Post-Exposure Prophylaxis

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Post-Exposure Prophylaxis

• Antonio Urbina, M.D.
• Associate Medical Director
• Center for Comprehensive Care, West Village
  Division
• St. Lukes Roosevelt Hospital

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24/7 NYS PEP Line

• 888-448-4911

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

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

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NON-OCCUPATIONAL PEP (nPEP)
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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

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Non-Occupational Estimated Transmission Risk1
Exposure Type if Source HIV infected Estimated Risk of Single Exposure
Needle-sharing 0.67 (1/150)
Receptive anal intercourse 0.5-3 (1/200-6/200)
Receptive vaginal intercourse 0.1 (1/1000)
Insertive anal intercourse 0.065 (1/1500)
Insertive vaginal intercourse 0.05 (1/2000)
Receptive oral sex with ejaculation 0.005-0.01
1Hivguidelines.org
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Probability of male-to-female HIV transmission
per coital act, as a function of HIV disease
stage in the index case
Cohen, JID, 2005
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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

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Risk Factors for HIV TransmissionCDC Case
Control Study - 1995

• Risk Factor Adjusted 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) use 0.2 (0.1-0.6)
• MMWR 12/95 Cardo et al., NEJM19973371485-90
  (updated)

All Risk Factors were significant (P lt 0.01)
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• 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

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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

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Key Elements

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

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Assess Risk

• Percutaneous injury
• Contact of mucous membrane
• Contact non-intact skin

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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

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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

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Assess Risk, cont.Non-risky Fluids

• Saliva, sputum or nasal secretions
• Tears
• Sweat
• Urine
• Stool
• Emesis
• Unless there is visible blood

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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 19963471762-1763. 2.
Pretty I et al. Am J Forensic Med Pathol
199920232-239.
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PEP of Non-Occupational Exposures
PEP recommended if source HIV, high-risk, unknown (e.g. sexual assault) PEP NOT recommended
Unprotected vaginal/anal intercourse (receptive or insertive) Unprotected receptive penile-oral contact with ejaculation Oral-vaginal contact with blood exposure Needle-sharing Injury with blood exposure needlestick, bite, accident Kissing, or oral-oral contact no mucosal damage Bites without blood Needles/sharps exposure not in contact with HIV or at-risk person Mutual masturbation intact skin Oral-anal contact Receptive penile-oral contact without ejaculation Insertive penile-oral contact Oral-vaginal no blood exposure
Hivguidelines.org
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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

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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

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Source HIV Status

• Obtain preexisting HIV test results
• Obtain consent for release of HIV information, or
• Contact sources 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

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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
• Dont delay PEP while waiting for results

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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

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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

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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 prolonged1
• Consider likelihood of HIV transmission

http//hivguidelines.org/GuideLine.aspx?pageID78
guideLineID2
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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

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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
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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

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4. PEP Recommendations CDC 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

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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

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Medication Side Effects

• Nausea
• Vomiting
• Fatigue
• Headache
• Loss of appetite
• Diarrhea

Emperically give ant-emetic like Reglan and
anti-diarrheal Immodium
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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

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6. PEP Follow-up
Monitoring Recommendations After Initiation of PEP (www.hivguidelines.org) Monitoring Recommendations After Initiation of PEP (www.hivguidelines.org) Monitoring Recommendations After Initiation of PEP (www.hivguidelines.org) Monitoring Recommendations After Initiation of PEP (www.hivguidelines.org) Monitoring Recommendations After Initiation of PEP (www.hivguidelines.org)
Visit CBC/diff Met/LFT HIV Ab
Baseline X X X X
Week 1 X      
Week 2 X X  
Week 3 X      
Month 1 X X
Month 3       X
Month 6       (X)
Pregnancy test at baseline Recommended even if PEP is declined optional if PEP not indicated Follow-up by HIV Specialist recommended monitor for acute retroviral syndrome Pregnancy test at baseline Recommended even if PEP is declined optional if PEP not indicated Follow-up by HIV Specialist recommended monitor for acute retroviral syndrome Pregnancy test at baseline Recommended even if PEP is declined optional if PEP not indicated Follow-up by HIV Specialist recommended monitor for acute retroviral syndrome Pregnancy test at baseline Recommended even if PEP is declined optional if PEP not indicated Follow-up by HIV Specialist recommended monitor for acute retroviral syndrome Pregnancy test at baseline Recommended even if PEP is declined optional if PEP not indicated Follow-up by HIV Specialist recommended monitor for acute retroviral syndrome
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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

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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 20011593430, Arch Int Med 19991592361-3
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Occupational Blood-borne ExposuresRelative Risk
of Seroconversion with Percutaneous Injury
.
From CDC. MMWR 200150 (RR11)1-42.
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Hepatitis B

• Management depends on
• Source hepatitis B surface antigen status
• Whether exposed person vaccinated
• Whether exposed person has immunity

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Recommended PEP for Hepatitis B Virus Recommended PEP for Hepatitis B Virus Recommended PEP for Hepatitis B Virus Recommended PEP for Hepatitis B Virus
Vaccination/Ab response status of exposed patient Treatment when source patient is Treatment when source patient is Treatment when source patient is
Vaccination/Ab response status of exposed patient HBsAg positive HBsAgnegative Source unknown or not available for testing
Unvaccinated/non-immune HBIG 1 initiate HB vaccine series Initiate HB vaccine series Initiate HB vaccine series
Previouslyvaccinated, known responder No treatment No treatment No treatment
Previouslyvaccinated, known non-responder HBIG 1 and initiate revaccination or HBIG 2 No treatment No treatment unless high-risk source if high-risk source, treat as if source were HBsAg positive
Previouslyvaccinated, response unknown Single vaccine booster dose No treatment No treatment unless high-risk source if high-risk source, treat as if source were HBsAg positive
Still undergoing vaccinated HBIG 1 complete series Complete series Complete series
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Hepatitis C

• No vaccine or treatment will prevent infection
• Immune globulin not recommended does not work
• Early infection effectively treated with
  Peg-interferon /- ribavirin

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Exposure to Hepatitis C
HCV Ab LFTS HCV RNA
Baseline (source HCV or unknown) X X
1 month X If source HCV X

3 months X X X
6 months X X
Increase in ALT in 1st 24 wks X
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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

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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

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nPEP Case

• Baseline rapid HIV test negative
• Labs CBC normal, LFTs 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

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nPEP Case

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