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Post-Exposure Prophylaxis

Post-Exposure Prophylaxis. Antonio Urbina, M.D. Associate Medical Director Center for Comprehensive Care, West Village Division St. Luke’s Roosevelt Hospital. 24/7 NYS PEP Line. 888-448-4911. NYS PEP/AIDS Widget. To Download Widget visit www.ceitraining.org. Overview.

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Post-Exposure Prophylaxis

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  1. Post-Exposure Prophylaxis Antonio Urbina, M.D. Associate Medical Director Center for Comprehensive Care, West Village Division St. Luke’s Roosevelt Hospital

  2. 24/7 NYS PEP Line 888-448-4911

  3. NYS PEP/AIDS Widget To Download Widget visit www.ceitraining.org

  4. Overview HIV Post-Exposure Prophylaxis (PEP) oPEP (occupational PEP) nPEP (non-occupational PEP) Background Guidelines Hepatitis B and C post-exposure protocols

  5. NON-OCCUPATIONAL PEP (nPEP)

  6. nPEP • Buy in from institution and staffs • Establish protocol and policies • Have first dose available to patient immediately • Educate Staff on follow up • Include Mental Health and SW

  7. Non-Occupational Estimated Transmission Risk1 1Hivguidelines.org

  8. Probability of male-to-female HIV transmission per coital act, as a function of HIV disease stage in the index case Cohen, JID, 2005

  9. Support for PEP Treatment Guidelines Clearly identified risk factors for HIV transmission ACTG 076 Study Decreased perinatal transmission by 67% CDC International Case Control Study Knowledge of pathogenesis of HIV seroconversion Laboratory and animal models No adequate human data on nPEP efficacy

  10. Risk Factors for HIV TransmissionCDC Case Control Study - 1995 Risk FactorAdjusted Odds Ratio (95% CI) Deep Injury 15 (6.1-44.6) Visible blood 6 (1.8-17.7) Terminal illness 6 (2.2-18.9) In vessel 4 (1.9-14.8) AZT (ZDV) use0.2(0.1-0.6) MMWR 12/95;Cardo et al., NEJM;1997;337:1485-90 (updated) All Risk Factors were significant (P < 0.01)

  11. NYS DOH Guidelines oPEP (occupational) January 2008 nPEP (non-occupational) January 2008 Updated guidelines 2009: Medical Care Criteria Committee of AIDS Institute www.hivguidelines.org CDC Guidelines • oPEP (occupational) • MMWR, 54 (RR-9), 9/30/05 • nPEP (non-occupational) • MMWR, 54 (RR-2), 1/21/05 • www.cdc.gov/mmwr

  12. Key Elements of Post-Exposure Prophylaxis (PEP) Programs Medical knowledge Indications Regimens Follow-up Programmatic readiness Awareness of need Timely availability of medical evaluation and PEP agents Availability of follow-up Confidentiality and documentation

  13. Key Elements • Assess Risk • Manage Exposure • Determine HIV Status of source, when possible • Dispense PEP if indicated • Educate and Counsel Exposed Patient • Documentation

  14. Assess Risk Percutaneous injury Contact of mucous membrane Contact non-intact skin

  15. Assess Risk: Blood or Body Fluid Fluids with Risk: Blood or visibly bloody fluid Semen Vaginal secretions Cerebrospinal fluid Synovial fluid Pleural fluid Pericardial fluid Amniotic fluid

  16. Community Needlestick Injuries Consider: HIV prevalence in the community or facility Surrounding prevalence of injection drug use Do not test discarded needles for HIV False negatives Risk

  17. Assess Risk, cont.Non-risky Fluids* Saliva, sputum or nasal secretions Tears Sweat Urine Stool Emesis *Unless there is visible blood

  18. Bites ~250,000 bites annually in U.S. HIV levels in saliva very low Documented transmission by blood-tinged saliva1,2 Consider PEP when: Blood exposure to biter and/or bitten person (e.g. source has bleeding gums or lesions) Blood exposure unknown 1. Vidmar L et al. Lancet 1996;347:1762-1763. 2. Pretty I et al. Am J Forensic Med Pathol 1999;20:232-239.

  19. PEP of Non-Occupational Exposures Hivguidelines.org

  20. Exposure Management Wash immediately w/ soap and water Flush mucous membranes with water No evidence that use of antiseptics or expressing fluid reduces potential transmission Antiseptics not indicated; caustic agents (bleach) not recommended “Milking the wound” may increase risk increases local inflammation

  21. 3. Source HIV Status Source HIV status unknown Voluntary HIV testing Document if source unwilling or unable to consent Rapid HIV testing +/- HIV RNA viral load test recommended OSHA regulations require rapid testing for occupational exposures HIV RNA if recent potential HIV exposure to source Rapid test result positive Give result to source; confirm by HIV Western blot

  22. Source HIV Status Obtain preexisting HIV test results Obtain consent for release of HIV information, or Contact source’s physician for documentation of results (patient consent not required) If source known HIV-, no PEP Consider HIV RNA viral load testing to rule out acute HIV infection

  23. 3. Source HIV Status Known HIV Infection Stage of infection (early, late or end stage) CD4, viral load testing, resistance testing Current and previous antiretroviral therapies Consider involvement of HIV Specialist Don’t delay PEP while waiting for results

  24. Risk Behavior PEP recommended Isolated exposure (sexual, needle, trauma) Lapse in risk-reduction practices Interest in behavioral change Repeated high-risk behavior or presentation for repeat courses of PEP Intensify education & prevention Behavioral change

  25. 4. PEP RecommendationsNYS DOH Guidelines PEP ASAP, ideally within 2 hrs, no later than 36 hrs from exposure HAART (3 antiretroviral drugs) x 4 weeks Baseline HIV serology of exposed person within 72 hours of initiating PEP HIV specialist follow-up within 72 hours

  26. 4. PEP Recommendations Beyond 36 Hours? “Decisions regarding initiation of nPEP beyond 36 hours post exposure should be made by the clinician in conjunction with the patient with the realization of diminished potential for success when timing of initiation is prolonged”1 Consider likelihood of HIV transmission http://hivguidelines.org/GuideLine.aspx?pageID=78&guideLineID=2

  27. 4. PEP Recommendations Selection of HIV PEP Regimen PEP regimen usually empiric If source known HIV+: consider HIV resistance genotype/phenotype/past antiretroviral drug history

  28. NYS: Preferred PEP Regimen Zidovudine (AZT) 300 mg po bid Lamivudine (3TC) 150 mg po bid PLUS Tenofovir 300 mg po daily with food OR Zidovudine 300 mg po bid PLUS Tenofovir 300 mg PO qd Emtricitabine 200mg po qd Combivir 1 po bid Truvada 1 po qd May substitute stavudine for AZT, nelfinavir or lopinavir for tenofovir; dosing by weight in children

  29. 4. PEP Recommendations CDC: Basic HIV PEP Regimen zidovudine (ZDV) + lamivudine (3TC) or emtricitabine (FTC) ZDV 300 mg BID; 3TC 300 QD or 150 BID; FTC 200 QD tenofovir (TNF) + lamivudine (3TC) or emtricitabine (FTC) TNF 300 mg QD// 3TC 300 QD or 150 BID; FTC 200 QD

  30. 4. PEP RecommendationsCDC: Preferred Expanded PEP Regimen Basic regimen plus lopinavir/ritonavir (LPV/RTV) (or efavirenz [nPEP] LPV/RTV: 400/100 mg = 2 tablets twice daily with food

  31. 5. Education and Counseling Explain to patient: Potential exposure risk Risks and benefits of PEP To report signs and symptoms of acute (primary) HIV infection Prevention of secondary transmissions Acknowledge fear/anxiety commonly encountered by exposed health care workers and offer counseling services

  32. Medication Side Effects Nausea Vomiting Fatigue Headache Loss of appetite Diarrhea Emperically give ant-emetic like Reglan and anti-diarrheal Immodium

  33. 5. More Education and Counseling What prescribed person needs to know: Knowledge about efficacy of PEP is limited ZDV best shown to prevent HIV transmission in humans No data on combination therapy, but experts recommend multiple drugs to increase potency and overcome potential drug-resistant virus Any or all drugs for PEP may be declined by the HCW

  34. 6. PEP Follow-up

  35. Longitudinal Care Recommend barrier protection for 3-6 months, while monitoring for PEP is ongoing Avoid breastfeeding for 3-6 months Women preferring to breastfeed between 3-6 months should carefully weigh risks/benefits

  36. Failure of Post-Exposure Prophylaxis Failure documented with zidovudine (AZT; Retrovir) monotherapy and with combination therapies Potential explanations: Viral resistance Large inoculum Delay in PEP Lack of adherence to PEP Infection at a time other than the known potential exposure AIDS 2001;1593:430, Arch Int Med 1999;159:2361-3

  37. Occupational Blood-borne ExposuresRelative Risk of Seroconversion with Percutaneous Injury . From: CDC. MMWR 2001;50 (RR11):1-42.

  38. Hepatitis B Management depends on: Source hepatitis B surface antigen status Whether exposed person vaccinated Whether exposed person has immunity

  39. Hepatitis C No vaccine or treatment will prevent infection Immune globulin not recommended; does not work Early infection effectively treated with Peg-interferon +/- ribavirin

  40. Exposure to Hepatitis C

  41. nPEP Case • JW, 21 year old WM presents to CCC, West Village on 7/15/10 for PEP. Reports going on-line and finding about PEP through www.pep411.com • Unprotected receptive anal sex with multiple partners the prior night • Last tested HIV -, 2 weeks ago in St. Louis, MO • First dose of PEP given in clinic within 32 hours of exposure

  42. nPEP Case • History of poly-substance abuse starting at age 16 • Cocaine, crystal meth (now reports IV use for last 4-6 months) • SW visit • Unemployed, moved to NYC to get away from drug scene • Referred to drug treatment programs (Realization Center, Andres Hoyas at Center) • Assisted in applying for Medicaid, food stamps and Waverly Job Center

  43. nPEP Case • Baseline rapid HIV test negative • Labs: CBC normal, LFT’s normal • F/U • 2 weeks: exam WNL, reports good tolerability and 100% adherence. No symptoms • Misses 2 appts with SW and PCP • 30 day rapid antibody negative. HIV viral load detectable at 96 copies

  44. nPEP Case • PE reveals exudative pharyngitis (L tonsil) • Repeat Labs are Drawn: • DNA PCR: 690 copies • HIV Elisa and WB are positive

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