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Supervisor
Dr Vaibhav
Assistant professor
Presenter
Dr Roopak Saini
PG Student
1
Learning Objective
• To know the basic structure of National Tuberculosis Elimination
Programme.
2
Lesson Plan
• Evolution of NTEP
• STOP TB Strategy
• End TB Strategy
• National Strategic Plan 2017-25
• Treatment regimen
• Nikshay
3
Evolution of NTEP
• 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 NTPbeing in existence, since no appreciable change in epidemiological
situation of TB in the country had been observed.
• In 1992
GOI, with WHO 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.
4
RNTCP
• In 2005, India 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.
5
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.
6
End TB Strategy
• In 2015
The World Health Assembly unanimously approved to end global TB
epidemic by "End TB Strategy“.
7
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.
8
Treat
Prevent
Build
Detect
National Strategic Plan (2017-2025)
Find all TB cases with an emphasis on reaching every
TB patient in the private sector
Treat all TB cases with high quality anti TB drugs
Prevent the emergence of TB in susceptible
populations and stop catastrophic expenditure
Build & strengthen supportive systems including
enabling policies, empowered institutions & human
resources
9
Scale up molecular
diagnostics to the
peripheral levels
Decentralize TB
screening to AB-
HWC levels
Early detection of
DRTB Universal DST
Vulnerability mapping &
Active case finding
Private sector
engagement
DETECT 10
Daily regimen
–Fixed Dose
Combination
Injection free
treatment regimens
Scale up of Newer
drugs/regimens
TREAT
Sustain treatment
success rate of
>90%
11
Contact Tracing &
TB Preventive
Treatment
Sustaining COVID
appropriate
behavior
Airborne Infection
Control in community &
Health Facilities
Community
Mobilization &
People’s Movement
PREVENT 12
B
U
I
L
D
Procurement and Supply Chain
management
IEC
Digital Interventions
Human Resources Development
Surveillance
Multisectoral Collaboration
Capacity Building
13
In view of End TB targets Revised National TB Control
Programme (RNTCP) nomenclature changed
TO
National Tuberculosis Elimination Program (NTEP)
from January 2020
14
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. 15
NTEP Organogram
16
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
17
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, urinary tract, joint and bones, meninges of
the brain etc.
18
Classification based on history of previous TB treatment
New guideline
• New TB patient
– ATB patient who has never had treatment
for TB or has taken anti-TB drugs for less
than one month is considered as a new TB
patient.
• Previously treated TB
– A patient who has received one month or
more of anti-TB drugs from any source in
the past.
• Recurrent TB patient - ATB Patient
previously declared as successfully treated
(cured/treatment completed) and is
subsequently found to be microbiologically
confirmed TB is a recurrent TB patient.
• Treatment after failure patients - those who
have previously been treated for TB and whose
treatment failed at the end of their most recent
course of treatment.
Previous guideline
• same as the new guideline
• previously called relapse
• called failure where a TB patient is sputum
positive at 5 months or more after initiation
of treatment
19
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. 20
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:
Type of TB case Treatment Regimen
in IP (Weeks)
Treatment Regimen
in CP (Weeks)
New and previously
treated cases
2 HRZE
(8 weeks)
4 HRE
(16 weeks)
21
Treatment Regimen
• Intensive phase (IP) - 8 weeks (56 doses) of isoniazid (H),
rifampicin (R), pyrazinamide (Z) and ethambutol (E) given
under direct observation in daily dosages as per weight band
categories.
• Continuation phase (CP) - 16 weeks (112 doses) of isoniazid,
rifampicin and ethambutol in daily dosages. Only pyrazinamide
will be stopped in the continuation phase. 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. Extension beyond 12
weeks should only be on recommendation of specialists. 22
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
23
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.
24
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.
25
Shorter oral Bedaquiline-containing MDR/RR-TB regimen
26
B. Longer oral Bedaquiline-containing MDR/RR-TB
regimen
Groups & steps Medicine(abbreviation)
Group A
Include all three
medicines
Levofloxacin(Lfx) orMoxifloxacin(Mfx),
Bedaquiline(Bdq), Linezolid(Lzd)
Group B
Add one or both
medicines
Clofazimine(Cfz)Cycloserine(Cs)
orTerizidone(Trd)
Group C
Add to complete the
regimen and when
medicines from Group A
and B cannot be used
Ethambutol (E), Delamanid(Dlm),
Pyrazinamide(Z),Imipenem-cilastatin(Ipm-
Cln) orMeropenem(Mpm), Amikacin(Am)(OR
Streptomycin(S)),Ethionamide(Eto)
orProthionamide(Pto),p-aminosalicylic
acid(PAS)
27
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 XDR-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.
28
29
30
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.
31
32
Treatment in Pregnancy and lactation
• 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.
33
Treatment in Pregnancy and lactation
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 potential teratogenicity in first trimester and risk of
hypothyroidism in the infant in second trimester.
34
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.
35
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.
36
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)
37
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.
38
Standards for Public Health and Prevention
I. 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.
39
Standards for Public Health and Prevention
II. 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.
III. 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.
IV. All providers must report both new and re-treatment tuberculosis cases and
their treatment outcomes to local public health authorities.
40
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
Medications Event Reminder Monitor (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.
41
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.
42
Nikshay Poshan Yojana
• Launched from 01st April 2018.
43
1. Honorarium to Treatment Supporters – For provision of treatment support to TB
patients (Adherence, ADR monitoring, counselling @Rs.1000/- to Rs.5000/-)
2. Patient Support to Tribal TB Patients (Financial Patient Support @Rs750/-)
3. Nutritional Support to All TB patients (Financial Support to Patients @Rs.500/-month)
4. Incentives to Private Providers (Rs.500/- for Notification & Rs.500/- for reporting of
Treatment Outcome
5. Incentives to Informant (Rs.500/- is given on diagnosis of TB among referrals from
community to public sector health facility)
Direct Benefit Transfer (DBT) schemes
44
SWOT Analysis
45
STRENGTHS
1. Strong Political and Administrative commitment
2. Free diagnosis and free drugs available
3. Universal Drug Susceptibility Testing (DST) 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) 46
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.
47
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.
48
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.
49
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.
50
References
• Kadri AM. IAPSM's Textbook of Community Medicine. Jaypee Brothers Medical Publishers; 2019 .
• Bratati Banerjee. DK Taneja's Health Policies & Programmes in India. Jaypee Brothers Medical Publishers
• 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
51
THANK YOU
52

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Understanding the National Tuberculosis Elimination Programme (NTEP

  • 2. Learning Objective • To know the basic structure of National Tuberculosis Elimination Programme. 2
  • 3. Lesson Plan • Evolution of NTEP • STOP TB Strategy • End TB Strategy • National Strategic Plan 2017-25 • Treatment regimen • Nikshay 3
  • 4. Evolution of NTEP • 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 NTPbeing in existence, since no appreciable change in epidemiological situation of TB in the country had been observed. • In 1992 GOI, with WHO 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. 4
  • 5. RNTCP • In 2005, India 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. 5
  • 6. 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. 6
  • 7. End TB Strategy • In 2015 The World Health Assembly unanimously approved to end global TB epidemic by "End TB Strategy“. 7
  • 8. 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. 8
  • 9. Treat Prevent Build Detect National Strategic Plan (2017-2025) Find all TB cases with an emphasis on reaching every TB patient in the private sector Treat all TB cases with high quality anti TB drugs Prevent the emergence of TB in susceptible populations and stop catastrophic expenditure Build & strengthen supportive systems including enabling policies, empowered institutions & human resources 9
  • 10. Scale up molecular diagnostics to the peripheral levels Decentralize TB screening to AB- HWC levels Early detection of DRTB Universal DST Vulnerability mapping & Active case finding Private sector engagement DETECT 10
  • 11. Daily regimen –Fixed Dose Combination Injection free treatment regimens Scale up of Newer drugs/regimens TREAT Sustain treatment success rate of >90% 11
  • 12. Contact Tracing & TB Preventive Treatment Sustaining COVID appropriate behavior Airborne Infection Control in community & Health Facilities Community Mobilization & People’s Movement PREVENT 12
  • 13. B U I L D Procurement and Supply Chain management IEC Digital Interventions Human Resources Development Surveillance Multisectoral Collaboration Capacity Building 13
  • 14. In view of End TB targets Revised National TB Control Programme (RNTCP) nomenclature changed TO National Tuberculosis Elimination Program (NTEP) from January 2020 14
  • 15. 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. 15
  • 17. 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 17
  • 18. 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, urinary tract, joint and bones, meninges of the brain etc. 18
  • 19. Classification based on history of previous TB treatment New guideline • New TB patient – ATB patient who has never had treatment for TB or has taken anti-TB drugs for less than one month is considered as a new TB patient. • Previously treated TB – A patient who has received one month or more of anti-TB drugs from any source in the past. • Recurrent TB patient - ATB Patient previously declared as successfully treated (cured/treatment completed) and is subsequently found to be microbiologically confirmed TB is a recurrent TB patient. • Treatment after failure patients - those who have previously been treated for TB and whose treatment failed at the end of their most recent course of treatment. Previous guideline • same as the new guideline • previously called relapse • called failure where a TB patient is sputum positive at 5 months or more after initiation of treatment 19
  • 20. 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. 20
  • 21. 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: Type of TB case Treatment Regimen in IP (Weeks) Treatment Regimen in CP (Weeks) New and previously treated cases 2 HRZE (8 weeks) 4 HRE (16 weeks) 21
  • 22. Treatment Regimen • Intensive phase (IP) - 8 weeks (56 doses) of isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E) given under direct observation in daily dosages as per weight band categories. • Continuation phase (CP) - 16 weeks (112 doses) of isoniazid, rifampicin and ethambutol in daily dosages. Only pyrazinamide will be stopped in the continuation phase. 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. Extension beyond 12 weeks should only be on recommendation of specialists. 22
  • 23. 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 23
  • 24. 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. 24
  • 25. 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. 25
  • 26. Shorter oral Bedaquiline-containing MDR/RR-TB regimen 26
  • 27. B. Longer oral Bedaquiline-containing MDR/RR-TB regimen Groups & steps Medicine(abbreviation) Group A Include all three medicines Levofloxacin(Lfx) orMoxifloxacin(Mfx), Bedaquiline(Bdq), Linezolid(Lzd) Group B Add one or both medicines Clofazimine(Cfz)Cycloserine(Cs) orTerizidone(Trd) Group C Add to complete the regimen and when medicines from Group A and B cannot be used Ethambutol (E), Delamanid(Dlm), Pyrazinamide(Z),Imipenem-cilastatin(Ipm- Cln) orMeropenem(Mpm), Amikacin(Am)(OR Streptomycin(S)),Ethionamide(Eto) orProthionamide(Pto),p-aminosalicylic acid(PAS) 27
  • 28. 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 XDR-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. 28
  • 29. 29
  • 30. 30
  • 31. 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. 31
  • 32. 32
  • 33. Treatment in Pregnancy and lactation • 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. 33
  • 34. Treatment in Pregnancy and lactation 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 potential teratogenicity in first trimester and risk of hypothyroidism in the infant in second trimester. 34
  • 35. 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. 35
  • 36. 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. 36
  • 37. 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) 37
  • 38. 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. 38
  • 39. Standards for Public Health and Prevention I. 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. 39
  • 40. Standards for Public Health and Prevention II. 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. III. 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. IV. All providers must report both new and re-treatment tuberculosis cases and their treatment outcomes to local public health authorities. 40
  • 41. 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 Medications Event Reminder Monitor (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. 41
  • 42. 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. 42
  • 43. Nikshay Poshan Yojana • Launched from 01st April 2018. 43
  • 44. 1. Honorarium to Treatment Supporters – For provision of treatment support to TB patients (Adherence, ADR monitoring, counselling @Rs.1000/- to Rs.5000/-) 2. Patient Support to Tribal TB Patients (Financial Patient Support @Rs750/-) 3. Nutritional Support to All TB patients (Financial Support to Patients @Rs.500/-month) 4. Incentives to Private Providers (Rs.500/- for Notification & Rs.500/- for reporting of Treatment Outcome 5. Incentives to Informant (Rs.500/- is given on diagnosis of TB among referrals from community to public sector health facility) Direct Benefit Transfer (DBT) schemes 44
  • 46. STRENGTHS 1. Strong Political and Administrative commitment 2. Free diagnosis and free drugs available 3. Universal Drug Susceptibility Testing (DST) 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) 46
  • 47. 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. 47
  • 48. 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. 48
  • 49. 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. 49
  • 50. 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. 50
  • 51. References • Kadri AM. IAPSM's Textbook of Community Medicine. Jaypee Brothers Medical Publishers; 2019 . • Bratati Banerjee. DK Taneja's Health Policies & Programmes in India. Jaypee Brothers Medical Publishers • 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 51