GUIDELINES FOR HIV POST-EXPOSURE 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

2. 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

3. 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

4. Parallels to Occupational Exposure • Point source exposure • Non-voluntary exposure • Overall HIV transmission is low

5. 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

6. 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

7. 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

8. 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

9. Development of Practice Guidelines: Limitations • No specific scientific evidence to support efficacy • No prospective controlled studies

10. 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?

11. 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?

12. 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

13. Recommendations: Timing of Sexual Assault PEP • Access to prompt treatment in ER or equivalent health care setting with appropriate medical resources

14. 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

15. Assessment of Survivor • History • Emotional status • Physical exam • HIV status • Readiness for treatment

16. Assessment of Survivor • History: • duration of time since assault • nature of assault • cognitive functioning

17. Assessment of Survivor:Physical Exam • Oral swab should be obtained immediately upon presentation and prior to any oral intake

18. 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

19. 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 survivor’s willingness and readiness to begin PEP

22. 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

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

24. 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

25. 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

26. 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.

27. 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

28. 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

29. 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

30. 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

31. HIV Testing of Survivor • Repeat HIV serologic testing should be performed at: • 4 weeks • 12 weeks • 6 months • 1 year after assault

32. 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

33. 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)

34. 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

35. 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

36. Follow-up Care: Role of The ER Or Urgent Care Clinician • Communicating information to survivor’s primary care provider or designee • Patients without a primary care physician should be referred to HIV Specialists or Centers of Excellence

37. 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

38. Special Considerations • Cost: • Insurance • Crime Victims Board • No mechanism for payment

39. Special Considerations • Drug toxicity • High cost of medications

40. Special Considerations • Education: • Clinicians • Emergency Room Staff • Rape Crisis Counselors • Criminal Justice system • Consumers

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

42. 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