Chemoprophylaxis After Occupational Exposure to HIV
To provide a standard of care for health care workers with occupational exposure to HIV.
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 HIV 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 effectiveness of post exposure prophylaxis in this study, the CDC published recommendations regarding post exposure propyhlaxis on June 7, 1996.
Studies on transmission in animals suggest that effectiveness of zidovudine is related to time of administration after exposure; therefore prompt administration (preferably within 2 hours) is recommended. Assessment of toxicities of antiretroviral medications medications used for post exposure prophylaxis is limited to short term adverse effects and the regimens chosen for prophylaxis are assessed for tolerability. HIV drugs are not approved by the Food and Drug Administration at this time for occupational exposure prophylaxis.
To address the issue of antiretroviral resistance and to optimize treatment efficacy, current HIV guidelines recommend combination antiretroviral regimens for HIV treatment. Thus, the most recent US Public Health Service Guidelines for the management of occupational exposures to HIV recommend three drug regimens for post exposure prophylaxis. 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 on a case by case basis, and prophylactic treatment recommended only if the risk of exposure is felt to be substantial and greater than the risks of treatment.
- All exposures will be evaluated on an emergent basis. Employees will be instructed to use pager # 5356 to report all exposures. When OHS is closed the beeper is transferred to the appropriate ED staff.
- 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 Clinic Nurse /Nurse Practitioners /Physicians in OHS 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 an Infectious Disease specialist or designee (Infectious Disease fellow on-call).
- In some instances the source patient may have resistance to antiretroviral medications and treatment for the exposed employee may be modified. The exposure should be discussed with an Infectious Disease specialist: the source patient’s UMHS treating physician, Dr. Tejal Gandhi, or a designee (Infectious Disease Fellow on-call) before starting treatment. If any deviation in chemoprophylaxis regimen is recommended the employee will be referred to an Infectious Disease Specialist for the duration of the chemoprophylaxis treatment. Diseases consultation will also be necessary in the following situations: Delayed exposure report, unknown sources, known or suspected pregnancy in the exposed employee, breast-feeding in the exposed employee, toxicities of the initial PEP regimen, and serious medical illness in the exposed employee (e.g renal disease) or if the exposed employee is taking multiple medications. The Infectious Diseases physician may need to review the employee’s and the source patient’s medical records when consulting on a case.
- 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, an Infectious Disease Specialist and pediatrician and after risks and benefits of prophylaxis are reviewed. Urine pregnancy testing should be performed on all women of child bearing potential when initiating treatment.
- 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 OHS 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, glucose, BUN, liver function tests and urinalysis if indicated will be done at baseline and weekly until the end of treatment. Coded (anonymous) HIV testing will be done at baseline and at the 6 week, 3 month and 6 month visits. A 12 month post-exposure evaluation will be done if specific circumstances warrant per OHS Medical Director or Infectious Disease Specialist. Extended HIV follow-up for 12 month is recommended for employees who become infected with Hepatitis C after exposure to a source patient with HIV and Hepatitis C.
- 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. Drug regimen may be altered if side effects warrant. Employees with psychological concerns will be referred to UM-HS EAP.
- Employee reports exposure to OHS by paging 5356. When OHS is closed the beeper is forwarded to the ED follow-up staff.
- OHS/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.
- OHS/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.
- OHS/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 run per laboratory policy, including an AHIV for the rapid assay (RHIV), 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.
- OHS/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, BUN, creatinine and glucose. Standard urinalysis will be obtained. Stat urine pregnancy test will be performed on women of childbearing potential. AHIV should not be drawn in ED, but will be drawn at first opportunity at OHS.
- Chemoprophylaxis regimen is as follows: Truvada (Tenofovir 300mg and Emtricitabine 200mg) one tablet daily and Raltegravir 400 mg bid. ED will give medication supply to last for three days or until OHS is available. If not already provided in the ED, OHS 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 the week two follow up visit. Workers’ Compensation designation should be written on prescriptions. OHS will review the prophylactic antiretroviral regimen with the UMHS HIV specialist who is providing care to the source patient to ensure absence of resistance to the standard chemopropylaxis.
- If initial call is to ED, employee will be told to report to OHS on the next business day. ED will fax exposure data form to OHS (763-7405).
- Protocols will be reviewed whenever CDC publishes updated recommendations or per recommendation of Infectious Disease Specialist. Most recent revision of protocol per U.S. PHS guideline published in Infection Control and Hospital Epidemiology August 2013.
- OSHA Regulations (Standards - 29 CFR) Bloodborne pathogens. - 1910.1030 (osha-slc.gov/OshStd_data/1910_1030.html) and Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens (osha-slc.gov/OshDoc/Directive_data/CPL_2-2_44D.html)
- Centers for Disease Control and Prevention. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HBV,HCV, and HIV and recommendations for postexposure prophylaxis. MMWR 2001; 50 (RR-11): 1-52.
- Centers for Disease Control and Prevention. Updated U.S. Public Health Service guidelines for the management of occupational exposure to HIV and recommendations for postexposure prophylaxis. MMWR 2005: 54 (RR09):1-17.
- Updated United States Public Health Service guidelines for management of occupational exposure to HIV August 2, 2013