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Tuberculosis (TB)

Sherylee Sanchez Santiago

Pharm.D. Candidate 2020

Preceptor:Kalumi Ayala

Objectives

  • Identify the clinical presentation of Tuberculosis

  • Discuss Diagnosis of LTBI and active TB

  • Discuss Pharmacotherapy for this condition (Prophylaxis and Tx)

  • Discuss monitoring and adverse effects of drugs

  • Discuss tx in pt with IRIS and TB

M. tuberculosis

Tuberculosis

  • Caused by Mycobacterium tuberculosis
  • Mode of transmission
  • Inhaled droplet nuclei containing organism
  • Aerolized via person to person (coughing/ sneezing)
  • Ocurrs at ANY CD4 cell count
  • People living with HIV are ~30 times more likely to become sick with TB
  • HIV/TB co-infection
  • Worlwide cases (2016)
  • 10.4 million develep TB
  • 374,000 HIV TB related deaths

Clinical Manifestation

Clinical Manifestations

  • Latent TB
  • Asymptomatic
  • Active TB
  • Presentation may vary depending degree of immunodeficiency

Clinical Manifestation Active TB

  • Most common s/sx:
  • Weight loss, fatigue, night sweats, productive cough, frank hemoptysis
  • Patients with greater degree of immunodeficiency may also develop:
  • Extrapulmonary TB (pleuritis, pericarditis, meningitis, lymphadenitis)
  • High fevers, rapid progression and sepsis syndrome
  • IRIS

Diagnosis of LTBI

Clinical Manifestation Active TB

  • Who should be tested for LTBI?
  • All patients with HIV
  • Testes used:
  • Tuberculin skin test (TST)
  • Interferon-gamma release assay (IGRA)
  • Presence of LTBI:
  • Positive TST
  • IGRAs
  • Rule out active TB
  • Chest radiography
  • Clinical evaluation

DIAGNOSIS OF ACTIVE TB

  • Chest radiography
  • Clinical evaluation
  • Sputum sample for AFB

Diagnosis

LATENT TB INFECTION (LTBI)

PREVENTING DISEASE

Prophylaxis

  • Start prophylaxis treatment if:
  • HIV+ patient tests positive for LTBI and has no evidence of TB disease
  • HIV+ patient in close contact with someone with infectious TB (regardless of LTBI test results)

LTBI: TREATMENT REGIMEN

PREVENTING DISEASE

Prophylaxis

Preferred regimen

  • Isoniazid (INH):
  • 300 mg daily for 9 months
  • 900 mg twice weekly for 9 months- DOT*

Adjunct treatment for INH

  • Pyridoxine 25 mg daily

Alternative regimen

  • Rifapentine(weight based dosing) PO once weekly plus isoniazid 15mg/kg PO once weekly
  • Rifampin (RIF) 600 mg daily for 4 months
  • Rifabutin (RFB) adjust dose base on ART for 4 months

DOT= Directly Observed Therapy

Active TB treatment

  • Start with empiric treatment
  • Multi-drug anti-TB regimen
  • DOT recommended for ALL HIV-related TB
  • 2 phase regimen

Treatment TB

ACTIVE TB: TREATMENT REGIMEN

Treatment

  • Initial phase (2 months):
  • INH + RIF or RFB + pyrazinamide (PZA)+ ethambutol (EMB) daily
  • EMB may be D/C before completion of 2 month regimen if confirmed susceptibility to INH & RIF*
  • Continuation phase (4 months):
  • INH + RIF or RFB daily or 3x/wk

** Duration for pulmonary TB (drug-susceptible)

ACTIVE TB: TREATMENT

Cont.

Total Duration of Therapy:

  • Pulmonary, drug-susceptible TB: 6 months
  • Pulmonary TB & positive culture at 2 months of TB treatment: 9 months
  • Extrapulmonary TB w/CNS: 9 to 12 months
  • Extrapulmonary TB w/bone or joint involvement: 6 to 9 months
  • Extrapulmonary TB in other sites: 6 months

Managing TB therapy pt on ART

Managing TB therapy pt on ART

  • In general:
  • No interaction w/ NRTIs
  • NNRTI, PI, INSTI, CCR5 antagonist interaction (hepatic metabolism)
  • PI-based regimen (unboosted or boosted):
  • RIF contraindicated
  • May use RFB instead (dose adjustments needed)
  • Cobicistat-containing regimens
  • RIF contraindicated

Rifamycin class has many interactions

Managing TB therapy pt on ART

Cont.

  • NNRTIs-based regimen:
  • RIF:
  • DOR, ETR, NVP, RPV- AVOID w/ RIF
  • May use with EFV- no dose change needed of EFV
  • RFB:
  • DOR: increase DOR to 100 twice daily
  • EFV: increase RFB to 450-600 mg daily; RFB 600 mg 3 times/week if EFV is not coadministered with a PI
  • RPV- increase RPV to 50 mg once daily

Managing TB therapy in patient on ART

IntrodManaging TB therapy pt on ART uction

  • CCR5-containing regimen:
  • RIF: increase MVC to 600 mg BID
  • INSTI-containing regimen:
  • RIF:
  • Increase RAL to 800mg BID (Do not coadminister with RAL 1200 mg daily)
  • Increase DTG to 50 mg BID (without INSTI mutations)
  • EVG/COBI/TDF or TAF/FTC- RIF contraindicated
  • BIC/TAF/FTC: RIF contraindicated
  • RFB
  • EVG/COBI/TDF or TAF/FTC: Do not coadminister w/ RFB
  • BIC/TAF/FTC: Do not coadminister with RFB

Initiating ART in Patients with TB

Potencial Issues:

Potencial Benefits:

  • Adherence issues
  • Multidrug therapy for HIV & TB
  • Drug-drug interaction
  • Overlapping side effects
  • Risk for IRIS

Managing TB therapy in patient on ART nt

  • Survival improvement
  • Decrease risk for other OIs
  • Achieve viral suppression
  • Improve TB treatment

outcomes

ARV Naive and active TB What should we do?

Active TB

Start TB tx immediately

ARV Naive and active TB What should we do?

CD4+ <50

CD4+ >50

Start ART within 2 weeks of TB treatment

Start ART within 8- 12 weeks of TB treatment

Monitoring

Monitoring

  • Response to therapy
  • Monthly sputum smear and culture
  • Other monthly labs:
  • CBC, Chem panel (LFTs, Creatine)
  • At every visit: evaluate patient’s adherence
  • Monitor for ADRs of anti-TB regimen
  • hepatotoxicity, gastrointestinal side effects, rash
  • IRIS

Patient with IRIS and TB

IRIS and TB

  • IRIS symptoms may begin
  • 1-4 weeks after starting ART (may last 2-3 months)
  • Risk factors for IRIS:
  • Low CD4 count at start of ART (<100 cells/μL)
  • High HIV viral load prior to ART
  • Disseminated or extrapulmonary TB
  • Starting ART within first 1-2 months of TB therapy
  • Difficult to distinguish IRIS from
  • Worsening TB
  • Treatment failure
  • New infection
  • ADRs

Patient with IRIS and TB Management

IRIS and TB

  • Management of IRIS
  • Mild IRIS
  • Treat according to symptoms
  • NSAIDs
  • Moderate-to-severe IRIS
  • Consider corticosteroids:
  • More rapid improvement seen,
  • No mortality benefit in non-CNS TB IRIS
  • Decreased mortality in CNS TB IRIS
  • Taper corticosteroids over 4 weeks or longer
  • Continue TB therapy
  • Continue ART if possible (unless life threatening IRIS)

References:

References

  • Nahid P, Dorman SE, Alipanah N, et al. Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment of Drug-Susceptible Tuberculosis. Clin Infect Dis 2016; 63:e147.
  • Panel on Opportunistic Infections in HIV-Infected Adults and Adolescents. Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: Recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. http://aidsinfo.nih.gov/contentfiles/lvguidelines/adult_oi.pdf (Accessed on Nov 16, 2019).
  • Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/AdultandAdolescentGL.pdf.
  • World Health Organization. Guidelines for treatment of drug-susceptible tuberculosis and patient care, 2017 update. http://apps.who.int/iris/bitstream/10665/255052/1/9789241550000-eng.pdf?ua=1 (Accessed on Nov 16, 2019).
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