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TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department [email protected] Or www.cdc.gov/mmwr/

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Page 1: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

TB Update 2003

Jacqueline Peterson Tulsky, MDwith thanks to Charles Daley, MD and Robert Jasmer, MD

SF TB control and SFGH Pulmonary Department

[email protected]

Or

www.cdc.gov/mmwr/

mailto:[email protected]
Page 2: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Summary of Points1. Latent Tuberculosis Infection (LTBI)1. Latent Tuberculosis Infection (LTBI)

• Rifampin and Pyrazinamide (PZA) for 60 doses

NOT RECOMMENDED ANY MORE

2. Active TB Treatment2. Active TB Treatment

• Avoid rifapentine

• Caution with twice weekly rifampin or rifabutin

• Stay calm in the face of immune reconstitution

Page 3: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

TB Screening

Page 4: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

TB Screening

Still important to do TB skin test on a

6-12 month routine basis Frequency tied to TB risk factors Symptom review, not x-ray for prior

PPD positives No anergy panels

Page 5: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Quantiferon™ (QFT)

Blood test looking for immune response to TB antigen

Not approved for HIV-infected persons

Not useful for diagnosing M. avium disease

Page 6: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Tuberculosis Screening Flowchart

Evaluate for active TB

At-risk person

Tuberculin test + symptom review

Negative Positive

Chest x-ray

Normal Abnormal

Treatmentnot indicated

Candidate for Rx of latent TB

Page 7: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Screening for TuberculosisChest Radiograph

• To screen for active TB you should still perform chest radiographs

Page 8: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Treatment of Latent Tuberculosis Infection

(LTBI)

ATS/CDC/IDSA GuidelinesMMWR August 8, 2003

Page 9: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Isoniazid Therapy for LTBI HIV (+) Patients

Location Regimens Reduction in TB

Haiti* 12 mo INH vs placebo 83%

Uganda 6 mo INH vs placebo 70%

Zambia* 6 mo INH2 vs placebo2 70%

Kenya* 6 mo INH vs placebo 40%

*These trials also included a TST (-) study arm in which no protection was observed

Page 10: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

New Treatment of LTBI

Regimen Duration Interval Comments (months)

Isoniazid 9 Daily Preferred regimen Twice-wkly DOT necessary

Isoniazid 6 Daily Not for HIV+ Twice-wkly DOT necessary

Rifampin 4 Daily For INH-R

ATS/CDC AJRCCM 2000;161:S221

Page 11: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

What Happened to Rifampin and PZA

for 60 doses for Treatment of

LTBI????

Page 12: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

An immigrant was tested and found to be PPD positive. The follow-up chest xray was normal and the patient was recommended for LTBI

• Denied hepatitis history or alcoholism• Offered and accepted short course therapy

with 60 doses of Rifampin/PZA • Provided meds by DOT without complaints

until last week of therapy• Severe hepatitis requiring hospitalization

Page 13: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

The patient had missed 2 clinic appointments during the course of treatment. No labs during the course of the Rifampin/PZA, should have had labs twice.

“However, because the patient did not speak English, comprehension might have been a barrier.”

Page 14: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

New Guidelines For Treatment of LTBI

• April, 2000 – Safety and efficacy of 60 doses of Rifampin and PZA lead to its recommendation

• October, 2000 – 1 patient dies, surveillance starts

• October, 2000 to June, 2002 – Cohort data collected on Rifampin/PZA patients

Page 15: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

More Severe Hepatotoxicity

Page 16: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Rifampin and PZA HepatoxicityIn 30 months ending June, 2003:

48 cases of severe liver injury – 37 recovered– 11 died

• Most deaths had onset of liver injury in 2nd month

• 2 deaths in HIV positive persons

CDC. MMWR, August 8, 2003

Page 17: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Rifampin/PZARifampin/PZA HepatotoxicityHepatotoxicity

Hepatotoxicity RIF/PZA INH OR* (95% CI) N=307 N=282

Grade 1/2/3 45 (15%) 30 (11%)

Grade 4† 9 (3%) 2 (1%) 8.05 (1.76-36.76)

Total 54 (18%) 32 (11%) 1.65 (1.00-2.75)

† Grade 4 toxicity - ALT ≥ 500 U/L or ≥ 250 with symptoms

Jasmer et al. Ann Intern Med 2002;137:640-647.

Page 18: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Treatment of LTBIAs of August, 2003

• Rifampin or Rifabutin and PZA for 60 doses is contraindicated in all patients needing treatment for LTBI.

(Rifampin or Rifabutin and PZA still okay for use in active TB with 1 or 2 other drugs.)

Page 19: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Treatment of LTBI(normal xray)

• HIV (–) persons– INH for 9 months is preferred over 6

• HIV (+) persons– INH for 9 months

• HIV (–) and HIV (+) persons– Rifampin for 4 months

Page 20: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Treatment of LTBIStable Fibrotic Scarring

• Acceptable regimens after active TB checked for include:– 9 mos of INH*

– 4 months of rifampin INH

*preferred in HIV+

ATS/CDC AJRCCM 2000;161:S221

Page 21: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Treatment of LTBIMonitoring

• Elimination of routine baseline and follow-up liver function tests, except:– HIV infection– Others with increase risk hepatitis

• Emphasis is on clinical monitoring for signs and symptoms of drug side effect

Page 22: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Treatment of LTBIMonitoring for INH-induced Hepatitis

Increased risk for hepatitis?*

Yes

Check baseline LFTs

Abnormal Normal

Monthly symptom review

< 4 X upper limit of normal

≥ 4 X upper limit of normal

No

Hold INHGive INH and repeat LFTs periodically

*HIV +Pregnant/postpartumChronic liver diseaseAlcohol abuse

Page 23: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Treatment of Tuberculosis

ATS, CDC, IDSA

MMWR June 20, 2003/52(RR11);1-77

www.cdc.gov/mmwr

Page 24: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Active TB and HIV

1. Ensuring completion of therapy is essential

2. Treatment of TB/HIV is the same as for HIV negative persons except:

Once-weekly rifapentine regimens cannot be used Twice-weekly rifampin or rifabutin should not be used if the CD4

cell count is < 100 cells/ul

3. Be alert for drug interactions and paradoxical reactions

Page 25: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Ensuring Completion 15 Essential

“The responsibility for successful treatment is clearly assigned to the public health program or private provider, not to the patient.”

“It is strongly recommended that the initial treatment strategy utilize patient-centered case management with an adherence plan that emphasizes direct observation of therapy.”

Page 26: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Adherence Related Concepts

Reach = Contact + Connect• Easy to Contact /Hard to Connect

ex: Homeless, IDUs, Street Youth, Inmates

• Hard to Contact/Easy to Connect ex: Undocumented immigrants, foreign language

Page 27: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Definitions

Corollaries of “Hard-to-Reach”

• Provider-resistant patients

• Patient-resistant providers

• Patient-resistant systems and

institutions* Rubel AJ and Garro LC. Public Health Reports, 1992;Vol 107

Page 28: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Treatment of Tuberculosis1. Four drugs until sensitivities of cultures back (RIPE)

2. Intitial phase: 3 drugs until 2 months passes

3. Continuation phase: 2 drugs (usually ____ and ______) for 4 or 7 months

Continuation phase usually becomes two or three times a week dosing…..UNLESS ADVANCED HIV

Page 29: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Treatment of Tuberculosis1. RIPE –

Rifampin/Isoniazid/Pyrazinamide/Ethambutol

2. Intitial phase: 3 drugs RIP

3. Continuation phase: 2 drugs RI

Continuation phase usually becomes two or three times a week dosing…..UNLESS ADVANCED HIV

Page 30: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Treatment of HIV and TB

Strongly recommend daily therapy if CD4 count <100 cells/ml

HIV positive at any stage of infection - The continuation phase of treatment with weekly (yes weekly!) Rifapentine and INH NOT recommended

Page 31: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

HIV and TB Drug-Drug Interactions

• Antiretroviral Drugs and TB drugs– NRTIs and NRSI okay

– NNRTI and PIs some interaction due to liver metabolism

Page 32: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

TB and HIV Drug-Drug Interactions

Rifamycins

Decrease in PIs and NNRTIs(L & S on speed)

Rifampin > rifapentine > rifabutin

Inducersof

CYP3A

Increase in serum concentration

rifabutin*(L & S after lunch)

Delavirdine and PIs

Inhibitorsof

CYP3A

*Rifampin and rifapentine are not substrates of CYP3A

Page 33: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

TB and HIV Drug-Drug Interactions

Protease Inhibitor Rifabutin Antiretroviral Regimen Dose DoseNelfinavir, indinavir, 150 mg daily or nelfinavir-consider to or amprenavir* 1500 mg q12hr

300 mg intermittently indinavir-consider to 1000 mg q 8hrs amprenavir-no change

Saquinavir* 300 mg daily or No change intermittently

Ritonavir** 150 mg biw No change

Lopinavir/ritonavir** 150 mg biw No change

*+ 2 nucleosides

** + 2 nucleosides and/or NNRTI Burman and Jones. AJRCCM 2001;162:7

Page 34: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Treatment of HIV-related TuberculosisDrug-Drug Interactions

Antiretroviral Rifabutin Antiretroviral Regimen Dose DoseNonnucleosides Efavirenz* 450-600 mg daily or biw No change

Nevirapine* 300 mg daily or intermittently No change

Nucleosides 2-3 nucleosides 300 mg daily or biw No change

PI + NNRTI Efavirenz or nevirapine 300 mg daily or biw Consider + PI (except ritonavir) dose of indinavir

* + 2 nucleosides Burman and Jones. AJRCCM 2001;162:7

Page 35: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

HIV and TB Drug-Drug Interactions

• Rifampin-based regimens:

– Ritonavir (600 mg bid) + Normal dose Rifampin (600 mg)

– Efavirenz (800 mg daily) + Normal dose Rifampin (600 mg)

– Do not use rifampin with low-dose ritonavir/PI combinations.

Burman and Jones. AJRCCM 2001;162:7

Page 36: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

35 year old woman with AIDS and CD4 of 45 developed active TB. Treated with 4 drug, then 3 drugs for 1 month by DOT.

Thoughtful HIV specialist saw pt, they agreed together to start AZT/3TC/Indinavir.

TB clinic changed patient from _________ to ________ and decreased the dose by half.

Page 37: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

TB clinic changed patient from Rifampin 600mg to Rifabutin 150mg (half the normal dose).

Page 38: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

In follow-up after 1 more month, patient decreased from 3 drugs to 2 drugs for TB.

4 months after initial diagnosis, the TB staff note patient coughing, losing weight and finally has a fever. Chest x-ray shows recurrent TB infection.

What is the key question in this patient’s medication history?

Page 39: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

• ARE YOU STILL TAKING YOUR ARV THERAPY?

• WHY IS THIS SO IMPORTANT?

Page 40: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

TB and HIV Drug-Drug InteractionsProtease Inhibitor Rifabutin Antiretroviral Regimen Dose DoseNelfinavir, indinavir, 150 mg daily or or amprenavir* 300 mg intermittently indinavir-consider to

1000 mg q 8hrs

SO, if NOT TAKING Indinavir, Rifabutin dose IS TOO LOW.

TB resistance can develop within 30 days if on single drug therapy!!

MUST COORDINATE HIV and TB MEDS

Page 41: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Treatment of HIV and TB

On HAART

No Yes

CD4 <200 CD4 200-350 CD4 > 350

BeginHAARTin 2 wks

Start 4-drugTB regimen

BeginHAARTin 2 mos

No HAART

Continueand adjust dosages

Page 42: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Paradoxical ReactionsImmune Restoration Syndromes

• Paradoxical reaction - transient worsening of condition after initiation of treatment; not the result of treatment failure

• Common manifestations (new or worsening):– Adenopathy – Pulmonary infiltrates– Serositis– Cutaneous or CNS lesions (spots)

Page 43: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Paradoxical ReactionWorsening Radiograph

Page 44: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Paradoxical ReactionsImmune Restoration Syndromes

• Three case series: 6-36% occurrence

• Median 15 days after starting ARV therapy

• Most patients have advanced HIV disease– median CD4 cell count of 35 cells/ mm3

– median viral load > 500,000 copies/ml

Page 45: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Paradoxical ReactionsManagement

• Diagnosis of exclusion– Treatment failure, drug toxicity, other infection– Often start treatment for presumed relapse or

reactivation

• Severe reactions– Corticosteroids or– Hold ARV therapy (Controversial)

Page 46: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Extra pulmonary TB Disease

• More common as HIV advances• Be sure to rule out pulmonary disease

• Guidelines recommend 9-12 months in patients with:– Meningeal TB

• Corticosteroids may be useful in some forms of extrapulmonary TB

Page 47: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

Summary of Points1. Latent Tuberculosis Infection (LTBI)1. Latent Tuberculosis Infection (LTBI)

• Rifampin and PZA for 60 doses

NOT RECOMMENDED ANY MORE

2. Active TB Treatment2. Active TB Treatment

• Avoid rifapentine

• Caution with twice weekly rifampin or rifabutin

• Stay calm in the face of immune reconstitution

Page 48: TB Update 2003 Jacqueline Peterson Tulsky, MD with thanks to Charles Daley, MD and Robert Jasmer, MD SF TB control and SFGH Pulmonary Department jtulsky@php.ucsf.edu

TB Update 2003

[email protected]

or

www.cdc.gov/mmwr/

mailto:[email protected]

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