS expansion and enhancements
• Addressing TB, HIV, MDR-TB and other challenges
• Contributing to health system strengthening
• Engaging all care providers
• Empowering patients and communities
• Enabling and promoting research.

End TB Strategy - A holistic approach to end TB
• In 2015
The World Health Assembly unanimously approved to end global TB epidemic
by "End TB Strategy“.

National Strategic Plan 2017-25
• Vision- TB-Free India with zero deaths, disease and poverty due to TB.
• Goal- To achieve a rapid decline in burden of TB, morbidity and
mortality while working towards elimination of TB in India by 2025.
• This NSP addresses requirements for achieving the SDG and End TB
targets for India and is driven by the 'DETECT-TREAT-PREVENT-BUILD'
approach.
• The focus is on
• early diagnosis of all the TB patients,
• prompt treatment with the right drugs and regimens
• along with suitable patient support systems including financial and
nutritional support.

In view of End TB targets
Revised National TB Control Programme (RNTCP)
nomenclature changed
TO
National Tuberculosis Elimination Program (NTEP)
from January 2020

NTEP
• Vision of NTEP-
The people suffering from TB receive the highest standards of care and support
from all healthcare providers of their choice.
• Objectives of NTEP-
1. To achieve 90% notification rate for all cases.
2. To achieve 90% success rate for all new and 85% for re-treatment cases.
3. To significantly improve the successful outcomes of treatment of DR-TB
cases.
4. To achieve decreased morbidity and mortality of HIV-associated TB.
5. To improve outcomes of TB care in the private sector.

Case definitions
• Microbiologically confirmed TB: –
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: –
Presumptive TB patient who is not microbiologically confirmed, but
diagnosed with active TB by a clinician on the basis of X-ray,
histopathology or clinical signs with a decision to treat the patient
with a full course of Anti-TB treatment.

TB cases are also classified according to:
– anatomical site of disease
– history of previous treatment
– drug resistance
Classification by anatomical site of disease
• Pulmonary tuberculosis (PTB):
any microbiologically confirmed or clinically diagnosed case of TB involving
lung parenchyma or tracheo-bronchial tree.
• Extra Pulmonary tuberculosis (EPTB):
any microbiologically confirmed or clinically diagnosed case of TB involving
organs other than lungs.
e.g. pleura, lymph nodes, intestine, genitourinary tract, joint and bones,
meninges of the brain etc.

Classification by H/O previous TB treatment
• New case –
TB patient who has never had treatment for TB or has taken anti-TB drugs for less than
one month.
• Previously treated patients-
have received 1 month or more of anti-TB drugs from any source in the past.
• Recurrent TB case –
TB Patient previously declared as successfully treated (cured/treatment completed)
and is subsequently found to be microbiologically confirmed TB case.
• Treatment After failure-
Patients who have previously been treated for TB and whose treatment failed at the
end of their most recent course of treatment.
• Treatment after lost to follow-up-
TB patient previously treated for TB for 1 month or more and was declared lost to
follow-up in their most recent course of treatment and subsequently found
microbiologically confirmed TB case.

Classification based on drug resistance
• Mono-resistant (MR):
TB patient, whose biological specimen is resistant to one first-line anti-TB drug only.
• Poly-Drug Resistant (PDR):
TB patient, whose biological specimen is resistant to more than one first-line anti-TB
drug, other than both INH and Rifampicin.
• Multi Drug Resistant (MDR):
TB patient, whose biological specimen is resistant to both isoniazid and rifampicin with
or without resistance to other first line drugs, based on the results from a quality
assured laboratory.
• Rifampicin Resistant (RR):
Resistance to rifampicin detected using phenotypic or genotypic methods, with or
without resistance to other anti-TB drugs excluding INH. Patients, who have any
Rifampicin resistance, should also be managed as if they are an MDR TB case.
• Extensively Drug Resistant (XDR):
MDR TB case whose biological specimen is additionally resistant to a fluoroquinolone
(ofloxacin, levofloxacin, or moxifloxacin) and a second-line injectable anti TB drug
(kanamycin, amikacin, or capreomycin) from a quality assured laboratory.

Treatment regimen
• In NTEP, the principle of treatment for tuberculosis (other than
confirmed DR-TB):
is to administer daily Fixed dose combinations of first line anti-tuberculosis
drugs in appropriate weight bands.
• Treatment is given in two phases:
(8 weeks) (16 weeks)

• The CP may be extended by 12-24 weeks in certain forms of TB like-
CNS TB, Skeletal TB, Disseminated TB etc. based on clinical decision of the
treating physician on case to case basis.
• Steroids as an adjunctive therapy is useful in patients with TB
pericarditis and meningeal TB, with an initial high dose tapered
downwards gradually over 6 - 8 weeks.
• Streptomycin is administered only in certain situations like-
TB meningitis or if any first line drug need to be replaced due to ADR as per
weight of the patient

Advantages of FDCs
• Simplicity of treatment
• Increased patient acceptance
– Fewer tablets to swallow
– Prevents irregularity in t/t
• Increased health worker compliance
– Fewer tablets to handle, hence quicker supervision of DOT
• Easier drug management
• Lower risk of emergence of drug resistance
• Easier to adjust dosages by body weight

TREATMENT OF DRUG-RESISTANT TB
• DR-TB continues to be a public health problem, taking a heavy toll on
patients, their families, communities and health-care systems.
• DR-TB regimens require
• a longer course,
• higher pill burden and
• higher toxicity profile,
resulting in lower adherence and poorer treatment outcomes, including
deaths.

A. Shorter oral Bedaquiline-containing MDR/RR-TB regimen
9–11 months duration is recommended in eligible patients with
confirmed MDR/RR-TB
• who have not been exposed to treatment with second-line TB
medicines used in this regimen for more than 1 month, and
• in whom resistance to fluoroquinolones has been excluded.

Shorter oral Bedaquiline-containing MDR/RR-TB regimen

B. Longer oral Bedaquiline-containing MDR/RR-TB regimen

Longer oral Bedaquiline-containing MDR/RR-TB regimen
• Recommended for patients who are excluded from shorter oral
Bedaquiline-containing MDR/RR-TB regimen and for the XDRT
TB patients.
• Start with all 5 drugs of Group A and B and continue with 4
drugs in the latter part of the regimen (beyond 6-8 months) if
the patient can tolerate the drugs.
• Longer oral M/XDR-TB regimen is of 18-20 months with no
separate IP or CP.

Treatment in Pregnancy and lactation
• Before initiating treatment for tuberculosis, women of childbearing
age should be asked about current or planned pregnancy and
counselled appropriately.
• A successful treatment of TB is important for successful outcome of
pregnancy.
• Except for streptomycin, the first line anti-TB drugs are safe for use in
pregnancy. Streptomycin is ototoxic to the fetus and should not be
used during pregnancy.

• A breastfeeding woman should receive a full course of TB treatment.
• Correct chemotherapy is the best way to prevent transmission of TB
to baby.
• Breast feeding must be continued.
• After ruling out active TB, the baby should be given 6 months of
isoniazid preventive therapy.
• The dose of INH for preventive therapy is 10 mg/kg body weight
administered daily for a minimum period of six months.

In MDR/RR-TB pts.
• Ethionamide is contraindicated during the first 32 weeks of
pregnancy.
• Hence, the shorter oral Bedaquiline-containing MDR/ RR-TB regimen
cannot be administered in pregnant women before 32 weeks due to
Eto led potential teratogenicity in first trimester and risk of
hypothyroidism in the infant in second trimester.

Treatment of Paediatric TB
• Paediatric cases are to be treated under NTEP in daily dosages as per
weight band categories.
• All adolescents up to 18 years of age and weighing <39 kg, are to be treated
using paediatric weight bands.
• Children weighing >39 kg with adult weight bands.
• Pediatric BDQ is available as 20 mg dispersible tablets and the
recommended dose is 200 mg daily for 2 weeks followed by 100 mg
thrice a week for 22 weeks.
• Pediatric Bdq is supplied in a jar which contains 60 tablets of the
whole course of 470 tablets.

TB and HIV
• Ideally all presumptive TB patients have to undergo HIV
screening.
• Oral MDR-TB regimen can be used in PLHIV, including those
who are receiving ART.
• This is important to ensure all HIV +ve TB patients receive ART
irrespective of CD4 count.
• TB patients living with HIV infection should receive the same
duration of TB treatment with daily regimen as HIV-negative TB
patients.
• If drug sensitive TB patient and on second line ART, Rifampicin
should be replaced with Rifabutin.

TB and HIV
Three “I” s to reduce burden of TB among PLHIV
• ICF: Intensified (TB) case finding (ICF) at ICTC, ART centres and Link
ART Centres (LAC)
• IC-AIC: Air-borne infection control measures for prevention of TB
transmission at HIV care settings
• IPT: Implementation of Isoniazid preventive treatment (IPT) for all
PLHIV (On ART + Pre-ART)

TB and Diabetes
• About 10% of TB cases globally are associated with diabetes.
• A large proportion of people with diabetes as well as TB is not
diagnosed, or is diagnosed too late.
• Early detection can help improve care and control of both diseases.
• DM can lengthen the time to sputum culture conversion and
theoretically this could lead to the development of drug resistance if a
4-drug regimen in the intensive phase of therapy is changed after 2
months to a 2-drug regimen in the presence of culture positive TB.
• People with diabetes who are diagnosed with TB have a higher risk of
death during TB treatment and a higher risk of TB relapse after
completing treatment.

Standards for Public Health and Prevention
Standard 18
All providers should ensure that persons in close contact with patients
who have infectious tuberculosis are evaluated and managed in line with
international recommendations.
The highest priority contacts for evaluation are:
• Persons with symptoms suggestive of tuberculosis
• Children aged <5 years
• Contacts with known or suspected immunocompromised states,
particularly HIV infection
• Contacts of patients with MDR/XDR tuberculosis.

Standard 19
Children <5 years of age and persons of any age with HIV infection who
are close contacts of a person with infectious tuberculosis, and who, after
careful evaluation, do not have active tuberculosis, should be treated for
presumed latent tuberculosis infection with isoniazid for at least six
months.

Standard 20
Each health care facility caring for patients who have, or are suspected of
having, infectious tuberculosis should develop and implement an
appropriate tuberculosis infection control plan to minimize possible
transmission of M. tuberculosis to patients and health care workers.
Standard 21
All providers must report both new and re-treatment tuberculosis cases
and their treatment outcomes to local public health authorities.

Nikshay
• TB surveillance using case based web based IT system.
• Launched in 2012.
• Nikshay provides-
1. A unified interface for public and private sector health care providers.
2. Integrates all adherence technologies such as 99DOTS and MERM.
3. Unified DSTB and DRTB data entry forms.
4. Mobile friendly website with mobile app.
• Notification can be done electronically directly from Health
Establishment on the NIKSHAY portal.

99-DOTS
• an IT enabled ‘pill-in-hand’ adherence
monitoring system for all DSTB patients on
daily regimen.
• This system requires custom envelops into
which each pack of medication is inserted
and sealed.
• The envelops have printed unique phone
numbers which the patient can see when
taking medication and use to give free calls to
report their medication.
• Patients are empowered to take their
medicine independently.

Nikshay Poshan Yojana
• Launched from 01st April 2018.

STRENGTHS
1. Strong Political and Administrative commitment
2. Free diagnosis and free drugs available
3. Universal Drug Susceptibility Testing (DST) NAAT testing is available in all
district
4. Decentralization of MDR-TB treatment up to district level through District
DR-TB Centre
5. Regular supervision and monitoring, review meeting organized quarterly
at District level and State Level.
6. Integration of NTEP with NHM make fund available to carry out activities.
7. NTEP Revised Guidelines are available.
8. External Support (WHO)

WEAKNESS
1. Lack of human resources.
2. Poor infection control and HCW fear of infection .
3. Full-time DTOs not in place in some districts.
4. High burden/prevalence of HIV/MDR-TB co-infection.
5. Programme is evolving very fast and regular sensitization and
updation required at field level.

OPPORTUNITIES
1. Integration with NHM leading to regular fund flow.
2. Video conferences to support regular and real-time monitoring and
interaction with all stakeholders.
3. Partnership/collaboration between research and clinical team well
established.
4. Emerging research on TB/HIV treatment integration and improved
outcome.
5. Prioritization of MDR-TB treatment in national spotlight.

THREATS
1. Transfer of already trained LT of DMCs to non-DMC.
2. Low health literacy.
3. Poor ART management.
4. Inter-provincial migration.
5. Natural calamities (Floods).
6. Unforeseen pandemics (Covid-19) forcing shift of priorities of health
system.
7. Un-timely release of funds for smooth conduction of activities as
per action plan.

SUMMARY
Government of India has committed to end TB by 2025, five years
ahead of the global target under Sustainable Development Goals. The
Ministry of Health & Family Welfare is implementing the National
Strategic Plan (NSP) for Tuberculosis Elimination (2017-2025) with
resources to rapidly decline TB incidence and mortality in India. Key
activities include active TB case finding, use of newer and shorter
regimen, private sector engagement, financial/nutritional support to TB
patients; IT enabled surveillance, preventive and awareness measures.

References
• Banerjee B, Revised National TB Control Programme , DK Taneja’s
Health Policies & Programmes in India, 16th ed. Jaypee Brothers
Medical Publishers (P) Ltd; 2019.p.238-72.
• Park K, Health Programmes in India, Park’s textbook of preventive and
social medicine, 25th ed. Jabalpur: M/s Banarsidas Bhanot Publishers;
2019. p.457-64.
• Training modules (1-4) for programme managers & medical officers.
National TB Elimination Programme, Central TB Division Ministry of
Health & Family Welfare, Government of India, New Delhi.
NTEPTrainingModules1to4.pdf

NTEP

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