Treatment of TB Infection Lisa Y. Armitige, MD, PhD April 7, 2015

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1 Treatment of TB Infection Lisa Y. Armitige, MD, PhD April 7, 2015 Tuberculosis Infection Diagnosis and Treatment April 7, 2015 El Paso, TX EXCELLENCE EXPERTISE INNOVATION Lisa Y. Armitige, MD, PhD has the following disclosures to make: No conflict of interests No relevant financial relationships with any commercial companies pertaining to this educational activity 1

2 Treatment of TB Infection Lisa Y. Armitige, MD, PhD Medical Consultant, Heartland National TB Center Associate Professor, Internal Medicine/Pediatrics/ID UT Health Northeast, Tyler, Texas Tuberculosis Infection Diagnosis and Treatment El Paso, TX April 7, 2015 EXCELLENCE EXPERTISE INNOVATION First! The single most important thing prior to starting treatment for TB Infection is to RULE OUT ACTIVE DISEASE!! 2

3 Active TB Disease or TB Infection? The Clinical Evaluation Standard Components of TB/TBI Evaluation If the TST or IGRA is Positive Patient History Physical examination Radiologic evaluation?collect sputum or other specimens 3

4 Patient History Symptoms Fever Chills Night Sweats Weight Loss Cough Productive Cough Hemoptysis PMH: Diabetes HIV Other Immunosuppression Silicosis Drug/alcohol/tobacco TB exposures or Risk? Physical Exam Lung exam Check for lymph nodes Palpate liver Look for anything that will complicate therapy! 4

5 Radiologic Exam CXR must be done Must be normal Or IF abnormal: Not consistent with Active TB Stable abnormality confirmed over a 3 month period Laboratory Exam Sputum AFB smear and culture Collect if you suspect active disease If you order, and AFB smear is negative, don t start TBI treatment until cultures are negative 6 weeks!!!!! 5

6 Management of TST+ or IGRA + With Abnormal CXR If Patient has NO signs or symptoms of Active TB: Collect 3 sputa for smears and culture Evaluate for symptoms If no symptoms Wait Repeat CXR If CXR stable at 2 3 months and cultures negative, treat for TBI Management of TST+ or IGRA + With Abnormal CXR If patient has ANY signs or symptoms of TB disease: The patient is a TB Suspect Collect 3 sputa for smear and culture Consider starting 4 drugs! Never (ever!) start a single drug in a patient with possible active TB 6

7 TBI Treatment Who should be treated for TBI? A decision to test is a decision to treat! Tests should only be placed on persons who would benefit from treatment Occasional tests placed for administrative reasons and these individuals should be evaluated on a case by case basis regarding initiation of treatment 7

8 Why should you treat small children who are exposed? Very high rate of infection Takes up to 3 months for the skin test to turn positive U.S. studies 10% to 20% of childhood TB cases can be prevented if children exposed in a household receive isoniazid WHO standards children <5 years old in a TB household should be treated Percent Risk of Disease by Age Age at Infection Risk of Active TB Birth 1 year* 43% 1 5 years* 24% 6 10 years* 2% years* 16% Healthy Adults HIV Infected Adults % lifetime risk 30 50% lifetime *Miller, Tuberculosis in Children Little Brown, Boston, WHO,

9 Risk of Progression to TB Disease by Age primary infection Birth 12months Risk of Disease Disease 50% Pulmonary Dis 30 40% Miliary or TBM 10 20% 1 2 years Disease 20 25% Pulmonary Dis 75% Miliary or TBM 2 5% Marais BJ. Int J Tuberc Lung Dis 2004;8: TB Prevention After a Child is Exposed Household contact with contagious person Teen or adult with pulmonary TB disease Usually >4 hours of contact Initial TST negative Window period for TST conversion (8 10 weeks) CXR and physical exam normal Window prophylaxis recommended: For children <5 yrs of age Immunosuppressed patients Patients on tumor necrosis factor alpha blockers May prevent progression to disease during window period Repeat TST 8 10 wks after exposure May stop INH if 2 nd TST negative <5mm in immunocompetent patients 9

10 Window Prophylaxis and TBI Treatment Options in Children Isoniazid (INH) = mainstay of therapy mg/kg single daily dose mg/kg twice weekly (must be given by health department) Duration of treatment for TBI: 9 months Alternative: rifampin mg/kg daily dose If person around child with TB is known to have INH resistant disease or if child is INH intolerant Duration of treatment for TBI: 6 months (may be shortened to 4 months soon) TBI Treatment Options for 5 y/o CDC Recommended Treatment regimens: INH x 9 months Daily (5 mg/kg: 300 mg max) or BIW (15 mg/kg: 900 mg max) Rifampin x 4 months Daily (10 mg/kg: 600 mg max) INH/Rifapentine x 3 months (3HP) Once weekly DOT x 12 weeks INH x 6 months (only if.) Daily or BIW CDC. November

11 3HP Must be administered by DOT Approved for individuals >12 y/o Published data shows safety down to age 2 Dosing: INH: 15 mg/kg rounded up to the nearest 50 or 100 mg; 900 mg maximum RPT: kg 300 mg kg 450 mg kg 600 mg kg 750 mg 50.0 kg 900 mg maximum Duration of Therapy INH 9 Rifampin INH +RPT 9 months (270 doses) 4 months (120 doses) 12 weeks (12 doses) The longer the duration/more doses, the less likely your patient is to complete Rx! Fewer than 60% complete 9 months of INH! 11

12 INH TBI Therapy INH TBI Therapy The standard treatment regimen for TBI is nine months of daily INH. The regimen is very effective and is the preferred regimen for HIV infected people taking antiretroviral therapy, and children on DOPT CDC. November

13 INH Side Effects Hepatotoxicity Migraine Headaches Gastrointestinal Nausea, Diarrhea, Constipation Rash Peripheral Neuropathy Pyridoxine 50mg daily can help prevent this INH Hepatotoxicity Asymptomatic elevation of aminotransferases: 20% of patients Clinical hepatitis: 0.6% of patients Fulminant hepatitis (hepatic failure) Approximately 4/100,000 persons completing therapy (continued INH with symptoms of hepatitis, prior INH hepatotoxicity, malnutrition). 13

14 Severe INH Liver Injuries Among Persons Being Treated for LTBI, U.S., MMWR 3/5/10/ 59(08); Medical providers should emphasize to patients that INH treatment should be stopped immediately upon the earliest onset of symptoms (e.g. excess fatigue, nausea, vomiting, abdominal pain, or jaundice), even before a clinical evaluation has been conducted, and that initial symptoms might be subtle and might not include jaundice. Rifampin TBI Therapy 14

15 4 Mos Rifampin vs 9 Mos INH for Treatment of TBI Menzies et al AJRCCM 2004, 170; 445 Completion of therapy significantly better with rifampin with fewer side effects than INH Lardizabal et al Chest 2006, 130; 1712 Patients receiving rifampin were significantly more likely to complete therapy than those receiving INH Menzies et al Ann Int Med 2008, 149; 689 Significantly higher rate of treatment completion with fewer serious adverse events Rifampin Treatment of TBI Pros: Higher Completion Rates Fewer Side Effects Less Hepatotoxicty Cons: Drug Interactions Hormone Contraceptives Warfarin Prednisone HIV Antiretrovirals And many more must look up all drugs for interactions!!!!! Orange Body Fluids Other Potential Side Effects: Rash Thrombocytopenia Anemia Leukopenia Allergic Interstitial Nephritis 15

16 INH/Rifapentine TBI Treatment INH/Rifapentine TBI Therapy It is another effective regimen option for otherwise healthy patients aged 2 years who have a predictive factor for greater likelihood of TB developing including: Recent TB contacts TST/IGRA Converters Radiographic findings of healed pulmonary TB CDC. November

17 INH + RPT is NOT recommended for: Children under 2 y/o HIV infected persons on Antiretroviral Therapy Presumed INH or Rifampin Resistance in the source case Pregnant women Pearls of Wisdom for Treating TBI Consider the shortest regimen possible to increase the odds of completion Be vigilant.and suspicious Be supportive..and forgiving 17

18 Pearls of wisdom for treating TBI in children Use INH suspension only in children 5 kg Compliance with 9 months of INH averages 50% be vigilant and skeptical, consider shorter course treatments Use DOPT for: recent contacts, infants, immune compromised When children aren t tolerating treatment, the problem is more often with the parent than the child Routine LFTs only for: other liver toxic drugs, liver disease, signs or symptoms of hepatitis The Pediatric Infectious Disease Journal : 2 18

19 Guidelines on Diagnosis and Treatment of TB Infection CDC. Targeted TB Testing and Treatment of LTBI. June ATS/CDC/IDSA. Controlling Tuberculosis in the U.S. November NTCA/CDC. Guidelines for the Investigation of Contacts of Persons with Infectious Tuberculosis. December CDC. Guidelines for Using the QuantiFERON-TB Gold Test for Detecting Mycobacterium tuberculosis Infection, United States. December 2005 CDC. TB Elimination, Treatment Options for Latent Tuberculosis Infection. November Questions? TEX LUNG 19

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