UMHS Employee Health Service/Emergency Department Policy
Chemoprophylaxis after occupational exposure to HIV
Purpose:
To provide a standard of care for health care workers with occupational exposure to HIV.
Rationale:
The primary method of protecting health care workers from exposure to HIV should be prevention of exposure. Safety devices, safe practices and when feasible, immunization, should be used to the fullest extent possible to avoid exposure to any bloodborne pathogen, including HIV.
Demonstration of effectiveness of post exposure prophylaxis for HIV has been hampered by the low risk of transmission of HIV through the occupational route (approximately 0.3%) as well as by difficulties with incomplete reporting of exposure incidents, lack of standardization of treatment regimens and little data on outcomes. In December 1995, the CDC published results of a case-control study of HIV seroconversion in healthcare workers after percutaneous exposures to HIV infected blood. This was a cooperative study from France, United Kingdom and the United States conducted on exposures from January 1988-August 1994.
This study demonstrated that the risk of seroconversion following occupational exposure was related to certain factors of the exposure and the source patient, and that postexposure use of zidovudine was associated with a lower risk for HIV transmission.
Factors associated with transmission included a deep injury, device visibly contaminated with the source patient's blood, procedures involving a needle placed directly in a vein or artery, and terminal illness in the source patient. This would imply that the risk is directly related to volume of blood and titer of HIV in the source blood. In addition, the use of zidovudine was associated with decreased transmission (adjusted odds ratio 0.2). Because of the small number of transmission cases, efficacy of various doses of zidovudine could not be determined.
Studies on transmission in animals suggest that effectiveness of zidovudine is related to time of administration after exposure and prompt administration (preferably within hours) is recommended.
Only the short term toxicity of zidovudine can be assessed from studies of healthcare workers using postexposure prophylaxis. These toxicities are primarily gastrointestinal effects, headache, fatigue and insomnia. Other side effects reported include anemia, neutropenia, thrombocytopenia and muscle inflammation. HIV drugs are not approved by the Food and Drug Administration at this time for postexposure prophylaxis.
The effectiveness of zidovudine post exposure prompted the Public Health Service to update the previous recommendations which did not endorse or oppose use of zidovudine prophylaxis. The new recommendations were published in the June 7, 1996 issue of the MMWR. To address the issue of zidovudine resistance and the emerging data of the added effectiveness of multi-drug regimens in treating HIV infection, the new recommendations include multi-drug regimens. It should be understood that decisions regarding chemoprophylaxis are based on risk-benefit considerations that are derived from incomplete data. Protocols are updated as further information or drugs become available. These recommendations are for exposures to known HIV infected blood/body fluids. Exposures from unknown HIV status material must be evaluated individually and prophylactic treatment recommended only if the risk of exposure is felt to be substantial and greater than the risks of treatment.
Policy:
- All exposures will be evaluated on an emergent basis. Employees will be instructed to use pager #5356 to report all exposures.
Eligibility for Prophylaxis: Chemoprophylaxis will be offered for percutaneous or mucous membrane exposures to HIV positive blood or fluids containing visible blood or other infectious fluids or tissue, which includes semen, vaginal secretions, cerebrospinal fluid, synovial, pleural, peritoneal, pericardial and amniotic fluids. Percutaneous includes exposure to non-intact skin, prolonged skin contact or spill over large area that might occur in a laboratory setting. Chemoprophylaxis for exposure to source with unknown HIV status will be determined on a case-by-case basis. Physicians in the ED and Nurse Practitioners/Physicians in EHS will recommend prophylaxis based on the likelihood of source infection and the type of exposure. When additional information becomes available, prophylactic treatment should be reviewed.
- Chemoprophylaxis will be initiated as soon as possible; preferably within two hours of exposure.
- If more than 36 hours has elapsed since exposure, chemoprophylaxis will be initiated only after consultation with the Hospital Epidemiologist or designee (Infectious Disease fellow on-call).
- Any deviation in chemoprophylaxis regimen should be discussed with the Hospital Epidemiologist or designee prior to treatment.
- If an employee suspects or knows that she is pregnant or breastfeeding, chemoprophylaxis will be initiated only after consultation with the employee's primary obstetric provider and pediatrician.
- Informed consent will be signed prior to initiation of chemoprophylaxis. This includes counseling for HIV testing, discussion of drug toxicities, follow up evaluation and safe sex guidelines.
- Declining recommended treatment will not affect the employee's work status or continued post- exposure follow up.
- The employee will be seen in EHS for follow up once weekly for the 4 weeks of treatment and at 6 weeks, 3 months and 6 months following exposure. CBC, creatinine, amylase, liver function tests and urinalysis will be done at baseline and at 2 weeks, and at end of treatment. Coded (anonymous) HIV testing will be done at baseline; at the 6 week, 3 month and 6 month visits. A 12 month post-exposure evaluation will be done if specific circumstances warrant per EHS Medical Director or Hospital Epidemiologist.
- Due to the complexity of selection of HIV PEP regimens, consultation with persons having expertise in antiretroviral therapy and HIV transmission will be obtained.
Additional resources:
PEPline resource:
PEPLine telephone 888-448-4911 - Weekly visits during drug treatment phase will include history for symptoms related to HIV infection or specific drug toxicities, directed physical exam as dictated by symptoms and assessment of psychological status. Employees with psychological concerns will be referred to MWorks EAP. Drug regimen may be altered if side effects warrant.
Procedure:
- Employee reports exposure to EHS by paging 5356.
- EHS/ED nursing staff will gather the initial information from the exposed employee, including name, registration number, location and service of source, circumstances of exposure, type of sharp or splash, type of body fluid as well as any known HIV or Hepatitis B/C infection in source. Nursing staff will check the computer for any HIV or Hepatitis serologies on the source.
- EHS/ED nursing staff will ascertain, from the exposed employee, the physician or nurse taking care of the patient or by chart review, whether there are factors that would put the source into a higher risk category for HIV or Hepatitis infection.
- EHS/ED nursing staff will page the phlebotomy supervisor with information regarding source location, and request AHIV, Hepatitis B Surface Antigen (HBSAG) and Hepatitis C Antibody (HCAB) to be drawn stat and if possible, set up for the day's AHIV run or for the rapid assay, if available. If patient is outpatient (other than outpatient surgery or ED), outpatient consent includes provision for AHIV testing in the event of an exposure.
- EHS/ED will counsel employee on the risks and benefits of post-exposure prophylaxis based on the information currently available. Consent for treatment is signed.
- Bloods drawn prior to initiation of treatment: AHIV (coded), CBC, ALT, AST, amylase, alkaline phosphatase and creatinine. Stat urine pregnancy test will be performed on women of childbearing potential. Coded AHIV and lab work required prior to initiation of treatment will not be drawn in ED, but will be drawn at first opportunity at EHS.
- Chemoprophylaxis regimen is as follows: Combivir (Zidovudine 300 mg/Lamivudine 150 mg) two times a day. Duration of treatment is 4 weeks. A protease ihnibitor, Kaletra (400 mg Lopinavir/100 mg Rotinavir) two times per day (dosage form is 200 mg Lopinavir/50 mg Rotinavir per tablet), may be added to the regimen for large volume exposures and/or high titer of HIV and/or drug resistance. Consultation with Hospital Epidemiologist or designee (ID fellow on call), can be obtained on a case by case basis. ED will give employee prescription or medication supply to last for three days or until EHS is available. EHS will give first dose of medications during initial visit and prescription for two weeks of treatment. Prescription for second 2 weeks will be given at week two follow up visit. Workers' Compensation designation should be written on prescriptions. EHS will arrange for employee to be registered with the supplying pharmacy to receive the four week supply of Kaletra.
- If initial call is to ED, employee will be told to report to EHS on the next business day. ED will fax exposure data form to EHS (763-7405) where it will be reviewed.
- Protocols whenever CDC publishes updated recommendations or per recommendation of Hospital Epidemiologist. Most recent revision of protocol per MMWR 9/30/05.
For more information on Infection Control's Bloodborne Pathogens Exposure Control Plan.
