Latest edition tog updates 3
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This document summarizes updates to India's Revised National Tuberculosis Control Program (RNTCP) guidelines. Some key changes include: - Expanding the criteria for presumptive TB cases to include high-risk groups like contacts of confirmed cases and those with comorbidities. - Introducing a new diagnostic algorithm and case definitions. Daily fixed-dose combination therapy is now recommended over intermittent regimens. - Updated treatment guidelines for drug-sensitive TB, drug-resistant TB, and special groups like pregnant women, those with liver or kidney disease. - New classifications, treatment durations and regimens defined for various resistance patterns from mono- to extensive drug resistance. - Revised follow-
Latest edition tog updates 3
- 2. Evolution of TB Control in India 1950s-60s Important TB research at TRC and NTI 1962 National TB Program (NTP) 1992 Program Review (GOI, WHO & SIDA) only 30% of patients diagnosed of these only 30% treated successfully 1993 RNTC pilot began 1998 RNTCP Scale up (2 % of the total population by RNTCP) 2001 450 million population covered 2004 > 08% of country covered 2006. Entire country covered by RNTCP 2016 Technical and operational guidelines 2017. RNTCP has updated guidelines for programmatic management of drug resistant TB
- 3. • To achieve 90% notification for all cases • To achieve 90% success rate for all new cases and 85% for previously treated cases • To significantly improve the successful outcome of treatment of DRTB cases. • To achieve decreased morbidity and mortality of HIV associated TB cases. • To improve outcome of TB care in private sectors. RNTCP: NATIONAL STRATEGIC PLAN 2012-2017
- 4. CASE DEFNITIONS MICROBIOLOGICALLY CONFIRMED TB CASE CLINICALLY DIAGNOSED TB CASE A presumptive TB patient with ● Biological specimen Positive for AFB in ● AFB smear ● Culture ● Molecular methods A presumptive TB patient with ● Radiological abnormalities ● Histopathology ● Clinical signs Consistent with active TB Case definition like smear positive TB, smear negative TB are removed in new guidelines
- 5. Case finding & Diagnostic strategy Presumptive pulmonary TB refer to patients with any of the symptoms and signs suggestive of TB • Cough> 2 weeks • Fever >2 weeks • Significant weight loss • Hemoptysis • Any abnormalities in chest radiograph NEW GUIDELINES PREVIOUS GUIDELINES In new guidelines in addition contacts of micro biologically confirmed TB patients, PLHIV ,DM ,malnourished, cancer pts, pts on immune suppressants are screened regularly Pulmonary TB suspect • Cough of >=2 weeks • Cough of any duration of 1. Contacts of smear positive TB 2. Contacts of EPTB 3. HIV positive patients.
- 6. Case finding & Diagnostic strategy Presumptive extra pulmonary TB Organ specific symptoms and signs • Like swelling of lymph nodes • Pain and swelling in joints. • Neck stiffness, disorientation And or constitutional symptoms • Significant weight loss • Persistent fever >2 weeks • Night sweats This is similar to previous guidelinesguidelines
- 7. Case finding & Diagnostic strategy Presumptive drug resistant TB • TB patients who failed treatment with first line anti tubercular drugs(ATD) • Pediatric TB non responder • TB patients who are contacts of DRTB • TB patients who are found positive on any follow up sputum smear examination during treatment with first line ATD • Previously treated TB cases • TB patients with HIV co infection.
- 8. Diagnostic Algorithm for Pulmonary TB
- 9. Diagnostic Algorithm for Extra Pulmonary TB
- 10. DIAGNOSTIC ALGORITHM FOR DRUG RESISTANT TB
- 11. Contd….. Classification based on drug resistance : • Monoresistant – resistance to one 1st lineATT • Poly drug resistant – resistance to more than one first line ATT other than INH & RIFA • Multiresistance drug– resistance to both INH & RIFA with or without resistant to other drugs • Extensive Drug resistance – MDR + resistance to 2nd line ATT ( fluroquinolones and injectable 2nd line ATT)
- 13. TREATMENT • Intermittent regimen • extension of IP by 1 month if sputum positive • Ethambutol in CP of cat II regimen only • No fixed dose, limited weight band • Follow up laboratory only. • No long term follow up • Daily drug – Fixed drug combination (FDC) according to weight bands. • No extension of IP • Ethambutol in CP of both catI & cat II regimen • Fixed dose combinatioc(FDC) as per weight band • Follow up– up clinical ,and / laboratory investigation • .Long term follow up up to 2 yrs PREVIOUS GUIDELINES NEW GUIDELINES
- 14. From Intermittent Regimen To Daily Fixed Dose combination as per weight 14
- 15. . FIXED DOSE COMBINATION : WEIGHT BANDS-ADULTS
- 16. Treatment : DRUG SENSITIVE TB PREVIOUS GUIDELINES Tb case IP CP NEW 2 (HRZE)3 4( HR)3 PREVIOUSLY TREATED 2 (HRZES)3 +(HRZE)3 5 (HRE)3 Tb case IP CP NEW 2 HRZE 4 HRE PREVIOUSLY TREATED 2 HRZES +HRZE 5 HRE • Daily regimen….FDC • Ethambutol introduced in cp of new cases. • No extension of IP NEW GUIDELINES
- 17. Tb case Intensive phase Continuation phase MDR (6-9)Km, Lfx ,Eto ,Cs, Z, E (18) Lfx ,Eto ,Cs, Z, E R-RESISTANT + H sensitive/ unknown (6-9)Km, Lfx ,Eto ,Cs, Z, E, H (18) Lfx ,Eto ,Cs, Z, E, H All MDR isolates • Liquid culture drug sensitivity done for Km and Lfx • Appropriate modification doneaccording to culture’ TREATMENT : DRUG RESISTANT TB
- 18. Diagnosis of EPTB using the Xpert MTB/RIF test ● Lymph node TB: ❖Xpert MTB/RIF should be used as an additional test to conventional smear microscopy,culture and cytology in FNAC SPECIMENS.
- 19. • TB Meningitis: ❖Xpert may be used as an adjunctive test for TBM . A negative Xpert result on a CSF specimen does not rule out TBM . Treatment decision can be taken based on clinical features and CSF profile.
- 20. ● Pleural TB ❖Xpert MTB/RIF should not be used to diagnose pleural TB.
- 21. . . PRE TREATMENT EVALUATION DRUG RESISTANT TB
- 22. Treatment : MONODRUG RESISTANT TB 5 EFFECTIVE DRUGS • Total treatment duration : 9 to 12 months • Intensive phase – 3 to 6 months • Continuation phase – 6 months (to discontinue injectable SLD) A TB patient ,whose biological specimen is resistant to one first line anti TB drug ( FLD )only. INJECTABLE SECOND LINE DRUGS FLUROQUINOLONE RIFAMPICIN SENSITIVE FIRST LINE DRUG (HZE) SENSITIVE FIRST LINE DRUG (HZE)
- 23. Treatment : INH MONO RESISTANT TB Tb case Intensive phase Continuation phase INH RESISTANT TB + RIFAMPICIN SENSITIVE (DST of SEZ not known) (3-6)Km, Lfx ,R Z, E (6) Lfx ,R, Z, E Decision to use INH in the regimen LIQUID CULTURE HIGH RESISTANC E OMIT INH LOW RESISTANC E HIGH DOSE INH LPA KAT G MUTATION OMIT INH INH A MUTATION HIGH DOSE INH
- 24. TREATMENT : POLYDRUG RESISTANT TB Biological specimen resistant to > one FLD other than H & R • Total treatment duration : 9 to 12 months • Intensive phase – 3 to 6 months • Continuation phase – 6 months (to discontinue injectable SLD) INJECTABLE SECOND LINE DRUGS FLUROQUINOLONE RIFAMPICIN SENSITIVE FIRST LINE DRUG (HZE) ANY ONE GROUP IV DRUG (Eto,Cs,PAS)
- 25. Treatment : MDR / RR-TB with additional resistance Resistance to EMB • omit EMB Resistance to PYZ • Omit PYZ Resistance to EMB + PYZ • omit EMB + PYZ / add PAS in IP + CP Resistanc e to LFX • omit LFX/ add MFX + PAS + CFZ Resistance to MFX • Omit MFX/ Add LFX + PAS + CFZ Resistance to LFX + MFX • omit LFX + MFX / add CFZ + PAS + LZD • Duration of IP 6-12 Months ADDITIONAL RESISTANCE TO FLD’S ADDITIONAL RESISTANCE TO FQ’S
- 26. Treatment : MDR / RR-TB with additional resistance Resistance to Km • omit Km/ add Cm Resistance to Cm • Omit Cm/ Add Km Resistance to Km + Cm • omit Km + Cm • add CFZ + PAS + LZD • Duration of IP 6-12 Months ADDITIONAL RESISTANCE TO INJECTABLE SLD’S
- 27. Duration of treatement for EPTB ● Lymph node TB ❖ Six-month ATT standard first-line regimen is recommended for peripheral lymph node TB . ● Abdominal TB ❖ Six-month ATT standard first-line regimen is recommended for abdominal TB. ● TB meningitis ● TB meningitis should be treated with standard first-line ATT for at leat nine months.
- 28. Tb case Intensive phase Continuation phase XDR (6-12)Cm, PAS, Mfx , High dose H CFZ,lzd, Amx/clv (18), PAS, Mfx , High dose H CFZ, lzd, Amx/clv • All DR –TB treatment are to be given on daily basis under supervision. TREATMENT : EXTENSIVE DRUG RESISTANT TB
- 29. FOLLOW UP : DRUG SENSITIVE TB positive DRUG SENSITIVITY TEST • MICROBIOLOGICAL - END OF IP - END OF TREATMENT • Weight- monthly • Chest xray – if required • Physical evaluation – whenever required LABORATORY CLINICAL • In the presence of clinical deterioration, the MO consider sputum examination • even during CP. • At completion of treatment sputum and/or culture done for every patient.
- 31. Drug Main effects Rare effects Isoniazid Peripheral neuropathy Skin rash Hepatitis Sleepiness and lethargy Convulsions Psychosis Arthralgia Anaemia Rifampicin Gastrointestinal: abdominal pain, nausea, vomiting Hepatitis Generalised cutaneous reactions Thrombocytopenic purpura Osteomalacia Pseudomemberanous colitis Pseudoadrenal crisis Acute renal failure Haemolytic anaemia Pyrazinamide Arthralgia Hepatitis Gastrointestinal Cutaneous reactions Sideroblastic anaemia Ethambutol Retrobulbar neuritis Generalised cutaneous reactions Arthralgia Peripheral neuropathy Hepatitis (very rare) Adverse drug reaction FLDs
- 32. ADVERSE DRUG EFFECTS :SLD • Ototoxicity • Nephrotoxicity • Vertigo • Electrolyte imbalance Kanamycin, capreomycin • GI symptoms, • convulsions • QTprolongation, • arthralgia Quinolones- oflox,mfx,Lf • GI upsets, excessive salivation, hepatitis • Hypothyroidism, • Gynaecomastia, • neuropathy ethionamide • CNS : convulsions, dizziness, • tremor, insomnia, • suicidal tendency, depression • hypersensitivity reaction CYCLOSERINE • GI upsets, skin rash hepatitis GI symptoms,QT • prolongation, arthralgia • Hypokalemia,hepatiti • Hypothyroidism PAS
- 33. TB IN PREGNANCY AND LACTATION •A successful TB treatment is important for successful outcome of pregnancy •With exception to STREPTOMYCIN all first line drugs are safe in pregnancy •Lactating women should receive ATT full course •Breastfeeding must be continued •Lactating mother to follow COUGH HYGINE MEASURES •Baby should receive BCG followed by INH prohylaxsis with pyridoxine 5mg/kg for 6 months
- 34. . DR-TB in pregnancy Pregnancy screening is mandatory in pretreatment evaluation Women of child bearing age group presumptive MDR-TB To use appropriate contraceptive till culture and DST results To take specialist opinion when found to be pregnant prior or during treatment
- 35. . Usual TB regimen with anticipation of hepatotoxicity Current excessive alcohol use h/o acute hepatitis Hepatitis virus carriage TB and Liver disorders
- 36. . • Pyrazinamide • Ethionamide • PAS HEPATOTOXIC DRUGS • SLDs can be used safely • Less hepatotoxic than FLDs • However PYZ + Etm should be avoided Mild hepatic impairment • Consider other etiologies • Alcohol,viral,Non TB drug induced etc.. Hepatitis when on SLDs TO MONITOR LFT DURING TREATMENT IF PRE TREATMENT LFT DERANGED DR-TB in Liver diseases Risk increases with pre existing liver disease
- 37. TB in Renal failure CKD Patients are at increased risk in developing Pulmonary & Extra pulmonary TB NEPHROTOXIC DRUGS Ethambuamol Metabolites of Pyrazinamide Streptomycin Requires dose and interval modifications
- 38. Dose modifications Pyrazinamide 25mg/kg (thrice weekly) Ethambutol 15mg/kg (thrice weekly) Streptomycin 15mg/kg (twice/thrice weekly) Dosing intervals must be increased in STAGE 4 & 5 CKD When on INH in severe renal insufficiency pyridoxine to be added to prevent peripheral neuropathy Contd…
Editor's Notes
- #15: Trainer Notes: Introduce the concept of Daily ATT for participants who might not be aware of the same. Simplicity of treatment Increased patient acceptance Fewer tablets to swallow Prevents ‘concealed’ irregularity Increased health worker compliance Fewer tablets to handle, hence quicker supervision of DOT Easier drug management Reduced use of monotherapy Lower risk of misuse of single drugs Lower risk of emergence of drug resistance Easier to adjust dosages by body weight