GUIDELINES FOR HIV POSTEXPOSURE PROPHYLAXIS FOLLOWING SEXUAL ASSAULT

1
GUIDELINES FOR HIV POST-EXPOSURE PROPHYLAXIS
FOLLOWING SEXUAL ASSAULT

• Developed by the New York State Department of
  Health, AIDS Institute and Rape Crisis

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Rationale for Sexual Assault PEP Guidelines

• HIV may be transmitted through mucous membrane
  exposure to infected semen or blood during sexual
  assault
• Risk is parallel to occupational exposure through
  mucous membrane contact
• Trauma and STDs enhance HIV transmission

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Rationale for Sexual Assault PEP Guidelines

• Prophylaxis may prevent HIV transmission
• Occupational exposure case-control study
• Animal data
• Perinatal prophylaxis data
• Develop consistent standards of clinical
  practice

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Parallels to Occupational Exposure

• Point source exposure
• Non-voluntary exposure
• Overall HIV transmission is low

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Parallels to Occupational Exposure

• Risk of exposure is quantifiable if assailant is
  known to be HIV infected
• per contact transmission probability ranges from
  0.0001- 0.07

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Risk of HIV Transmission For Specific Sexual Acts

• Estimates of limited available statistics are
• -Unprotected receptive anal intercourse
  8/1,000-32/1,000
• -Receptive vaginal intercourse
  5/10,000-15/10,000
• -Insertive vaginal intercourse
  3/10,000-9/10,000
• -Insertive anal intercourse 3/10,000
• There are no risk/episode estimates for oral sex
• Mastro, T and de Vincent Probabilities of sexual
  HIV-1 Transmission AIDS 1996, 10 (suppl A)S75-82
• Smith, D. The Use of Post-Exposure Therapy to
  Prevent Non-Occupational Transmission of HIV.
  CDC Presentation, 1998

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Parallels to Occupational Exposure

• Exposure risk depends on viral load in ejaculate
  or blood, and nature of exposure
• Risk is increased significantly with trauma to
  mucosal tissue

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Development of Practice Guidelines Strengths

• Parallels to occupational exposure
• Consensus of panel including clinical experts,
  rape crisis counselors and advocates (NYSCASA)
• Benefits of PEP would outweigh potential harm

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Development of Practice Guidelines Limitations

• No specific scientific evidence to support
  efficacy
• No prospective controlled studies

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Questions Addressed By The Medical Criteria
Committee

• Under what circumstances, if any, would rape
  survivors benefit from HIV PEP?
• What is the appropriate timing for initiation of
  PEP? Is there a time after which PEP would not
  be indicated or advisable?
• Which drugs should be used for prophylaxis?

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Questions Addressed By The Medical Criteria
Committee

• How long should therapy be continued?
• What is the most reliable diagnostic test for
  detecting infection?
• What other infectious diseases could be prevented
  through prophylactic treatment following sexual
  assault?

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Eligibility Criteria For PEP

• Direct contact of vagina, mouth or anus with
  semen or blood of perpetrator
• Tissue damage or presence of blood at site of
  assault, with or without physical injury

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Recommendations Timing of Sexual Assault PEP

• Access to prompt treatment in ER or equivalent
  health care setting with appropriate medical
  resources

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Recommendations Timing of Sexual Assault PEP

• PEP should be offered as soon as possible
  following exposure, preferably within 24 hours
• No prophylaxis should be offered beyond 36 hours
  from exposure

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Assessment of Survivor

• History
• Emotional status
• Physical exam
• HIV status
• Readiness for treatment

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Assessment of Survivor

• History
• duration of time since assault
• nature of assault
• cognitive functioning

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Assessment of SurvivorPhysical Exam

• Oral swab should be obtained immediately upon
  presentation and prior to any oral intake

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Assessment of the Survivor

• Emotional status
• trauma following assault
• readiness to consider possible HIV infection
  immediately following sexual assault
• decision-making ability
• Support systems
• psychosocial
• clinical
• education

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Considering The HIV Status Of The Perpetrator

• Recommendations for initiating HIV PEP should not
  be based on the likelihood of HIV infection in
  the assailant
• If the HIV status is confirmed, it should guide
  PEP recommendations

20
Initiation of Therapy

• The perceived seroprevalence of HIV in a
  particular geographic location where the assault
  occurred should not influence the decision to
  recommend HIV PEP

21
Initiation of Therapy

• Discussion should include
• potential benefits of prophylaxis
• possibility of side effects
• nature/duration of treatment and monitoring
• importance of adherence/drug resistance
• assessment of survivors willingness and
  readiness to begin PEP

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Initiation of Therapy

• If the survivor is pregnant
• full discussion of benefits and risks of PEP for
  both maternal and fetal health should occur
• therapy with certain antiretroviral agents during
  the first trimester may be associated with fetal
  toxicity
• advise not to breast-feed until a definitive
  diagnosis has been made

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PEP Initiation

• Regimen recommended
• -zidovudine (300 mg BID)
• -lamivudine (150 mg BID)
  -nelfinavir (750 mg TID) or -indinavir
  (800 mg TID)
• FOUR WEEK THERAPY

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PEP Initiation

• The provider should
• educate the patient about the clinical signs and
  symptoms of primary HIV infection
• instruct him or her to seek immediate medical
  care from an HIV specialist should they occur
• review information the next day whether or not
  PEP is initiated
• review risk reduction

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PEP Initiation

• Practitioners who recommend PEP for sexual
  assault survivors should ensure that patients
  have the following
• appropriate arrangements for follow-up care
• referral to, or treatment in consultation with an
  HIV Specialist
• monitoring of antiretroviral treatment
• repeat diagnostic HIV testing

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PEP Initiation

• In the case of an indeterminate HIV test or in
  the setting of symptoms suggestive of primary HIV
  infection (unless the patient is confirmed to be
  HIV negative), the clinician should continue PEP
  until a definitive diagnosis is established.

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PEP Initiation

• For patients without insurance or refusing to use
  insurance, or ineligible for special payment
  programs, the treating institution has the
  ethical responsibility for ensuring a timely,
  uninterrupted supply of medications

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HIV Testing of Survivor

• In New York State, an ELISA test with a
  confirmatory Western Blot antibody test must be
  performed in order to confer a diagnosis of HIV
  infection

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HIV Testing of Survivor

• Baseline HIV serologic testing to be obtained
  prior to PEP initiation
• PEP should be started immediately after serologic
  testing
• Refusal to undergo baseline testing should not
  preclude initiation of therapy
• Confidential HIV testing should be provided by
  the treating physician

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HIV Testing of Survivor

• Physician performing the test is responsible for
• communicating HIV test result, especially when a
  primary care physician is unavailable
• transferring the results to the treating
  physician upon agreement from survivor
• coordinating treatment with an HIV Specialist

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HIV Testing of Survivor

• Repeat HIV serologic testing should be performed
  at
• 4 weeks
• 12 weeks
• 6 months
• 1 year after assault

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Rape Crisis Counselors

• Should be an active participant in the discussion
  about prophylaxis management
• critical in providing comfort, assistance and
  information about the benefits and risks of
  prophylaxis
• convey importance of adherence
• facilitate referrals
• coordinate consultation with HIV Specialist

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Follow-up Care

• Survivors of sexual assault should also be tested
  for the following
• hepatitis B (vaccine HBIG should be given)
• sexually transmitted diseases bacterial
  vaginosis, trichomoniasis, chlamydia, gonorrhea
  and syphilis (treatment should be given, as
  appropriate)

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Follow-up Care

• Follow-up visit within 24 hrs to review
• PEP regimen
• adherence
• follow-up care
• If prophylaxis was not initiated
• possible initiation of PEP after 24 hours
• alternatives

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Follow-up Care

• Management of PEP includes referral to an HIV
  Specialist
• If an HIV Specialist is not in the community, the
  local primary care provider should consult an HIV
  Specialist

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Follow-up Care Role of The ER Or Urgent Care
Clinician

• Communicating information to survivors primary
  care provider or designee
• Patients without a primary care physician should
  be referred to HIV Specialists or Centers of
  Excellence

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Follow-up Care Role of Rape Crisis Counselor

• Plan for follow-up care should be discussed with
  rape crisis counselor or outreach worker
• Potential continuing contact with survivor
• Counselor support will likely enhance
• adherence to prophylaxis
• expeditious handling of medical problems
• continuity of care

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Special Considerations

• Cost
• Insurance
• Crime Victims Board
• No mechanism for payment

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Special Considerations

• Drug toxicity
• High cost of medications

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Special Considerations

• Education
• Clinicians
• Emergency Room Staff
• Rape Crisis Counselors
• Criminal Justice system
• Consumers

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Institution Responsibility

• Ensuring PEP is immediately available
• Policy and procedure to ensure efficient and
  prompt management of PEP for sexual assault
• Education of Staff

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Acknowledgements

• New York State Department Of Health
• HIV Medical Care Criteria Committee
• Rape Crisis Program
• New York State Coalition Against Sexual Assault
• The New York Hospital of Queens Clinical
  Education Initiative
• Christine A. Williams, RN, MPH
• David S. Rubin, MD