July 3, III. VA policy:

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1 Antiretroviral Postexposure Prophylaxis After Sexual, Injection- Drug Use, or Other Nonoccupational Exposure to HIV (nonoccupational post- exposure prophylaxis [npep]) VA Greater Los Angeles Healthcare System July 3, 2015 I. Definition: Use of antiretrovirals to prevent HIV infection after sexual, injection- drug use, or other nonoccupational exposure to HIV is referred to as nonoccupational post- exposure prophylaxis (npep) II. Rationale: data from animal transmission models, perinatal clinical trials, studies of health- care workers receiving prophylaxis after occupational exposures, and observational studies indicate that npep might sometimes reduce the risk for HIV infection after nonoccupational exposures. III. VA policy: VA providers may prescribe npep in appropriate circumstances if the exposed individual is a veteran eligible for VA Treatment and testing of source individuals is not permitted unless that individual is also a veteran eligible for VA 1. IV. Counseling: Exposed patients should be informed that Knowledge about the efficacy and toxicity of npep is limited; Data are limited regarding toxicity in persons without HIV infection or who are pregnant; Persons with non- occupational exposures to HIV should observe precautions (e.g.., condom use) to prevent possible secondary transmission VI. Overview of procedures Follow- up: If npep will be initiated: 1. Review detailed procedures as provided below! 2. Order and review baseline laboratory tests 3. Give patient an initial prescription for 7 days of therapy 4. Electronically consult Infectious diseases for follow- up in Infectious Diseases Clinic within one week Regardless of whether npep is given, patients should be tested for GC, Chlamydia, syphilis, Hepatitis B & C, and HIV 2. For questions regarding npep, call or page the Infectious Diseases Fellow on- call (call schedule available through operator]). If no response is received call or page the Infectious Diseases Consult Service Attending, or Dr. Matthew Goetz, Chief, Infectious Diseases. 3. CDC recommendations for npep: 1

2 V. Detailed procedures A. Determination of eligibility for npep Frequency of exposure: 4. npep should be used only for infrequent exposures. 5. Persons who engage in behaviors that result in frequent, recurrent exposures that would require sequential or near- continuous courses of antiretroviral medications (e.g., discordant sex partners who rarely use condoms or injection- drug users who often share injection equipment) should not take npep. HIV Status of source 6. npep is recommended only if the source is known to be HIV- infected. 7. When the HIV status of the source is unknown, it should be determined whether the source is available for HIV testing. 8. Testing of source individuals is not permitted at GLA unless that individual is also a veteran eligible for VA 9. Case- by- case decisions should be made for nonoccupational post- exposure prophylaxis (npep) made if the HIV status of the source is unknown. Transmission risk from exposure 10. npep is recommended only for exposures that offer substantial risk of HIV exposure/infection. Substantial Risk for HIV Exposure Exposure of vagina, rectum, eye, mouth, or other mucous membrane, nonintact skin, or percutaneous contact With blood, semen, vaginal secretions, rectal secretions, breast milk, or any body fluid that is visibly contaminated with blood When the source is known to be HIV- infected Exposure route to an infected source Blood transfusion Needle- sharing injection- drug use Receptive anal intercourse Percutaneous needle stick Receptive penile- vaginal intercourse Insertive anal intercourse Insertive penile- vaginal intercourse Receptive oral intercourse Insertive oral intercourse Estimated risk per 10,000 exposures to an infected source 9, Negligible Risk for HIV Exposure Exposure of vagina, rectum, eye, mouth, or other mucous membrane, intact of nonintact skin, or percutaneous contact With urine, nasal secretions, saliva, sweat, or tears if not visibly contaminated with blood Regardless of the known or suspected HIV status of the source Timing of exposure 2

3 11. Initiation of npep is recommended only if the exposure occurred in the preceding 72 hours 12. Effectiveness of npep has not been demonstrated if it is begun greater than 72 hours after exposure. B. Choice of treatment for npep Recommended regimens Once daily dolutegravir (50 mg) plus once daily tenofovir & emtricitabine (Truvada ) first choice, do not use tenofovir if baseline CrCl< 50 Once daily dolutegravir (50 mg) plus twice daily Zidovudine & lamivudine (Combivir ), use for Creatinine clearance < 50 Alternatives to dolutegravir (all used in combination with Truvada (preferred unless CrCl<50) or Combivir) Darunavir (800 mg) plus ritonavir (100 mg), rilpivirine; all given once daily If used, rilpivirine is best given as Complera (also contains tenofovir & emtricitabine) Note increased drug- drug interactions with ritonavir- containing regimens 13. Abacavir- containing products are CONTRAINDICATED for use as post- exposure prophylaxis unless B*5701 testing has been previously performed and HLA B*5701 has been shown to be absent. Persons with HLA B*5701 have a 60% risk of developing hypersensitivity reactions which can be severe and fatal. 14. Post- exposure prophylaxis with nevirapine is CONTRAINDICATED. Fatal hypersensitivity reactions can occur. Antiretroviral resistance and selection of post- exposure prophylaxis 15. An HIV strain is more likely to be resistant to a specific antiretroviral agent if it is derived from a patient who has had viremia (HIV viral load > 500) for 3 6 months while receiving antiretroviral therapy. 16. Assistance from Infectious Diseases should be sought for management of exposure to HIV that is likely to be resistant to one or more anti- retroviral agents. Pregnancy: There are no specific contra- indications to the use of anti- retroviral agents recommended in this document for post- exposure prophylaxis during pregnancy. Further information regarding the safety of anti- retroviral agents during pregnancy and the effects of individual agents on the effectiveness of hormonal birth control can be found at guidelines/0/. 17. Efavirenz is a CLASS D AGENT in pregnancy (Positive Evidence of Fetal Risk). Do not use in pregnancy, especially during the first trimester or in women of child- bearing potential who are not using effective contraceptives. 18. Dosing recommendations and other medication side effect 19. Agent Standard Adult dosage# Side effects and toxicities NRTIs (use combination products) Tenofovir/emtricitabine (TFV/FTC, Truvada ) May be taken with or without food 1 tablet once daily 200 mg FTC/300 mg TFV Reduce dose to 1 tablet qod for CrCl < 50 TFV: Nausea, vomiting, diarrhea; headache; asthenia; flatulence; and renal impairment FTC: Minimal toxicity; lactic acidosis and hepatic steatosis is a rare but possibly life- threatening event Zidovudine/lamivudine 1 tablet twice daily ZDV: Anemia, neutropenia, GI intolerance; headache; 3

4 # (ZDV/3TC, Combivir ) INSTI (integrase strand transfer inhibitor) Dolutegravir (Tivicay ) May be taken with or without food PIs (protease inhibitors) Darunavir (Prezista ) Take with food 300 mg ZDV/150 mg 3TC Reduce dose for CrCl < 15 insomnia; asthenia; and myopathy 3TC: Minimal toxicity; lactic acidosis and hepatic steatosis is a rare but possibly life- threatening event 50 mg once daily Well tolerated; Insomnia, nausea, fatigue, headache, and severe skin and hypersensitivity reactions have been reported. 800 mg once daily Must use with 100 mg ritonavir per day Diarrhea, nausea, vomiting; asthenia; transaminases; hyperglycemia; fat redistribution; lipid abnormalities; possible increased bleeding in persons with hemophilia; and pancreatitis Ritonavir 100 mg once daily Lipid abnormalities; multiple- drug- drug interactions NNRTI (non- nucleoside reverse transcriptase inhibitor Rilpivirine plus tenofovir & emtricitabine (Complera ) Take with food 1 tablet daily Well tolerated Caution when coadministered with H2 receptor antagonists and antacids; coadministration with proton pump inhibitors is contraindicated Combination products should be used unless dose adjustments are necessary for individual components due to renal or hepatic insufficiency. 20. Baseline laboratory evaluation: Complete blood count, kidney panel and liver panel. Pregnancy testing should be done in all women of child- bearing potential. 21. Total duration of treatment: 7 days of therapy should be initially prescribed. 21 days of therapy will be given at the follow- up appoint to complete the total recommended duration of therapy (28 days). C. Other evaluation: 22. Evaluation and prophylaxis for sexually transmitted disease, Hepatitis B and Hepatitis C. 23. Baseline HIV testing should be offered to all persons at risk for acquiring HIV infection due to potential nonoccupational exposure to HIV. HIV testing conducted for any reason in VA requires pre- test counseling and signature consent on VA form D. Counselling: Exposed HCP should be advised to use precautions (eg, use of barrier contraception and avoidance of blood or tissue donations, pregnancy, and, if possible, breast- feeding) to prevent secondary transmission, especially during the first 6 12 weeks after exposure. E. Follow- up 24. Clinical follow- up: After initiating PEP, enter an electronic consult for patient to be followed up in the next Infectious Diseases clinic (WLA Infectious Diseases meets Tuesday afternoon and Friday morning, Sepulveda Infectious Diseases Clinic meets on Wednesday morning, and Los Angeles Ambulatory Care Center Infectious 4

5 Diseases clinic meets on Monday morning). This must be done regardless of other communications with Infectious Diseases. Patients living at remote sites (e.g., San Luis Obispo, Santa Barbara, Bakersfield) may be followed by their primary provider in consultation with infectious Diseases 25. Laboratory follow- up: Complete blood count, kidney panel and liver panel (baseline and 2 weeks after starting PEP). Consult Infectious Diseases if subjective or objective toxicity is noted. Follow- up HIV testing at 1, 3 and 6 months 26. Medical follow- up: Risk- reduction counseling and indicated intervention services should be provided to reduce the risk for recurrent exposures. Vaccination for hepatitis B (for those not immune) VI. References 1. CDC. Antiretroviral Postexposure Prophylaxis After Sexual, Injection- Drug Use, or Other Nonoccupational Exposure to HIV in the United States MMWR Recommendations and Reports. 2005;54 (RR2): UCSF Prophylaxis Following Nonoccupational Exposure to HIV. HIV InSite Knowledge Base Chapter. authors&doc=kb CDC. Updated US Public Health Service Guidelines for the management of occupational exposures to HBV, HCV, and HIV and recommendations for postexposure prophylaxis. MMWR. 2001; 50:RR1-11: CDC. Case- control study of HIV seroconversion in health- care workers after percutaneous exposure to HIV- infected blood France, United Kingdom, and United States, January 1988 August MMWR 1995;44: Henderson DK, Dembry L, Fishman NO, et al. SHEA Guideline for Management of Healthcare Workers Who Are Infected with Hepatitis B Virus, Hepatitis C Virus, and/or Human Immunodeficiency Virus. Infect Control Hosp Epidemiol. 2010; 31: HIV prophylaxis following occupational exposure. New York State Department of Health AIDS Institute. guidelines/post- exposure- prophylaxis/hiv- prophylaxis- following- occupational- exposure/; updated October 2014, accessed July 3, Kuhar DT, Henderson DK, Struble KA, et al. Updated US Public Health Service Guidelines for the Management of Occupational Exposures to Human Immunodeficiency Virus and Recommendations for Postexposure Prophylaxis. Infect Control Hosp Epidemiol 2013;34(9): The MMWR recommendations can be accessed on- line at 5

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