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Initial Treatment of Tuberculosis Your name Institution/organization Meeting Date International Standards 7, 8, 10, 11, 17.

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Presentation on theme: "Initial Treatment of Tuberculosis Your name Institution/organization Meeting Date International Standards 7, 8, 10, 11, 17."— Presentation transcript:

1 Initial Treatment of Tuberculosis Your name Institution/organization Meeting Date International Standards 7, 8, 10, 11, 17

2 ISTC Training Modules 2008 Initial Treatment of Tuberculosis Objectives: At the end of this presentation, participants will have an understanding of: Drug regimens used in the initial treatment of both pulmonary and extrapulmonary tuberculosis The basis for the public health benefits of treating tuberculosis The clinical and microbiological effects of treatment The rationale for patient monitoring and reporting The main adverse effects of antituberculosis drugs

3 ISTC Training Modules 2008 Initial Treatment of Tuberculosis Overview: Effect of appropriate treatment on public health First-line treatment recommendations Treatment of extrapulmonary tuberculosis Monitoring of treatment Adverse reactions Recording and reporting International Standards 7, 8, 10, 11, and 17

4 ISTC Training Modules 2008 Standards for Treatment

5 ISTC Training Modules 2008 Initial Treatment of Tuberculosis Standards 7 & 8

6 ISTC Training Modules 2008 Standard 7: Public Health Effects of Treatment Any practitioner treating a patient for tuberculosis is assuming an important public health responsibility. To fulfill this responsibility, the practitioner must not only prescribe an appropriate regimen, but also be capable of assessing the adherence of the patient to the regimen and addressing poor adherence when it occurs. By so doing, the provider will be able to ensure adherence to the regimen until treatment is completed.

7 ISTC Training Modules 2008 Effect of Treatment on Public Health Why is TB Treatment a Public Health Measure? Effective treatment rapidly kills organisms, reducing the bacillary population in respiratory secretions, thus reducing the potential for transmission. Effective multiple-drug treatment greatly reduces the risk of resistant organisms emerging. Effective treatment decreases the duration and severity of illness and reduces the risk of death.

8 ISTC Training Modules 2008 Effect of Treatment on Public Health Pulmonary TB cases/100,000 DOTS 1990 PTB falling at 6%/yr case finding Effects of Treatment on the Incidence of Tuberculosis in Peru

9 ISTC Training Modules 2008 All patients (including those with HIV infection) who have not been treated previously should receive an internationally accepted first- line treatment regimen using drugs of known bioavailability. The initial phase should consist of two months of isoniazid, rifampicin, pyrazinamide and ethambutol. Standard 8: Initial Phase of Treatment (1 of 4)

10 ISTC Training Modules 2008 Mixed population (susceptible and resistant) INH resistant bacilli Emergence of INH resistant strain because of ineffective treatment (INH monotherapy ) Effective multi-drug therapy Effect of Treatment on Bacillary Population Weeks Log cfu

11 ISTC Training Modules 2008 Months of Rx0579 INH RIF EMB Smear++++ Culture++++ Susceptibility INHR*RRR RIFS*RRR EMBS*SSR * Results not known to clinician Unintended Monotherapy and Resistance

12 ISTC Training Modules 2008 Treatment Goals Microbiological Goals of Antituberculosis Chemotherapy Kill tubercle bacilli rapidly (early bactericidal effect) Prevent the emergence of drug resistance Eliminate persistent bacilli to prevent relapse (sterilizing effect)

13 ISTC Training Modules 2008 Activities of Antituberculosis Drugs Highest ++++ High +++ Intermediate ++ Low + Drug Early bactericidal activity Preventing drug resistance Sterilizing activity Isoniazid Rifampicin Pyrazinamide Streptomycin ++ Ethambutol

14 ISTC Training Modules 2008 Standard 8: Continuation Phase of Treatment The preferred continuation phase consists of isoniazid and rifampicin given for four months. Isoniazid and ethambutol given for six months is an acceptable continuation phase regimen that may be used when adherence cannot be assured, but is associated with a higher rate of failure and relapse, especially in patients with HIV infection. (2 of 4)

15 ISTC Training Modules 2008 Ethambutol may be omitted in the initial phase of treatment for adults and children who have negative sputum smears, who do not have extensive pulmonary tuberculosis or severe forms of extrapulmonary disease, and who are known to be HIV negative. Standard 8: Continuation Phase of Treatment (3 of 4)

16 ISTC Training Modules 2008 Treatment Recommendations 1. Streptomycin may be substituted for EMB 2. Ethambutol may be omitted for adults and children who have negative sputum smears, do not have extensive pulmonary tuberculosis or severe forms of extra-pulmonary disease and who are HIV negative 3. Associated with higher rate of treatment failure and relapse; should generally not be used in patients with HIV infection. RankingInitial Phase (2 mos.)Continuation Phase Preferred INH, RIF, PZA, EMB 1,2 dailyINH, RIF daily, 4 mos. INH, RIF, PZA, EMB 1,2 3x/wk.INH, RIF 3x/wk, 4 mos. Optional 3 INH, RIF, PZA, EMB dailyINH, EMB daily, 6 mos.

17 ISTC Training Modules 2008 The doses of antituberculosis drugs used should conform to international recommendations. Fixed-dose combinations of two (INH and RIF), three (INH, RIF and PZA), and four (INH, RIF, PZA, and EMB) drugs are highly recommended, especially when medication ingestion cannot be observed. Standard 8: Drug Formulations and Doses (4 of 4)

18 ISTC Training Modules 2008 Dose Recommendations DrugDaily3x Week INH5 (4-6), max 300/d10 RIF10 (8-12), max 600/d10 (8-12) max 600/ d PZA25 (20-30)35 (30-40) EMB children: 20 (15-25)* adults: 15 (15-20)* 30 (25-35) Streptomycin15 (12-18) *The recommended daily dose of ethambutol is higher in children (20 mg/kg) than in adults (15mg/kg), because the pharmacokinetics are different (peak serum ethambutol concentrations are lower in children than in adults receiving the same mg/kg dose) mg/kg (range)

19 ISTC Training Modules 2008 Treatment of Extrapulmonary TB

20 ISTC Training Modules 2008 In general, extrapulmonary tuberculosis is treated the same as pulmonary tuberculosis Some experts recommend extending the duration of therapy in patients with: Meningeal tuberculosis Bone/joint tuberculosis Corticosteroids may be useful adjunctive treatment in some forms of extrapulmonary tuberculosis Treatment of Extrapulmonary TB

21 ISTC Training Modules 2008 Treatment Duration and Use of Steroids SiteLength of Rx (mos.)Corticosteroids Lymph node6No Bone/Joint6-9No Pleural6No Pericarditis6Yes CNS9-12Yes Disseminated6No Genitourinary6No Abd/Peritoneal6No Treatment of Extrapulmonary TB

22 ISTC Training Modules 2008 Monitoring Treatment for TB and Public Health Reporting Standards 10, 11, & 17

23 ISTC Training Modules 2008 All patients should be monitored for response to therapy, best judged in patients with pulmonary tuberculosis by follow-up sputum smear microscopy (2 specimens) at least at the time of completion of the initial phase of treatment (2 months), at 5 months, and at the end of treatment. Patients who have positive smears during the 5 th month of treatment should be considered as treatment failures and have therapy modified appropriately. Standard 10: Monitoring Treatment (1 of 2)

24 ISTC Training Modules 2008 In patients with extrapulmonary tuberculosis and in children, the response to treatment is best assessed clinically. Follow-up radiographic examinations are usually unnecessary and may be misleading Standard 10: Monitoring Treatment (2 of 2)

25 ISTC Training Modules 2008 Isoniazid Rifampicin Pyrazinamide Ethambutol months Initial Phase Continuation Phase Diagnostic End of intensive phase Assessment for failure Completion Monitoring: Timing of Sputum Specimens

26 ISTC Training Modules 2008 Treatment Outcomes for Pulmonary TB 98% 64% 32% 20% 18% 50% 10% Dead Sputum negative Sputum positive No Chemotherapy Poor Chemotherapy Good Chemotherapy 0.8% 1.2% Grzybowski S et al, Bull Int Union Tuberc 1978; (53)2: 70-5

27 ISTC Training Modules 2008 Monitoring: Adverse Reactions Drugs are listed in order of relative likelihood of causing adverse reaction. INH/RIF and RIF/PZA appear to have synergistic effects in causing hepatitis Adverse ReactionDrugs RashPZA, INH, RIF, EMB Gastrointestinal intolerance PZA, RIF Liver toxicityPZA, INH, RIF Peripheral neuropathyINH, (EMB) Optic neuritisEMB GoutPZA

28 ISTC Training Modules 2008 Adverse Reactions: Rash Severe skin rash from thioacetazone Classic drug-related rash

29 ISTC Training Modules 2008 Drug-induced Hepatotoxicity Hepatotoxic reactions: Transaminase elevation age-dependent with INH Transaminase elevation dose-dependent with PZA Cholestasis (increase in bilirubin and alkaline phosphatase) with RIF Symptoms imply significant hepatotoxicity (Mild transaminase elevation may not be clinically significant)

30 ISTC Training Modules 2008 Managing Hepatotoxicity Management Hold all medications and follow liver enzymes for significant hepatotoxicity Re-challenge depends on circumstances and severity of liver dysfunction In general, patients should be restarted with EMB (the least hepatotoxic drug) and RIF, usually followed in several days by INH if there is no worsening of liver function

31 ISTC Training Modules 2008 A written record of all medications given, bacteriologic response, and adverse reactions should be maintained for all patients Standard 11: Monitoring Treatment

32 ISTC Training Modules 2008 Standard 17: Reporting Cases All providers must report both new and retreatment tuberculosis cases and their treatment outcomes to local public health authorities, in conformance with applicable legal requirements and policies. ISTC Training Modules 2008

33 Summary: Appropriate treatment and assessment of adherence to treatment is an important public health issue. The use of internationally accepted first- line treatment regimens is associated with a high cure rate and a low risk of acquired drug resistance. Initial Treatment of Tuberculosis

34 ISTC Training Modules 2008 Summary (cont.): Pulmonary and extrapulmonary TB are generally treated with the same regimens. (Exception: extended duration in meningeal and bone/joint disease.) Monitoring for both response to treatment and for potential adverse events is essential. Initial Treatment of Tuberculosis

35 ISTC Training Modules 2008 Summary: ISTC Standards Covered* Standard 7: Practitioners assume an important public health responsibility in ensuring both appropriate treatment regimens and assessment of treatment adherence for their patients. Standard 8: All patients who have not been previously treated should receive an internationally accepted treatment regimen: Initial phase: 2 months INH, RIF, PZA, and EMB Continuation phase: 4 months INH and RIF, or 6 months of INH and EMB (higher failure in HIV) * Abbreviated versions

36 ISTC Training Modules 2008 Standard 8: (continued) EMB may be omitted in the initial phase for non- HIV smear-negative cases without severe disease. The doses of anti-TB drugs used should conform to international recommendations. Fixed-dose combinations are highly recommended. Standard 10: All patients should be monitored for response to therapy, best judged in patients with pulmonary TB by follow-up sputum smear microscopy (at 2 and 5 months and end of treatment). Summary: ISTC Standards Covered* * Abbreviated versions

37 ISTC Training Modules 2008 Standard 10: (continued) Positive smears during the 5 th month of treatment are considered treatment failures and treatment should be modified appropriately. Response to treatment in extrapulmonary TB is best assessed clinically. Follow-up radiographs are usually unnecessary and may be misleading. * Abbreviated versions Summary: ISTC Standards Covered*

38 ISTC Training Modules 2008 Standard 11: A written record of all medications given, bacteriologic responses, and adverse reactions should be maintained for all patients. Standard 17: All providers must report both new and retreatment TB cases and their treatment outcomes to local public health authorities * Abbreviated versions Summary: ISTC Standards Covered*

39 ISTC Training Modules 2008 Alternate Slides

40 ISTC Training Modules 2008 Purpose of ISTC

41 ISTC Training Modules 2008 ISTC: Key Points 17 Standards Differ from existing guidelines: standards present what should be done, whereas, guidelines describe how the action is to be accomplished Evidence-based, living document Developed in tandem with Patients Charter for Tuberculosis Care Handbook for using the International Standards for Tuberculosis Care

42 ISTC Training Modules 2008 Audience: all health care practitioners, public and private Scope: diagnosis, treatment, and public health responsibilities; intended to complement local and national guidelines Rationale: sound tuberculosis control requires the effective engagement of all providers in providing high quality care and in collaborating with TB control programs ISTC: Key Points

43 ISTC Training Modules 2008 Questions

44 ISTC Training Modules 2008 Initial Treatment of Tuberculosis 1. A 28 year-old woman taking standard four-drug treatment for TB for five weeks now complains of nausea, vomiting, and right upper-quadrant discomfort. When seen in clinic she is noted to have scleral icterus and right upper-quadrant tenderness. Her urine is dark colored. What is the appropriate action to take at this time? A.Stop all drugs B.Stop isoniazid C.Give pyridoxine (vitamin B6) D.Replace pyrazinamide with streptomycin

45 ISTC Training Modules 2008 Initial Treatment of Tuberculosis 2. A 68 year-old woman with smear-positive TB needs to start treatment. She lives too far to be given directly- observed treatment (DOT) by your office. Which treatment regimen is preferred for this patient? A.Isoniazid and ethambutol for twelve months B.Isoniazid/rifampicin/ethambutol for the first two months, followed by isoniazid/rifampicin for an additional four months C.Fixed-dose combination of isoniazid/rifampicin/pyrazinamide for nine months D.Fixed-dose combinations of isoniazid/rifampicin/ethambutol/pyrazinamide for the first two months, followed by isoniazid/rifampicin for an additional four months

46 ISTC Training Modules 2008 Initial Treatment of Tuberculosis 3. In considering treatment for extrapulmonary disease, all of the following statements are correct except: A.Extrapulmonary disease is a sign of disseminated disease, and therefore always requires a longer duration of treatment B.Most presentations of extrapulmonary TB can be treated with the same standard six month regimens used for pulmonary TB C.Extending the duration of therapy is recommended by many experts for central nervous system (CNS) and bone/joint extrapulmonary TB D.Corticosteroids are sometimes recommended for pericardial and central nervous system (CNS) extrapulmonary TB


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