WHO TB GUIDELINES 2009/ 2010 WHAT IS NEW ?

WHO TB GUIDELINES 2009/ 2010 WHAT IS NEW ?
DR. TUSHAR SAHASRABUDHE PROFESSOR AND HEAD DEPARTMENT OF PULMONARY MEDICINE DR. D.Y.PATL MEDICAL COLLEGE

THE CURRENT SITUATION IN THE COUNTRY

TB INDIA 2010 STATUS REPORT RNTCP since % coverage (1164 million population) achieved in 2006. TB treatment success rates have tripled 25 % to 87% Death rates dropped 7 fold from 29% to less than 5%. Consistently meets target of 70% case detection rate and 85% success rate Pediatric treatment boxes have been introduced since 2006 for different weight bands (6-10, 11-17, 18-30) RNTCP accreditation protocol for IRL (Intermediate Reference Laboratories) being followed

TB INDIA 2010 STATUS REPORT Annual risk of TB infection 1.5% per year.
Prevalence of disease reduced from 568/ 1 lakh population to 185/ 1 lakh population by 2008. New case annual Incidence 1.98 million last year (2009) Death rate reduced to 24/ 1 lakh population (2 deaths per every 3 minutes). 17.6% deaths from communicable diseases & 3.5% of all cause mortality. Expenditure: US $ 34 per patient (Approx Rs. 1700)

THE NEGATIVE SIDE TB prevalence still remains high (1st in world). India is highest TB burden country. Has 1/5th of global annual incidence. HIV co-infection is on the rise million (0.36% adults in country). Third in world. 2008 estimates: 6.7% TB cases are HIV positive MDR-TB 3% primary and 14-17% acquired XDR-TB less than 1 % but a great potential to rise due to open availability of second line drugs & their misuse. DOTS cures 85% new cases and 63% retreatment cases ! Who is raising voice against spitting ???? RNTCP runs on loan !

THERE ARE INCONSISTENCIES ABOUT HOW WE TREAT TB TODAY……
THERE ARE INCONSISTENCIES ABOUT HOW WE TREAT TB TODAY…….. THESE NEED CLARIFICATION

WHAT DO WE FOLLOW IN RNTCP TODAY?
Always do sputum AFB. Only 2 samples Negative sample… give antibiotic course….repeat sputum No guidelines on how to diagnose extra pulmonary TB. DOTS Category I, II, III regimens defined 6 months intermittent regimens for all new cases 8 months intermittent regimen for relapse/ failure Sputum at beginning, 2nd, 3rd (optional), 5th and 6th month Sputum positive on Cat I/III at end of 3 months shifts to Cat II Thrice a week supervision in Intensive phase and weekly supervision in the continuation phase

WHAT DO WE FOLLOW IN PRIVATE PRACTICE TODAY?
Sputum is invariably checked for PTB. 2/3 samples. Sputum usually not checked for extra pulmonary TB AFB culture for treatment failure, occasionally for relapse Treatment categories not followed except retreatment regimen Regimen for new TB: most commonly 2HREZ/4HR Variations: 2SHREZ/ 4HR, 2HREZ/4HRE, 2HREZL/4HR, 2SHREZL/4HR, 2HRZE/10HE Regimen for retreatment: 2SHREZ/1HREZ/5HRE. Levofloxacin frequently added. Daily regimen: Relative supervised/ unsupervised TBM/ TB spine. Miliary: continuation phase extended. Variations: 9 months, 1 year, 1.5 years

QUESTIONS IN OUR MIND How many sputum samples should we check? 2…3….5…more? How to diagnose TB when sputum is negative? Which antibiotic is to be preferred? Should the patient receive daily or intermittent regimen? Are the DOTS categorization and regimens adequate? How Frequently should we do sputum test? When should we do AFB culture? Is it enough to give only HR in the continuation phase for a country like ours with high prevalence of initial resistance to INH?

QUESTIONS IN OUR MIND Is it correct to shift to Cat II on failure of Cat I/III? Weight corrected dosing not possible with DOTS kits Shall we use FDCs or not?? How do we manage the common adverse reactions? GI intolerance…Jaundice….Neuropathy…..Arthritis Should we prolong treatment in certain situations? Miliary….Spine TB….Meningitis What should be the approach to a failing regimen? Should the treatment be same for HIV positive patients? How do we manage ART with ATT?

NOW MANY HAVE BEEN ANSWERED BY WHO CLEARLY….

THE 4TH EDITION OF TB TREATMENT GUIDELINES BY WHO
Follows the new WHO procedures for development of guidelines Has inputs from external experts 7 key questions have been identified Systematic reviews were conducted for each question The guidelines group based its recommendations on quality of evidence assessed according to the GRADE methodology, patient values and costs, judgements about tradeoffs between benefits and harms

Rating of recommendations
The grading Quality of evidence The definition Comments Strong High quality Has only a small amount of uncertainty or variability the desirable effects of adherence to a recommendation clearly outweigh the undesirable effects No alternatives are listed Conditional Low quality Is associated with a large amount of uncertainty or variability the desirable effects of adherence to a recommendation probably outweigh the undesirable effects Alternatives are listed Weak There is insufficient evidence and therefore the recommendations are based on filed application and expert opinion

Rating of recommendations
For policy makers The recommendations should be UNEQUIVOCALLY be used for setting policy Policy makers will require extensive debate For patients Most individuals would want the recommended course of action The recommended course of action could be adjusted based on the feasibility and acceptability For health care providers Most patients should be treated according to the recommended course of action. Adherence to the recommendations is a reasonable measure of good quality care

REVISED DEFINITIONS

Revised Case definitions
Characteristics Tuberculosis suspect Any person who presents with the symptoms or signs suggestive of TB The most common presenting symptom is a productive cough for more than 2 weeks AND may be accompanied with Respiratory symptoms Shortness of breath, chest pains, Hemoptysis AND/OR constitutional symptoms Case of tuberculosis A treatment health worker (clinician or any other medical practitioner) has diagnosed TB and has decided to treat the patient with a full course of TB Note: Any person given treatment for TB should be recorded as a case. Incomplete “trial” of TB treatment should not be considered as a method of diagnosis

Revised Case definitions
Characteristics Definite case of tuberculosis A patient with Mycobacterium tuberculosis complex identified from a clinical specimen, either by a culture or be a newer method such as a molecular line probe assay. In countries that lack the laboratory facilities to routinely identify Mycobacterium tuberculosis, a pulmonary case with one or more initial sputum smear examinations positive for acid fast bacilli (AFB) is also considered to be a definite case of tuberculosis provided there is a functional external quality assurance (EQA) system with blind rechecking

Anatomical site of disease
Type Features Pulmonary tuberculosis (PTB) TB involving the lung parenchyma. Miliary tuberculosis is classified as pulmonary tuberculosis as there are lesions in the lungs. A patient with both pulmonary and extra pulmonary tuberculosis should be classified as a case of pulmonary tuberculosis

Anatomical site of disease
Type Features Extra pulmonary tuberculosis (EPTB) TB involving organs other than the lungs e.g. pleura, lymph nodes, abdomen, genitourinary tract , skin, bones, joints and meninges. Tuberculosis intrathoracic lymphadenopathy or tuberculous pleural effusion without radiographic abnormalities in the lungs. The case definition of an EPTB patient with several sites affected depends on the site representing the most severe form of the disease. Unless the case of EPTB is confirmed with culture as caused by Mycobacterium tuberculosis, it cannot meet the definite case definition.

Sputum microscopy Bacteriology refers to the smear status of pulmonary cases and the identification of M. Tuberculosis for any case by culture or newer methods. ALL patients suspected of having pulmonary tuberculosis should submit at least 2 sputum samples for microscopic examination in a quality assured laboratory.

Sputum microscopy When possible at least one early morning specimen should be obtained as sputum collected at this time has the highest yield of bacteria ALL patients with chest radiographic findings suggestive of tuberculosis should submit sputum specimens for microbiologic examination A case of pulmonary TB is considered to be smear positive if one or more sputum specimens at the start of treatment are positive for AFB (provided there is a functional EQA with blind rechecking)

Sputum negative TB cases
Should either have…… A. Sputum that is smear negative but culture positive for Mycobacterium tuberculosis A case of pulmonary TB is considered to be sputum negative if at least 2 of the specimens at the start of the treatment are negative for AFB in countries with a functional EQA system, where the work load is very high and human resources are limited. In all settings with an HIV prevalence of >1% in pregnant women or >5%TB patients, sputum culture should be performed who are sputum smear negative to confirm the diagnosis of TB

Should either have…… B. Met the following diagnostic criteria Decision by a clinician to treat with a full course of anti TB therapy and Radiographic abnormalities consistent with active pulmonary TB and either laboratory or strong clinical evidence of HIV infection OR

Should either have…… C. Met the following diagnostic criteria If HIV –negative or unknown HIV status living in an area of low HIV prevalence), no improvement in response to a course of broad spectrum antibiotics (excluding anti TB drugs and Fluoroquinolones and aminoglycosides ) Pulmonary TB cases without smear results are no longer classified as smear negative. They are now classified as “smear not done” on the TB register For patients having EPTB, specimens should be obtained from the suspected sites of involvement. Where available culture and histopathological examination should also be carried out. Additionally a chest X ray and examination of sputum may be useful especially in patients with HIV.

History of previous treatment
New patients These patients have never had treatment for TB, or have taken anti TB drugs for less than 1 month. New patients may have positive or negative bacteriology and may have disease at any anatomical site Previously treated patients These patients have received 1 month or more of anti TB treatment in the past, may have positive or negative bacteriology and may have disease at any anatomical site

HIV status Determining and recording the patient’s HIV status is critical for the treatment decisions as well as for monitoring trends and assessing programs performance. The WHO’s revised TB treatment card and TB register include dates of HIV testing , starting cotrimoxazole and starting ART.

THE WHO DEFINED 7 KEY QUESTIONS ON THE TREATMENT OF TB
Duration of rifampicin treatment in new patients Dosing frequency in new patients Initial regimen for new TB patients in countries with HIGH levels of isoniazid resistance TB treatment in persons living with HIV Sputum monitoring during TB treatment Treatment extension Retreatment

Question 1: Duration of rifampicin in new patients

New patients with pulmonary TB Strong/High grade of evidence
Recommendation 1.1 New patients with pulmonary TB Strong/High grade of evidence Should receive a regimen containing 6 months of rifampicin: 2HRZE / 4HR Remark a: This recommendation also applies to extrapulmonary TB except TB of the CNS, bone or joint for which some expert groups suggest longer therapy. Remark b: WHO recommends that national TB control programs provide supervision and support for all TB patients in order to ensure completion of the full course of therapy. Remark c: WHO recommends drug resistance surveys (or surveillance) for monitoring the impact of the treatment program, as well as for designing standard regimens

New patients with pulmonary TB Strong/High grade of evidence
Recommendation 1.2 New patients with pulmonary TB Strong/High grade of evidence The 2HRZE / 6HE treatment regimes should be phased out.

Question 2: Dosing frequency in new patients
When a country selects 2 HRZE / 4HR, should patients be treated with daily or 3 times weekly intensive therapy?

Two alternatives to Recommendation 2.1
Recommendation 2.1A New patients with pulmonary TB may receive a daily intensive phase followed by three times weekly continuation phase [2HRZE/4(HR)3] provided that each dose is directly observed (Conditional/High or moderate grade of evidence) Recommendation 2.1B Three times weekly dosing throughout therapy [2(HRZE)3 /4(HR)3] is another alternative to Recommendation 2.1, provided that every dose is directly observed and the patient is NOT living with HIV or living in an HIV-prevalent setting (Conditional/High or moderate grade of evidence)

Recommendation 2.2 New patients with TB should not receive twice weekly dosing for the full course of treatment unless this is done in the context of formal research Strong/High grade of evidence Remark The available evidence showed equivalent efficacy of daily intensive-phase dosing followed by two times weekly continuation phase. However, twice weekly dosing is not recommended on operational grounds, since missing one dose means the patient receives only half the regimen.

Question 3: Initial regimen in countries with high levels of isoniazid resistance
Should the continuation phase (containing isoniazid and rifampicin) be changed in the standard treatment of ALL new cases in order to prevent the development of multidrug resistance?

Recommendation 3 In populations with known or high levels of isoniazid resistance, new TB patients may receive HRE as therapy in the continuation phase as an acceptable alternative to HR Weak /Insufficient evidence Remark a : There is inadequate evidence to quantify the ability of ethambutol to protect rifampicin in patients with pretreatment isoniazid resistance The risk of permanent blindness with ethambutol exists Further research is needed to define the level of isoniazid resistance that would warrant the addition of ethambutol to the continuation phase of the standard new patients regimen where INH susceptibility testing is not done before the continuation phase begins Remark b : Daily rather than 3 times weekly intensive phase dosing may also help prevent the acquired drug resistance in TB patients starting treatment with INH resistance

Question 4: TB treatment in patients living with HIV
Should intermittent regimens be used for persons living with HIV? What should be the duration of TB treatment in people living with HIV ?

Recommendation 4.1 TB patients with known positive HIV status and all TB patients living in HIV-prevalent settings should receive daily TB treatment at least during the intensive phase Strong/High grade of evidence Remark. HIV-prevalent settings are defined as countries, subnational administrative units, or selected facilities where the HIV prevalence among adult pregnant women is ≥1% or among TB patients is ≥ 5%.

Recommendation 4.2 For the continuation phase, the optimal dosing frequency is also daily for these patients Strong/High grade of evidence

Recommendation 4.3 If a daily continuation phase is not possible for these patients, three times weekly dosing during the continuation phase is an acceptable alternative Conditional/High and moderate grade of evidence

Recommendation 4.4 It is recommended that TB patients who are living with HIV should receive at least the same duration of TB treatment as HIV-negative TB patients Strong/High grade of evidence Remark a: Some experts recommend prolonging TB treatment in persons living with HIV Remark b: Previously treated TB patients who are living with HIV should receive the same retreatment regimens as HIV-negative TB patients.

SUMMARY: Dosing frequency for NEW TB patients
Intensive phase Continuation phase Comment Daily Optimal 3 times per week Acceptable alternative for any new TB patient receiving DOTS Acceptable alternative provided the patient is receiving daily DOTS and is NOT living with HIV or living in an HIV prevalent setting NO INTERMITANT THERAPY FOR HIV COINFECTED !! Daily rather than 3 times per week intensive phase dosing may help to prevent acquired drug resistance in TB patients starting treatment with INH resistance

Additional recommendations for the co-infected
Do HIV testing of all TB suspects & cases Contact tracing for all HIV positive TB cases Give cotrimaxazole throughout TB treatment 2 NRTI zidovudine/ Tenoflovir + Lami/ emcitrabine and 1 NNRTI: Efavirenz Start ATT first and consider starting ART later but within 8 weeks of ATT (less mortality, better cure rate and less IRIS noted. Pill burden is a concern) Do DST for all HIV positive TB patients INH chemoprophylaxis to all

Question 5: Sputum monitoring during TB treatment of smear positive pulmonary TB
In pulmonary TB patients who are initially smear positive, how effective is monitoring sputum specimens for predicting relapse, failure and pretreatment isoniazid resistance?

Sputum monitoring by smear microscopy in new pulmonary TB patients
Months of treatment 1 2 3 4 5 6 HRZE HR Sputum smear examination Sputum smear examination a If SS +ve, obtain culture, DST Sputum smear examinationa a : Omit if patient was smear negative at the start of treatment and at 2 months Note: If patient has MDR TB at any time during the therapy, treatment is declared a failure and the patient is reregistered and should be referred to an MDR Treatment program

Sputum monitoring by smear microscopy in new pulmonary TB patients if SS +ve at month 2 and month 3
Months of treatment 1 2 3 4 5 6 HRZE HR Sputum smear examination +ve Sputum smear examination +ve, obtain culture and DST If SS +ve, obtain culture, DST

Sputum monitoring of pulmonary TB patients receiving the 8 month retreatment regimen with 1st line anti TB drugs 1 2 3 4 5 6 7 8 HRZES HRZE HRE If Sputum smear +ve, obtain culture and DST Sputum smear +ve, obtain culture and DSTa a : Smear or culture positively at the 5th month of therapy (or detection of MDR TB at any point) or later is defined as treatment failure and necessitates re registration and change of treatment

Recommendation 5.1 For smear-positive pulmonary TB patients treated with first-line drugs, sputum smear microscopy may be performed at completion of the intensive phase of treatment Conditional/High and moderate grade of evidence Remark a: This recommendation applies both to new patients treated with regimens containing 6 months of rifampicin, and to patients returning after default or relapse and now receiving the 8-month retreatment regimen (2HRZES/1HRZE/5HRE). Note that the end of the intensive phase may be at 2 months or 3 months, depending on the regimen.

Recommendation 5.1 For smear-positive pulmonary TB patients treated with first-line drugs, sputum smear microscopy may be performed at completion of the intensive phase of treatment Conditional/High and moderate grade of evidence Remark b: Available evidence showed that smear status at the end of the intensive phase is a poor predictor of relapse, failure and pretreatment isoniazid resistance. Nonetheless, WHO continues to recommend performing smear microscopy at this stage because a positive smear should trigger an assessment of the patient, as well as additional sputum monitoring. Sputum smear conversion at the end of the intensive phase is also an indicator of TB programme performance.

Recommendation 5.2 In new patients, if the specimen obtained at the end of the intensive phase (month 2) is smear-positive, sputum smear microscopy should be obtained at the end of the third month Strong/High grade of evidence

Recommendation 5.3 In new patients, if the specimen obtained at the end of month 3 is smear-positive, sputum culture and drug susceptibility testing (DST) should be performed Strong/High grade of evidence Remark: National TB control programmes (NTPs) should continue to follow the current WHO recommendation to obtain sputum specimens for smear microscopy at the end of months 5 and 6 for all new pulmonary TB patients who were smear-positive at the start of treatment. Patients whose sputum smears are positive at month 5 or 6 (or who are found to harbour MDR-TB strains at any time) will be re-registered as having failed treatment and be treated according to Recommendation 7

Recommendation 5.4 In previously treated patients, if the specimen obtained at the end of the intensive phase (month 3) is smear-positive, sputum culture and drug susceptibility testing (DST) should be performed Strong/High grade of evidence

Question 6: Treatment extension in new pulmonary TB patients
In new pulmonary TB patients, how effective is extension of treatment for preventing failure or relapse?

NO ADVANTAGE OF EXTENDING INTENSIVE PHASE
Recommendation 6 In patients treated with the regimen containing rifampicin throughout treatment, if a positive sputum smear is found at completion of the intensive phase, the extension of the intensive phase is not recommended Strong/High grade of evidence Remark: WHO recommends that a positive sputum smear at completion of the intensive phase should trigger a careful review of the quality of patient support and supervision, with prompt intervention if needed. It should also trigger additional sputum monitoring NO ADVANTAGE OF EXTENDING INTENSIVE PHASE

Question 7: Previously treated patients
Which ( if any) groups of patients should receive a retreatment regimen with 1st line drugs?

MDR & previously treated patients
Global data: WHO surveillance data: Dec % of relapse cases/ defaulters had MDR 49% of failure cases had MDR TB RNTCP data: 4th Quarter 2009 Cure rate of DOTS II for relapse cases: 68% Cure rate of DOTS II for failure case: 50.9% Total cure rate: 63.1%

DO DST FOR EVERY PATIENT WITH
Recommendation 7.1 Specimens for culture and drug susceptibility testing (DST) should be obtained from all previously treated TB patients at or before the start of treatment. DST should be performed for at least isoniazid and rifampicin. Remark a: DST may be carried out by rapid molecular-based methods or by conventional methods. Sputum should be obtained, as well as appropriate specimens for extra pulmonary TB, depending on the site of disease. Remark b: Obtaining specimens for culture and DST should not delay the start of treatment. Empirical therapy should be started promptly, especially if the patient is seriously ill or the disease is progressing rapidly. DO DST FOR EVERY PATIENT WITH TB TREATMENT IN PAST

Recommendation 7.2 In settings where rapid molecular-based DST is available, the results should guide the choice of regimen

START MDR TREATMENT FOR TREATMENT FAILURE CASES
Recommendation 7.3 In settings where rapid molecular-based DST results are not routinely available to guide the management of individual patients, empirical' treatment should be started as follows Recommendation 7.3.1 TB patients whose treatment has failed or other patient groups with high likelihood of multidrug-resistant TB (MDR-TB) should be started on an empirical MDR regimen Recommendation 7.3.2 TB patients returning after defaulting or relapsing from their first treatment course may receive the retreatment regimen containing first-line drugs 2HRZES/1HRZE/5HRE if country-specific data show low or medium levels of MDR in these patients or if such data are unavailable Remark a: In the absence of culture and DST results, the patient should be clinically evaluated before the MDR regimen is administered. Remark b: Other examples of patients with high likelihood of MDR-TB are those relapsing or defaulting after their second or subsequent course of treatment. START MDR TREATMENT FOR TREATMENT FAILURE CASES AND NOT DOTS-II Remark: When DST results become available, regimens should be adjusted appropriately.

Recommendation 7.4 In settings where DST results are not yet routinely available to guide the management of individual patients, the empirical regimens will continue throughout the course of treatment

Recommendation 7.5 National TB control programmes should obtain and use their country-specific drug resistance data on failure, relapse and default patient groups to determine the levels of MDR. Remark Country-specific drug resistance data should include data stratified by type of regimen given for the patient's first course of TB treatment (i.e. 2 vs. 6 months of rifampicin).

General principles for designing MDR TB treatment regimens - 1
Comments Use at least 4 drugs certain to be effective The more of these factors is present the more likely the drug will be effective Resistance to the drug is known to be rare from surveys DST results from reliable labs show susceptibility : Fluoroquinolones, injectable agents The drug is NOT commonly used in the area (No known close contacts with history of resistance to the drug ) DO not use drugs for which there is a possibility of cross resistance Many anti TB drugs exhibit cross resistance both within and across drug classes Eliminate drugs that are not safe Quality of the drug is unknown

Groups of drugs to treat MDR TB
1st line oral drugs Pyrazinamide Ethambutol Rifabutin Group 2 Injectable drugs Kanamycin Amikacin Capreomycin Streptomycin Group 3 Fluoroquinolones Levofloxacin Moxifloxacin Ofloxacin

Groups of drugs to treat MDR TB
Oral bacteriostatic 2nd line drugs Paraaminosalicylic acid Cycloserine Ethionamide Protionamide Group 5 Agents with unclear role in the treatment of drug resistant TB Clofazimine Linezolid Amoxicillin clavulanate Thioacetazone Imipenem cilastatin High dose isoniazid Clarithormycin

General principles for designing MDR TB treatment regimens - 2
Comments Include drugs from Table given in a hierarchal order based on potency Use any oral 1st line drug that is likely to be effective (Group 1) Use an effective aminoglycoside or polypeptide by injection ( Group 2) Use a Fluoroquinolone ( Group 3) Use the remaining group 4 drugs to complete a regimen of at least 4effective drugs For regimens with fewer than 4 effective drugs, consider adding 2 group 5 drugs. Often the total number of drugs will be 5 to 7

EXTRAPULMONARY TB section 8.2
Treatment recommendations are same as for pulmonary TB 9-12 months treatment for TBM (expert opinion) 9 month treatment for TB bones and joints (expert opinion) EMB to be replaced by SM in TBM Steroids to be used in TBM and TB pericarditis unless drug resistance is suspected

TB IN SPECIAL SITUATIONS section 8.4
All first line drugs safe in pregnancy except SM Breast feeding should continue with full ATT Newborn should receive INH after ruling out active TB Pyridoxine 10 mg for all pregnant and breast feeding patients Possible regimens for chronic hepatic disease (ALT> 3 times normal): 9HRE, 2SHRE/6HR, 9REZ, 2SHE/10HE, 24SEL. Monitoring indicated Renal disease: 2HREZ/4HR (thrice weekly PZA 25 mg/kg and EMB 15 mg/kg). Avoid SM, give pyridoxine 10 mg

STANDARD TREATMENT REGIMENS section 3.3
Drug Daily Thrice/ week dose maximum Isoniazide 5 300 10 900 Rifampicin 600 Ethambutol 15 --- 30 Streptomycin Pyrazinamide 25 35 Suggested weight bands for DOTS: 30-39, 40-54, & above 70kg

Intensive phase of treatment a Continuation phase of treatment
Standard regimens for new TB patients (presumed or known to have drug susceptible TB) SO..NO CATEGORY III !! Applies only in counties without high levels of INH resistance In new TB patients and where INH drug susceptibility testing is not done or results are unavailable before the continuation phase begins Intensive phase of treatment a Continuation phase of treatment 2 months of HRZE 4 months of HR a : WHO no longer recommends omission of ethambutol in the intensive phase of treatment for patients with non Cavitory smear negative pulmonary TB or extra pulmonary TB patients who are known to be HIV negative. In TB meningitis ethambutol should be replaced by streptomycin

Standard regimens for new TB patients
(in settings where INH resistance among new TB cases is high and DST for INH is not done before the continuation phase begins) Intensive phase of treatment a Continuation phase of treatment 2 months of HRZE 4 months of HRE IT APPLIES TO INDIA VERY WELL !! a : WHO no longer recommends omission of ethambutol in the intensive phase of treatment for patients with non Cavitory smear negative pulmonary TB or extra pulmonary TB patients who are known to be HIV negative. In TB meningitis ethambutol should be replaced by streptomycin

Summary of recommended regimens
Intensive phase Continuation phase Comments 2 months of HRZE a 4 months of HR Presumed or known to have drug susceptible TB 2 months of HRZE b 4 months of HRE Applies only in countries with HIGH levels of INH resistance in new TB patients where DST is not done or results are unavailable before the continuation phase begins a : WHO no longer recommends omission of ethambutol in the intensive phase of treatment for patients with non Cavitory smear negative pulmonary TB or extra pulmonary TB patients who are known to be HIV negative. In TB meningitis ethambutol should be replaced by streptomycin b: Use of FDC has been allowed

MANAGING ADVERSE REACTIONS section 4.10
Dizziness, vertigo, deafness: Stop SM Shock, ARF, purpura: Stop RMP Neuropathy: Pyridoxine mg daily Flu-like symptoms: make RMP daily Orange urine, drowsiness: reassurance Hepatitis: start SEL and stop HRZ. Reintroduce one at a time later

PATIENT CENTERED APPROACH & TREATMENT DELIVERY
Patients are not passive recipients but active partners ! Public private mix for providing DOTS Social and psychological support Supervise each dose Be flexible. Do not add to patient’s hardship NTP has to provide training and monitor them Incentive for community members, volunteers and sometimes even patients

Thank you

WHO TB GUIDELINES 2009/ 2010 WHAT IS NEW ?

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WHO TB GUIDELINES 2009/ 2010 WHAT IS NEW ?

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