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Post Exposure Prophylaxis

  1. OBJECTIVE/PURPOSE:

    To standardize medical care following a Blood or Bodily Fluid Exposure (BBFE)

  2. SCOPE:

    All Exposed Individuals (as defined below) who present for post-exposure management of BBFEs

  3. DEFINITIONS:
    1. ART - Antiretroviral treatment
    2. BBFE (Blood or Bodily Fluid Exposure) - Any percutaneous (puncture or cut through skin), mucosal (e.g. eyes or mouth) or non-intact dermal (e.g. abraded skin, chapped skin or dermatitis) exposure to blood or a potentially infectious bodily fluid of another individual (“source”).
    3. Source Individual - the person whose blood or bodily fluid was the source of the exposure.
    4. Exposed Individual - for the purpose of this policy, an exposed individual shall refer to any individual occupationally exposed to blood or potentially infectious bodily fluid of another individual. 
    5. HBV – Hepatitis B Virus
    6. HCV – Hepatitis C Virus
    7. HIV – Human Immunodeficiency Virus
    8. Potentially Infectious Bodily Fluid - Blood, tissue, visibly bloody fluids, semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, amniotic fluid and inflammatory exudates are considered potentially infectious materials for HIV, HBV and HCV.  Materials which are not considered potentially infectious for HIV, HBV and HCV include feces, urine, nasal secretions, saliva, sputum, sweat, tears and vomitus, unless these materials are visibly bloody. Any direct contact (i.e., contact without barrier protection) to concentrated virus in a research laboratory/production facility or direct contact with a cadaveric specimen from a patient known to be infected with HIV, HBV and HCV or patient with unknown infection status requires clinical evaluation.
  4. POLICY:
    1. Upon presentation for post-exposure management of a BBFE, the risk of exposure will be assessed considering the nature and severity of the exposure and the risk level of the source of the blood or bodily fluid.  The exposed individual will be appropriately counseled, with care provided according to CDC guidelines and current medical practices, and shall be offered post-exposure prophylaxis if clinically indicated.
    2. Attempts will be made to rapidly identify and test the source patient for HIV, HBV and HCV.  If HIV positive, attempts will be made to determine the history of antiretroviral drug treatment and/or prior genotypic antiretroviral resistance testing (GART). 
    3. Baseline testing of the exposed individual will be performed for HIV, HBV and HCV.  Consent (either verbal or written) for HIV testing must be documented in the medical record.  DMC healthcare workers found to be infected with any of these agents will be subject to the DMC HIV/HBV/HCV Infected Healthcare Worker Policy (1 CLN 023).  Those found to be infected on baseline will be referred to their personal physician for management. 
    4. Informed consent will be obtained prior to testing or treatment. The DMC General Consent for Admission and Treatment forms for both inpatient and outpatient provide adequate consent for source individual HIV testing. 
    5. An infectious disease consultation and/or second level counseling by an infectious disease expert shall be arranged whenever indicated.
  5.  PROVISIONS:
    1.  All DMC employees with BBFEs must complete an incident report and report to their designated DMC OHS clinic (or service providing back up coverage for DMC OHS after hours such as nursing administrator or emergency department) for post-exposure management. 
    2. Exposed individuals whose initial visit was not at their designated DMC OHS clinic must report to the DMC OHS clinic as soon as possible within 72 hours following the incident.
    3. Infectious Disease Specialist consultation may be obtained by the treating provider when clinically indicated by paging the on-call BBFE consultant at DMC pager 4052 for DMC Central Campus, DMC Pager 2312 for Sinai-Grace Hospital, and 248-937-3607 for Huron Valley Hospital.  Alternatively, expert consultation can be obtained from the National Post-Exposure Prophylaxis hotline (PEPLine) at 888-448-4911.  However, the PEPLine will not have access to historic information on source patients that may be treated by the DMC infectious diseases clinic.
    4.  Post-Exposure Management for HIV:
      1. Risk Assessment:  Risk for transmission of HIV shall be assessed based upon the exposure material (type of potentially infectious material), the type and severity of exposure, and the source status.  The following provide general guidelines for categorizing risk, recognizing that some situations may fall between categories and will require clinical judgment.  Consultation with an infectious disease expert shall be sought whenever the clinician is in doubt. 
        1. Sharp (e.g. needlestick or other sharp object) percutaneous exposures are considered less severe when the puncture is superficial or results from a solid needle.  Exposures are considered more severe when the exposure involves a large bore needle, a deep puncture wound, the needle has been in an artery or vein of the source patient, or there is visible blood on the device.
        2. Source status shall be classified as follows:
          1. HIV positive.
          2. HIV negative but source individual is at high risk for recent seroconversion or has symptoms consistent with acute retroviral syndrome
          3. Known source; status unknown; no known HIV risk factors
          4. Known source; status unknown; known HIV risk factors
          5. Unknown source; not a setting in which exposure to HIV infected persons is likely
          6. Unknown source; setting in which exposure to HIV infected persons is likely
      2. Source Testing – Following a BBFE, source patient testing shall include a rapid HIV test in order to facilitate decision-making regarding ART.  If the source has symptoms of acute retroviral syndrome, or is considered to be at high risk for recent exposure, PCR testing for HIV virus should be performed.
      3. Counseling of the individual potentially exposed to HIV shall include:
        1. Risk of occupational exposure based on up to date epidemiologic information from the CDC.  Currently, the risk of HIV transmission following a typical percutaneous needlestick exposure is believed to be approximately 0.23% (about 2 per 1,000).  The risk for a typical mucosal exposure is believed to be near zero.  The risk for a typical exposure to non-intact skin is believed to be less. 
        2. Prevention of secondary transmission to others shall be discussed, including safer sex practices, and the need to avoid blood or tissue donation, pregnancy and breast feeding, especially during the first 6 to 12 weeks following exposure. 
        3. Modifications to an exposed individual’s patient-care responsibilities are not necessary based upon the exposure incident.
        4. Safe work practices and prevention of future exposure.
        5. The benefits and side effects or risks of antiretroviral therapy (ART) for the prevention of HIV transmission based upon up to date information from the CDC.  The counseling should include the following:
          1. Studies suggest that ART may reduce risk of HIV transmission by as much as 80%.  As of the publication of the June 29, 2001 MMWR, while many persons have taken ART following BBFE, there have only been 21 cases worldwide of individuals who developed HIV infection despite taking ART (please note that only 3 of these cases received > 3 drugs for PEP).
          2. Known side effects, risks and potential drug (and herbal agent) interactions with ART.  This consideration is especially important for individuals who will be placed on a protease inhibitor.  Such drug interactions may be serious or even life-threatening in some cases.  The provider should refer to Appendix 2 and drug packet inserts or consult with a pharmacist when indicated.  The individual receiving ART should be advised that evaluation of certain new, severe symptoms should not be delayed.  ART drugs most commonly used today (Truvada and Isentress) are much better tolerated than drugs used in the past (such as Combivir and Kaletra).
          3. Individuals taking ART who rely upon oral contraceptives must be advised to use supplemental contraception, as  certain prophylaxis regimens may impair the effectiveness of oral contraceptives. 
          4. There may be yet unknown side effects of these medications.  Data regarding the long-term effects in otherwise healthy persons, including mutagenesis, carcinogenesis, teratogenesis, and fertility are lacking or inadequate. 
      4. Consultation with and/or counseling by an Infectious Disease Expert  (see provision 3 above for telephone numbers) shall be arranged when:
        1. Individual is pregnant or breastfeeding (starting PEP, however, should not be delayed while awaiting consultation).
        2. Source is known HIV positive and is or has been on ART, or has had genotypic antiretroviral resistance testing (GART) performed, or there is any other reason to suspect resistance of the source virus to ART agents.  Note that the DMC ID specialist may have access to the “NexGen” database which has data on HIV patients being followed by the ID department.  Starting PEP should not be delayed, however, pending investigation of resistance. 
        3. Individual has a pre-existing medical condition which may increase the risks associated with ART (e.g. renal or hepatic disease, bone marrow suppression or disorder).
        4. Individual is taking a drug or herbal remedy (such as St. John’s Wort) that may interact with ART.
        5. Acute retroviral syndrome or HIV seroconversion is suspected in the source (starting PEP, however, should not be delayed while awaiting consultation).
        6. Initial presentation is delayed (over 72 hours from time of BBFE).
        7. Side effects of ART might require altering the ART regimen.
        8. Either the treating clinician or the patient have questions which would be best answered by such a consultation.     
        9. when the source is unknown (e.g., needle in sharps disposal container or laundry).
      5. Treatment with ART
        1. When ART is offered, treatment must begin as soon as possible (preferably within 2-4 hours of exposure).  The ART regimen may be subsequently discontinued or changed to a different regimen if additional data collected changes the recommendation.  The patient should be offered the option to begin the first doses of ART even while pending the results of source testing, especially when testing delays are anticipated. 
        2. ART will be recommended and/or offered to the exposed individual for Post-Exposure Prophylaxis (PEP) according to the following guidelines.  ART is to be provided for 28 days.  It is recognized that clinically justified deviations may occur.
          1. No ART will be provided without counseling and informed consent.  The individual must agree to compliance with treatment monitoring and the HIV testing protocol. 
          2. All females of reproductive capacity will undergo a rapid pregnancy test, and if pregnant, the case will be discussed with an infectious disease expert. However PEP should not be delayed while awaiting consultation.  Breastfeeding women will be encouraged to discontinue breastfeeding for at least 6 weeks.  The use of ART in pregnant women should be reported to the National Antiretroviral Pregnancy Registry (www.APRegistry.com). 
          3. If the exposed individual is either known to be positive for HIV or tests positive for HIV on baseline testing, then he or she will be referred to his or her personal physician, and will not be treated with chemoprophylaxis. 
          4. Drugs taken by the exposed individual, including over the counter and herbal remedies, and drug allergies will be documented, and consideration be given to known drug interactions prior to beginning ART.
          5. Sharps Exposures shall be managed based upon the following 3 categories of recommendation:
            1. ART not indicated - ART will not be offered by the provider.  Circumstances in which ART is not indicated include:
              1. HIV antibody negative source, unless source is at high risk for recent seroconversion or has symptoms of acute retroviral syndrome.
              2. No exposure (e.g. intact skin, needle not contaminated with blood or potentially infectious material)
            2. ART is Optional–ART may be elected at the option of the exposed individual.  Circumstances include:
              1. Known source; Status unknown; No known risk factors
              2. Unknown source; Setting not likely for HIV infected individuals
            3. ART is Recommended. Circumstances include:
              1. HIV positive source
              2. Source at risk for recent seroconversion, or has symptoms of acute retroviral syndrome
              3. Known source; Risk factors for HIV
              4. Unknown source; Setting is likely for HIV infected individuals
            4. Splash Exposures shall be managed based upon the following 3 categories of recommendation:
              1. ART not indicated - ART will not be offered by the provider if the source is known to be HIV negative and not at high risk, or if the splash is merely to the intact skin surface. 
              2. ART is Optional - ART may be elected at the option of the exposed individual.  Circumstances include:
                1. Small volume; Known source; Status unknown
                2. Large volume; Known source; Status unknown, but no known risk factors
                3. Small volume; Unknown source
                4. Large volume; Unknown source; Setting not likely for HIV infected individuals
              3. ART is recommended.  Circumstances include:
                1. HIV positive source
                2. Source at risk for recent seroconversion, or has symptoms of acute retroviral syndrome
                3. Large volume; Known source; Status unknown; Risk factors for HIV present
                4. Large volume; Unknown source; Setting is likely for HIV infected individuals
      6. Selection of ART agents – The exposed individual should be started on the following standard preferred regimen: Truvada (tenofovir 300 mg plus emtricitabine 200 mg) 1 tablet daily and either Isentress (raltegravir 400 mg) one tablet twice a day or Tivicay (dolutegravir 50 mg) once per day (unless other agents are clinically indicated due to medical condition (renal failure (dose adjustments) or other relevant history, source history of ART treatment, genotypic antiretroviral resistance testing (GART), drug allergies). Alternative regimens may be found per the US Public Health Services Guidelines or discussed with the ID physician on call for BBFE.
      7. Monitoring ART toxicity – Upon beginning ART, baseline tests shall include a CBC, a blood chemistry panel which includes hepatic and renal function tests, urinalysis, and  blood glucose.  Testing shall be repeated and reviewed by the physician two weeks following the initiation of ART.  Additional toxicity testing may be ordered by the physician as clinically indicated.  Symptoms will be reported to the physician, who will provide treatment as clinically indicated.  Blood glucose will be monitored weekly for women who are pregnant and receiving protease inhibitor based prophylaxis which is usually preferred during pregnancy. .  The patient should be informed of symptoms to watch for and report without delay (rash, fever, back or abdominal pain, painful urination, bloody or dark urine, jaundice, and symptoms of hyperglycemia - frequent urination/thirst). 
      8. Medication intolerance – If the exposed individual is experiencing ART side effects, agents should be offered to ameliorate the symptoms (e.g. antiemetics, analgesics, antispasmodics).  If there is medication intolerance to the extent that compliance may be compromised, an infectious disease expert shall be consulted to consider modifications to the ART regimen.
      9. Follow up HIV Testing – Follow-up of the exposed individual should be arranged within 72 hours regardless of whether they are started on PEP or not since additional information on exposure and source patient may be available.  In addition to the baseline HIV test, the exposed individual will be tested for HIV at 6 weeks, 12 weeks and 6 months. If a provider is using 4th generation HIV Ag/Ab HIV testing can be concluded in 4 months rather than 6 months.  If the source was positive for both HCV and HIV, and the exposed individual becomes HCV positive but not HIV positive, then HIV testing will also be performed at 12 months.  If the exposed individual should develop an illness compatible with acute retroviral syndrome, then HIV testing will be repeated regardless of the interval since exposure. 
      10. Any exposed individual who is confirmed positive for HIV infection on baseline testing will be referred to his or her personal physician.  Any individual who is confirmed positive for HIV infection on follow up testing will be referred to a specialist knowledgeable in the management of HIV infection.
    5. Post-Exposure Management for Hepatitis B (HBV):
      1. Risk Assessment:  Risk for transmission of HBV shall be assessed based upon the exposed individual’s immunity status, exposure material (type of potentially infectious material), the type and severity of sharp or splash exposure, and the source status. 
      2. Hepatitis B Immunity:  The exposed individual’s immunity to Hepatitis B will be evaluated by a review of documentation and/or testing whenever a BBFE occurs.  Individuals who have both completed the full vaccine series and have a documented adequate anti-HBs (Hepatitis B surface antibody) titer will be considered immune, and will not require additional testing or prophylactic treatment.  Those with documentation of having completed the vaccine series but no testing for a titer will be tested.  Individuals, who lack documentation of having completed the vaccine series, will not be evaluated for a titer, and will be offered the vaccine series regardless of source status. 
      3. Source Testing – Source testing for Hepatitis B surface antigen (HBsAg) shall occur whenever the exposed individual lacks documentation of immunity to Hepatitis B.  If the source is unknown or source Hepatitis B status cannot be determined, management shall be the same as though the source were positive.
      4. Positive or Unknown Source:
        1. Fully vaccinated exposed individual (with documentation) with previously undocumented titer:  If the post-exposure titer is adequate, the individual shall be considered immune.  If inadequate, the exposed individual will be treated with a single dose of HBIG, revaccination with a full series of three, and evaluated with a baseline Hepatitis B Core Antibody (anti-HBc).  At six months, he or she will be tested for anti-HBc, Anti-HBs, and HBsAg (testing will be delayed, however, if vaccinated within the prior month or received HBIG within the prior 6 months whichever comes later.
        2. Documentation of full vaccine series lacking:  A post-exposure titer for anti-HBs will not be performed (as results would be misleading).  The exposed individual will be treated with a single dose of HBIG, vaccinated to complete a series of three vaccinations, and evaluated with a baseline Hepatitis B Core Antibody (anti-HBc).  At six months, he or she will be tested for anti-HBc, anti-HBs, and HBsAg (testing will be delayed, however, if vaccinated within the prior month or received HBIG within the prior 6 months whichever comes later.  If the HCW is insistent that he or she was fully vaccinated but lacks documentation, and refuses HBIG and vaccination without first being tested for anti-HBs, and documents their declination of treatment in writing, he or she may be tested for anti-HBs with the understanding that results are misleading if the full vaccine series had not been completed. 
        3. Non-responders:  Exposed individuals who have completed six doses of Hepatitis B vaccine, and lack an adequate anti-HBs titer, are considered “non-responders” and will be treated with two doses of HBIG, one month apart.
        4. When HBIG and/or the Hepatitis B vaccine series are indicated, they should be administered as soon as possible (preferably within 24 hours of exposure).  If the exposed individual presents late, HBIG may be given up to 7 days following exposure.  HBIG and the HBV vaccine may be administered simultaneously in different sites (the HBV vaccine must be administered in the deltoid muscle). 
      5. Counseling of the individual potentially exposed to HBV shall include:
        1. Risk of occupational exposure based on up to date epidemiologic information from the CDC.  The risk for HBV in the exposed individual who has immunity (documented fully vaccinated PLUS adequate anti-HBs titer) is negligible, and no treatment or special precautions are necessary. The risk for the exposed individual who does not have immunity to HBV of developing clinical hepatitis following a needlestick injury with an HBV positive source can range from approximately 1% to 30%.  This risk can be significantly reduced through post-exposure prophylactic treatment.
        2. Prevention of secondary transmission (if exposed to HBV and not immune) to others.  The exposed individual should avoid blood, plasma, semen, tissue and organ donation.  The CDC does not recommend changes in sexual practices for long-term monogamous partners.  Those with multiple sexual partners or in more casual relationships, however, should be counseled to employ safer sex practices (e.g. condoms).  The CDC has no recommendations against becoming pregnant or breastfeeding.  No modifications to an exposed individual’s patient-care responsibilities are necessary solely based upon the exposure incident.
        3. Safe work practices and prevention of future exposure.
        4. The benefits and side effects of treatment for individuals who do not have HBV immunity.
          1. Hepatitis B Immunoglobulin (HBIG) vaccine alone initiated within one week following percutaneous exposure will reduce the transmission risk by approximately 75%.
          2. The addition of the Hepatitis B vaccine series following exposure is believed to further reduce transmission risk and will provide the additional protection from future exposures.
          3. Safety of the vaccines.  Common side effects include local soreness at the injection site and sometimes mild to moderate fever.  These vaccines are safe for use in pregnancy.
          4. A Michigan Vaccine Information Sheet (VIS) shall be provided prior to vaccination.
      6. Follow up (positive or unknown source) shall include:
        1. For those who are offered and decline vaccination, follow up testing shall be performed for HBsAg, anti-HBs  and anti-HBc at six months post exposure (however, delayed if vaccinated with Hepatitis B vaccine in the prior month).  If follow up testing fails to demonstrate immunity, then consideration shall be given to additional vaccination in accordance with CDC guidelines.
        2. Those initiating the HBV vaccine series will receive their 2nd and 3rd doses of vaccine at 1 and 6 months after the first dose. 
        3. Those who require a 2nd dose of HBIG shall receive it 1 month after the first dose. 
        4. Exposed individuals shall be educated to report symptoms which may indicate the development of hepatitis (e.g. jaundice, dark urine, nausea, vomiting, right upper quadrant pain, etc.), and present to OHS as soon as possible for follow up evaluation. 
        5. Any exposed individual who is confirmed positive for HBV infection on baseline testing will be referred to his or her personal physician.  Any exposed individual who is confirmed positive for HBV infection on follow up testing will be referred to a specialist knowledgeable in the management of HBV infection.
    6. Post-Exposure Management for Hepatitis C (HCV):
      1. Risk Assessment:  Risk for transmission of HCV shall be assessed based upon the exposure material (type of potentially infectious material), the type and severity of sharp or splash exposure, and the source status. 
      2. Counseling of the individual potentially exposed to HCV shall include:
        1. Risk of occupational exposure based on up to date epidemiologic information from the CDC.  The risk to the individual for acquiring HCV infection following a needlestick injury with an HCV positive source is estimated to be approximately 1.8%. 
        2. There is no known effective post-exposure prophylaxis for HCV, but follow up testing will be provided.
        3. The exposed individual should avoid blood, plasma, semen, tissue and organ donation.  The CDC does not recommend changes in sexual practices for long-term monogamous partners.  Those with multiple sexual partners or in more casual relationships, however, should be counseled to employ safer sex practices (e.g. condoms).  The CDC has no recommendations against becoming pregnant or breastfeeding.  No modifications to an exposed individual’s patient-care responsibilities are necessary solely based upon the exposure incident. 
        4. Safe work practices and prevention of future exposure.
      3. Management and Follow Up of the HCV exposed individual shall include:
        1. test source patient for HCV RNA. If the source patient is HCV RNA negative then no further testing or follow up is required in the exposed individual.
        2. If the source was determined to be HCV RNA positive or unknown then the exposed individual will undergo baseline testing for HCV antibody.
        3. If the exposed individual is HCV antibody positive on baseline testing then this should be confirmed by HCV RNA testing. If HCV RNA testing is positive in exposed individual on baseline testing then the individual will be referred to his or her personal physician.
        4. If the baseline HCV antibody is negative or if baseline HCV antibody is positive but HCV RNA is negative in the exposed individual then the individual will undergo follow up HCV RNA testing ≥ 3 weeks after exposure. If the follow up HCV RNA is positive then the individual should be referred to a specialist knowledgeable in the management of HCV infection. 
        5. If the follow up HCV RNA test done ≥ 3 weeks after exposure is negative then no further testing or follow up required.
        6. Exposed individuals shall be educated to report symptoms which may indicate the development of hepatitis (e.g. jaundice, dark urine, nausea, vomiting, right upper quadrant pain, etc.), and present to OHS as soon as possible for follow up evaluation.

    Questions regarding this policy should be referred to the Chief, Division of Infectious Diseases, Hospital Epidemiologist, Occupational Health Services or (for administrative purposes) or for administrative purposes the SVP Human Resources.

  6. REFERENCES
    1. Schillie S, Murphy TV, Sawyer M, et al, “CDC Guidance for Evaluating Health-Care Personnel for Hepatitis B Virus Protection and for Administering Postexposure Management”, MMWR, December 20, 2013, Vol. 62/No. 10.
    2. “Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures and Recommendations for Postexposure Prophylaxis”, MMWR, September 30, 2005, Vol. 54/No RR-9
    3. “Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis”. MMWR June 29, 2001 Vol. 50/No RR-11
    4. David T. Kuhar, MD; David K. Henderson, MD; Kimberly A. Struble et al. “Updated US Public Health Service Guidelines for the Management of Occupational Exposures to HIV and to Human Immunodeficiency Virus and Recommendations for Postexposure Prophylaxis.” Infection Control and Hospital Epidemiology, Vol. 34, No. 9 (September 2013), pp. 875-892
    5. Occupational HIV Transmission and Prevention among Health Care Workers, https://www.cdc.gov/hiv/pdf/workplace/cdc-hiv-healthcareworkers.pdf
    6. PEP Quick Guide for Occupational Exposures, http://nccc.ucsf.edu/clinical-resources/pep-resources/pep-quick-guide/

VII. Appendix/Attachments

            Appendix 1A BBFE Administrative Guidelines /Procedure CHM DRH HUH HTZ RIM

            Appendix 1B BBFE Administrative Guidelines/Procedure HVSH

            Appendix 1C BBFE Administrative Guidelines/Procedure SG

            Appendix B BBFE ART Management Consent

VIII  ADMINISTRATIVE RESPONSIBILITY

The Market Chief Medical Officer/COO and Market Human Resource Officer have overall administrative responsibility for this policy. The Executive Director of Occupational Health has day to day responsibility for administration of this policy.

APPROVAL

This policy has been approved and is duly authorized by Detroit Medical Center, Children’s Hospital of Michigan, Detroit Receiving Hospital, Harper/Hutzel Hospital, Huron Valley-Sinai Hospital, Rehabilitation Institute of Michigan, and Sinai-Grace Hospital.  The posting of the policy on the DMC intranet signifies that it is in full force and effect.