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  1. 1. RNTCP Current Trends Dr. Ganesh Patel Resident (3rd) MD (Pulmonary Medicine) Dept. of Pulmonary Medicine, GMC Kota Guided by Dr Suman Khangarot (Professor )GMC Kota
  2. 2. In our country…
  3. 3. Evolution of TB Control In India • 1962 National TB Programme (NTP) • 1992 Programme Review (GOI, WHO and SIDA) » only 30% of patients diagnosed; » of these, only 30% treated successfully • 1993 RNTCP pilot began • 1998 RNTCP scale-up ( 2% of the total population coverage by RNTCP) • 2001 450 million population covered • 2004 >80% of country covered • 2006 Entire country covered by RNTCP
  6. 6. Introduction • TB was declared as a global health emergency in 1993 • RNTCP as a Pilot project: 1993 • RNTCP Phase-1: 1999–2006 • RNTCP Phase-II: 2006-2011 • Five year plan of “TB Free India”
  7. 7. Difference in NTP and RNTCP 8 NTP RNTP Case detection and treatment 70% case detection and 85% cure rate Case finding was active by the health worker Case finding is passive by quality microscopy Only one sputum smear examination used to be done 2 sputum examination ( spot, morning) Patients not categorised for treatment Patient categorised into two types for treatment purpose Chemotherapy was not supervised Chemotherapy is supervised by DOTs- agent Case detection rate and success rate less than 50% Case detection rate is more than 85% and success rate is more than 85%
  8. 8. • Goal 6: “Combat HIV/AIDS, malaria and other diseases” – Target 8: “By 2015, to have halted and begun to reverse the incidence of malaria and other major diseases…” • Indicator 23: between 1990 and 2015 to halve prevalence of TB disease and deaths due to TB • Indicator 24: to detect 70% of new infectious cases and to successfully treat 85% of detected sputum positive patients Millennium Development Goals
  9. 9. By 2005: ◦ At least 70% people with sputum smear positive TB will be diagnosed. ◦ At least 85% cured. By 2015: ◦ Global burden of TB (prevalence and death rates) will be reduced by 50% relative to 1990 levels.  Reduce prevalence to <150 per lakh population  Reduce deaths to <15 per lakh population ◦ Number of people dying from TB in 2015 should be less than 1 million, including those co-infected with HIV By 2050: ◦ Global incidence of TB disease will be less than or equal to 1 case per million population per year Stop TB Partnership Targets
  10. 10. • Vision: A world free of TB • Goal: To dramatically reduce the global burden of TB by 2015 in line with Millennium Development Goals and the Stop TB Partnership targets Stop TB Strategy, 2006
  11. 11. Global TB report • Globally, TB incidence has fallen by an average of 1.5% per year since 2000 and is now 18% lower than the level of 2000. • In 2014, TB killed 1.5 million people (1.1 million HIV-negative and 0.4 million HIV- positive).
  12. 12. • Of the 9.6 million new TB cases in 2014, 58% were in the South-East Asia (SEAR) and Western Pacific regions. • From 2016, the Goal is to end the global TB epidemic by implementing the End TB Strategy. Global TB report
  13. 13. • The Target of Halving the TB Mortality rate by 2015 (compared with 1990) met in 4 WHO regions - The Region of the Americas, - The Eastern Mediterranean Region, - The South-East Asia Region, - The Western Pacific Region & Global TB report
  14. 14. • All three of the 2015 targets (for incidence, prevalence and mortality) were met in: Brazil, Cambodia, China, Ethiopia, India, Myanmar, the Philippines, Uganda and Viet Nam. Global TB report
  15. 15. Population Coverage and Patients Registered A brief history of tuberculosis control in India. Geneva, Switzerland: World Health Organisation; 2010.
  16. 16. India • India: 2nd most populous country • Accounts for a Quarter of the world's annual incidence of TB. • Every year in India: 2 million- Develop TB in India & 300,000- Die of TB. • Treated: Over 15 million patients and • Lives saved: 3 million, by the Revised National TB Control Programme (RNTCP) over the last decade.
  17. 17. India Accounts for Nearly One-third of the Global TB Burden
  18. 18. TB is a Leading Killer of Women 48,000 101,000 493,000 538,000 605,000 Tropical Diseases STD Maternal Mortality Malaria TB Deaths among women Source: World Health Report, 1999.
  19. 19. 0 5000 10000 15000 20000 25000 30000 0-14 15-24 25-34 35-44 45-54 55-64 >65 Male Female Age (years) New Smear-positive Case Detection by Age and Sex—2001 More than 80% of the patients are in the economically productive (15-54 years) age group Data Source:1.8 lakh new smear-positive patients detected during 2001
  20. 20. Statistics-2014 • In 2014, RNTCP covered a population of 12,656 lakh. • TB suspects examined by sputum smear microscopy: 87.83 lakh • Cases Registered for treatment: 14.44 lakh • Registered TB cases Knowing their HIV status: 72% • HIV infected TB patients were initiated on CPT: 94% • Initiated on ART: 91%
  21. 21. TB and AIDS 10% 60% 0% 10% 20% 30% 40% 50% 60% 70% PPD+/HIV-negative PPD+/HIV-positive Lifetime risk of TB
  22. 22. Making TB a notifiable disease in India With the aim of improving the collection of patient care information, in 7 May 2012 India declared TB to be a notifiable disease.
  23. 23. Indicators
  24. 24. Burden of Tuberculosis
  25. 25. Case finding activities & Notification rates
  26. 26. 12th Five year Plan (2012-17) • Budget: 4500 Crore • Theme: Universal Access for Quality Diagnosis & Treatment for all TB patients in the community • Target “Reaching the Unreached”. • Goal: “Universal access to TB care and treatment for all” • Vision 2020: To significantly reduce TB burden in India by ensuring universal access to quality assured TB care as per Standards for TB Care in India (STCI).
  27. 27.  Early detection & Rx of 90% cases (DR-TB & HIV-TB)  Rx 90% of new TB patients, 85% of previously-treated  Reduce default rate : new TB cases to < 5% re-treatment TB cases to < 10%  Extend RNTCP services to patients in private sector  To ensure Notification of all TB cases in Nikshay (incremental step to close the gap of missing TB cases in India)  13,000 microscopy centers for sputum smear microscopy and Culture and DST laboratories. Objectives 31
  28. 28. Contd… • 62 RNTCP certified Culture and DST laboratories in the country which includes laboratories from Public sector (IRL, Medical College), Private and NGO laboratories. • Currently 89 Cartridge Based Nucleic Acid Amplification Test (CBNAAT) • First National anti TB Drug Resistance Survey (NDRS) is being conducted across 120 TB Units in the country and will test drug resistance to drugs other than Rifampicin and Isoniazid.
  29. 29. • More than 330 Medical Colleges are involved with RNTCP through the task force mechanism and are contributing in diagnosis, management and formulating policies for the program.
  30. 30. Successful Partnerships • Indian Medial Association (IMA), • Catholic Bishops’ Conference of India (CBCI), • Foundation for Innovative New Diagnostics (FIND), • World Vision, The International Union against Tuberculosis and Lung Diseases (The UNION) & • The Clinton Health Access Initiative (CHAI)
  31. 31. oThe objectives of RNTCP are to achieve and maintain a cure rate of at least 85% among new sputum smear-positive cases and to achieve and maintain detection of atleast 70% of such cases in the population.
  32. 32. NTCP
  33. 33. RNTCP
  34. 34. 1.Political and administra tive commitme nt 2.Good quality diagnosis, primarily by sputum smear microscop y 3.Uninterr upted supply of good quality drugs 4.Directly observed treatment (DOT) 5.Systemat ic monitoring and accountabi lity Components of DOTS
  35. 35. 40 Structure of RNTCP
  36. 36. Microscopy vs X-ray Sputu m AFB X-ray 0 10 20 30 40 50 60 70 80 90 100 X-ray 40% FalsePositiveTruePositive 60% Specificity NTI, Bangalore, 1974 98% 50%
  37. 37. Directly observed treatment (DOT) is one element of the DOTS strategy An observer watches and helps the patient swallow the tablets Direct observation ensures treatment for the entire course • with the right drugs • in the right doses • at the right intervals Directly Observed Treatment
  38. 38. DOT is Necessary Even When Drug Supply Ensured 88% 61% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Treatment Success DOT No DOT Source: Chaulk CP, Kazandjian VA. Directly observed therapy for treatment completion of pulmonary tuberculosis: Consensus Statement of the Public Health Tuberculosis Guidelines Panel. JAMA 1998;279:943-8.
  39. 39. Risk of Failure or Relapse was 15 Times Higher among Patients Taking Treatment Without Observation Compared to Patients Receiving Treatment Under Observation 0% 10% 20% 30% 40% 50% Observed treatment Unobserved treatment Data Source: Pathanamthitta District, Kerala, IJTLD, 2000 3% 44%
  40. 40. Unique features of RNTCP • District TB Control Society • Modular training • Patient wise boxes • Sub-district level supervisory staff (STS, STLS) for treatment & microscopy • Robust reporting and recording system
  41. 41. o A pulmonary TB suspect is defined as: An individual having cough of 2 weeks or more Contacts of smear-positive TB patients having cough of any duration Suspected/confirmed extra-pulmonary TB having cough of any duration HIV positive patient having cough of any duration
  42. 42. Diagnostic Algorithm for PTB
  43. 43. What is New in RNTCP, effective April 2009 EARLIER NOW 3 weeks cough 2 weeks cough 3 sputum specimens required 2 sputum specimens At least 2specimens should be positive 1 positive is enough
  44. 44. 49 Definitions: Revised definitions as per WHO • Presumptive case: Patient who present with symptoms or signs suggestive of TB ( earlier known as TB suspect) • Case Definitions • A bacteriologically confirmed TB case (BCTB): Biological specimen positive by microscopy, culture or Xpert MTB/RIF. • A clinically diagnosed TB case (CDTB): Clinically diagnosed by the practitioner but not bacteriologically confirmed. • Both the above case can be classified according to • Anatomical site of disease • History of Previous treatment • Drug resistance • HIV resistance
  45. 45. • PTB:Any BCTB or CDTB case involving the lung parenchyma or tracheobronchial tree. A person with both PTB and EPTB should be classified as PTB • EPTB:Any BCTB or CDTB involving organs other than lungs. 50 Classification based on anatomical site of disease Classification based on history of previous TB treatment. ( Patient registration group) • New patients:Never been treated or taken ATT for less than one month. • Previously treated patients: Patients who received 01 month or more of ATT in the past; • Relapse • Treatment after failure • Treatment after loss to follow up • Other previously treated patients • Patients with unknown previous TB treatment history
  46. 46. 51 Previously treated patients Declared cured or treatment completed diagnosed with recurrent episodes of TB treatment failed at the end of treatment earlier called as Treatment after default declared lost to follow up at the end of treatment outcome not known or undocumented Previously treated patients but does not fit in any above category Relapse Previously treated patients Previously treated patients Previously treated patients Treatment after Failure Treatment after loss to follow up Other previously treated patients Patients with unknown previous TB treatment history
  47. 47. Classification based on Drug Resistance 52 resistance to one 1st line Anti-TB drug only Monoresistance resistance to more than one 1st line Anti-TB drug only Polydrug resistance resistance to at least both H and R Multi drug resistance resistance to any fluoroquinolone and at least 3 second line injectables ( Capreomycin, Kanamycin and amikacin) in addition to MDR Extensively drug resistance resistance to Rifampicin with or without resistance to other drugs RR-TB
  48. 48. Classification based on HIV status 53 BCTB or CDTB HIV positive result HIV - Positive TB patients HIV negative result HIV - Negative TB patients No result of HIV testing HIV - status unknown TB patients
  49. 49. Scientific Basis of DOTS • Domiciliary Treatment • Diagnosis by Microscopy • Short course chemotherapy • Intermittent chemotherapy • Directly observed treatment
  50. 50. Basis for Domiciliary Treatment Smear-positive TB patients can be treated effectively at home with no added risk to contacts Series Total Patients Favorable Response (%) Relapse (%) Total contacts Attack rate (%) Home 82 86 14 245 10.5 Sanat- orium 81 92 12 264 11.5 TRC, 1959
  51. 51. Which bacilli are acted upon by the ATT drugs?
  52. 52. Treatment Regimens Category of Treatment Type of Patient Regimen* Category I All new pulmonary (smear-positive and negative), extra pulmonary and ‘others’ TB patients. 2H3R3Z3E3+ 4H3R3 Category II TB patients who have had more than one month anti-tuberculosis treatment previously Relapse , Failure, Treatment After Default, Others 2H3R3Z3E3S3 + 1H3R3Z3E3 + 5H3R3E3
  53. 53. Basis for Regimens CAT I: New sputum smear Positive patients, high bacillary population, chances for naturally occurring resistant mutants higher,therefore 4 drugs in intensive phase CAT II: Because of previous treatment, chances of harboring resistant bacilli are higher; hence 5 drugs in IP and total duration of treatment is 8 months.In continuation phase lower bacterial population;hence less chance of resistant organisms, therefore 3 drugs are enough. Best way to Prevent MDR/XDR TB is cure TB patients with DOTS Famous saying is "FIRST HIT IS BEST HIT"
  54. 54. Regimen for Non-DOTS treatment in RNTCP Areas o Self administered non rifampicin containing regimen o Needed in few cases of adverse reaction to rifampicin and pyrazinamide o Upto a maximum of 1% of patients may get Non-DOTS treatment in an RNTCP area. o Tuberculosis treatment card to be filled for these patients as well
  55. 55. Regimen for Non-DOTS treatment in RNTCP Areas Treatment Regimen Non-DOTS Regimen 2HSE+10 HE
  56. 56. Remember the correct doses of anti TB Drugs!
  57. 57. Basis for Intermittent Therapy Growth of M. tuberculosis during and after exposure to INH Log Viable Units of M TB Days INH added INH washed All anti-tuberculosis drugs except Thioacetazone, have a lag phase
  58. 58. Comparing the Daily Versus the Intermittent Regimens of the Anti- Tubercular Chemotherapy in the Initial Intensive Phase in Non-HIV, Sputum Positive, Pulmonary Tuberculosis Patients Pranab Kumar Mandal,1 Abhijit Mandal,2 and Sujit Kumar Bhattacharyya3 J Clin Diagn Res. 2013 Feb; 7(2): 292–295. • Conclusion: Both the intermittent and the daily regimens showed equal sputum conversion rates and the drug default cases were found more in the intermittent group. However, the adverse reactions were found more in the daily regimen category.
  59. 59. Drug doses in RNTCP
  60. 60. THE CODE AND DOSAGE Patients who weigh 60kg or more receive additional Rifampicin 150mg. Patients who are more than 50 years old ,receive streptomycin 500mg Patients who weigh less than 30 kg, receive drug as per body weight.
  61. 61. Pediatric weight bands
  62. 62. Monitoring of Treatment o Follow up sputum microscopy determines o Conversion rate o Cure rate o Sputum smear microscopy schedule o Initial sputum examination o End of Intensive phase of treatment o 2 months into Continuation phase of treatment o End of treatment
  63. 63. Cat. of Rx Pre–Rx Sputu m Test at month If: result Then Cat–1 + 2 - C.P. – Sputum at 4 & 6 m + I.P. for 1month, Sp. At 3, 5 & 7 - 2 - C.P. Sputum at 6 months + I.P. for 1 month, SP. at 3, 5 & 7 Cat–II + 3 - C.P. Sputum at 5 & months + I.P. for 1 month, Sp. at 4, 6 & 9 Schedule of follow-up sputum smear examination
  64. 64. Treatment outcome definition 69
  65. 65. Advanced RNTCP Regimes Drug Resistant TB (PMDT) o MDR TB – Resistant to INH & Rifampicin
  66. 66. CAT V- XDR TB o XDR TB- MDR TB+ Resistant to Second line injectable Anti TB drug & Fluroquinolone
  67. 67. Public Health Concern • The decline in TB incidence: Slow • Mortality- Unacceptably High and • Emergence of Drug-Resistant TB: Major public health concern. Challenges: • Prompt, accurate diagnosis and effective treatment of TB. • Uninterrupted supply of Drugs • Engaging the private sector effectively.
  68. 68. Private sector health care A source of mismanagement of TB and hence of drug resistance. - Use of incorrect Diagnostics - Incorrect regimes - Lack of supervision - Lack of regulation for over the counter drugs for TB
  69. 69. • why people in India seek care from the private sector - poor knowledge about TB - poor knowledge about services available through the national programme - the convenience of services - a desire for confidentiality - a desire for personalized care. Private sector health care
  70. 70. “Many people are unaware that all the medicines needed to treat TB patients are available free of cost at Indian government hospitals. Most people tend to spend huge amounts in private hospitals.” -Bhalchandra Chorghade (Sr Correspondent DNA)
  71. 71. Why are correct doses important? Ref: Mishra G, Mulani J. Tuberculosis Prescription Practices In Private And Public Sector In India. NJIRM. 2013; 4(2): 71-78.
  72. 72. Why are correct doses important? Ref: Mishra G, Mulani J. Tuberculosis Prescription Practices In Private And Public Sector In India. NJIRM. 2013; 4(2): 71-78.
  73. 73. World TB Day 2015: Gear up to end TB
  74. 74. Some practical points o 1. TB is a notifiable disease. o 2. If you are not sure of individualized treatment regime, please do not start it. Instead you may register the patient under RNTCP. o 3. Do not start a fluroquinolone to a TB suspect. o 4.Please do simple sputum microscopy for afb smear for all TB suspects, rather than directly starting from higher investigations like CT scan. o 5. Serological TB tests are banned in India eg. TB IgG and TB IgM. o 5. Do not even attempt to treat drug resistant TB, in absence of requisite training. Refer to specialist/ RNTCP /PMDT.
  75. 75. References • National Strategic Plan for Tuberculosis Control 2012–2017; RNTCP • TBFACTS.ORG; Information about Tuberculosis • TB India 2015; Annual Status Report • Global Tuberculosis Report 2015 by WHO • Standards for TB Care in India Manual by WHO.
  76. 76. Thanks a lot for your cooperation