6/8/2018 TB TREATMENT. Bijan Ghassemieh, MD Seattle TB Clinical Intensive Disclosures. None

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1 TB TREATMENT Bijan Ghassemieh, MD Seattle TB Clinical Intensive 2018 Disclosures None 1

2 Objectives Understand the following Rationale and goals for standard TB regimen When to initiate TB treatment Standard regimen and potential side effects How to monitor patients When to deviate from the standard TB regimen Treatment completion Management of treatment failure What I m Not Going To Talk About Treatment of latent TB infection Treatment of MDR TB Treatment of extrapulmonary TB Treatment of TB in special situations: HIV, pediatrics, pregnancy All possible side effects Every potential TB treatment scenario you have or will ever encounter 2

3 2016 US TB TREATMENT GUIDELINES Nahid CID 2016 Nomenclature DRUG ABBREVIATION SINGLE LETTER ABREVIATION Isoniazid INH I (or H) Rifampin RIF R Pyrazinamide PZA P (or Z) Ethambutol EMB E Fluoroquinolones (Moxifloxacin, Levofloxacin) FQ 3

4 Outline Rationale and Goals of TB treatment TB treatment initiation The standard TB regimen ( RIPE or HRZE ) Common side effects of first line TB medications Monitoring during TB treatment Managing treatment interruptions When to deviate from the standard regimen Treatment in special situations: liver disease, renal disease, advanced age Treatment failure / completion Why Is TB Therapy So Long? Horsburgh NEJM

5 Why Is TB Therapy So Long? Horsburgh NEJM 2015 Why Is TB Therapy So Long? 5

6 Why So Many Drugs? Why So Many Drugs? In a population of TB bugs, there is a constant natural low level mutation rate resulting in drug resistance Single drug therapy causes selective pressure favoring resistant bugs In patients with high burden disease, the likelihood of naturally occurring mutations to Single drug is likely Two drugs is possible Three drugs is highly unlikely Development of drug resistance on treatment is very unlikely if appropriate multidrug regimen is ingested and absorbed Never add a single drug to a failing regimen 6

7 How Did We Get To The Standard 6 Month Regimen? First curative TB treatment: INH, SM, aminosalicylic acid for up to 2 years Series of clinical trials (late 1940s to mid 1980s) RIF plus INH allowed shortening duration from 18 to 9 months Adding PZA to the first 2 months allowed shortening from 9 to 6 months ( short course regimen ) 2014: 4 trials of 4 month regimen including FQ showed unacceptable rates of relapse (13 20%) EMB added to regimen to prevent resistance Horsburgh NEJM Goals of TB Treatment Rapid killing of multiplying bacteria Individual impact: Decrease severity of disease and prevent death Population impact: Decrease transmission Eradicate remaining bacteria ( persisters ) to achieve durable cure ( sterilization ) Prevent acquisition of drug resistance during therapy 7

8 First Line TB Drug Activity Drug Early bactericidal Preventing Sterilizing activity drug resistance activity Isoniazid Rifampin Pyrazinamide Ethambutol +/ Highest ++++, High +++, Intermediate ++, Low + Slide c/o Masa Narita First Line Drug Take Home Points Rapid killing of multiplying bacteria INH Sterilizing Effect preventing relapse PZA, RIF Prevent drug resistance INH, RIF, EMB Not PZA (limited effectiveness against rapidly growing bacteria, and works in acidic microenvironments) EMB included in regimen to prevent drug resistance 8

9 Outline Rationale and Goals of TB treatment TB treatment initiation The standard TB regimen ( RIPE or HRZE ) Common side effects of first line TB medications Monitoring during TB treatment Managing treatment interruptions When to deviate from the standard regimen Treatment in special situations: liver disease, renal disease, advanced age Treatment failure / completion Case 1: 21 yo M From India Close contact to infectious TB case 2 months of fever, cough, weight loss, sweats, hemoptysis. Looks awful Sputum: AFB smear positive, MTB PCR positive About to return to college dorm from summer break Start treatment? 9

10 Case 2: 72 yo F From Seattle 0mm TST No symptoms Alcoholic cirrhosis No travel Hermit Sputum: AFB smear negative, MTB PCR negative Start treatment? Case 3: 50 yo M From Vietnam Chronic cough, attributes to smoking. Worsening? Sputum: AFB smear negative, MTB PCR negative Start treatment? What if he had prolonged fever and weight loss? What if he had cirrhosis? What if he is homeless? More investigation? 10

11 DECIDING TO INITIATE TREATMENT Nahid CID 2016 Treatment Initiation Considerations: Risk for drug resistance? Obtain molecular DST Previous treatment, non DOT and/or without RIF From country with high rate of drug resistance Known contact to drug resistant case Comorbidities: Liver disease, renal disease, HIV, severe gout Drug interactions Few medications impact TB drugs INH impacts a few drugs RIF impacts MANY drugs Assess barriers to adherence 11

12 Outline Rationale and Goals of TB treatment TB treatment initiation The standard TB regimen ( RIPE or HRZE ) Common side effects of first line TB medications Monitoring during TB treatment Managing treatment interruptions When to deviate from the standard regimen Treatment in special situations: liver disease, renal disease, advanced age Treatment failure / completion The Standard Regimen Initial Phase Continuation Phase Isoniazid* Rifampin Pyrazinamide Ethambutol** Months *Administer B6 with INH to those at risk of peripheral neuropathy **EMB can be stopped if TB is sensitive to INH and RIF 12

13 Duration of Treatment Depends on Severity of disease Comorbidities Drugs used ( weaker drugs require a longer duration) Response to treatment Most patients with drug susceptible pulmonary TB will be treated for 6 months Compromise: Accept overtreatment of some (many?) to ensure cure of the overall population Treatment shortened (culture negative TB) or prolonged in certain situations Dosing Frequency STRONGER Intensive Phase Continuation Phase Regimen Drugs Frequency Drugs Frequency 1 RIPE 7 days/wk X 8 wks 5 days/wk X 8 wks 2 RIPE 7 days/wk X 8 wks 5 days/wk X 8 wks RI RI 7 days/wk X 18 wks 5 days/wk X 18 wks TIW X 18 wks 3 RIPE TIW X 8 wks RI TIW X 8 wks WEAKER Daily dosing is preferred TIW during continuation phase an acceptable alternative Use Regimen 3 with caution if: HIV, smear positive, or cavitary disease. Missed doses can lead to risk of treatment failure, relapse, drug resistance BIW dosing not recommended. Dose missed? weekly dosing (inferior) 13

14 Dosing Frequency and Relapse Risk Cavitary Non cavitary 6 month regimens 2 month culture + 2 month culture 2 month culture + 2 month culture Daily throughout 6.0% 2.2% 1.8% 0.6% Daily intensive phase THEN TIW continuation phase Daily intensive phase THEN BIW continuation phase 6.1% 3.3% 2.2% 1.2% 15.6% 5.7% 5.4% 1.9% TIW throughout 14.5% 5.3% 4.6% 1.7% Chang AJRCCM 2006 DOT DOT is recommended for all patients Growing familiarity/comfort/evidence for video DOT If logistically not feasible for all, priorities for DOT are (next slide) 14

15 DOT: Priorities Smear positive Drug resistance Treatment failure or relapse HIV Previous treatment Intermittent dosing Non adherent Substance abuse Children Disability (mental, emotional, physical) Congregate settings (correctional facility, nursing home) Homeless Outline Rationale and Goals of TB treatment TB treatment initiation The standard TB regimen ( RIPE or HRZE ) Common side effects of first line TB medications Monitoring during TB treatment Managing treatment interruptions When to deviate from the standard regimen Treatment in special situations: liver disease, renal disease, advanced age Treatment failure / completion 15

16 First Line TB Medication Side Effects Common (~5 18% require regimen adjustment) Can be severe Drug induced liver injury (PZA>INH>RIF) Blindness (EMB) Hypersensitivity reaction (RIF) General principals: Minor side effects managed symptomatically Major side effects: Drugs stopped, likely offending agent avoided (may require drug challenge to identify culprit) Goal is to kill the TB without killing the person or causing significant long term side effects First Line TB Medication Side Effects Excellent Resource: Curry Center Drug Resistant TB Survival Guide. Chapter 5: Medication Fact Sheets Available free online 16

17 First Line TB Medication Side Effects Adverse Reaction Rash Gastrointestinal intolerance Liver toxicity Peripheral neuropathy Optic neuritis Gout Drugs* PZA, INH, RIF, EMB PZA, RIF PZA, INH, RIF INH, (EMB) EMB PZA *Listed in order of most likely offending agent Slide c/o Lisa Chen Drug Induced Liver Injury (DILI) 17

18 Drug Induced Liver Injury (DILI) Most common severe adverse reaction from RIPE Symptoms: anorexia, nausea/vomiting, abdominal pain, fatigue, jaundice (late finding) Caused by: PZA > INH > RIF Risks: Underlying liver disease, older age, hepatotoxic medications Definition: ALT > 3 times ULN with symptoms ALT > 5 times ULN without symptoms Patterns: Elevated ALT/AST: PZA, INH, RIF Cholestatic (elevated alk phos and bili): RIF DILI Management Rule out other causes (viral hepatitis, alcohol, other meds, biliary tract disease) Severe (ie ALT >500): Stop RIPE. No further PZA or INH Start liver sparing regimen : FQ, EMB, injectable Consider retrying RIF once ALT < ~ 2 times ULN Mild/moderate: Stop RIPE Once ALT < 2 times ULN, sequential drug challenge at ~3 7 day intervals: RIF (+/ EMB) INH +/ PZA If cholestatic pattern, consider different sequence 18

19 Rash Rash All TB meds can cause rash Minor: Manage symptomatically (ie antihistamine) Signs of more severe rash: Mucous membrane involvement suggests SJS/TEN Fever, CBC abnormalities (eosinophilia, anemia, thrombocytopena), renal failure, transaminitis suggests potential hypersensitivity reaction Petechial rash suggests thrombocytopenia from RIF If concerned, check safety labs (CBC, Cr, LFTs) and hold medications Sequential drug challenge (q 2 3 days): RIF INH EMB/PZA 19

20 Optic Neuritis Optic Neuritis Cause: EMB >>>>>>>>>>>>>>> INH Onset: Usually after > 1 month of EMB, but can occur within days Challenging to differentiate DM related eye symptoms from EMB toxicity Low threshold to stop EMB if concerned (remember: main purpose of EMB is to prevent resistance) Ophtho consult if severe or persists 20

21 GI Upset GI Upset Symptoms: Nausea/vomiting, epigastric discomfort, poor appetite Need to hold meds and rule out DILI Meds: Any, but PZA and RIF most common Strategies: Take at bedtime Start antacid (may decrease absorption of FQs) Start PPI Start anti nausea medication Take with light snack (food decreases absorption of all meds except rifabutin) Split doses (not ideal: may decrease drug effectiveness) 21

22 Peripheral Neurotoxicity Peripheral Neurotoxicity Symptoms: symmetric, length dependent numbness/tingling (no motor symptoms) Meds: INH (rarely EMB) Risk factors indicating B6: DM, alcohol, pregnancy, infants, HIV, malnutrition, renal failure, elderly We give B6 to everyone If signs/symptoms of neuropathy, can try increasing B6 dose (but caution that this can rarely actually make neuropathy worse) 22

23 Monitoring During Treatment Shaded: optional With DOT, ask about: GI symptoms, joints, rash, vision, neuropathy Checklists are your friend Nahid CID 2016 Outline Rationale and Goals of TB treatment TB treatment initiation The standard TB regimen ( RIPE or HRZE ) Common side effects of first line TB medications Monitoring during TB treatment Managing treatment interruptions When to deviate from the standard regimen Treatment in special situations: liver disease, renal disease, advanced age Treatment failure / completion 23

24 Treatment Interruptions Interruptions are common (side effects, nonadherence) The earlier and longer the interruption, the more the need to restart from beginning If prolonged interruption, obtain smear/culture (and DST) and if positive need to restart from beginning Limited evidence to guide decisions. Following slide has one approach (adapted from NYC TB program) Treatment Interruption During Intensive Phase During Continuation Phase Details Lapse < 14 days Lapse > 14 days Received >80% and smear negative at diagnosis Received >80% and smear positive at diagnosis Received < 80% and lapse < 3 mo Received < 80% and lapse > 3 mo Management Continue treatment Restart Further treatment may not be necessary Continue treatment, unless lapse >2 consecutive months (restart) Continue treatment Restart Nahid CID

25 Outline Rationale and Goals of TB treatment TB treatment initiation The standard TB regimen ( RIPE or HRZE ) Common side effects of first line TB medications Monitoring during TB treatment Managing treatment interruptions When to deviate from the standard regimen Treatment in special situations: liver disease, renal disease, advanced age Treatment failure / completion Adjusting The Standard Regimen: Risk Factors For Relapse Cavitary Non cavitary 6 month regimens 2 month culture + 2 month culture 2 month culture + 2 month culture Daily throughout 6.0% 2.2% 1.8% 0.6% Daily intensive phase THEN TIW continuation phase Daily intensive phase THEN BIW continuation phase 6.1% 3.3% 2.2% 1.2% 15.6% 5.7% 5.4% 1.9% TIW throughout 14.5% 5.3% 4.6% 1.7% Chang AJRCCM

26 Adjusting The Standard Regimen: Risk Factors For Relapse If cavitary disease AND culture positive at 2 months extend continuation phase to 7 months (9 total months of treatment) If cavitary disease OR culture positive at 2 months, consider extending to 9 total months if. IBW < 10% Active smoker Poorly controlled DM HIV or other immunosuppression Extensive disease on CXR Adjusting The Standard Regimen: Culture Negative TB Culture Negative TB: Clinical syndrome consistent with TB Radiographic findings consistent with TB Sputum AFB smear/culture negative Other conditions unlikely or ruled out Positive TST/IGRA (not required) Clinical/radiographic improvement (2 mo CXR) Treatment: 2 months RIPE, 2 months RI If didn t get better at 2 months, stop therapy and considered them treated for LTBI 26

27 Adjusting The Standard Regimen: Liver Disease Options for severe underlying liver disease (ie baseline ALT > 3 times ULN or advanced cirrhosis): PZA free regimen: 2 months RIE, 7 months RI PZA and INH free: months of RE + FQ/injectable/cycloserine Liver sparing regimen : months of FQ, EMB, injectable, +/ cycloserine Need careful and frequent monitoring on treatment Consultation with expert advised Adjusting The Standard Regimen: Renal Disease Therapeutic drug monitoring may be necessary If on HD or creatinine clearance < 30, need to change frequency to TIW (after HD) for. PZA EMB Levofloxacin 27

28 Adjusting The Standard Regimen: Advanced Age Guidance in advanced age: Risk of hepatitis and other side effects increases Some experts avoid PZA for those > 75 Consider PZA if high bacillary burden or drug resistance Higher risk for drug interactions Patients require careful monitoring Adjusting The Standard Regimen: Summary Cavitary disease AND culture positive at 2 months: Extend continuation phase to 7 months Consider extension if Cavitary OR culture positive at 2 months with specific risk factors Culture negative TB: 4 total months of treatment Severe baseline liver disease: Consider avoiding hepatotoxic medications (PZA > INH > RIF) Severe renal disease: Decrease frequency of PZA and EMB, consider drug level monitoring Advanced age: Consider PZA free regimen 28

29 Adjusting The Standard Regimen: Mono resistance or intolerance Without INH: 6 9 months of REP +/ FQ 9 12 months RE + FQ Without RIF: MUCH different than WHO guidelines months of IE + FQ. PZA for at least 1 st 2 months 18 months IPE Consider injectable for 1 st 2 months if severe or shooting for 12 months Without PZA: 9 months RI with initial use of EMB white waiting for DST Curry Center Drug Resistant TB Survival Guide Outline Rationale and Goals of TB treatment TB treatment initiation The standard TB regimen ( RIPE or HRZE ) Common side effects of first line TB medications Monitoring during TB treatment Managing treatment interruptions When to deviate from the standard regimen Treatment in special situations: liver disease, renal disease, advanced age Treatment failure / completion 29

30 Treatment Failure Definition: Culture positive at 4 months 90 95% of patients will be culture negative at 3 months if on regimen with INH and RIF If culture positive at 3 months, look for Adherence issues Occult drug resistance (repeat molecular and phenotypic DST) Malabsorption Consider therapeutic drug monitoring Treatment Completion Based on number of doses, not duration Definition Intensive phase completed in 3 months Continuation phase completed in 6 months So total therapy completed in 9 months If targets not met, manage as treatment interruption End of treatment counseling: Inform future providers about previous TB and baseline CXR abnormalities Seek medical evaluation if signs/symptoms TB recurrence 30

31 Resources ATS/CDC/IDSA 2016 Treatment Guidelines Infect Dis Nahid cid_ciw376.pdf Curry Center Drug Resistant TB Survival Guide Great resource overall, details medication fact sheets Horsburgh. Treatment of Tuberculosis. NEJM Nov 26, 2015 Good basic overview Outlines differences between US and international guidelines Curry Center warmline Us! 31

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