National treatment guidelines of TB (NTEP).pptx

THIS PPT IS ABOUT TB AND ANTITUNERCULAR DRUGS.
LATEST GUIDELINES OF TB TREATMENTS.
ALL KIND OF RESISTANT TB TREATMENT.
RECENT AMENDMENTS OF TB ELIMINATION PROGRAM.
DEFINITIONS OF DIFFRENT KIND OF TB

1. National treatment guidelines of TB (NTEP) Dr. Parmanand Atal Resident Doctor Department of Pharmacology SMS Medical college, Jaipur

2. Introduction: Chronic granulomatous disease Caused by mycobacterium tuberculosis (Mtb) Acid fast bacilli Robert Koch first discovered bacilli in 1882 “Myco”- Greek word refers to waxy appearance due to composition of cell wall. World TB day- 24 march Goodman & Gilman's THE PHARMACOLOGICAL BASIS OF THERAPEUTICS ( 13 TH EDITION )

3. Definitions 1. Presumptive Pulmonary TB A person with any of the symptoms and signs suggestive of TB including cough for > 2 weeks fever>2 weeks significant weight loss haemoptysis + any abnormality in chest radiogra ph.

4. 2. Presumptive Extra Pulmonary TB Organ specific symptoms and signs Constitutional symptoms like Significant weight loss, Persistent fever for ≥ 2 weeks , night sweats.

5. 3. Presumptive Paediatric TB Children With Persistent Fever And / Or Cough For More Than 2 Weeks Loss Of Weight */ No Weight Gain And/Or History Of Contact With Infectious Tb Case ** * History of unexplained weight loss or no weight gain in past 3 months ; loss of weight is defined as loss of more than 5% body weight as compared to highest weight recorded in last 3 months. **In a symptomatic child contact with a person with any form of active TB within last 2 years may be significant.

6. 4. Presumptive DR-TB Those TB patients who have failed treatment with first line drugs Paediatric TB patients , non responders TB patients who are contact of DR-TB TB patients who are found positive on any follow - up smear examination during treatment Previously treated TB case TB patient with HIV co- infection.

7. Clinically diagnosed TB case Not microbiologically confirmed, but diagnosed with active TB by a clinician on the basis of- X-ray abnormalities Histopathology Clinical signs with a decision to treat the patient with a full course of Anti-TB treatment

8. Microbiologically confirmed TB case A presumptive TB patient with biological specimen Positive for A cid F ast B acilli (MICROSCOPY) Positive for Mycobacterium tuberculosis on CULTURE Positive for tuberculosis through Quality Assured Rapid Diagnostic molecular test (CB NAAT )

9. Definitions: Monoresistance: Resistance to one 1 st line drug only Poly drug resistance: Resistance to more than one 1 st line anti TB drug (other than both isoniazid & rifampicin). Multi drug resistance (MDR): resistance to at least both isoniazid & rifampicin. Extensive drug resistance (XDR): resistance to any fluoroquinolones (Fq) and at least one of three 2 nd line injectable (SLI) drugs (capreomycin, kanamycin, amikacin) in addition to multidrug resistance. Rifampicin resistance: resistance to rifampicin with or without resistance to other anti TB drugs . ________________________________________________________________ Park’s Textbook of PREVENTIVE AND SOCIAL MEDICINE ( 26 TH EDITION )

10. Drugs: Anti tubercular drugs 1 st line drugs Isoniazid(H) Rifampicin(R) Pyrazinamide(Z) Ethambutol(E) 2 nd line drugs Fluoroquinolones Ofloxacin Moxifloxacin(Mfx) Levofloxacin(Lfx) Ciprofloxacin Other oral drugs Ethionamide(Eto) Prothionamide Para-amino salicylic acid(PAS) Cycloserine Terizidone Rifabutin Rifapentine Injectable drugs Streptomycin (S) Kanamycin(Km) Amikacin(Am) Capreomycin

11. Newer drugs: Bedaquiline Delamanid Pretomanid

12. DS TB

13. GUIDELINE FOR TREATMENT INITIATION Counselling should be offered on- 1.cough etiquettes, proper disposal of sputum 2.all close contacts (especially household contacts) screened at the earliest.-- TPT 3. diet/DBT 4.HIV / Comorbid condition management 5. Substance abuse

14. GUIDELINE FOR TREATMENT INITIATION The TB patient should be counseled About the disease, Its mode of spread The treatment (dosage schedule, duration, common side-effects, etc.) Adherence Should be encouraged to involve family members for treatment support.

15. Treatment regimen- DS TB Daily regimen. Daily fixed dose combinations of first–line anti-tuberculosis drugs in appropriate weight bands

16. Dosage Frequency of dosage : DAILY (7 day/week) Single daily dosage 4 weeks per month, i.e. 28 doses No extension of Intensive Phase

17. Treatment of Drug Sensitive TB Type of TB Case Treatment regimen in IP Treatment regimen in CP New/ Previously Treated (2) HRZE (4) HRE No separate regimen for Retreatment cases. The drugs are given daily The dose of drugs are according to body weight Fixed Dose Combination (FDC) tablets are used Loose Drugs would be needed as substitutions in case of adverse drug reaction or with comorbid conditions. No need for extension of IP 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. Extension beyond 12 weeks should only be on recommendation of experts of the concerned field.

18. Daily Dose Schedule for Adults (as per weight bands) Weight band Number of tablets Intensive phase Continuation phase HRZE HRE 75/150/400/275 mg 75/150/275 mg 25-34 kg 2 2 35-49 kg 3 3 50-64 kg 4 4 65-75 Kg 5 5 >75 6 6

19. Drug Dosage for Paediatric TB Weight category Number of tablets (dispersible FDCs) Intensive phase Continuation phase HRZ E HR E 50/75/150 100 50/75 100 4-7 kg 1 1 1 1 8-11 kg 2 2 2 2 12-15 kg 3 3 3 3 16-24 kg 4 4 4 4 25-29 kg 3 + 1A * 3 3 + 1A * 3 30-39 kg 2 + 2A * 2 2 + 2A * 2 * A=Adult FDC (HRZE = 75/150/400/275; HRE = 75/150/275 )

20. Follow up of Treatment Components of follow up: Clinical follow up Laboratory follow up Clinical follow up at least monthly (Patient visits the clinical facility or the MO reviews during home visit Improvement on chest symptoms, increase in weight etc. may indicate good prognosis Control of comorbid conditions like HIV and diabetes Symptoms and signs of adverse reactions to drugs should be specifically asked

21. Fortnightly Clinical Review of all TB patients All TB patients on ATT should undergo clinical review by Medical Officer PHC/CHC once a fortnight. Ophthalmic evaluation by optometrist at Block PHC Field staff to monitor any ADR Checklist to be attached to treatment card by PHC MO

22. Grouping of medicines recommended for use in longer MDR- TB regimens: Groups and steps Medicine Group A: include all 3 medicines Levofloxacin or Lfx Moxifloxacin Mfx Bedaquiline Bdq Linezolid Lzd Group B: Add 1 or both medicine Clofazimine or Cfz Cycloserine or Cs Terizidone Tz Group C: add to complete the regimen and when medicine from group A and B can not be used Ethambutol E Delamanid Dlm Pyrazinamide Z Imipenam- cilastatin or Ipm- Cln Meropenem Mpm Amikacin (or streptomycin) Am(S) Ethionamide or Eto prothionamide Pto Para-amino salicylic acid PAS

23. Standard regimen for initiating treatment of MDR/ RR TB or H mono/ poly DR TB: * If the intensive phase is prolonged, the injectable agent is only given three times a week in the extended intensive phase. ** Reduce Lzd to 300 mg/day after 6 to 8 months. *** Pyridoxine to be given to all DR TB patients as per weight band. This regimen will also be used for treatment of XDR TB patients with 20 months duration. ____________________________________________________________________________________________ Regimen class IP CP H mono/ poly DR TB (R resistance not detected & H resistance): All oral H mono/ poly DR TB regimen*** (6) Lfx R E Z MDR/ RR TB: Shorter MDR TB regimen*** (4-6) Mfx(high dose) Km/ Am* Eto Cfz Z H(high dose) E (5) Mfx(high dose) Cfz Z E All oral longer MDR TB regimen*** (18-20) Bdq (6) Lfx Lzd** Cfz Cs BPaL regimen (6) Bdq Pa Lzd

24. Management of DR-TB in Pregnancy: Duration of pregnancy < 20 weeks Advise MTP MTP done Start/ Continue shorter MDR-TB regimen Patient unwilling for MTP Start/ continue modified conventional regimen < 12 weeks: omit Km and Eto; add PAS > 12 weeks: omit Km only; add PAS Replace PAS with Km after delivery and continue till end of IP > 20 weeks Start/ continue modified conventional MDR- TB regimen Omit Km: add PAS till delivery Replace PAS with Km after delivery & continue till end of IP Park’s Textbook of PREVENTIVE AND SOCIAL MEDICINE ( 26 TH EDITION )

25. Vaccine: BCG vaccine: Live attenuated vaccine given at birth Dose: 0.1 ml Route: Intradermal

26. Nikshay Nikshay is the centralized and integrated information management and surveillance system that tracks each TB patient’s health care service provision and related health records in India. Following are its features of system: Unified interface for all healthcare providers of both public and private sectors. Unified DSTB and DRTB patient cascade and flows. Records for all adherence technologies such as 99DOTS and MERM. Provide direct access to staff to access the system using their own logins(staff level logins) Mobile-friendly websites with mobile app.

27. Nikshay Poshan Yojana (NPY) All unique TB Patients notified on or after 1 st April 2018 Beneficiary To provide nutritional support to TB patient at the time of notification and subsequently during the course of treatment Objective Rs.500 for treatment month paid in installments of up to Rs.1000 an advance Benefit amount

28. Transport support for TB patient in notified tribal areas All notified TB patients form notified tribal areas Beneficiary To provide financial support as transport allowance for TB patients belonging to notified tribal areas Objective Rs.750 as a one-time payment at the time of notification Benefit amount

29. Incentive for private sector providers Private providers( private practitioner, hospital, laboratory and chemist) who notify TB patients to NTEP on Nikshay Beneficiary To provide financial incentives for notification and subsequent follow-up until completion of treatment of TB patients who are diagnosis /treated by the private provider Objective Rs.500 as a one-time payment on notification Rs.500 to private practitioner or hospital for updating the patient’s treatment outcome Incentive amount

30. Treatment supporter’s honorarium Community treatment supporters who support patient during treatment, leading to a successful outcome (cured or completed) Beneficiary To provide an honorarium to treatment supporters for supporting TB patients Objective Rs.1000 as a one-time payment on the update of outcome for drugs sensitive TB patients Rs.2000 on completion of IP and Rs.3000 on completion of CP of treatment for drugs-resistant TB patient Incentive amount

31. A new initiative for TB-free India (End TB by 2025) TB-Mukt Panchayat Initiative: Aims to measure and appreciate the efforts of Gram Panchayats at village level to make India TB free. To receive the TB-Mukt Panchayat status, panchayats should provide support to patient with TB and monitor their progress quarterly based on certain prerequisite indicators. TB Preventive Treatment (TPT): family member for every confirmed patient with TB will be enrolled under NIKSHAY, making them a primary caregiver. This ensures timely recovery, proper nutrition, and reduction in social stigma to patient

32. A weekly dose of Rifapentine + Isoniazid for 3 months is recommended for all household contact (>2 years old) of pulmonary TB patients and people living with HIV after ruling out active TB (except in children living with HIV). 3. Family-centric model for TB: One family member for every confirmed patient with TB will be enrolled under NIKSHAY, making them a primary caregiver. This ensures timely recovery, proper nutrition, and reduction in social stigma to patient. A caregiver should be >14 years old, spend maximum time with the patient, consented to take responsibility and is acceptable to patient.

33. To galvanize efforts towards TB elimination, Her Excellency, Smt. Droupadi Murmu, Hon’ble President of India on 9th September 2022 launched “ Pradhan Mantri TB Mukt Bharat Abhiyan ‘’ for community support to TB patients to provide people with TB and their families increased nutritional, diagnostic, and vocational support, delivered within the community. As per the clarion call of the Hon’ble Prime Minister of India, Shri Narendra Modi at Delhi End TB Summit in March 2018 to eliminate TB by 2025, five years ahead of Sustainable Development Goal,

34. The three-fold objectives of the initiative are: • Provide additional patient support to improve treatment outcome of TB patients • Augment community involvement in meeting India’s commitment to end TB • Leverage Corporate Social Responsibility (CSR) activities

35. The expected outputs of the initiative are: 1. This initiative will increase the active involvement of society in the fight against tuberculosis 2. This activity aims at increasing awareness among the public regarding tuberculosis 3. Involvement of the community in supporting the treatment cascade shall also help in the reduction of stigma 4. Provision of additional support to the TB patient shall also result in the reduction of the out-of-pocket expenditure for the family of the TB patient 5. Ultimately improved nutrition for the TB patient shall result in better treatment outcomes