Rationale for Post-Exposure Prophylaxis (PEP)
The Committee recommends the use of highly active antiretroviral therapy (HAART) regimens for all significant-risk occupational exposures when the health care worker (HCW) is evaluated within 36 hours of exposure.
Recording Information Following Occupational Exposure
When an occupational exposure occurs, the following information should be recorded in the HCW's confidential medical record:
- Date and time of the exposure
- Details of the procedure being performed and the use of protective equipment at the time of the exposure
- The type, severity, and amount of fluid to which the HCW was exposed
- Details about the exposure source
- Medical documentation that provides details about post-exposure management
General Management Considerations
Wound and skin sites should be cleansed with soap and water immediately. Exposed mucous membranes should be flushed with water.
PEP is recommended for exposure to blood or visibly bloody fluid or other potentially infectious material (e.g., semen; vaginal secretions; and cerebrospinal, synovial, pleural, peritoneal, pericardial, and amniotic fluids) associated with potential human immunodeficiency virus (HIV) transmission and in any of the following exposure situations:
- Break in the skin by a sharp object (including both hollow-bore and cutting needles or broken glassware) that is contaminated with blood, visibly bloody fluid, or other potentially infectious material, or that has been in the source patient's blood vessel
- Bite from an HIV-infected patient with visible bleeding in the mouth that causes bleeding in the HCW
- Splash of blood, visibly bloody fluid, or other potentially infectious material to a mucosal surface (mouth, nose, or eyes)
- A non-intact skin (e.g., dermatitis, chapped skin, abrasion, or open wound) exposure to blood, visibly bloody fluid, or other potentially infectious material
If HIV serostatus of the source is unknown, voluntary HIV testing of the source should be sought. In New York State, specific informed consent for HIV testing is required.
If rapid blood testing is available on site, it should be used to determine the HIV status of the source patient. Results are usually available within 30 minutes of testing. Rules regarding confidentiality and consent for this testing are identical to those for other HIV tests.
If the preliminary rapid test result is positive, the result should be given to the source patient. To establish a diagnosis of HIV infection, the test must be confirmed by a Western blot assay, which should be performed as soon as possible.
If the result from testing the source patient is not immediately available and PEP is indicated based on assessment, the initiation of PEP should not be delayed pending the test result.
The New York State Department of Health/AIDS Institute (NYSDOH AI) Medical Care Criteria Committee believes that the critical decision point should be to determine whether the HCW has had a percutaneous, mucocutaneous, or non-intact skin exposure to potentially HIV-infected blood, visibly bloody fluid, or other potentially infectious material. For these exposures, prompt initiation of PEP followed by telephone or in-person consultation with a clinician experienced in HIV PEP is recommended.
Implementing PEP
PEP should be initiated as soon as possible, ideally within 2 hours and no later than 36 hours post-exposure. The prescribing provider should ensure that the HCW has access to the full course of antiretroviral (ARV) medications.
HAART is always recommended for at-risk exposures. Any variance from the recommended regimens should be made in consultation with an HIV Specialist or an occupational health clinician experienced in providing PEP (see HIV Specialist Policy in Appendix I of the original guideline document).
ARV medications for PEP should be readily available to HCWs who sustain a known or highly suspect occupational exposure to HIV. In establishing plans for providing PEP, employers should determine the following:
- How PEP will be made available within 1 to 2 hours of an exposure
- How a 24- to 48-hour supply of PEP will be made available for urgent use
- Who will be given authority for releasing drugs for this purpose
- How the HCW will obtain PEP drugs to complete the 4-week regimen (some individuals may be reluctant to go to their local pharmacy)
Confidential baseline HIV antibody testing of the HCW should be obtained at the time the occupational exposure is reported or within 72 hours of initiating PEP.
Confidential HIV testing of the source should be obtained as soon as possible after the exposure. A special consent form for testing the source patient is available and must be used (see Appendix C in the original guideline document).
If the source patient's HIV test result is negative, the HCW should be informed of the small chance that it could be a false-negative result if the source patient has been recently infected. PEP should be recommended in situations when a significant risk exposure has occurred and the clinician suspects that the source patient has a strong likelihood of having recently acquired HIV infection.
If a recommendation to begin PEP is declined, this decision should be documented in the medical record of the HCW.
All patients placed on PEP should be re-evaluated within 72 hours of their exposure. This allows for further clarification of the nature of the exposure, review of available source patient serologies, and evaluation of adherence to and toxicities associated with the PEP regimen.
A total of 4 weeks of treatment is recommended. This treatment duration is based on animal data and is generally recommended by HIV Specialists.
If an HCW presents for evaluation of a high-risk exposure at a time >36 hours after the incident, rather than late initiation of PEP, close monitoring of the HCW for signs and symptoms of acute HIV infection is generally recommended with subsequent introduction of HAART if acute seroconversion occurs (see Figure 1 in the original guideline document, which provides a clinical algorithm for "PEP Following Occupational Exposure").
Recommended PEP Regimens
Clinicians should initiate three-drug ARV therapy for significant occupational exposures to HIV. The preferred PEP regimen is zidovudine 300 mg orally (po) twice a day (bid) + lamivudine 150 mg po bid (or Combivir 1 po bid) plus tenofovir 300 mg po once per day (qd), or Zidovudine300 mg po bid plus Emtricitabine 200 mg po qd + Tenofovir 300 mg po qd (or Truvada 1 po qd). Alternative agents may be used in the setting of drug intolerance or toxicity (see Table 3 and Appendix A in the original guideline document).
The PEP regimen should be continued for 4 weeks.
When the source is known to be HIV infected and information regarding previous ARV therapy, current level of viral suppression, or genotypic/phenotypic resistance profile is available, the clinician, in consultation with an HIV Specialist, should individualize the regimen to more effectively suppress viral replication.
Monitoring the HCW Following Occupational Exposure
Clinicians should closely monitor people receiving PEP to detect ARV-induced toxicities (See the National Guideline Clearinghouse [NGC] summary of the New York State Department of Health [NYSDOH] guideline Antiretroviral Therapy for monitoring recommendations).
Because of the complexity and potential adverse effects of the treatment regimens, longitudinal care of the exposed HCW should be provided either directly by or in consultation with an HIV Specialist or an experienced occupational health clinician who is familiar with the most current PEP guidelines.
Sequential confidential HIV testing should be obtained at baseline, 1, 3, and 6 months post-exposure even if PEP is declined (see Table 4, "Monitoring Recommendations after Initiation of PEP Regimen Following Occupational Exposure Among HCWs" in the original guideline document). In New York State, if the test result is positive, a Western blot assay must be performed to confirm the diagnosis of HIV infection. See Appendices D and E of the original guideline document for specific counseling recommendations.
If the HCW presents with signs or symptoms of acute HIV seroconversion, immediate consultation with an HIV Specialist should be sought for optimal diagnostic testing and treatment options.
The HCW should be evaluated weekly over the first month to assess PEP adherence, adverse effects of the ARV therapy, interval physical complaints, and emotional status. (See the NGC summaries of the NYSDOH guidelines Antiretroviral Therapy, Long-Term Complications of Antiretroviral Therapy, and HIV Drug-Drug Interactions for monitoring recommendations, adverse drug effects, and important drug interactions, respectively).
PEP for the Pregnant HCW
Before administering PEP to a pregnant woman, the clinician should discuss the potential benefits and risks to her and to the fetus. Drugs to avoid during pregnancy include the following:
- Efavirenz
- Combination of stavudine and didanosine
- Unboosted indinavir in the second and third trimester
Based on increasing clinical experience with HAART, PEP is indicated at any time during pregnancy when a significant exposure has occurred, despite possible risk to the woman and the fetus. Expert consultation should be sought. When PEP is indicated, it should be initiated ideally within 2 hours and generally no later than 36 hours post-exposure.
Efavirenz, which has been associated with teratogenicity in monkeys, should not be used in pregnant women.
The combination of didanosine and stavudine should be avoided due to an increased risk of mitochondrial toxicity in pregnant women.
Unboosted indinavir should not be used in pregnant women in the second or third trimester due to a substantial decrease in antepartum indinavir plasma concentrations.
Clinicians should advise women who may have been exposed to HIV through occupational exposure to avoid breastfeeding for 6 months after the exposure.
Occupational PEP for Hepatitis B and C
The hepatitis B vaccine series should be initiated in non-hepatitis B virus (HBV)-immune HCWs who sustain a blood or body fluid exposure.
Administration of prophylactic hepatitis B immune globulin (HBIG) and the initiation of the hepatitis B vaccine series (at different sites) are recommended when the non-HBV-immune HCW sustains a blood or body fluid exposure to a source with known acute or active HBV (see Table below).
Following an occupational exposure, the source patient's HBV and hepatitis C virus (HCV) serologic status should be determined.
If the source patient is known to be HCV-antibody positive or if the serostatus is unknown, baseline HCV serology and serum alanine aminotransferase (ALT) should be obtained from the exposed HCW and should be repeated at 4 to 6 months post-exposure.
If the source patient is known to be HCV-antibody positive, an HCV antibody and qualitative HCV viral load (HCV ribonucleic acid polymerase chain reaction [RNA PCR]) should be obtained from the exposed HCW 4 weeks after exposure.
In the setting of an acute elevation of ALT in the exposed HCW in the first 24 weeks post-exposure, a qualitative HCV RNA PCR should be obtained.
When HCV infection is identified early, the HCW should be referred for medical management to a clinician with experience in treating HCV.
Table
Recommended Post-Exposure Prophylaxis for Occupational Exposure to Hepatitis B Virus |
| Vaccination and/or Antibody Response Status of Exposed Patient* |
Treatment when Source Is: |
| HBsAg Positive |
HBsAg Negative |
Source Unknown or not Available for Testing |
| Unvaccinated/ non-immune |
HBIG (dose 0.06 mL/kg intramuscularly) x 1; initiate HB vaccine series |
Initiate HB vaccine series |
Initiate HB vaccine series |
| Previously vaccinated, known responder** |
No treatment |
No treatment |
No treatment |
| Previously vaccinated, known non-responder** |
HBIG (dose 0.06 mL/kg intramuscularly) x 2 or HBIG (dose 0.06 mL/kg intramuscularly) x 1 and initiate revaccination*** |
No treatment |
If known high-risk source, treat as if source were HBsAg positive |
| Previously vaccinated, antibody response unknown |
Test exposed person for anti-HBs:
- If adequate**, no treatment
- If inadequate**, HBIG x1 and vaccine booster
|
No treatment |
Test exposed person for anti-HBs:
- If adequate**, no treatment
- If inadequate**, initiate revaccination
|
Reprinted from the Updated US Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Post-Exposure Prophylaxis. MMWR Morb Mortal Wkly Rep 2001;50(RR-11):1-42. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5011a1.htm.
HBsAg, hepatitis B surface antigen; HBIG, hepatitis B immune globulin; anti-HBs, antibody to hepatitis B surface antigen.
*Persons who have previously been infected with HBV are immune to re-infection and do not require PEP.
** Responder is defined as person with adequate levels of serum antibody to HBsAg (serum anti-HBs >10mIU/mL); non-responder is a person with inadequate response to vaccination (serum anti HBs <10mIU/mL).
*** The option of giving one dose HBIG and re-initiating the vaccine series is preferred for non-responders who have not completed a second 3-dose vaccine series. For persons who previously completed a second vaccine series but failed to respond, two doses of HBIG are preferred.
