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REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAME DAILY REGIMEN

- The document summarizes changes to India's Revised National Tuberculosis Control Program (RNTCP) guidelines. - Key changes include shifting to a daily drug regimen, redefining presumptive and confirmed TB cases, classifying cases based on anatomical site and history of treatment, and improving follow-up procedures. - Treatment outcomes are also redefined, and isoniazid preventive therapy guidelines for people living with HIV are expanded. - Management of extra-pulmonary and drug-resistant TB sees some adjustments as well, such as potentially extending treatment duration for certain types of extra-pulmonary TB.

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RNTCP Daily Regimen Dr. Satyadeo Choubey, M.D Assistant Professor Respiratory Medicine MGM Medical College, Indore
Goal of TB Treatment • Decrease case fatality & morbidity by ensuring relapse free cure • Minimize & prevent development of drug resistance • Render patient non-infectious, break the chain of transmission and decrease pool of infection
Contribution of India to annual notification among High Burden Countries New Smear positives Relapse 30% 70% India Other HBCs 50% 50% Very high relapse notification in India Continued transmission
Summary of evidences • Relapse rates – Relapse rates are high – more than many high burden countries, over a period time, in all states – Relapse rates high with treatment interruption but not significantly different in patients without treatment interruption – Relapse rates are high among NSP TB patients in area with no private sector presence – Relapse rates are higher with intermittent regimen • INH resistance – Pre-treatment INH resistance is high (>10%) – pre-treatment INH resistance lead to amplification of resistance (acquired rifampicin resistance), leading to MDR
RNTCP regimen & body weight of Indian patients • Current RNTCP regimens for adults < 30 kg 30-60 kg > 60 kg • Dose of INH is inappropriately high for those in the band of 30-40 kg. ( ~ 45% in our cohort) • Drug toxicity related to INH in underweight patients is possibly one of the reasons for adverse effects and default.
Presumptive TB cases Old guideline • An individual having cough for 2 weeks or more • Contacts of smear-positive TB patients having cough for any duration • Suspected/confirmed extra- pulmonary TB having cough for any duration • HIV-positive patient having cough for any duration. New Guideline • Cough >2 weeks, • Fever >2 weeks, • Significant weight loss, • Haemoptysis, • Any abnormalities in chest radiography.
Presumptive DRTB cases • TB patients who have failed treatment with first- line anti-tubercular drugs (ATD) • Paediatric 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.
Case definition: There are significant changes in the definition of cases as per New Guidelines: • Microbiologically confirmed TB case refers to a presumptive TB patient with biological specimen positive for acid-fast bacilli, or positive for mycobacterium TB on culture, or positive for TB through Quality Assured Rapid Diagnostic molecular test. • Clinically diagnosed TB case refers to a presumptive TB patient who is not microbiologically confirmed, but has been diagnosed with active TB by a clinician on the basis of X-ray abnormalities, histopathology or clinical signs with a decision to treat the patient with a full course of anti-TB treatment. Microbiologically confirmed or clinically diagnosed cases of TB are classified according to Anatomical site of disease • History of previous TB • Drug resistance.
Classification on the basis of history of the previous treatment New case – A TB patient who has never had treatment for TB or has taken ATT for <1 month. (No change in new guidelines.) • Previously treated patients have received one month or more ATD in the past. This may be: – Recurrent TB case – A TB patient previously declared as successfully treated (cured/treatment completed) and who is subsequently found to be microbiologically confirmed TB case is a recurrent TB case. (Previously called relapse.) – Treatment after failure – Patients are those who have previously been treated for TB and whose treatment failed at the end of their most recent course of treatment. • Previously, it was called failure where a TB patient is sputum-positive at 5 months or more after initiation of treatment. Treatment after loss to follow-up – A TB patient previously treated for TB for one month or more and who was declared lost to follow-up in their most recent course of treatment and subsequently found microbiologically confirmed TB cases. Previously called treatment after default – a patient who has received treatment for TB for a month or more from any source and return for treatment after having defaulted, that is, not taking ATD consecutively for 2 months or more and found to have smear-positive.
Classification done on the basis of drug resistance • Mono resistance (MR) – A TB patient whose biological specimen is resistant to one first-line anti-TB drug only. • Poly resistance (PDR) – A TB patient whose biological specimen is resistant to more than one first-line anti-TB drug, other than both INH and Rifampicin. • Multi-drug resistance (MDR) – A TB patient whose biological specimen is resistant to both INH and Rifampicin with or without resistance other first-line ATD, based on results from a Quality Assured Laboratory. (No changes.) • Rifampicin resistance (RR) – Resistance to Rifampicin detected by phenotypic or genotypic methods with or without resistant to other ATD excluding INH. Patient with RR should be managed as if they are in MDR TB case. • Extensive drug resistance (XDR) – MDR TB case whose biological specimen was resistant to a Fluroquinolone (FQ) and a second-line injectable ATD from a Quality Assured Laboratory. (No changes.)
• Drug regimen in the new guidelines: Principle of treatment of TB has been shifted towards daily regimen with administration of daily fixed dose combination of first-line ATT as per appropriate weight bands. For new TB cases Treatment in IP will consist of 8 weeks HRZE in daily dosages as per four weight bands categories • There will be no need for extension of IP • Only Z will be stopped in CP while the other three drugs will be continued for another 16 weeks as daily dosages. For previously treated cases: IP will be of 12 weeks, where injection Streptomycin will be stopped after 8 weeks and the remaining four drugs in daily dosages as per weight band for another 4 weeks • No need of extension of IP • At the start of CP, Pyrazinamide will be stopped while rest of the drugs will be continued for another 20 weeks as daily dosages.
• Management of extra-pulmonary TB (new guidelines) – There is only one change as follows: The CP in both new and previously treated cases may be extended 3–6 months in certain TB such as CNS, skeletal, disseminated TB, and so on based on clinical decision of the treating physicians • Extension beyond 3 months will only be on recommendation of experts of concerned field.(In the previous guidelines, extension of ATD in case of CNS and skeletal TB was maximum 3 months).
In patients above 50 years of age, maximum dose of Streptomycin should be 0.75 g.
Follow up • Follow-up of treatment: There are some changes in the new guidelines: Clinical follow-up – (new addition) Should be at least monthly – the patient may visit the clinical facility, or the medical officer may conduct the review when she/he visits the house of the patient to observe improvement of chest symptoms, weight gain, control the co-morbid conditions such as HIV and diabetes and to monitor any adverse reaction to ATD. Follow-up laboratory investigation For PTB cases – sputum smear examination at the end of IP and at the end of treatment. (In the previous guidelines, follow-up sputum smear to be done at 2, 4 and 6 months for new cases and 3, 5 and 8 months in previously treated cases.) In case of clinical deterioration, the Medical Office may consider repeat sputum smear even during CP. (New addition.) • At the completion of treatment, sputum smear and culture should be done for every patient • CXR – to be offered whenever required and available. • Long-term follow-up After completion of treatment, the patient should be followed up at the end of 6, 12, 18 and 24 months. Any clinical symptoms and/or cough, sputum microscopy and/or culture should be considered. (New addition) However, there was no provision of long-term follow-up in the previous guidelines.
Treatment outcomes Cured A microbiologically confirmed TB at the beginning of the treatment who was smear- or culture-negative at the end of complete treatment. (Changed). Treatment success TB patients either cured or treatment completed are accounted in the treatment success. (New addition). Failure A TB patient whose biological specimen is positive by smear or culture at the end of the treatment. (Changed). Failure to respond For paediatric TB patients. (New addition). Lost to follow-up A TB patient whose treatment was interrupted for one consecutive month or more. (New addition). Not evaluated A TB patient for whom no treatment outcome is assigned. (Former transfer out). Treatment regimen changed Previously, it was called as switched over to MDR treatment.
Isoniazid Preventive Therapy (IPT) for PLHIVs • Adult and adolescents living with HIV should be screened for TB and those who are unlikely to have active TB should be offered IPT • Children with HIV who have no TB symptoms and who are unlikely to have active TB on symptom-based screening should be offered IPT regardless of their age • All children with HIV who have successfully completed treatment for TB disease should receive IPT. Dosage of INH preventive therapy: Adult and adolescent: INH 300 mg + Pyridoxine 50 mg per day for 6 months. Children above 12 months: INH 10 mg/kg + Pyridoxine 25 mg per day for 6 months.
DRTB • MDR/RR TB cases (without additional resistance) Treatment regimen for MDR TB contains 6–9 months of IP with Kanamycin, Levofoxacin, Ethambutol, Pyrazinamide, Ethionamide and Cycloserine and 18 months of CP with Levofoxacin, Ethambutol, Ethionamide and Cycloserine (no change). But if INH resistance is not known or DST result shows sensitivity to INH, then addition of INH in the above- mentioned regimen of ATD is to be done. (New addition)
• All MDR TB cases would be subjected to LC and DST at baseline for Kanamycin and Levofloxacin. • Appropriate modification of the treatment regimen can be done in case of additional resistance. If isoniazid resistance is found, the use of isoniazid depends on: If high-level resistance detected by liquid culture – omit INH. • If low-level resistance detected by LC – add high dose INH. • If LPA reports INH resistance by Kat G mutation – omit INH. • If LPA reports INH resistance by INH A mutation – add high dose INH.
• There are some new additions If RR by CBNAAT, then add INH in the standard dose till result of LPA or LC and DST. • For new patients diagnosed as TB and RR by CBNAAT – repeat CBNAAT and send the sample for liquid culture – If second CBNAAT shows RR then start standard MDR till result for culture DST available. Perform DST to INH and SLDST on liquid culture. – If second CBNAAT shows R sensitiveness, continue regimen for new TB cases and wait for LC and DST. As soon as LC result is available, modify the regimen as follows: • If LC shows R sensitiveness – continue regimen for new TB cases • If LC shows R resistance – refer the patients to DRTB centre for decision regarding starting MDR or continuing regimen for new TB cases depending on the response to treatment given so far. • For mixed resistance pattern, consider oral drug in the sequence of preference – Pyrazanamide, Ethambutol, Ethionamide, Cycloserine, PAS, Clofazimine, Linezolide, Coamoxyclave, high dose INH, Clarythromycin • Regimen designing or modification will be prerogative of the DRTB centre committee only.
Follow up MDR/RR Schedule for sputum culture examination for MDR TB (no change):
• For mono DR and poly DRTB patients – Schedule for sputum culture examination: Microbiological: Sputum smear and culture at second and third months and then culture examination at three monthly interval till completion of the treatment. For mono/poly DRTB patients – – IP should given for at least 3 months – After this, the patient will be reviewed – If after the 3 months the smear result remains positive, the sputum sample is sent for genotypic DST to Rifampicin for CBNAAT or LPA and liquid/solid culture and DST to see for resistance amplification – Shifting from IP to CP will be based on the result of culture – The IP can be extended maximum 3 months – Duration of CP is 6 months • MDR TB patients with additional drugs resistance including XDR TB patients Change from IP to CP will be done after achievement of culture conversion, that is, two consecutive negative cultures taken at least one month apart • In case of delay in culture conversion, IP can be extended from 6 months to maximum 12 months. •
Outcome for RR/MDR and/or XDR TB patients (new guidelines) Cure – Treatment completed as recommended by the National Policy without evidence of failure and three or more consecutive cultures taken at least 30 days apart are negative after IP Treatment completed – Treatment completed as recommended by the National Policy without evidence of failure but no record that three or more consecutive cultures taken at least 30 days apart are negative after IP Treatment success – The sum of cured and treatment completed Treatment failed – Treatment terminated or need for permanent regimen change of at least two or more ATD in CP because of lack of microbiological conversion by the end of IP or microbiological reversion in the CP after conversion to negative or evidence of additional acquired resistance FQ or second-line injectable drugs, or adverse drug reaction. Outcomes for mono/poly drug-resistant TB patient Cure – A microbiologically confirmed TB at the beginning of treatment who was culture-negative in the last month of treatment and on at least one previous occasion Treatment completed – A patient who has completed treatment according to the guidelines but does not meet the definition for cure or treatment failure due to lack of microbiological results Failure – Treatment terminated or need for permanent regimen change of at least two or more anti-TB drugs in CP because of: Evidence of additional acquired resistance to Rifampicin, Rluroquinolone or second-line injectable during treatment Severe ADR Culture-positive during CP or at end of treatment Died – A patient who dies for any reason during the course of M/X DRTB treatment Loss to follow-up – A patient whose treatment was interrupted for one month or more for any reasons Not evaluated – A DRTB patient for whom no treatment outcome is assigned, and this included former ‘transfer out’. •
Side effects of first line drugs 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)
Side effects of second line drugs Drugs Side effects Injectables – Kanamycin / Capreomycin  Ototoxicity (6,7)  Nephrotoxicity  Vertigo  Electrolyte imbalance Quinolones – Ofloxacin, Levofloxicin, Moxifloxacin  Gastro Intestinal symptoms: diarrhoea, vomiting, and abdominal pain  Central nervous system (CNS): dizziness and convulsions  Phototoxicity and photosensitivity  Tendinopathy and tendinitis  Skin rash  Cardiotoxicity – QT prolongation  Arthralgia Ethionamide  Gastro-intestinal: epigastric discomfort, anorexia, nausea, metallic taste, vomiting,  excessive salivation, and sulfurous belching  Psychiatric: hallucination and depression  Hepatitis  Hypothyroidism and goitre with prolonged administration  Gynaecomastia, menstrual disturbances, impotence, acne, headache, and peripheral  neuropathy Cycloserine  CNS: dizziness, slurred speech, convulsions, headache, tremor, and insomnia  Psychiatric: confusion, depression, altered behaviour, and suicidal tendency  Hypersensitivity reaction PAS  Gastro-intestinal: anorexia, nausea, vomiting, and abdominal discomfort  Skin rash  Hepatic dysfunction  Hypokalemia  Hypothyroidism and goitre with prolonged administration
Warning symptoms for some serious adverse reactions Warning Symptoms For Medical officer / General practitioner (GP): When to refer the patient  Rash  Skin lesions on oral cavity, nose If mucous membranes are involved OR rash is more than 1/10th of body surface area without mucous membrane involvement OR associated with fever and generalized swelling (edema); refer to specialist / tertiary care center immediately. Pain in eye/s, Blurring of vision and Disturbance in color vision Indicates Eye toxicity. Refer the patient to specialist for evaluation. Loss of hearing / Diminished hearing, Ringing in the ears, Dizziness and Loss of balance Indicates Ear toxicity. Refer the patient to specialist for evaluation. Puffiness of face, Swelling over feet and Oliguria, Anuria Indicates Kidney toxicity. Treat the symptoms and refer the patient to specialist for evaluation. Hallucinations, Seeing abnormal things and Suicidal or abnormal thoughts or actions Indicates Psychiatric disturbances. Refer the patient to specialist for evaluation.
Absolute contraindications of anti-TB drugs:( Benefit – Risk) Drug Absolute contraindications Reason Rifampicin With Saquinavir and Ritonavir Potential for hepatotoxicity is increased. Rifampicin is CYP3A4 inducer and can decrease Saquinavir level and effect Ethambutol Optic neuritis Ethambutol can cause optic neuritis Pyrazinamide Acute porphyria Gouty arthritis Hepatic diseases Pyrazinamide can precipitate acute porphyria Can inhibit excretion of urates Can cause drug induced hepatitis Neomycin Kanamycin, Tobramycin, Amikacin, Capreomycin, Streptomycin Concurrent use of two aminoglycosides With potent diuretics e.g. Furosemide Soon after use of anesthetics and muscle relaxants Can potentiate nephrotoxicity Can potentiate ototoxicity Can result in respiratory paralysis Levofloxacin, Ofloxacin, Moxifloxacin History of tendon disorders Associated with risk of tendinitis and tendon rupture Ethionamide Severe hepatic impairment Risk of worsening Cycloserine Epilepsy, Psychiatric illness - Depression, Severe anxiety, Psychosis Severe renal insufficiency Can precipitate seizures Can lead to severe psychosis and depression Can lead to Cycloserine toxicity Clarithromycin With Pimozide, Astemizole With Lovastatin or Simvastatin Hypokalemia and in patients with prolonged QT interval Risk of QT prolongation Can cause rhabdomyolysis Risk of further QT prolongation Imipenem With Valproic acid and Probenecid Decrease in valproic acid concentration and Increase in plasma levels of imipenem Linezolid With Monoamine oxidases A or B inhibitors (e.g. phenelzine, isocarboxazid, selegiline, moclobemide) within two weeks Risk of MAO inhibition leading to serotonin syndrome
Algorithm for reintroduction of anti-TB drugs Adverse drug reaction Advice on reintroduction Hepatotoxicity  Reintroduction after liver enzyme returns to ≤ 2 X ULN Ocular toxicity  Main suspect drug is EMB  Reintroduction of Ethambutol is not recommended Immune mediated Nephritis  Main suspect drug is RIF  Reintroduction with RIF is not recommended Non serious cutaneous ADRs - no mucous membrane involvement or less than 10 % of BSA.  After withholding all drugs reintroduce one drug at a time Serious Cutaneous adverse drug reactions - mucous membrane involvement or more than 10 % of BSA.  Reintroduction is not recommended (applies for all anti-TB drugs). Immune thrombocytopenia  Main suspect drug is RIF  Reintroduction with RIF is not recommended Gynecomastia  Symptoms takes long time to resolve (4-12 month) hence usually reintroduction is not required. Aplastic Anemia  Main suspect drug is INH  Reintroduction with INH is not recommended Nephrotoxicity  Main suspect drugs are AGs.  AGs can be reintroduced at low doses after the renal function returns to normal. Ototoxicity  Main suspect drugs are AGs.  Reintroduction of AGs is not recommended. Cardiac arrhythmias including Torse de pointes (TdP)  Main suspect drugs are FQs.  Reintroduction with FQs is not recommended. Diarrhea  Reintroduction is recommended with one drug at a time every fourth day, once diarrhea is resolved Seizures  Main suspect drugs are FQs.  Reintroduction with FQs is not recommended. Psychosis  Main suspect drugs is cycloserine.  Reintroduction with cycloserine can be done at low dose but if symptoms recur than completely discontinue the drug.
Stepwise increase in the dosage for Reintroduction Drug Day 1 Day 2 Day 3 Isoniazid 50 mg Full dose Full dose Rifampicin 75 mg 300 mg Full dose Pyrazinamide 250 mg 1000 mg Full dose Ethionamide / Prothionamide 125 mg 250 mg Full dose Fluoroquinolones 50 mg 200 – 250 mg Full dose Cyclosporine 125 mg 250 mg Full dose Ethambutol 100 mg 500 mg Full dose PAS 1 g 4 g Full dose Capreomycin 125 mg 500 mg Full dose Kanamycin 125 mg 500 mg Full dose Amikacin 125 mg 500 mg Full dose
Commonly used ancillary medicinesIndication Drugs Nausea, vomiting, Stomach upset Domeperidone, metoclopramide, prochlorperazine, promethazine, ondansetron Heartburn, indigestion and acidity H2-blockers (ranitidine etc.), proton pump inhibitors (omeprazole, pantoprazole etc) Antacid syrups and the antacids if prescribed should be taken at least 2 hours apart from anti-TB drugs Oral candidiasis Fluconazole, clotrimazole lozenges, nystatin suspension Diarrhoea ORS sachets Prophylaxis of neurological complications of cycloserine and isoniazid Pyridoxine (vitamin B6) Musculoskeletal pain, Arthralgia, headaches Give paracetamol / ibuprofen / aspirin / diclofenac. If caused by fluoroquinolones, refer to specialist immediately. Tendonitis can progress to tendon rupture. Cutaneous reactions, itching Hydrocortisone cream, calamine lotion Systemic hypersensitivity Reactions Antihistamines (diphenhydramine, chlorpheniramine, dimenhydrinate) Systemic corticosteroids (prednisone, prednisolone, Dexamethasone) are reserved only for very severe reactions Bronchospasm Inhaled beta-agonists (salbutamol, albuterol, etc.), inhaled corticosteroids (beclomethasone, etc.) Hypothyroidism Levothyroxine Electrolyte wasting Potassium and magnesium replacement therapy (oral formulations) Depression Selective serotonin reuptake inhibitors (fluoxetine, sertraline), tricyclic antidepressants (amitriptyline) Severe anxiety Lorazepam, diazepam, clonazepam Insomnia Any hypnotic Psychosis Haloperidol, thorazine, risperidone (consider benzotropine or biperiden to prevent extrapyramidal Effects), Buromazine, thioridazine Seizures Phenytoin, carbamazepine, valproic acid, phenobarbital Peripheral neuropathy Amitriptyline, gabapentin
Introduction of new ATD under RNTCP Bedaquiline (BDQ): – New class of drug, diarylquinoline that targets mycobacterial ATP synthase, and enzyme essential for supply of energy to mycobacterium TB – Strong bactericidal and sterilizing activities against MTB • It has no cross-resistance with first- and second-line ATD • Significant benefit in improving the time to culture conversion in MDR TB patients • RNTCP introducing BDQ at six sites in the country initially • Basic criterion – Adult aged ≥18 years having pulmonary MDR TB • Female should not be pregnant.
Thank You
REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAME DAILY REGIMEN
REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAME DAILY REGIMEN

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In this document
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Introduction to the RNTCP daily regimen presented by Dr. Satyadeo Choubey.

Focus on reducing TB morbidity, preventing drug resistance, and breaking transmission chains.

India's contributions to TB notifications highlighting a 70% relapse rate among smear-positive cases.

High relapse rates in India with significant pre-treatment INH resistance leading to MDR.

RNTCP drug dosing concerns for underweight patients, highlighting INH toxicity risks.

Updated guidelines for identifying presumptive TB cases based on symptoms like cough and fever.

Essential criteria for identifying presumptive DRTB cases, including treatment failures.

Changes in case definitions, distinguishing microbiologically confirmed and clinically diagnosed TB.

New classification for TB cases based on treatment history and definitions for recurrent cases.

Detailed classification of TB based on drug resistance including mono, poly, and multi-drug resistance.

New daily regimen for TB treatment including adjustments for weight categories and treatment phases.

Change in guidelines for the management duration of extra-pulmonary TB under new guidelines.

Age-specific dosage recommendations for Streptomycin in patients over 50 years.

Changes in follow-up procedures including monthly clinical checks and sputum examinations.

Clarification on treatment outcomes including success, failure, and definitions for new cases.

IPT guidelines for PLHIVs, emphasizing screening and treatment protocols.

MDR/RR TB treatment regimen details including drug options and duration.

Resistance testing protocols and modifications based on drug resistance findings.

Guidelines for managing patients with rifampicin resistance identified by molecular tests.

Sputum culture follow-up schedule remains unchanged for MDR cases.

Follow-up examination and treatment schedule for mono and poly drug-resistant TB patients.

Outcomes for MDR/XDR patients based on culture conversion and treatment compliance.

Common side effects associated with first-line anti-TB drugs, detailing main and rare effects.

Common side effects related to second-line anti-TB drugs and their potential risks.

Symptoms indicating serious adverse reactions to anti-TB drugs requiring referral.

Absolute contraindications for various anti-TB drugs highlighting associated risks.

Guidelines on reintroducing anti-TB drugs after adverse reactions.

Stepwise dosage increase protocol for reintroducing anti-TB drugs post-reaction.

Commonly used ancillary medications and their indications to support TB treatment.

Introduction of Bedaquiline for MDR-TB treatment, highlighting its efficacy and use criteria.

Conclusion and thanks for the presentation.

REVISED NATIONAL TUBERCULOSIS CONTROL PROGRAME DAILY REGIMEN

  • 1.
    RNTCP Daily Regimen Dr.Satyadeo Choubey, M.D Assistant Professor Respiratory Medicine MGM Medical College, Indore
  • 2.
    Goal of TBTreatment • Decrease case fatality & morbidity by ensuring relapse free cure • Minimize & prevent development of drug resistance • Render patient non-infectious, break the chain of transmission and decrease pool of infection
  • 3.
    Contribution of Indiato annual notification among High Burden Countries New Smear positives Relapse 30% 70% India Other HBCs 50% 50% Very high relapse notification in India Continued transmission
  • 4.
    Summary of evidences •Relapse rates – Relapse rates are high – more than many high burden countries, over a period time, in all states – Relapse rates high with treatment interruption but not significantly different in patients without treatment interruption – Relapse rates are high among NSP TB patients in area with no private sector presence – Relapse rates are higher with intermittent regimen • INH resistance – Pre-treatment INH resistance is high (>10%) – pre-treatment INH resistance lead to amplification of resistance (acquired rifampicin resistance), leading to MDR
  • 5.
    RNTCP regimen &body weight of Indian patients • Current RNTCP regimens for adults < 30 kg 30-60 kg > 60 kg • Dose of INH is inappropriately high for those in the band of 30-40 kg. ( ~ 45% in our cohort) • Drug toxicity related to INH in underweight patients is possibly one of the reasons for adverse effects and default.
  • 6.
    Presumptive TB cases Oldguideline • An individual having cough for 2 weeks or more • Contacts of smear-positive TB patients having cough for any duration • Suspected/confirmed extra- pulmonary TB having cough for any duration • HIV-positive patient having cough for any duration. New Guideline • Cough >2 weeks, • Fever >2 weeks, • Significant weight loss, • Haemoptysis, • Any abnormalities in chest radiography.
  • 7.
    Presumptive DRTB cases •TB patients who have failed treatment with first- line anti-tubercular drugs (ATD) • Paediatric 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.
  • 10.
    Case definition: Thereare significant changes in the definition of cases as per New Guidelines: • Microbiologically confirmed TB case refers to a presumptive TB patient with biological specimen positive for acid-fast bacilli, or positive for mycobacterium TB on culture, or positive for TB through Quality Assured Rapid Diagnostic molecular test. • Clinically diagnosed TB case refers to a presumptive TB patient who is not microbiologically confirmed, but has been diagnosed with active TB by a clinician on the basis of X-ray abnormalities, histopathology or clinical signs with a decision to treat the patient with a full course of anti-TB treatment. Microbiologically confirmed or clinically diagnosed cases of TB are classified according to Anatomical site of disease • History of previous TB • Drug resistance.
  • 11.
    Classification on thebasis of history of the previous treatment New case – A TB patient who has never had treatment for TB or has taken ATT for <1 month. (No change in new guidelines.) • Previously treated patients have received one month or more ATD in the past. This may be: – Recurrent TB case – A TB patient previously declared as successfully treated (cured/treatment completed) and who is subsequently found to be microbiologically confirmed TB case is a recurrent TB case. (Previously called relapse.) – Treatment after failure – Patients are those who have previously been treated for TB and whose treatment failed at the end of their most recent course of treatment. • Previously, it was called failure where a TB patient is sputum-positive at 5 months or more after initiation of treatment. Treatment after loss to follow-up – A TB patient previously treated for TB for one month or more and who was declared lost to follow-up in their most recent course of treatment and subsequently found microbiologically confirmed TB cases. Previously called treatment after default – a patient who has received treatment for TB for a month or more from any source and return for treatment after having defaulted, that is, not taking ATD consecutively for 2 months or more and found to have smear-positive.
  • 12.
    Classification done onthe basis of drug resistance • Mono resistance (MR) – A TB patient whose biological specimen is resistant to one first-line anti-TB drug only. • Poly resistance (PDR) – A TB patient whose biological specimen is resistant to more than one first-line anti-TB drug, other than both INH and Rifampicin. • Multi-drug resistance (MDR) – A TB patient whose biological specimen is resistant to both INH and Rifampicin with or without resistance other first-line ATD, based on results from a Quality Assured Laboratory. (No changes.) • Rifampicin resistance (RR) – Resistance to Rifampicin detected by phenotypic or genotypic methods with or without resistant to other ATD excluding INH. Patient with RR should be managed as if they are in MDR TB case. • Extensive drug resistance (XDR) – MDR TB case whose biological specimen was resistant to a Fluroquinolone (FQ) and a second-line injectable ATD from a Quality Assured Laboratory. (No changes.)
  • 13.
    • Drug regimenin the new guidelines: Principle of treatment of TB has been shifted towards daily regimen with administration of daily fixed dose combination of first-line ATT as per appropriate weight bands. For new TB cases Treatment in IP will consist of 8 weeks HRZE in daily dosages as per four weight bands categories • There will be no need for extension of IP • Only Z will be stopped in CP while the other three drugs will be continued for another 16 weeks as daily dosages. For previously treated cases: IP will be of 12 weeks, where injection Streptomycin will be stopped after 8 weeks and the remaining four drugs in daily dosages as per weight band for another 4 weeks • No need of extension of IP • At the start of CP, Pyrazinamide will be stopped while rest of the drugs will be continued for another 20 weeks as daily dosages.
  • 16.
    • Management ofextra-pulmonary TB (new guidelines) – There is only one change as follows: The CP in both new and previously treated cases may be extended 3–6 months in certain TB such as CNS, skeletal, disseminated TB, and so on based on clinical decision of the treating physicians • Extension beyond 3 months will only be on recommendation of experts of concerned field.(In the previous guidelines, extension of ATD in case of CNS and skeletal TB was maximum 3 months).
  • 17.
    In patients above50 years of age, maximum dose of Streptomycin should be 0.75 g.
  • 19.
    Follow up • Follow-upof treatment: There are some changes in the new guidelines: Clinical follow-up – (new addition) Should be at least monthly – the patient may visit the clinical facility, or the medical officer may conduct the review when she/he visits the house of the patient to observe improvement of chest symptoms, weight gain, control the co-morbid conditions such as HIV and diabetes and to monitor any adverse reaction to ATD. Follow-up laboratory investigation For PTB cases – sputum smear examination at the end of IP and at the end of treatment. (In the previous guidelines, follow-up sputum smear to be done at 2, 4 and 6 months for new cases and 3, 5 and 8 months in previously treated cases.) In case of clinical deterioration, the Medical Office may consider repeat sputum smear even during CP. (New addition.) • At the completion of treatment, sputum smear and culture should be done for every patient • CXR – to be offered whenever required and available. • Long-term follow-up After completion of treatment, the patient should be followed up at the end of 6, 12, 18 and 24 months. Any clinical symptoms and/or cough, sputum microscopy and/or culture should be considered. (New addition) However, there was no provision of long-term follow-up in the previous guidelines.
  • 21.
    Treatment outcomes Cured A microbiologicallyconfirmed TB at the beginning of the treatment who was smear- or culture-negative at the end of complete treatment. (Changed). Treatment success TB patients either cured or treatment completed are accounted in the treatment success. (New addition). Failure A TB patient whose biological specimen is positive by smear or culture at the end of the treatment. (Changed). Failure to respond For paediatric TB patients. (New addition). Lost to follow-up A TB patient whose treatment was interrupted for one consecutive month or more. (New addition). Not evaluated A TB patient for whom no treatment outcome is assigned. (Former transfer out). Treatment regimen changed Previously, it was called as switched over to MDR treatment.
  • 23.
    Isoniazid Preventive Therapy(IPT) for PLHIVs • Adult and adolescents living with HIV should be screened for TB and those who are unlikely to have active TB should be offered IPT • Children with HIV who have no TB symptoms and who are unlikely to have active TB on symptom-based screening should be offered IPT regardless of their age • All children with HIV who have successfully completed treatment for TB disease should receive IPT. Dosage of INH preventive therapy: Adult and adolescent: INH 300 mg + Pyridoxine 50 mg per day for 6 months. Children above 12 months: INH 10 mg/kg + Pyridoxine 25 mg per day for 6 months.
  • 24.
    DRTB • MDR/RR TBcases (without additional resistance) Treatment regimen for MDR TB contains 6–9 months of IP with Kanamycin, Levofoxacin, Ethambutol, Pyrazinamide, Ethionamide and Cycloserine and 18 months of CP with Levofoxacin, Ethambutol, Ethionamide and Cycloserine (no change). But if INH resistance is not known or DST result shows sensitivity to INH, then addition of INH in the above- mentioned regimen of ATD is to be done. (New addition)
  • 25.
    • All MDRTB cases would be subjected to LC and DST at baseline for Kanamycin and Levofloxacin. • Appropriate modification of the treatment regimen can be done in case of additional resistance. If isoniazid resistance is found, the use of isoniazid depends on: If high-level resistance detected by liquid culture – omit INH. • If low-level resistance detected by LC – add high dose INH. • If LPA reports INH resistance by Kat G mutation – omit INH. • If LPA reports INH resistance by INH A mutation – add high dose INH.
  • 26.
    • There aresome new additions If RR by CBNAAT, then add INH in the standard dose till result of LPA or LC and DST. • For new patients diagnosed as TB and RR by CBNAAT – repeat CBNAAT and send the sample for liquid culture – If second CBNAAT shows RR then start standard MDR till result for culture DST available. Perform DST to INH and SLDST on liquid culture. – If second CBNAAT shows R sensitiveness, continue regimen for new TB cases and wait for LC and DST. As soon as LC result is available, modify the regimen as follows: • If LC shows R sensitiveness – continue regimen for new TB cases • If LC shows R resistance – refer the patients to DRTB centre for decision regarding starting MDR or continuing regimen for new TB cases depending on the response to treatment given so far. • For mixed resistance pattern, consider oral drug in the sequence of preference – Pyrazanamide, Ethambutol, Ethionamide, Cycloserine, PAS, Clofazimine, Linezolide, Coamoxyclave, high dose INH, Clarythromycin • Regimen designing or modification will be prerogative of the DRTB centre committee only.
  • 28.
    Follow up MDR/RR Schedulefor sputum culture examination for MDR TB (no change):
  • 29.
    • For monoDR and poly DRTB patients – Schedule for sputum culture examination: Microbiological: Sputum smear and culture at second and third months and then culture examination at three monthly interval till completion of the treatment. For mono/poly DRTB patients – – IP should given for at least 3 months – After this, the patient will be reviewed – If after the 3 months the smear result remains positive, the sputum sample is sent for genotypic DST to Rifampicin for CBNAAT or LPA and liquid/solid culture and DST to see for resistance amplification – Shifting from IP to CP will be based on the result of culture – The IP can be extended maximum 3 months – Duration of CP is 6 months • MDR TB patients with additional drugs resistance including XDR TB patients Change from IP to CP will be done after achievement of culture conversion, that is, two consecutive negative cultures taken at least one month apart • In case of delay in culture conversion, IP can be extended from 6 months to maximum 12 months. •
  • 30.
    Outcome for RR/MDRand/or XDR TB patients (new guidelines) Cure – Treatment completed as recommended by the National Policy without evidence of failure and three or more consecutive cultures taken at least 30 days apart are negative after IP Treatment completed – Treatment completed as recommended by the National Policy without evidence of failure but no record that three or more consecutive cultures taken at least 30 days apart are negative after IP Treatment success – The sum of cured and treatment completed Treatment failed – Treatment terminated or need for permanent regimen change of at least two or more ATD in CP because of lack of microbiological conversion by the end of IP or microbiological reversion in the CP after conversion to negative or evidence of additional acquired resistance FQ or second-line injectable drugs, or adverse drug reaction. Outcomes for mono/poly drug-resistant TB patient Cure – A microbiologically confirmed TB at the beginning of treatment who was culture-negative in the last month of treatment and on at least one previous occasion Treatment completed – A patient who has completed treatment according to the guidelines but does not meet the definition for cure or treatment failure due to lack of microbiological results Failure – Treatment terminated or need for permanent regimen change of at least two or more anti-TB drugs in CP because of: Evidence of additional acquired resistance to Rifampicin, Rluroquinolone or second-line injectable during treatment Severe ADR Culture-positive during CP or at end of treatment Died – A patient who dies for any reason during the course of M/X DRTB treatment Loss to follow-up – A patient whose treatment was interrupted for one month or more for any reasons Not evaluated – A DRTB patient for whom no treatment outcome is assigned, and this included former ‘transfer out’. •
  • 31.
    Side effects offirst line drugs 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)
  • 32.
    Side effects ofsecond line drugs Drugs Side effects Injectables – Kanamycin / Capreomycin  Ototoxicity (6,7)  Nephrotoxicity  Vertigo  Electrolyte imbalance Quinolones – Ofloxacin, Levofloxicin, Moxifloxacin  Gastro Intestinal symptoms: diarrhoea, vomiting, and abdominal pain  Central nervous system (CNS): dizziness and convulsions  Phototoxicity and photosensitivity  Tendinopathy and tendinitis  Skin rash  Cardiotoxicity – QT prolongation  Arthralgia Ethionamide  Gastro-intestinal: epigastric discomfort, anorexia, nausea, metallic taste, vomiting,  excessive salivation, and sulfurous belching  Psychiatric: hallucination and depression  Hepatitis  Hypothyroidism and goitre with prolonged administration  Gynaecomastia, menstrual disturbances, impotence, acne, headache, and peripheral  neuropathy Cycloserine  CNS: dizziness, slurred speech, convulsions, headache, tremor, and insomnia  Psychiatric: confusion, depression, altered behaviour, and suicidal tendency  Hypersensitivity reaction PAS  Gastro-intestinal: anorexia, nausea, vomiting, and abdominal discomfort  Skin rash  Hepatic dysfunction  Hypokalemia  Hypothyroidism and goitre with prolonged administration
  • 33.
    Warning symptoms forsome serious adverse reactions Warning Symptoms For Medical officer / General practitioner (GP): When to refer the patient  Rash  Skin lesions on oral cavity, nose If mucous membranes are involved OR rash is more than 1/10th of body surface area without mucous membrane involvement OR associated with fever and generalized swelling (edema); refer to specialist / tertiary care center immediately. Pain in eye/s, Blurring of vision and Disturbance in color vision Indicates Eye toxicity. Refer the patient to specialist for evaluation. Loss of hearing / Diminished hearing, Ringing in the ears, Dizziness and Loss of balance Indicates Ear toxicity. Refer the patient to specialist for evaluation. Puffiness of face, Swelling over feet and Oliguria, Anuria Indicates Kidney toxicity. Treat the symptoms and refer the patient to specialist for evaluation. Hallucinations, Seeing abnormal things and Suicidal or abnormal thoughts or actions Indicates Psychiatric disturbances. Refer the patient to specialist for evaluation.
  • 34.
    Absolute contraindications ofanti-TB drugs:( Benefit – Risk) Drug Absolute contraindications Reason Rifampicin With Saquinavir and Ritonavir Potential for hepatotoxicity is increased. Rifampicin is CYP3A4 inducer and can decrease Saquinavir level and effect Ethambutol Optic neuritis Ethambutol can cause optic neuritis Pyrazinamide Acute porphyria Gouty arthritis Hepatic diseases Pyrazinamide can precipitate acute porphyria Can inhibit excretion of urates Can cause drug induced hepatitis Neomycin Kanamycin, Tobramycin, Amikacin, Capreomycin, Streptomycin Concurrent use of two aminoglycosides With potent diuretics e.g. Furosemide Soon after use of anesthetics and muscle relaxants Can potentiate nephrotoxicity Can potentiate ototoxicity Can result in respiratory paralysis Levofloxacin, Ofloxacin, Moxifloxacin History of tendon disorders Associated with risk of tendinitis and tendon rupture Ethionamide Severe hepatic impairment Risk of worsening Cycloserine Epilepsy, Psychiatric illness - Depression, Severe anxiety, Psychosis Severe renal insufficiency Can precipitate seizures Can lead to severe psychosis and depression Can lead to Cycloserine toxicity Clarithromycin With Pimozide, Astemizole With Lovastatin or Simvastatin Hypokalemia and in patients with prolonged QT interval Risk of QT prolongation Can cause rhabdomyolysis Risk of further QT prolongation Imipenem With Valproic acid and Probenecid Decrease in valproic acid concentration and Increase in plasma levels of imipenem Linezolid With Monoamine oxidases A or B inhibitors (e.g. phenelzine, isocarboxazid, selegiline, moclobemide) within two weeks Risk of MAO inhibition leading to serotonin syndrome
  • 35.
    Algorithm for reintroductionof anti-TB drugs Adverse drug reaction Advice on reintroduction Hepatotoxicity  Reintroduction after liver enzyme returns to ≤ 2 X ULN Ocular toxicity  Main suspect drug is EMB  Reintroduction of Ethambutol is not recommended Immune mediated Nephritis  Main suspect drug is RIF  Reintroduction with RIF is not recommended Non serious cutaneous ADRs - no mucous membrane involvement or less than 10 % of BSA.  After withholding all drugs reintroduce one drug at a time Serious Cutaneous adverse drug reactions - mucous membrane involvement or more than 10 % of BSA.  Reintroduction is not recommended (applies for all anti-TB drugs). Immune thrombocytopenia  Main suspect drug is RIF  Reintroduction with RIF is not recommended Gynecomastia  Symptoms takes long time to resolve (4-12 month) hence usually reintroduction is not required. Aplastic Anemia  Main suspect drug is INH  Reintroduction with INH is not recommended Nephrotoxicity  Main suspect drugs are AGs.  AGs can be reintroduced at low doses after the renal function returns to normal. Ototoxicity  Main suspect drugs are AGs.  Reintroduction of AGs is not recommended. Cardiac arrhythmias including Torse de pointes (TdP)  Main suspect drugs are FQs.  Reintroduction with FQs is not recommended. Diarrhea  Reintroduction is recommended with one drug at a time every fourth day, once diarrhea is resolved Seizures  Main suspect drugs are FQs.  Reintroduction with FQs is not recommended. Psychosis  Main suspect drugs is cycloserine.  Reintroduction with cycloserine can be done at low dose but if symptoms recur than completely discontinue the drug.
  • 36.
    Stepwise increase inthe dosage for Reintroduction Drug Day 1 Day 2 Day 3 Isoniazid 50 mg Full dose Full dose Rifampicin 75 mg 300 mg Full dose Pyrazinamide 250 mg 1000 mg Full dose Ethionamide / Prothionamide 125 mg 250 mg Full dose Fluoroquinolones 50 mg 200 – 250 mg Full dose Cyclosporine 125 mg 250 mg Full dose Ethambutol 100 mg 500 mg Full dose PAS 1 g 4 g Full dose Capreomycin 125 mg 500 mg Full dose Kanamycin 125 mg 500 mg Full dose Amikacin 125 mg 500 mg Full dose
  • 37.
    Commonly used ancillarymedicinesIndication Drugs Nausea, vomiting, Stomach upset Domeperidone, metoclopramide, prochlorperazine, promethazine, ondansetron Heartburn, indigestion and acidity H2-blockers (ranitidine etc.), proton pump inhibitors (omeprazole, pantoprazole etc) Antacid syrups and the antacids if prescribed should be taken at least 2 hours apart from anti-TB drugs Oral candidiasis Fluconazole, clotrimazole lozenges, nystatin suspension Diarrhoea ORS sachets Prophylaxis of neurological complications of cycloserine and isoniazid Pyridoxine (vitamin B6) Musculoskeletal pain, Arthralgia, headaches Give paracetamol / ibuprofen / aspirin / diclofenac. If caused by fluoroquinolones, refer to specialist immediately. Tendonitis can progress to tendon rupture. Cutaneous reactions, itching Hydrocortisone cream, calamine lotion Systemic hypersensitivity Reactions Antihistamines (diphenhydramine, chlorpheniramine, dimenhydrinate) Systemic corticosteroids (prednisone, prednisolone, Dexamethasone) are reserved only for very severe reactions Bronchospasm Inhaled beta-agonists (salbutamol, albuterol, etc.), inhaled corticosteroids (beclomethasone, etc.) Hypothyroidism Levothyroxine Electrolyte wasting Potassium and magnesium replacement therapy (oral formulations) Depression Selective serotonin reuptake inhibitors (fluoxetine, sertraline), tricyclic antidepressants (amitriptyline) Severe anxiety Lorazepam, diazepam, clonazepam Insomnia Any hypnotic Psychosis Haloperidol, thorazine, risperidone (consider benzotropine or biperiden to prevent extrapyramidal Effects), Buromazine, thioridazine Seizures Phenytoin, carbamazepine, valproic acid, phenobarbital Peripheral neuropathy Amitriptyline, gabapentin
  • 38.
    Introduction of newATD under RNTCP Bedaquiline (BDQ): – New class of drug, diarylquinoline that targets mycobacterial ATP synthase, and enzyme essential for supply of energy to mycobacterium TB – Strong bactericidal and sterilizing activities against MTB • It has no cross-resistance with first- and second-line ATD • Significant benefit in improving the time to culture conversion in MDR TB patients • RNTCP introducing BDQ at six sites in the country initially • Basic criterion – Adult aged ≥18 years having pulmonary MDR TB • Female should not be pregnant.
  • 48.