GUIDELINES FOR HIV POST-EXPOSURE PROPHYLAXIS FOLLOWING SEXUAL ASSAULT Developed by the New York State Department of Health, AIDS Institute and Rape Crisis

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 Other probability of infection through sexual exposure, although it varies greatly, appears to be lower than than that of infection through other routes of exposure.

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

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

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 The presence of reproductive tract infections is strongly associated with susceptibility to HIV. The prevalence of genital ulcer disease (chancroid, syphillis, or herpes) is associated with an increased relative risk of HIV infection, ranging from 1.5 to 7.0 in both men and women, Gonorrhea, chlamydia and trichomonas infections are associated with an increase of 60% to 340% in HIV prevalence in men and women. Bacterial vaginosis and genital ulcer disease may have potentiating effects on the incidence of HIV infection. Measurement of HIV in genital secretions indicates that HIV infectiousness may be greater in the presence of concurrent reproductive tract infections.

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

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

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

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

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?

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?

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

Recommendations: Timing of Sexual Assault PEP Access to prompt treatment in ER or equivalent health care setting with appropriate medical resources Careful examination of the survivor may be necessary to ascertain whether one of the above factors is present. Studies have shown that genital trauma occurs in nearly two-thirds of rape survivors with anal trauma in slightly over half. Women who have been anally assaulted often show manifestations of genital trauma. Absence of visible trauma does not indicate that that rape did not occur. Microabrasions are common; appearance of manifestations may be delayed. Oral trauma may also occur with rape and should be assessed using the same criteria for vaginal or anal assault.

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

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

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

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

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

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

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

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 Evidence shows the need to begin PEP within hours of exposure. The provider is in the delicate position of deciding how strongly to advise the survivor to initiate the regimen, balancing readiness with the knowledge that the most efficacious intervention must occur promptly. If the decision to defer recommending PEP is made initially, the follow-up visit to consider PEP should occur within 24 hours

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 Antiretroviral therapy risks and benefits should be weighed against those of the mother. Therapy during the later stages of pregnancy may confer additional benefit to prevent perinatal transmission if HIV infection has been transmitted

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

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

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

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.

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

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

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

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

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

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 Rape crisis counselor is usually a community volunteer: -is not an employee of the hospital or representative of DOH. -role in the decision-making process depends solely on the acceptance of the survivor. -to the extent that this continuing role can be encouraged through the coordinated input of the treating clinician, it should be pursued. -the rape crisis counselor can become the crucial link between the survivor and the clinician, thus facilitating follow-up care for the survivor.

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)

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

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

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

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

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

Special Considerations Drug toxicity High cost of medications

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

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

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