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Treatment of Tuberculosis (2003)

Tuberculosis in the United States


 

Slide 1: Title
TREATMENT OF TUBERCULOSIS, 2003

American Thoracic Society
Centers for Disease Control and Prevention
Infectious Diseases Society of America

Division of Tuberculosis Elimination
Centers for Disease Control and Prevention

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Slide 2: Why a New TB Treatment Statement?

  • Last TB treatment statement published in 1994
  • Several new drugs available e.g., rifapentine, newer fluoroquinolones
  • New research information on treatment regimens

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Slide 3: 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

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Slide 4: 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 interaction

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Slide 5: 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

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Slide 6: 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

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Slide 7: 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

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Slide 8: 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 approved by the U.S. Food and Drug Administration for use in the treatment of TB.

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Slide 9: Drug Abbreviations

Ethambutol EMB
Isoniazid INH
Pyrazinamide PZA
Rifampin RIF
Rifapentine RPT
Streptomycin SM

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Slide 10: 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 HIV-negative adults with drug-susceptible noncavitary TB and negative AFB smears at completion of initial phase of treatment

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Slide 11: 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

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Slide 12: Factors Guiding Treatment Initiation

  • Epidemiologic information
  • Clinical, pathological, chest x-ray findings
  • Microscopic examination of acid-fast bacilli (AFB) in sputum smears
  • Nucleic acid amplification test (when performed)

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Slide 13:  When to Consider Treatment Initiation

  • Positive AFB smear
  • Treatment should not be delayed because of negative AFB smears if high clinical suspicion:
    • History of cough and weight loss
    • Characteristic findings on chest x-ray
    • Emmigration from a high-incidence country

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Slide 14: Baseline Diagnostic Examinations for TB

  • Chest x-ray
  • Sputum specimens (= 3 obtained 8-24 hours apart) for AFB microscopy and mycobacterial cultures
  • Routine drug-susceptibility testing for INH, RIF, and EMB on initial positive culture

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Slide 15: Other Examinations to Conduct When TB Treatment Is Initiated (1)

  • Counseling and testing for HIV infection
  • CD4+ T-lymphocyte count for HIV-positive persons
  • Hepatitis B and C serologic tests, if risks present

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Slide 16: Other Examinations to Conduct When TB Treatment Is Initiated (2)

  • Measurements of aspartate aminotransferase (AST), alanine aminotransferase (ALT), bilirubin, alkaline phosphatase, serum creatinine, and platelet count
  • Visual acuity and color vision tests (when EMB used)

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Slide 17: IDSA/USPHS* Rating System for Treatment Recommendations

Strength of Recommendation
A. Preferred; should generally be offered
B. Alternative; acceptable to offer
C. Offer when preferred/ alternative regimens cannot be given
D. Should generally not be offered
E. Should never be offered

Quality of Supporting Evidence
I. At least one properly randomized trial with clinical endpoints
II. Clinical trials that either are not randomized or were conducted in other populations
III. Expert opinion

*IDSA- Infectious Diseases Society of America; USPHS-U.S. Public Health Service

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Slide 18: 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)
  • Continuation phase: additional 4 months or (7 months for some patients)

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Slide 19: Why Extend Continuation-Phase Treatment for 3 Months?

  • Cavitary disease and positive sputum culture at 2 months associated with increased relapse in clinical trials
  • Extended continuation phase decreased relapses in silicotuberculosis (from 20% to 3%)

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Slide 20: When to Extend Continuation-Phase Treatment for 3 Months?

  • Cavitary pulmonary disease and positive sputum cultures at completion of initial phase
  • Initial phase excluded PZA
  • Once-weekly INH and rifapentine started in continuation phase and sputum specimen collected at the end of initial phase is culture positive
  • HIV-infected with positive 2-month sputum culture

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Slide 21: Algorithm to Guide Duration of Continuation-Phase Treatment for Culture-Positive TB Patients 

If there is high clinical suspicion for active TB, place patient on the initial-phase regimen of INH, RIF, EMB, and PZA for 2 months. If the specimen collected at the end of the initial phase (2 months) is not culture positive, then give continuation-phase treatment of INH/RIF daily or twice weekly for 4 months.

Note: This text is continued on the next slide.

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Slide 22: Algorithm to Guide Duration of Continuation-Phase Treatment for Culture-Positive TB Patients (Continued)

Note: This text is continued from the previous slide.

If the specimen collected at the end of the initial phase (2 months) is culture positive, determine if there was cavitation on the initial chest x-ray. If there was cavitation on the initial chest x-ray, then give continuation-phase treatment of INH/RIF daily or twice weekly for 7 months.

If there was no cavitation on the initial chest x-ray, then determine if the patient is HIV positive. If the patient is not HIV positive, then give continuation-phase treatment of INH/RIF daily or twice weekly for 4 months. If the patient is HIV positive, then give continuation-phase treatment of INH/RIF daily or twice weekly for 7 months.

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Slide 23: 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.

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Slide 24: Treatment of Culture-Positive TB (2): 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.

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Slide 25: Treatment of Culture-Positive TB (3): 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)

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Slide 26: Treatment of Culture-Positive TB (4): 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

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Slide 27: Algorithm to Guide Rifapentine (RPT) Use in Continuation Phase

If the patient is HIV positive, he/she is not eligible for RPT. If the patient is HIV negative, determine if there was cavitation on the initial chest x-ray. If there was cavitation, then the patient is not eligible for RPT. If there was no cavitation, then determine if the sputum was AFB smear positive at 2 months. If the sputum was AFB smear positive, then the patient is not eligible for RPT.

Note: This text is continued on the next slide.

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Slide 28: Algorithm to Guide Rifapentine (RPT) Use in Continuation Phase (Continued)

Note: This text is continued from the previous slide.

If the sputum was not AFB smear positive, then determine if RPT should be considered for treatment. If RPT should not be considered for treatment, then give treatment of INH/RIF daily or twice weekly for 4 months. If RPT is considered for treatment, begin treatment with once weekly INH/RPT. Then, determine if specimen collected at the end of initial phase (2 months) is culture positive. If it is not culture positive, then continue treatment until 4 months of INH/RPT is completed. If it is culture positive, then extend treatment with INH/RPT for a total of 7 months.

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Slide 29: Treatment of Culture-Positive TB: Rifapentine in Continuation Phase (Rated: BI for HIV-negative*, EI for HIV-positive patients)

Initial Phase
Options:

  1. 2 months - INH, RIF, PZA, EMB daily (56 doses, within 8 weeks)
  2. 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, RPT once weekly (18 doses, within 18 weeks)
  2. 7 months - INH, RPT once weekly (31 doses, within 31 weeks)

*Regimen is limited to noncavitary disease in HIV-negative patients. Sputum must be smear negative at completion of 2 months of treatment

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Slide 30: Algorithm to Guide Treatment of Culture-Negative TB

High clinical suspicion for active TB despite negative smears based on:

  • Abnormal chest x-ray
  • Clinical symptoms
  • No other diagnosis
  • Positive tuberculin skin test

Patient placed on initial phase regimen: INH, RIF, EMB, PZA for 2 months

Note: The text is continued on the next slide.

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Slide 31: Algorithm to Guide Treatment of Culture-Negative TB (Continued)

Note: The text is continued from the previous slide.

If the initial culture is positive, continue treatment for culture-positive TB. If the initial culture is not positive, then determine if there was symptomatic or chest x-ray improvement after 2 months of treatment. If there was no improvement, then discontinue treatment; patient is presumed to have LTBI, and treatment is completed. If there was improvement, then give continuation-phase treatment of INH/RIF daily or twice weekly for 2 months.

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Slide 32: 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

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Slide 33: 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

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Slide 34: 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

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Slide 35: 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 > 15-20 mg/kg

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Slide 36: 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

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Slide 37: 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

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Slide 38: Management of Initial Phase Treatment Interruptions

  • If lapse ³ 14 days, start from beginning
  • If lapse < 14 days, continue treatment to complete total doses warranted (if can be completed within 3 months)

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Slide 39: Algorithm for Management of Treatment Interruptions in the Initial Phase

If the interruption is ³14 days, then start treatment over from the beginning. If the interruption is <14 days, then determine if the treatment is completed within 3 months. If not, then start treatment over from the beginning. If it is within 3 months, then continue treatment to complete total number of doses warranted.

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Slide 40: Management of Continuation Phase Treatment Interruptions

  • If received ³ 80% continuation-phase doses and:
    1. sputum AFB smear negative on initial presentation, further therapy not necessary
    2. sputum AFB smear positive on initial presentation, continue to complete full course

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Slide 41: Management of Continuation Phase Treatment Interruptions

  • If received < 80% continuation-phase doses and:
    1. lapse < 3 months duration, continue to complete full course (as long as all doses can be completed within 6-months)
    2. lapse was 3 months or greater, then start initial phase 4-drug regimen from the beginning

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Slide 42: Algorithm for Management of Continuation Phase Treatment Interruptions

If the total percentage of doses completed is >80%, then additional treatment may not be necessary if sputum was AFB smear negative at baseline. If sputum smear was positive, continue treatment to complete planned total number of doses warranted. If it is <80%, then determine if the duration of interruption is <3 months. If it is >3 months, then start initial phase 4-drug regimen from beginning. If it is <3 months, then continue treatment; if not completed in 6 months, start initial phase 4-drug regimen from beginning.

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Slide 43: Common Adverse Reactions to Drug Treatment (1)

Any of the anti-tuberculosis drugs can cause an allergic reaction. The sign/symptom associated with this type of adverse reaction is skin rash. 

Ethambutol can cause an adverse reaction of eye damage. Signs/symptoms associated with this type of adverse reaction include blurred or changed vision, and/or changed color vision. 

Isoniazid, Pyrazinamide, or Rifampin can cause the adverse reaction of hepatitis. Signs/symptoms associated with this type of adverse reaction include abdominal pain, abnormal liver function test results, fatigue, lack of appetite, nausea, vomiting, yellowish skin or eyes, and/or dark urine.

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Slide 44: Common Adverse Reactions to Drug Treatment (2)

Isoniazid can cause the adverse reaction of peripheral neuropathy. Signs/symptoms associated with this type of adverse reaction include tingling sensation in the hands and feet. 

Pyrazinamide can cause the following adverse reactions:

  • Gastrointestinal intolerance with the signs/symptoms of upset stomach, vomiting, and/or lack of appetite.
  • Arthralgia with the signs/symptoms of joint aches.
  • Arthritis with the rare sign/symptom of gout.

Streptomycin can cause the following adverse reactions:

  • Ear damage with the signs/symptoms of balance problems, hearing loss, and/or ringing in the ears.
  • Kidney damage as indicated by abnormal kidney function test results.

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Slide 45: Common Adverse Reactions to Drug Treatment (3)

Rifamycins, which include Rifabutin, Rifapentine, and Rifampin, can cause the following adverse reactions:

  • Thrombocytopenia with the signs/symptoms of easy bruising and/or slow blood clotting.
  • Gastrointestinal intolerance with the sign/symptom of upset stomach.
  • Drug interactions which can interfere with certain medications, such as birth control pills, birth control implants, and methadone treatment.

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Slide 46: Drug Interactions

  • Relatively few drug interactions substantially change concentrations of antituberculosis drugs
  • Antituberculosis drugs sometimes change concentrations of other drugs
    • Rifamycins can decrease serum concentrations of many drugs, (e.g., most of the HIV-1 protease inhibitors), to subtherapeutic levels
    • Isoniazid increases concentrations of some drugs (e.g., phenytoin) to toxic levels

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Slide 47:  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

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Slide 48:  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

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Slide 49:  Treatment Failure

  • Defined as positive cultures after 4 months of treatment in patients for whom medication ingestion was ensured
  • Single new drug should never be added to a failing regimen; it may lead to acquired resistance to the added drug
  • Add at least three new drugs (e.g., fluoroquinolone, ethionamide, and an injectable drug:  SM, amikacin, kanamycin, or capreomycin) to the existing regimen being cognizant of the possibility of drug resistance

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Slide 50:  Drug Resistance (1)

  • Established only by drug-susceptibility testing
  • Treatment of TB caused by drug-resistant organisms should be done in close consultation with an expert
  • Patients not on DOT in the past or who had irregular treatment are at risk of drug resistance

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Slide 51:  Drug Resistance (2)

  • Consider the following expanded regimen for drug resistance:
    • INH, RIF, PZA, EMB plus three additional agents based on probability of in vitro susceptibility (e.g., fluoroquinolone, ethionamide, or an injectable drug: SM, amikacin, kanamycin, or capreomycin)

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Slide 52:  Special Treatment Situations HIV/AIDS

  • Treatment for HIV-positive patients same as for HIV-negative patients, except
    1. Once-weekly INH-rifapentine in continuation phase is contraindicated in HIV-positive patients
    2. Twice-weekly INH-RIF or INH-rifabutin should not be used in patients with CD4+ T-lymphocyte counts less than 100/ml
  • Every effort should be made to use a rifamycin-based regimen for the entire course of therapy

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Slide 53:  Special Treatment Situations (Children and Adolescents)* (1)

  • Use DOT
  • Treat young children (<5 years old) with three (rather than four) drugs in initial phase (i.e., INH, RIF, and PZA)
  • EMB not recommended unless increased likelihood of INH resistance or diagnosis of adult-like TB**

*Defined as persons <15 years old

**Defined as upper-lobe infiltration and cavitation associated with sputum production

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Slide 54:  Special Treatment Situations Children and Adolescents (2)

  • Thrice-weekly therapy not recommended
  • Recommended duration of treatment is 6 months (absence of factors associated with increased risk of relapse)

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Slide 55:  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

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Slide 56:  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

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Slide 57:  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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Slide 58:  Special Treatment Situations Renal Insufficiency and End-Stage Renal Disease (1)

  • Renal insufficiency complicates management of TB because some antituberculosis medications are cleared by the kidneys
  • Dosage should not be decreased because peak serum concentrations may be too low; smaller doses may decrease drug efficacy

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Slide 59:  Special Treatment Situations Renal Insufficiency and End-Stage Renal Disease (2)

  • Dosing interval of antituberculosis drugs should be increased
  • Most drugs can be given 3 times weekly after hemodialysis; for some drugs, dose must be adjusted

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Slide 60:  Special Treatment Situations Hepatic Disease (1)

Must consider regimens with fewer hepatotoxic agents for patients with liver disease
Recommended regimens:

  1. Treatment without PZA
    Initial phase (2 months):  INH, RIF, and EMB
    Continuation phase (7 months):  INH and RIF
  2. Treatment without INH
    Initial phase (2 months):  RIF, PZA, and EMB
    Continuation phase (4 months): RIF, EMB, and PZA

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Slide 61:  Special Treatment Situations Hepatic Disease (2)

Recommended regimens: (continued)

  1. Regimens with only one potentially
    hepatotoxic drug
    • RIF should be retained
    • Duration of treatment is 12-18 months
  2. Regimens with no potentially hepatotoxic drugs
    • Duration of treatment is 18-24 months

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Slide 62: Continuing Education Credits (1)

  • Participants will be able to receive one of the following:
    • Continuing Medical Education (CME) credit = 3.75
    • Continuing Nursing Education (CNE) credit = 4.3
    • Continuing Education Unit (CEU) = 0.43
    • Certified Health Education Specialist (CHES) credit = 3.5
  • Participants are required to read and study the treatment guidelines, take a test, and complete an evaluation

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Slide 63: Continuing Education Credits (2)

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Slide 64: Treatment Guidelines Online Availability

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Slide 65: Additional TB Resources

For additional information on tuberculosis, visit the Division of Tuberculosis Elimination Web site at: http://www.cdc.gov/tb

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