# Presentation: 494489

## Post-Exposure Chemoprophylaxis (PEP) for Bioterrorism-Related Anthrax: Adherence and Adverse Events

**Nancy Rosenstein, M.D.**
**Meningitis and Special Pathogens Branch**
**Centers for Disease Control and Prevention**
**Speaker 3 of 4 for program “CDC Responds: Update on Options for Preventive Treatment for Persons at Risk for Inhalational Anthrax,” broadcast December 21, 2001**

## Anthrax Post-Exposure Chemoprophylaxis (PEP)

- About 10,000 individuals offered 60 days PEP
- Initiated October 8 – November 25, 2001
- 6 sites (FL, DC-postal, DC-Capitol, NJ, NY, CT)
- Primarily occupational exposure (AMI employees, postal workers, congressional staffers)

## Outline of PEP

- Denominators and demographics
- Adherence promotion
- Adherence monitoring
- Adverse events monitoring

## PEP Denominators

|  | 
Recommended | Potentially higher risk |
| --- | --- | --- |
| FL | 1149 | 369 |
| NJ | 1529 | 1529 |
| DC-postal | 2510 | 2510 |
| DC-Capitol Hill | 1200 | 75 |
| NY | 3714 | 1200 |
| CT | 1200 | pending |

## PEP Demographics

|  | FL

(n=435) | NJ

(n=437) | DC-postal
(n=1234) | DC-Capitol
(n=171) | NY

(n=3714) |
| --- | --- | --- | --- | --- | --- |
| Male  | 53% | 66% | 57% | 61% | 57% |
| For women,
    pregnant | 
1% | 
1% | 
1% | 
0% | 
1% |
| Black | n/a | 27% | 74% | 10% | n/a |
| Age <18 yrs | 5% | 1% | 3% | 1% | 1% |
|     18-64 yrs | 90% | 94% | 84% | 95% | 86% |
|     >65 yrs  | 3% | 5% | 2% | 0% | 3% |

## Adherence Promotion Activities

- Distribution of educational materials
- Telephone calls to individuals who did not return for refill medications
- Small group and focus group meetings
- Health fairs
- Individual counseling

## PEP Adherence MonitoringMethods

- Counting individuals returning for refills
- Cross-sectional evaluations
- 7-14 days and 30 days
- Standardized questionnaires
- Self-, nurse-, or telephone-administered
- Participation 50-100%
- Data collection and analysis ongoing

## PEP AdherenceCurrently Taking Antibiotics 

|  | 
10-14d | 
30d |
| --- | --- | --- |
| FL (n= 1000, 435) | 70% | 45%* |
| NJ (n= 1529) | 74% | 67% |
| DC-postal (n= 2437, 1347) | 98% | 88% |
| DC-Capitol Hill (n=369) | -- | 88%^ |
| NY (n= 1786) | 48% | 40% |

- * Adherence among high risk group = 70%
- ^Of 38 of 39 Daschle workers for whom information is available, all report taking PEP

## 30-day Adherence EvaluationNJ and DC-Postal

|  | NJ
(n=980) | DC- postal (n=1347) |
| --- | --- | --- |
| Currently taking antibiotics | 88% | 88% |
| Took all antibiotics yesterday | 78% | 70% |
| Taking antibiotic everyday | 70% | 61% |

## 30-day Evaluation, NJ and DC-Postal, Ciprofloxacin vs Doxycycline

|  | Ciprofloxacin (n=157) | Doxycycline
(n=1722) |
| --- | --- | --- |
| Took all antibiotics yesterday | 74% | 75% |
| Took all antibiotics day before yesterday | 74% | 75% |
| Taking antibiotic everyday | 68% | 65% |

## PEP Adverse Events MonitoringMethods

- Passive surveillance
- Active surveillance
- 7 – 14 day and 30 day evaluations
- Screening questionnaire
- All potentially severe events evaluated
**patient and health care provider interviews**
**medical chart review**
**categorized by FDA criteria**

## PEP Adverse Events, Self-reported, 10-14 days, All Sites

|  | Ciprofloxacin
(n=3856) | Doxycycline
(n=232) |
| --- | --- | --- |
| Severe gastrointestinal symptoms | 19% | 13% |
| Fainting, light-headedness, dizziness | 13% | 7% |
| Heartburn or acid reflux | 6% | 8% |
| Rash, hives, itchy skin | 6% | 5% |
| Required follow-up for adverse events | 2% | 5% |
| Required hospitalization | 0 | 0 |
| Discontinued antibiotics because of adverse events | 3% | 3% |

## PEP Adverse Events, Self-reported, 30 days

|  | Ciprofloxacin
(n=668) | Doxycycline
(n=1876) |
| --- | --- | --- |
| Severe gastrointestinal symptoms | 33% | 45% |
| Fainting, light-headedness, dizziness | 21% | 18% |
| Heartburn or acid reflux | 12% | 13% |
| Rash, hives, itchy skin | 14% | 14% |
| Required follow-up for adverse events | 13% | 12% |
| Required hospitalization | pending | pending |
| Missed doses of or discontinued antibiotics because of side effects | 6% | 12% |

## Future Plans

- End of therapy/60 day program evaluation
- Adherence and adverse events assessed
- Adherence promotion activities and evaluation
- Surveillance for anthrax and adverse events associated with PEP among all exposed groups