For further information, please contact BC Women s Sexual Assault Service at Thank-you.

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2 The following guideline has been developed for use within BC Women s Hospital and Health Centre. There are support systems at BC Women s Hospital and Health Centre that may not exist in other clinical settings and therefore any adoption of these materials cannot be the responsibility of BC Women s Hospital and Health Centre. Agencies other than BC Women s Hospital and Health Centre should use this information as a guideline for reference purposes only. All materials are the property of BC Women s Hospital and Health Centre and may only be reprinted in whole or in part with our expressed permission. For further information, please contact BC Women s Sexual Assault Service at Thank-you.

3 Please use Guidelines for Offering HIV PEP Following a Sexual Assault to assess whether HIV PEP should be offered to a sexual assault patient. If you have questions about how to use these Guidelines, or would like assistance in developing patient information handouts or a FAX form (see SAMPLE) to facilitate dispensation of remaining PEP medication, please contact BC Women's Sexual Assault Service (BCW SAS) at

4 BC WOMEN S SEXUAL ASSAULT SERVICE (SAS) Guidelines for Offering HIV Post Exposure Prophylaxis (PEP) Following a Sexual Assault RISK ASSESSMENT GUIDE Significant Risk: May be indicated by what is known about the source or what is known about the setting in which the sexual assault took place. SOURCE Known HIV positive source or Known high-risk source e.g., injection drug user (IDU) or man who has sexual contact with men (MSM) or Known multiple assailants PLUS TYPE OF EXPOSURE Non-consensual: Unknown exposure or Anal intercourse or Vaginal intercourse RECOMMENDATIONS Recommend strongly the combination of 3 drugs: tenofovir, lamivudine (3TC ), Kaletra initiated within 36 hours after sexual assault. See Important Notes below. SETTING Sexual assault occurs in a setting considered high risk for HIV (e.g., Vancouver s Downtown Eastside, drug paraphernalia at scene, etc) PLUS TYPE OF EXPOSURE Non-consensual: Unknown exposure or Anal intercourse or Vaginal intercourse RECOMMENDATIONS Recommend the combination of 3 drugs: tenofovir, lamivudine (3TC ) and Kaletra initiated within 36 hours after sexual assault. See Important Notes below. IMPORTANT NOTES: If the patient is currently on any medication, contact the St. Paul s Hospital Pharmacy Hotline at or your hospital pharmacist to check for possible interactions between current medications and HIV PEP. Kaletra reduces the levels of estradiol and thus interferes with the action of the birth control pill. Advise patient to use additional protection for pregnancy prevention while taking Kaletra and for 2 months after completing Kaletra. Kaletra does not interfere with the Emergency Contraceptive Pill levonorgestrel (Plan B ), but can decrease the effectiveness of Ovral. Ideally, PEP is most effective if initiated within two hours of exposure. Delays should be avoided. If a patient is at significant risk, but is unsure about taking

5 PEP, suggest that the patient begin the starter kit immediately and review the decision later, rather than delay treatment. HIV PEP is not regularly offered later than 36 hours after exposure as it is thought that use after 36 hours may not prevent HIV transmission. However when the perpetrator is known to be HIV positive, the at risk patient may be started on PEP after 36 hours as it may favourably alter the subsequent disease in the exposed person. If you are uncertain about whether to initiate a starter kit, consult the St. Paul s Hospital Ambulatory Pharmacy at , or the Centre Physician Hotline at , or contact BC Women s Paging at and ask to speak to the SAS examiner on-call. Negligible Risk: Source known to be negative or no reason to believe that the source is positive. Setting not considered high risk for HIV. OR TYPE OF EXPOSURE No vaginal exposure and No anal exposure or Oral exposure only RECOMMENDATION Do not offer PEP to patients in this category. Adequate counselling and education of the patient is needed to reduce anxiety ESTIMATED RISKS OF BECOMING INFECTED WITH HIV: Risks in consensual sex after one exposure: (where the man is known to be HIV positive, and the receiving individual is negative) Receptive Vaginal: 1:1000 (0.1%) Receptive Anal Penetration: 1:200 (0.5%) Receptive Oral: 1:10,000 (0.01%) In non- consensual sex after one exposure (where one person is known to be HIV positive), the risk is thought to be higher than the risk in consensual sex because of potential injuries, but the numbers are unknown. 2

6 Potential Adverse Effects of One Month of Antiretroviral Therapy These estimates are based on the experience of the BC Centre for Excellence in HIV/AIDS in the use of HIV prophylaxis and also use in the treatment of HIV infection. In most cases, the estimates are based on the use of two drugs and the adverse effects of three drugs may be higher. Minor adverse reactions e.g., nausea, fatigue etc. (70% of patients). Serious reactions e.g., unable to work for the month of therapy (30-60% of patients). Long term adverse effects (poorly defined) 1:5000. Risk of death is unknown but we would estimate it at 1:15,000 to 1:150,000. With three drugs in an uncontrolled situation, such as accidental exposures, it may be higher. With the exception of the minor adverse reactions, these risks are not based on solid data and are provided only as a rough guide to physicians and exposed persons, using a crude estimate of the hazards. MEDICATION DOSAGE Recommended PEP is for a total of 28 days. The 5-day starter kit in the emergency department will consist of the following: Tenofovir 300mg once daily Lamivudine (3TC) 150mg twice a day Kaletra 2 tablets twice a day IF PATIENT S WEIGHT < 4O kg, call the St. Paul s Ambulatory pharmacist for dosage adjustment, and administration at If at any time you have questions about the medications or about the patient s ability to tolerate medications please call the St. Paul s Ambulatory Pharmacy and speak to one of the pharmacists at USE CAUTION IN THE FOLLOWING SITUATIONS: An expert opinion should be sought if the source is known to be HIV positive and on antiretroviral therapy. If the source has taken or is currently on antiretrovirals, resistance could have developed and the usual combination of drugs may not be effective for this patient. An alternate regimen may be advised. Start the patient on the 5-day starter kit and contact the St. Paul s Ambulatory Pharmacy at the next weekday to discuss whether alternate medications are recommended. 3

7 Use with extreme caution for patients with chronic kidney or liver problems, bone marrow insufficiencies, and any patients who have been on myelosuppressive, nephrotoxic, or hepatotoxic drugs in the 2 weeks prior to starting antiretroviral therapy. A history of hepatitis does not automatically rule out the use of PEP. However, in the event of acute symptomatic illness or severely elevated liver enzyme levels, use may be contraindicated. If unsure, consult the St. Paul s Ambulatory Pharmacy at Tenofovir is a Pregnancy Category B drug. When pregnancy is confirmed or suspected, consultation with an expert in the field of HIV in pregnancy is strongly recommended. Begin the starter kit of tenofovir, lamivudine and Kaletra. Then have the patient contact the Oak Tree Clinic at BC Women s Hospital at the next weekday. Breastfeeding should be discontinued if suspicion of HIV infection is high enough to initiate PEP. HIV transmission from breast milk increases risk of infection to the baby by 14%. Kaletra interferes with the action of the birth control pill. If the patient is on the birth control pill advise the patient to use additional forms of protection to prevent pregnancy while taking Kaletra, and up to 2 months after completing Kaletra. Kaletra does not interfere with the actions of levonorgestrel (Plan B ), but can decrease the effectiveness of Ovral. CONTRAINDICATIONS: Kaletra is contraindicated when the patient is on the following drugs: Seldane, Hismanal, rifampin; cisapride (GI motility agent); some benzodiazopines (in particular triazolam, midazolam); some lipid lowering agents (simvastatin, lovastatin); some antiarrhythmics (quinidine, amiodarone; ergot derivatives (ergotamine, dihydroergotamine); and pimozide (anti- psychotic). Non-essential medications and alternative therapy should be discontinued during PEP. If the patient is on any medication, particularly narcotics or any medications affecting the CYP 3A4 enzyme, contact the St. Paul s Hospital Ambulatory pharmacist at or your hospital pharmacist to check for possible interactions between current medications and HIV PEP. PATIENT TEACHING: Review and be sure the patient understands how to take the medication and is aware of the possible side effects. Review and ensure patient understands follow-up procedures. To receive copies of BCW SAS patient handouts you may contact BCW SAS at Discuss protecting others from possible exposure. 4

8 Inform the patient that the St. Paul s Ambulatory Pharmacy in Vancouver is closed on weekends and holidays. To prevent any disruption in treatment, we recommend the patient see a doctor the first weekday after initiating PEP to obtain a prescription for the remaining 23 days of medication, and to arrange for its pickup or delivery. Answer any questions the patient may have regarding their treatment. HIV TESTING: BC Women s SAS does not do HIV testing. Providing sensitive and comprehensive HIV testing requires extensive pre and post test counselling. Due to emotional trauma felt by survivors of sexual assault, it is often not possible to do comprehensive counselling at the time of the sexual assault exam. As well, a baseline test only indicates the HIV status of the patient before the sexual assault. Baseline and other HIV testing should be managed in follow up. Patients who seroconvert usually do so within 12 weeks after exposure to HIV infected blood or body fluids. Seroconversion after 12 weeks is less common and after 24 weeks extremely unlikely, although PEP may delay seroconversion. Recommend to patients who may have been exposed to HIV to be tested at: 4-6 weeks post-exposure 12 weeks post-exposure 24 weeks post-exposure 52 weeks if PEP has been given PLEASE NOTE: The cost for PEP medications for sexual assault patients who are from a province other than BC or from outside of Canada are covered by BC Centre for Excellence in HIV/AIDS. The follow-up physician may have to remind the St. Paul s Ambulatory Pharmacy (at ) that out-of-province /country sexual assault patients are covered. Patients who are not eligible to take the free medications provided by the Centre because their risk is not deemed significant or the sexual contact was consensual, may be able to purchase the medication with a doctor s prescription. The cost is approximately $1300 for a 28-day supply. Please acknowledge the BC Women s Sexual Assault Service, (SAS), Vancouver, BC, Canada in any reprinting of this material. We would like to acknowledge the BC Centre for Excellence in HIV/AIDS, the AIDS Committee of Toronto, Women and AIDS Program, and the BC Centre for Disease Control, for assistance with this document. October 2009 REVISED 0ctober 29,

9 Date: Addressograph Examiner: category discussed HIV RISK/POST-EXPOSURE PROPHYLAXIS (PEP) DISCUSSION & FAX FORM (A) Significant risk discussed. Risk may be indicated by what is known about the source or what is known about the setting in which the sexual assault took place: SOURCE Known HIV positive source or Known high-risk source e.g. injection drug user (IDU) or man who has sexual contact with men (MSM) or Known multiple assailants PLUS TYPE OF EXPOSURE Non-consensual: Unknown exposure or Anal intercourse or Vaginal intercourse RECOMMENDATIONS HIV PEP: tenofovir, lamivudine, and Kaletra initiated within 36 hours after sexual assault Indicate how patient meets criteria by circling or underlining the relevant information. SETTING Sexual assault occurs in a setting considered high risk for HIV (e.g. Vancouver s Downtown Eastside, drug paraphernalia at scene, etc.) PLUS TYPE OF EXPOSURE Non-consensual: Unknown exposure or Anal intercourse or Vaginal intercourse RECOMMENDATIONS HIV PEP: tenofovir, lamivudine, and Kaletra initiated within 36 hours after sexual assault (B) Negligible risk discussed: Source known to be negative or no reason to believe that the source is positive. Setting not considered high risk for HIV OR TYPE OF EXPOSURE No vaginal exposure and No anal exposure Oral penetration only RECOMMENDATION Do not offer PEP to patients in this category. Adequate patient counselling and education is needed to reduce anxiety (C) Estimated risks of becoming infected with HIV discussed: Risks in consensual sex after one exposure: (where the man is known to be HIV positive, and the receiving individual is negative) Receptive Vaginal: 1:1000 (0.1%) Receptive Anal Penetration: 1:200 (0.5%) Receptive Oral: 1:10,000 (0.01%) HIV risk discussed? Yes: No: If no, reason: PEP dispensed: Yes: No: reason: PEP dispensed: does not meet above criteria: Please explain: Taking PEP provided: Yes: No: What To Do After You Leave Emergency provided Yes: No: HIV PEP Take This To Your Next Doctor s Visit provided:yes: No: Follow-up discussed with patient Yes: No: Comments: FAX to ST. PAUL S OUTPATIENT PHARMACY AT WHEN HIV PEP IS DISPENSED