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Rationale for Additional Post-Exposure Prophylaxis Options

Rationale for Additional Post-Exposure Prophylaxis Options. Bradley A. Perkins, M.D. Meningitis & Special Pathogens Branch, Division of Bacterial and Mycotic Diseases, NCID, CDC

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Rationale for Additional Post-Exposure Prophylaxis Options

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  1. Rationale for Additional Post-Exposure Prophylaxis Options Bradley A. Perkins, M.D. Meningitis & Special Pathogens Branch, Division of Bacterial and Mycotic Diseases, NCID, CDC Speaker 1of 4 for program “CDC Responds: Update on Options for Preventive Treatment for Persons at Risk for Inhalational Anthrax,” broadcast December 21, 2001

  2. Additional Options for Those Exposed to Bacillus anthracis spores • Earlier Recommendation - 60 days of antibiotics + medical monitoring • Additional Option 1 - 40 additional days of antibiotic treatment + medical monitoring • Additional Option 2 – 40 additional days of antibiotic treatment + 3 doses of anthrax vaccine over 4 weeks + medical monitoring

  3. Advisory Committee on Immunization Practices (ACIP) Recommendations • “Use of Anthrax Vaccine in the US: Recommendations of the [ACIP]” MMWR, December 15, 2000 • Post-exposure prophylaxis (PEP) is recommended following aerosol exposure to B. anthracis spores • Antibiotics > 30 days if used alone, & longer therapy (up to 42 to 60 days) might be indicated • If anthrax vaccine is available, antibiotics can be discontinued after 3 doses of vaccine (0, 2, and 4 weeks)

  4. Epidemiologic Investigations 5. Oxford, CT – 11/20 2. New York City – 10/12 4. Trenton, NJ – 10/17 3. Washington, DC – 10/15 1. Palm Beach County – 10/3

  5. Public Health Decisions, Actions, & Options Regarding Post-Exposure Prophylaxis • Investigational new drug (IND) application filed with FDA to use anthrax vaccine for PEP • 60 days of antibiotics recommended for PEP • ACIP re-convened & endorsed routine use of 60 days of antibiotics for PEP • 217,000 doses of anthrax vaccine obtained by DHHS from DoD • ACIP encourages provision of anthrax vaccine under IND to exposed persons

  6. Inhalational Case NYC NJ FL DC Bioterrorism-associated Anthrax: Inhalational and Cutaneous Cases CT inhalational anthax case, date of onset - 11/14 Senator envelopes 10/9* NYC envelopes 9/18* 5 4 3 Cases 2 1 0 9/17 9/21 9/25 9/29 10/3 10/7 10/11 10/15 10/19 10/23 10/27 Date of Onset *Postmark date of known contaminated envelopes

  7. Post-Exposure Prophylaxis for Prevention of Inhalational Anthrax • Approximately 10,000 individuals recommended to take 60 days of antibiotic therapy • Initiated October 8 – November 25, 2001 • Primarily occupational exposures (media outlets, postal workers, congressional staffers)

  8. Key Non-Human Primate Studies • Henderson DW, Peacock S, Belton FC. Observations on the prophylaxis of experimental pulmonary anthrax in the monkey. J Hygiene 1956;54: 28-36. • Aerosol challenge: 4 & 8 LD50 (1LD50=50,000 spores) • Friedlander AM, Welkos SL, Pitt ML, et al. Postexposure prophylaxis against experimental inhalational anthrax. J Infect Dis 1993;167: 1239-42. • Aerosol challenge: 8 LD50

  9. Henderson DW, Peacock S, Belton FC. Observations on the prophylaxis of experimental pulmonary anthrax in the monkey. J Hygiene 1956; 54: 28-36.

  10. Henderson DW, Peacock S, Belton FC. Observations on the • prophylaxis of experimental pulmonary anthrax in the monkey. J Hygiene 1956; 54: 28-36.

  11. B. anthracis Spore Clearance • Data adapted from Henderson DW et al J Hygiene 1956; 54: 28-36.

  12. Survival Friedlander AM, Welkos SL, Pitt ML, et al. Postexposure prophylaxis against experimental inhalational anthrax. J Infect Dis 1993;167: 1239-42.

  13. Senator Daschle & Leahy Envelopes: Postmarked 10/9/01

  14. Risk Assessment of Anthrax Threat Letters* • Feb-April, 2001 @ Defence Research Establishment Suffield (DRES), Canada • Weapons-grade B. globigii spores used to simulate an envelope release of B. anthracis • 18x10x10 foot “office-size” chamber for release • Extensive sophisticated aerosol sampling • Estimated 480-3,080 LD50s in 10 min exposure

  15. Conclusions • Among persons with heavy exposures to B. anthracis spores, 60 days of antibiotics alone may eliminate risk for inhalational anthrax • Additional antibiotics, or antibiotic & vaccine, may benefit persons who remain at risk for inhalational anthrax after 60 days of antibiotics alone

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