TB Diagnosis and Management James B. McAuley, MD, MPH, MDiv July 22, 2008

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1 Preventing TB on the College Campus Springfield, Illinois July 22, 2008 TB Diagnosis and Management James B. McAuley, MD, MPH, MDiv July 22, 2008 TB Diagnosis and Management July 2008 James B. McAuley MD MPH MDiv Rush University Medical Center Chicago, Illinois

2 Outline TB Epidemiology TB Disease LTBI Causes of under-five child mortality Source: Bryce J. et al., Lancet, 2005

3 TB Morbidity United States, Year Cases Rate* , , , , , , , *Cases per 100,000, updated as of April 6, TB Rates*, Illinois U.S. Cases per 100, *per 100,000 population Illinois US Source: Population data - Illinois Department of Public Health, Center for Health Statistics; and U.S. Bureau of the Census **Case rate for 2005 estimated using 2004 Population estimate.

4 Reported TB Cases: Chicago, No. of TB Cases Selected Risk Factors Associated with Tuberculosis: Chicago, 2007 Selected Risk Factors No. of Cases % Injecting Drug Use 2 <1% Non-Injecting Drug Use 36 14% Excess Alcohol Use 60 23% Any Substance Abuse 77 30% Homeless 29 11% Correctional Facility at 14 5% Diagnosis Long-Term Care Facility 5 2% at Diagnosis 8

5 Transmission and Pathogenesis Transmission of M. tuberculosis Spread by droplet nuclei Expelled when person with infectious TB coughs, sneezes, speaks, or sings Close contacts at highest risk of becoming infected Transmission occurs from person with infectious TB disease (not latent TB infection)

6 Probability TB Will Be Transmitted Infectiousness of person with TB Environment in which exposure occurred Duration of exposure Virulence of the organism Pathogenesis 10% of infected persons with normal immune systems develop TB at some point in life HIV strongest risk factor for development of TB if infected - Risk of developing TB disease 7% to 10% each year Certain medical conditions increase risk that TB infection will progress to TB disease

7 Common Sites of TB Disease Lungs (75-85%) Pleura Central nervous system Lymphatic system Genitourinary systems Bones and joints Disseminated (miliary TB) Evaluation for TB Medical history Physical examination Mantoux tuberculin skin test Chest radiograph Bacteriologic or histologic exam

8 Latent Tuberculosis Infection (LTBI) Infection with Mycobacterium tuberculosis without disease. Tuberculosis elimination in the U.S. depends on accurate diagnosis of LTBI. Diagnosis of LTBI currently depends on Tuberculin Skin Testing. TIMETABLE OF TB: from infection to disease Miliary and meningeal develop rapidly Adenopathy segmental Lymph node (cervical) Pleural effusion Skeletal Renal 1-12 months 2-12 months 2-12 months 3-9 months 6 months - 2 years 1-5 years TST Positive window period Time From Exposure

9 Diagnostic Tools Who Should be Tested for TB Infection? Those at epidemiological increased risk of having TB infection Those at increased individual risk of developing TB disease if infected ONLY test if you are going to treat the patient a decision to test is a decision to treat

10 The Initial Test for TB Infection is the History Questionnaire Risk Assessment for TB Infection in Children - NYCDOH Ozuah et al. JAMA;285:451 Risk factor Sens. Spec. PPV NPV OR Contact to a case Birth/travel to endemic area Contact to HR adult Age > 11 yr

11 Epidemiologically-Defined Groups with HIGH Prevalence of Tuberculosis Infection Immigrants from areas of world with a high incidence of TB Homeless persons, and other low income groups with poor access to health care Elderly persons Residents and employees in congregate living facilities serving persons at high risk of TB (correctional institutions, homeless shelters, health care facilities, nursing homes, assisted living facilities, AIDS housing) Underlying Medical Conditions Which Increase Risk for Progression to Active TB Disease HIV infection Chronic renal failure Immunosuppressive Rx Diabetes mellitus Malignancy TNF Alpha blocker therapy Transplant recipients > 15 mg Prednisone/day Silicosis

12 Before Treatment of LTBI: Exclude Active Tuberculosis Absence of symptoms Negative CXR Negative medical evaluation Order and wait for sputum culture if any question How Should Immunosuppressed Persons at Risk of TB Be Managed? Empiric treatment for LTBI is warranted even when TST or IGRA is negative on repeat testing 8-10 weeks after exposure Advanced HIV infected contacts Children < 6-9 months who are contacts Contacts with other causes of immunosuppresion Persons at risk for exposure to TB who are to receive treatment with TNF alpha antagonists

13 TNF alpha Antagonists Block TNF alpha activity which is required for granuloma formation and control of TB infection Used for rheumatoid arthritis, Crohn s disease, psoriasis and a variety of other immune mediated diseases Remicade (inflixamab) Embril (entanercept) Humira (adalimubab) Tuberculosis susceptibility genes P2X7 Y Y VDR IFNγR1 IFNγ Y Y MBL Y NRAMP1 inos HLA-DR2 STAT1 IL-1β TNF IL-10 Infected Macrophage IFNγR2 IL-12 IL-12Rβ2 IL-12Rβ1 T cell/nk cell Shown to be linked or associated with TB in more than one population Conflicting studies both +ve and ve associations with TB reported Single study shows association with TB Negative studies not shown mostly not published!

14 Incidence of Tuberculosis by Selected Risk Factors in Persons with a Positive TST Risk Factor Recent TB Infection Infection < 1 year past Infection 1-7 years past HIV/AIDS Injection Drug Use HIV-positive HIV-negative or unknown Silicosis Radiographic findings consistent with old TB Weight Deviation from Standard ( 5% overweight 15% underweight) TB Cases/1000 person-years Identification of Priority Subpopulations Local TB-control agency identifies groups with high TB risk through epidemiologic analysis Populations at risk separated into 3 tiers: Incidence of TB Prevalence of TB Risk for acquiring TB disease if infected Likelihood of accepting & adhering to LTBI treatment Ease of access to the population In a congregate setting, consequence of transmission

15 Priorities for Targeted Testing and Treatment of LTBI Tier 1 Persons working in or served by clinics providing care to HIV-infected persons Prisoners Legal immigrants and refugees with Class B1 & B2 TB notification status Recently arrived refugees Well defined groups in congregate living facilities Persons enrolled in substance abuse treatment programs Priorities for Targeted Testing and Treatment of LTBI Tier 2 Jail detainees Persons working or living in homeless shelters Immigrants reporting for adjustment of status Tier 3 Other foreign-born persons at high risk (i.e. those that immigrated 5 years from countries with a high incidence of TB

16 Tuberculosis Class 2 - LTBI Those at risk of TB who are: TST Positive, CXR normal, asymptomatic Sputum, if done, negative New guidelines - no mention of age as a factor TREATMENT RECOMMENDED for: Positive at 5 and 10 mm cut-points unless contraindication Close Contacts of active case TST Converter (10 mm increase) Contacts of Active TB Case Among close contacts approximately 30% have LTBI and 1-3% have active TB disease Without treatment, approximately 5% of contacts with newly acquired LTBI progress to TB disease within 2 years Examination of contacts is one of the most important activities for identifying persons with disease and with LTBI

17 Management of Contacts Who Have an Initial Negative TST Close Contacts Asymptomatic with a negative CXR Treatment with INH should be started for: HIV Infected Children < 5 Significant Immunosuppressant Repeat TST in 3 months for all others Symptomatic Evaluate for Active TB CXR, smears and culture If a TB suspect, treat for TB disease Window Prophylaxis The immune system typically requires from 2 to 10 weeks following infection to develop a suffcient T-cell response leading to a positive TST During this window period children under the age of 4 are at high risk of developing disseminated TB, so treatment is to be started regardless of the results of the initial TST

18 Tuberculin Skin Testing Induration of >5mm Considered a Positive TST HIV positive persons Recent contacts of TB cases Fibrotic Changes on CXR c/w old (not treated) TB Patients with organ transplants or other immunosuppression Prednisone therapy 15 mg/day > 1 month

19 Induration of >10mm> Considered a Positive TST Recent arrivals (<5 yrs) high prevalence countries IDU Residents/employees - high-risk congregate facilities (health care, prisons, shelters, etc.) Induration of >10mm> Considered a Positive TST TB lab personnel Persons with high-risk medical conditions Children <4 yrs or exposed to adults at risk

20 Induration of >15mm> Considered a Positive TST Persons with no risk factors Usually shouldn t be tested unless as part of baseline assessment for those at risk due to jobs in high risk settings Factors that May Affect the Skin Test Reaction Type of Reaction False-positive False-negative Possible Cause Nontuberculous mycobact. BCG vaccination Anergy Recent TB infection Very young age (< 6 mos ) Live-virus vaccination Overwhelming TB disease

21 Invention of BCG Vaccine By Calmette and Guérin, TB and BCG Vaccination Efficacy for adult pulmonary TB 0-80% in randomized clinical trials Best efficacy against serious childhood disease 64% protection against TB meningitis 78% protection effect against disseminated TB BCG important for young children, inadequate as single strategy Colditz GA et al. JAMA 1994; 271:

22 JAMA 2001;286:1740 Interferon Gamma Release Assays Quantiferon measure of interferon gamma in supernatant, currently at third generation test Quantiferon Gold In-tube Elispot measure of individual T-cells that produce interferon gamma. Newer data suggests IGRAs may be highly predictive of progression to TB disease (Am J Respir Crit Care Med vol 177, 2008)

23 Treatment of LTBI Treatment regimens: INH x 9 months Alternative: Rifampin 600mg daily x 4 months for adults, 6 months for children and HIV+ Possible: INH & Rifampin x 3 to 4 months INH, Rifampin, EMB & PZA x 2 months No longer used: Rifampin/PZA x 2 months New? Rifapentine & INH weekly x 12 weeks

24 ISONIAZID ISONIAZID PREVENTIVE THERAPY Worldwide Trials, controlled trials in 11 countries: United States Japan Canada Netherlands Greenland France Mexico Tunisia Kenya India Philippines Over 100,000 participants Household contacts (6), Entire communities (3), Inactive pulmonary lesions (5), Children with primary TB (2), School children (1) Railway workers (1), Mentally ill patients (1) 25-92% protection

25 How Much Isoniazid Is Needed for the Prevention of Tuberculosis? Longer durations of therapy corresponded to lower TB rates among those who took 0-9 mo No extra increase in protection among those who took >9 months Community based study, Bethel Alaska Comstock GW, Int J Tuberc. Lung Dis 3: IUATLD Study of INH Therapy for LTBI Reduction in culture positive TB at 5 years all participants 6 months therapy 65% 12 months therapy 75% Reduction in culture positive TB at 5 years in the group of completer-compliers (took > 80% of doses): 6 months therapy 69% 12 months therapy 93%

26 Interpretation of These Data has Led to the Current Recommendation of 9 months of INH in Most Situations Treatment of LTBI in HIV Infected Persons

27 Group (n) Preventive Therapy Trial of HIV Associated TB Infection, Uganda PPD-Positive Cohort Cases of Tuberculosis Crude Relative Risk P Value Adjusted Relative Risk No. Rate* (95% CI) (95% CI) Placebo (464) H (536) ( ) ( ) 3HR (556) ( ) ( ) 3HRZ (462) ( ) ( ) * Definite and probable cases per 100 person-years Whalen, 1997 Adjusted for age, sex, white blood count, hemoglobin, Karnofsky score, body-mass index, and presence of HIV-related infection Summary of Data on HIV Related TB Infection Data suggest 6 months or 12 months (not presented) effective compared to placebo. Data on 9 months versus 6 or 12 months are lacking. Two months of Rifampin plus Pyrazinamide showed efficacy comparable to 12 months of Isoniazid but wide spread use revealed increased toxicity.

28 Summary of Literature Describing INH Hepatitis & Deaths Study N Hepatitis* Hospitalization* Deaths* Garibaldi , ( 8) 11 (5) 2 (1) Kopanoff , ( 7) NR 8 (0.6) Riska , ( 5) NR 3 (0.1) Franks ,681 5 ( 1) NR 2 (0.5) Steele , ( 5) 11 (0.2) 13 (0.3) Snider ,084,760 NR NR 152 (0.1) Salpeter , (13) NR 0 (0) 182,285 2,187 (12) NR 2 (0.01) Millard ,084,760 NR NR 46 (0.04) Nolan , ( 1) 1 (0.1) 0 (0) *No. and rate per 1000 initiated INH Definitions of hepatitis vary by study; NR: Not recorded Risk of Isoniazid-Associated Hepatitis Age Hepatitis Incidence (%) <20 Very rare >64 0.8

29 Managing Medication Toxicities Current LTBI Monitoring Recommendations Clinical and Laboratory Monitoring Elimination of routine baseline and follow-up laboratory monitoring in most persons with latent TB infection, except for those with HIV infection, pregnant and post-partum women, and history or risk of liver disease Emphasis on clinical monitoring for signs and symptoms of adverse effects, with prompt evaluation and changes in treatment as indicated

30 Monthly Monitoring During Therapy for Persons with Latent TB Infection Evaluate for signs and symptoms of active TB and drug reactions Remind patient of signs and symptoms of hepatotoxicity Repeat liver function tests for patients with abnormal baseline or persons with HIV infection, pregnant and post-partum women, history/risk of liver disease Review all medications and assess for potential drug interactions Adverse Drug Events Hepatotoxicity Who is most at risk? Those with underlying liver disease Alcoholics Chronic Hepatitis B and C Women Young Hispanic and African American women Immediate (4 months) post-partum period Those on other hepatotoxic medications HIV-infected

31 Adverse Drug Events Hepatotoxicity If hepatitis suspected, hold medications and obtain LFT s immediately Continue therapy LFT s (AST/ALT) < 5 times upper limit of normal and asymptomatic and high risk of progression to TB disease Stop therapy LFT s (AST/ALT) > 3 times upper limit of normal and symptomatic LFT s (AST/ALT) > 5 times upper limit of normal and asymptomatic Disproportionate increases in bilirubin and/or alk. phos. Evaluate for underlying liver disease and exposure to other hepatotoxins LTBI with abnormal CXR CLASS 4 - TB Not Clinically Active Exclude active disease Abnormal but stable CXR findings (>2-3 mo) NODULES/ FIBROTIC LESIONS OF OLD TB PLEURAL THICKENING CALCIFIED GRANULOMA BRONCHIECTASIS Sputum smear and cultures negative Isolated CXR with nodules/fibrotic lesions 4 drug therapy until CXR stable & cultures negative

32 Management of LTBI in Pregnancy (HIV Negative) Evaluate patients at risk of progression during pregnancy with TST Asymptomatic TST positive women should have CXR after first trimester Symptomatic women should have immediate CXR to exclude active disease even in first trimester Women should be counseled that x-ray exposure from a single diagnostic procedure does not result in harmful fetal effects. Specifically, exposure to less than 5 rad has not been associated with an increase in fetal anomalies or pregnancy loss. ACOG, Committee on Obstetric Practice, Guidelines for diagnostic imaging during pregnancy. ACOG opinion no.158. Washington DC; ACOG, 1995

33 Treatment of LTBI During Pregnancy or While Breastfeeding During pregnancy treat only those at high risk of progression to active disease INH daily or twice weekly Pyridoxine supplementation Treatment while breast-feeding safe Avoid PZA during pregnancy Increased risk of hepatotoxicity first 3 months postpartum HIV+ Pregnant Women at Risk of Tuberculosis Increased morbidity and mortality in HIV TB in pregnant women noted in US and developing world HIV infected women with LTBI at risk of rapid progression to active disease Treatment of both LTBI and Disease should be aggressive and instituted when diagnosis is made.

34 Other Agents for LTBI Contacts Of INH Resistant TB Four month regimen daily Rifampin for adults Six month regimen daily Rifampin for HIV infected Six month regimen daily Rifampin for children

35 Incidence of TB in Skin Test Converters Exposed d to Isoniazid and Streptomy omycin Resistant TB by b Type of Preventive Therapy No. No. with Type of Therapy converters TB (%) P-value No therapy 71 6 (8.4) - Isoniazid 38 3 (7.9) 0.62 Rifampin Isoniazid and rifampin Rifampin-containing 86 0 <0.01 regimen Boston, Polesky, 1996 Treatment of Latent TB Infection in Special Situations For children and adolescents (<18 years old): - Isoniazid for 9 months For pregnant women: - Isoniazid for 9 or 6 months - may defer except for HIV- infected women and those recently infected with Mycobacterium tuberculosis For persons exposed to isoniazid resistant TB: - Rifampin for 4 months For persons likely infected with multidrug-resistant TB: - Pyrazinamide and ethambutol, or pyrazinamide and quinolone for 6-12 months (i.e., at least 2 drugs to which the organism is susceptible)

36 Treatment of Latent TB Infection Future Directions Efficacy and safety of other intermittent regimens Studies in children and pregnant women Reporting and monitoring of treatment of TBI in new settings New cost-effectiveness/decision analyses Assessment of new medications and regimens TB Disease

37 AFB smear AFB (shown in red) are tubercle bacilli National Tuberculosis Curriculum Consortium, CSF Microbiology in TB Meningitis, Vietnam 107/132 (81%) with microbiologic confirmation: AFB smear sensitivity 52%, culture sensitivity 64% Multivariate analysis showed increased CSF volume increased sensitivity (> 6 ml gave 80% sensitivity) as did time examining slide (> 30 min) Thwaites, J Clin Micro, Jan

38 Cultures Use to confirm diagnosis of TB Culture all specimens, even if smear negative Results in 4 to 14 days when liquid medium systems used Colonies of M. tuberculosis growing on media Drug Susceptibility Testing Drug susceptibility testing on initial M. tuberculosis isolate Repeat for patients who - Do not respond to therapy - Have positive cultures despite 2 months of therapy Promptly forward results to the health department

39 Persons at Increased Risk for Drug Resistance History of treatment with TB drugs Contacts of persons with drug-resistant TB Foreign-born persons from high prevalent drug resistant areas Smears or cultures remain positive despite 2 months of TB treatment Received inadequate treatment regimens for >2 weeks Chest Radiograph Abnormalities often seen in apical or posterior segments of upper lobe or superior segments of lower lobe May have unusual appearance in HIV-positive persons Cannot confirm diagnosis of TB Arrow points to cavity in patient's right upper lobe.

40 Basic Principles of Radiography Series of overlying shadows The more dense the material or the more material there is the less x-ray penetrates and exposes film, the lighter the area Filmless systems work on the same principle but the receiver is a digital sensor, not film Basic Principles of Radiography The respiratory tree (trachea, bronchi, alveoli) is/are pulmonary The other areas (mediastinum, hilum, pleura) are extrapulmonary but intrathoracic The bones (ribs, vertebrae, etc.) are seen on chest radiograph but are extra-thoracic Pneumonia simply means infection (fluid wbc, bacteria, etc.) in alveoli does not indicate cause.

41 Normal Chest Radiograph Reviewing a Chest Radiograph

42 Pulmonary TB Bilateral upper lobe TB

43 Right upper lobe TB Severe cavitary disease

44 Extensive TB Extensive bilateral TB

45 Bilateral cavitary disease Right Middle lobe cavity

46 Early TB subtle infiltrate Apical disease infiltrate plus cavity

47 Extensive disease in a 7 year old Pleural TB

48 Hilar adenopathy Miliary TB in a child

49 CNS Imaging, San Diego Basal enhancement present on noncontrast CT study 13/20 (68%) of children with definite TB CT findings did not correlate with long term neurological outcome Saitoh, Pediatr Infect Dis J. March Typical MRI Findings National Tuberculosis Curriculum Consortium,

50 Tuberculoma National Tuberculosis Curriculum Consortium, What s New? (1) Provider/program responsibility for successful treatment, not the patient Patient-centered case management with emphasis on directly observed therapy (DOT) Evidence-based ratings of treatment options Role of two-month sputum cultures to identify patients at increased relapse risk

51 What s New? (2) Extend treatment for patients with drug-susceptible pulmonary TB at increased risk for relapse Role of new drugs (rifabutin, rifapentine, and fluoroquinolones) Practical aspects of therapy: drug administration, fixed-dose combinations, adverse effects monitoring and management, and drug interactions What s New? (3) Treatment completion defined primarily by number of doses ingested within specified time Description of special treatment situations: HIV/AIDS Children Extrapulmonary TB Culture-negative TB Pregnancy and breast feeding Hepatic and renal disease

52 What s New? (4) Updated guidelines for management of drug-resistant TB Recommendations compared with those of the World Health Organization (WHO) and the International Union Against TB and Lung Disease (IUATLD); WHO DOTS strategy described Current research status to improve treatment Fundamental Responsibility and Approach in TB Treatment Provider (or program) responsible for prescribing appropriate regimen AND ensuring successful completion of therapy Directly observed therapy (DOT) with patient-centered case management is preferred approach

53 Antituberculosis Drugs First-Line Drugs Isoniazid Rifampin Pyrazinamide Ethambutol Rifabutin* Rifapentine Second-Line Drugs Streptomycin Cycloserine p-aminosalicylic acid Ethionamide Amikacin or kanamycin* Capreomycin Levofloxacin* Moxifloxacin* Gatifloxacin* * Not appr proved by the e U.S. Food od and Drug Administr stration for use in the trea eatment t of TB Role of New Drugs (1) Rifabutin: For patients receiving medications having unacceptable interactions with rifampin (e.g., persons with HIV/AIDS) Rifapentine: Used in once-weekly continuation phase for HIVnegative adults with drug-susceptible noncavitary TB and negative AFB smears at completion of initial phase of treatment

54 Role of New Drugs (2) Fluoroquinolones (Levofloxacin, Moxifloxacin, Gatifloxacin): Used when -first-line drugs not tolerated; -strains resistant to RIF, INH, or EMB; or -evidence of other resistance patterns with fluoroquinolone susceptibility Treatment Regimens Four regimens recommended for treatment of culture-positive TB, with different options for dosing intervals in continuation phase Initial phase: standard four drug regimens (INH, RIF, PZA, EMB), for 2 months, (except one regimen that excludes PZA - children) Continuation phase: additional 4 months or (7 months for some patients)

55 Treatment of Culture-Positive TB (1) (Rated: AI in HIV-negative, AII in HIV-positive patients) Initial Phase 2 months - INH, RIF, PZA, EMB daily (56 doses, within 8 weeks) Continuation Phase Options: 1) 4 months - INH, RIF daily (126 doses, within 18 weeks) 2) 4 months - INH, RIF twice / week (36 doses, within 18 weeks) 3) 7 months - INH, RIF daily (217 doses, within 31 weeks)* 4) 7 months - INH, RIF twice / week (62 doses, within 31 weeks)* * Continuation phase increased to 7 months if initial chest x-ray shows cavitation and specimen collected at end of initial phase (2 months) is culture positive Twice-Weekly Options (Rated: AII for HIV-negative, BII for HIV-positive patients*) Initial Phase 0.5 months - INH, RIF, PZA, EMB daily (10-14 doses, within 2 weeks) THEN 1.5 months - INH, RIF, PZA, EMB twice / week (12 doses, within 6 weeks) Continuation Phase Options: 1) 4 months - INH, RIF twice / week (36 doses, within 18 weeks) 2) 7 months - INH, RIF twice / week (62 doses, within 31 weeks) * Regimen rated BII for HIV-positive patients with CD4+ T-lymphocytes cell count >100/µl. Not recommended for those with CD4+ T-lymphocytes cell count < 100/µl

56 Thrice-Weekly Options (Rated: BI for HIV-negative, BII for HIV-positive patients) Initial Phase 2 months - INH, RIF, PZA, EMB 3 times / week (24 doses, within 8 weeks) Continuation Phase Options: 1) 4 months - INH, RIF 3 times / week (54 doses, within 18 weeks) 2) 7 months - INH, RIF 3 times / week (93 doses, within 31 weeks) Regimens without Pyrazinamide (Rated: CI for HIV-negative, CII for HIV-positive patients) Initial Phase 2 months - INH, RIF, EMB daily (56 doses, within 8 weeks) Continuation Phase Options: 1) 7 months - INH, RIF daily (217 doses, within 31 weeks) 2) 7 months - INH, RIF twice / week (62 doses, within 31 weeks)* * Twice weekly dosing is not recommended for persons with CD4+ T-lymphocytes cell count < 100/µl

57 Treatment of Culture-Negative TB* Initial Phase 2 months - INH, RIF, EMB, PZA daily (56 doses, within 8 weeks) Continuation Phase Options: 1) 2 months - INH, RIF daily (56 doses, within 8 weeks) 2) 2 months - INH, RIF twice / week (16 doses, within 8 weeks) * All cultures are negative, but evaluation at 2 months reveals clinical and chest x-ray response to antituberculosis drug therapy Treatment Monitoring (1) Monthly sputum for AFB smear and culture (until 2 consecutive cultures negative) Serial sputum smears every 2 weeks to assess early response Additional drug-susceptibility tests if culture-positive after 3 months of treatment

58 Treatment Monitoring (2) Periodic (minimum monthly) evaluation to assess adherence and identify adverse reactions Repeat chest x-ray: -At completion of initial treatment phase for patients with initial negative cultures -At end of treatment for patients with culture-negative TB -Generally not necessary for patients with culture positive TB Treatment Monitoring (3) Renal function, AST, ALT, bilirubin, and platelet count if abnormalities at baseline Visual acuity and color vision monthly if EMB used > 2 months or doses > mg/kg

59 Determining Drug Completion (1) Completion primarily defined by number of ingested doses within specified time frame Examples 1) 6-month daily regimen (7 days/wk) = at least 182 doses of INH and RIF, and 56 doses of PZA 2) 6-month daily regimen (5 days/wk) = at least 130 doses Determining Drug Completion (2) Specified doses must be administered 1) Within 3 months for initial phase 2) Within 6 months for 4-month continuation phase Consider therapy interrupted if target doses not met within specified time period

60 Relapse (1) A patient s cultures become and remain negative while receiving antituberculosis drugs, but at some point after completion of therapy: 1) patient develops culture-positive TB disease again, or 2) patient experiences clinical or radiographic deterioration consistent with active TB disease Most relapses occur within the first 12 months after completion of therapy Relapse (2) Patients with cavitation on initial chest radiograph and a positive culture at completion of 2 months of therapy are at increased risk of relapse with standard 6-month regimens Patients with relapse are at increased risk for acquired drug resistance, especially if the therapy was not directly observed

61 Special Treatment Situations Extrapulmonary TB Similar treatment regimen for pulmonary TB* 6- to 9-month regimens that include INH and RIF are effective Corticosteroids used as adjunctive therapy for patients with TB meningitis and pericarditis If PZA cannot be used in the initial phase, continuation phase must be increased to 7 months * Except for central nervous system (CNS) TB, including meningitis; length of therapy is 9-12 months Special Treatment Situations Pregnancy and Breastfeeding (1) Untreated TB represents greater hazard to a woman and her child than treatment of disease Treatment of pregnant woman with suspected TB should be started if probability of TB is moderate to high Initial phase treatment regimen should consist of INH, RIF, and EMB

62 Special Treatment Situations Pregnancy and Breastfeeding (2) SM should not be substituted for EMB because of possible teratogenic effects PZA not generally recommended for pregnant women in the United States

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