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Alberta Guidelines for Post-Exposure Management and Prophylaxis: HIV, Hepatitis B, Hepatitis C and Sexually Transmitted Infections Ministry of Health, Government of Alberta March 2019 For more information about this document, contact: Office of the Chief Medical Officer of Health 24th Floor, ATB, 10025 Jasper Avenue Edmonton, Alberta T5J 1S6 Email: [email protected] ISBN 978-1-4601-4336-0 © 2019 Government of Alberta This document is made available under the Open Government License – Alberta https://open.alberta.ca/licence This document is available online at: https://open.alberta.ca/publications/9781460143360 Alberta Guidelines for Post-Exposure Management and Prophylaxis: HIV, HBV, HCV and STIs 2 © 2019 Government of Alberta Table of Contents ACRONYM LIST ………………………………………………………………………………………………….….5 QUICK REFERENCE GUIDE …………………………………………………………………………………..…..7 INTRODUCTION ...……………………………………………..…………………………………..…………..….18 Goal ..………………………………………………...………………………………………..................19 Target Audience ……………………………………………………..………………………………..…19 Roles and Responsibilities ...……………………………………………………………………..…...19 Occupational Health and Safety Act …………………………………………………………..……..19 Mandatory Testing and Disclosure Act ...…………………………...…………………………..…..20 GENERAL CONSIDERATIONS FOR HIV PEP ……………………………………………………………..….21 Rationale for HIV PEP ………………………………………………………………………………..…21 Evidence for the Use of PEP ………………………………………………………………………..…21 Animal Studies ...………………………………………………………………..……...............21 Human Studies ………………………………………………………………….……...............21 Vertical Transmission ...…………………………….……………………………...… 21 Occupational Exposure …………………………………………………………….....22 Sexual Exposure ...…………………………..…………………………..…………....22 Factors Reducing the Efficacy of PEP ………………………………………………..……………..22 Considerations for Providing PEP ………...………………………………………..….................. 23 Safety ...……………………………………………….………………………………...............23 Cost ...…………………………………………………………………………..………………...24 Behavior …...…………………………………………………………………..………………...24 Anxiety …...…………………………………………………………………..…………………..24 Consideration of other HIV Prevention Interventions ………………….…………………... .25 Social and Ethical Considerations ……………………………………………………………..25 Risk of HIV Transmission and Factors Influencing Risk ..…………………………………........25 Suppressed Viral Load ………………………………………………………………………… 26 Consensual Exposure to HIV ….………………………………………………………………..…..…27 Infrequent Consensual Exposure …………………………………………………….………..27 Related Consensual Exposure ..………………………………………………….…………...27 Pre-Exposure Prophylaxis ...……………..…………………………………………………………...28 MANAGEMENT OF HIV PEP…………………………………………………………………………….………..29 Management of the Exposed Site ..………………………………………………………..…………29 Recommendations for Prescribing PEP ..………………………………………………..………....29 Assessment of the Exposed ..………………………………………………………………………...29 Assessment of the Source ………………………………………….………………………...………30 Needlestick Injury in the Community Setting .………………….………………………...…….....31 Alberta Guidelines for Post-Exposure Management and Prophylaxis: HIV, HBV, HCV and STIs 3 © 2019 Government of Alberta Human Bites...……………………………………………………………………………………………31 Timing of PEP ...………………………………………………………………………………………....31 Duration of PEP ………………………………………………………………………………………....32 Choice and Number of Antiretroviral Drugs used for PEP …………………………….………..32 Nucleoside Reverse Transcriptase Inhibitors (NRTI) ………………………………………….…33 Integrase Strand Transfer Inhibitors (INSTI) …………………………………………………….…33 Children ……………………………………………………………………………………………….….34 Pregnancy …………………………………………………………………………………………….….35 Breastfeeding ………………………………………………………………………...…………….…...36 Dispensing of HIV PEP …………………………………………………………………………….…..37 Education …………………………………………………………………………………………….…..37 Follow up of Patients Prescribed HIV PEP ……………………………………………………..….37 HEPATITIS B VIRUS (HBV) ………………………………………………….……………………………….….38 HEPATITIS C VIRUS (HCV) ……………………………………………………………………………………...40 SEXUALLY TRANSMITTED INFECTIONS (STIs) ………………………………………..............................41 REFERENCES ……………………………………………………………………………………………………..42 APPENDIX ………………………………………………………………………………………………………….50 Table 1. Risk of HIV transmission per exposure from a known HIV-positive individual.......50 Table 2. HIV/AIDS Diagnosis Data………………………………………………………….......…….51 Table 3. Risk Assessment ……...……..………………………………………………………………52 ACKNOWLEDGEMENTS ………………………………………………………………………………………...53 Alberta Guidelines for Post-Exposure Management and Prophylaxis: HIV, HBV, HCV and STIs 4 © 2019 Government of Alberta Acronym List AIDS Acquired Immunodeficiency Syndrome Anti-HBs Hepatitis B surface antibody ART Antiretroviral therapy ARV Antiretroviral BBFE Blood and Body Fluid Exposure BBP Blood-borne Pathogen CADTH Canadian Agency for Drugs and Technology in Health Care CDC US Centres for Disease Control and Prevention CDN Canadian CT Chlamydia DNA Deoxyribonucleic acid DRV/r Ritonavir-boosted Darunavir DTG Dolutegravir EFV Efavirenz EIA Syphilis Enzyme immunoassay FDA US Food and Drug Administration FTC Emtricitabine GC Gonorrhea HBeAg Hepatitis B “e” antigen HBIG Hepatitis B Immune Globulin HBsAg Hepatitis B surface antigen HHS US Department of Health and Human Services Anti-HBs Antibody to hepatitis B surface antigen Anti-HBc Antibody to hepatitis B core antigen HBV Hepatitis B Virus HCV Hepatitis C Virus HIVQUAL Human Immunodeficiency Virus- qualitative viral load test HIVQUANT Human Immunodeficiency Virus- quantitative viral load test HCV-RNA Hepatitis C Virus-Ribonucleic acid HIV Human Immunodeficiency Virus IU/L International unit/Litre IDU Injection drug use ICER Incremental cost effectiveness ratio INSTI Integrase Strand Transfer Inhibitor kg kilogram 3TC Lamivudine LMP Last Menstrual Period LPV/r Ritonavir-boosted Lopinavir mg milligram ml/mL milliliter MDR Multi-drug resistance MMWR Morbidity and Mortality Weekly MSM Men Who Have Sex With Men MTDA Mandatory Testing and Disclosure Act NAAT Nucleic Acid Amplification Test NTD Neural Tube Defects NNRTI Non-Nucleoside Reverse Transcriptase Inhibitor NRTI Nucleoside Reverse Transcriptase Inhibitor Alberta Guidelines for Post-Exposure Management and Prophylaxis: HIV, HBV, HCV and STIs 5 © 2019 Government of Alberta OHS Occupational Health and Safety PEP Post-Exposure Prophylaxis PHAC Public Health Agency of Canada PI Protease inhibitor POCT Point-of-Care Test PrEP Pre-Exposure Prophylaxis PWID People Who Inject Drugs QALY Quality Adjusted Life Year RAL Raltegravir RCTs Randomized Control Trials RNA Ribonucleic acid RPR Rapid Plasma Reagin SIV Simian Immunodeficiency Virus STI Sexually Transmitted Infection TDF Tenofovir Disoproxil Fumarate US/USA United States/United States of America VL Viral Load WHO World Health Organization ZDV Zidovudine Alberta Guidelines for Post-Exposure Management and Prophylaxis: HIV, HBV, HCV and STIs 6 © 2019 Government of Alberta Quick Reference Guide: Tables and Figures Figure 1. Algorithm: Detailed HIV Risk Assessment for Post-Exposure following BBFE ……………………8 Table 1. Factors that Increase the Risk of HIV Transmission…………………………………….....................9 Table 2. Testing Recommendations-All…………………………………………………………………………..10 Table 3A. HIV Post-Exposure Prophylaxis Recommendations for Sexual Exposures……………………….11 Table 3B. HIV Post-Exposure Prophylaxis Recommendations for Other Exposures………………………...12 Table 4. HIV PEP Drug Regimen – Adult and Adolescent Regimen…………………………………………...13 Table 5. HIV PEP Drug Regimen – Pediatric Regimen………………………………………………………….14 Table 6. HIV PEP - Pregnancy Regimen……………………………………………………………...................15 Table 7. HBV PEP - High Risk Source...………………………………………………………………………….16 Table 8. HBV PEP - Low Risk Source……..…………………..……….………………………………………...17 Alberta Guidelines for Post-Exposure Management and Prophylaxis: HIV, HBV, HCV and STIs 7 © 2019 Government of Alberta Quick Reference Guide: Figure 1- DETAILED HIV RISK ASSESSMENT for Post-Exposure Following BBFE Step 1: Did a significant EXPOSURE occur? Higher Risk Exposures Lower Risk Exposures Negligible Risk Exposures · Condomless receptive sex (anal and · Condomless oral sex (receptive and vaginal-penile) insertive) · Discarded needles found in · Condomless insertive sex (anal and · Percutaneous injury (solid bore needle, the community vaginal-penile) superficial injury) · Human bites not involving · Needle-Sharing (IDU) · Permucosal exposure (to non-blood blood · Percutaneous needlestick (hollow bore) containing bodily fluids or non-intact · Contact with intact skin; · Occupational Mucous Membrane (splash skin exposure to blood or visible blood- · Superficial scratches that do stained bodily fluid) not bleed to eyes, nose, mouth) Stop · Human bites involving blood YES Step 2: Baseline Testing (Refer to Table 2) NO Step 3: Is the patient presenting within 72 HOURS after exposure? No YES NO PEP Step 4: Is the SOURCE at high risk of being HIV infected? No PEP Consider HIV PEP when source is: Refer to Tables 3A and 3B · Known HIV Positive OR · Known HIV negative but recent high risk activity or symptoms of acute HIV seroconversion (window period) OR · Unknown HIV status but known to be in a major risk group: - MSM - Illicit drug use - Time in endemic country - Hepatitis C positive - History of incarceration - Partners of known or suspected HIV positive If in an Acute Care Setting (Emergency Department): Starter - Initiate a starter pack (3-7 days) and refer to a physician knowledgeable in HIV to continue the risk assessment Pack If Physician Knowledgeable in HIV: - May consider the viral load in an HIV positive source for consensual