Transcript 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
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Overview
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HIV Post-Exposure Prophylaxis (PEP)
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oPEP (occupational PEP)
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nPEP (non-occupational PEP)
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Background
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Guidelines
Hepatitis B and C post-exposure protocols
NON-OCCUPATIONAL PEP
(nPEP)
nPEP
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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
Non-Occupational Estimated Transmission Risk1
Exposure Type if Source
HIV infected
Estimated Risk of Single
Exposure
Needle-sharing
0.67%
Receptive anal intercourse
0.5%-3% (1/200-6/200)
Receptive vaginal
intercourse
Insertive anal intercourse
0.1%
(1/1000)
0.065%
(1/1500)
Insertive vaginal intercourse 0.05%
Receptive oral sex with
ejaculation
1Hivguidelines.org
(1/150)
(1/2000)
0.005-0.01%
Probability of male-to-female HIV transmission per coital act, as
a function of HIV disease stage in the index case
Cohen, JID, 2005
Support for PEP Treatment
Guidelines
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Clearly identified risk factors for HIV transmission
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ACTG 076 Study
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Decreased perinatal transmission by 67%
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CDC International Case Control Study
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Knowledge of pathogenesis of HIV seroconversion
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Laboratory and animal models
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No adequate human data on nPEP efficacy
Risk Factors for HIV Transmission
CDC Case Control Study - 1995
Risk Factor
Deep Injury
Visible blood
Terminal illness
In vessel
AZT (ZDV) use
Adjusted Odds Ratio (95% CI)
15
6
6
4
0.2
(6.1-44.6)
(1.8-17.7)
(2.2-18.9)
(1.9-14.8)
(0.1-0.6)
MMWR 12/95; Cardo et al., NEJM;1997;337:1485-90 (updated)
All Risk Factors were significant (P < 0.01)
NYS DOH Guidelines
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oPEP (occupational)
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January 2008
Updated guidelines 2009:
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January 2008
nPEP (non-occupational)
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CDC Guidelines
oPEP (occupational)
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MMWR, 54 (RR-9), 9/30/05
nPEP (non-occupational)
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MMWR, 54 (RR-2), 1/21/05
Medical Care Criteria
Committee of AIDS Institute  www.cdc.gov/mmwr
www.hivguidelines.org
Key Elements of Post-Exposure
Prophylaxis (PEP) Programs
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Medical knowledge
Indications
 Regimens
 Follow-up
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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
1.
Assess Risk
2.
Manage Exposure
3.
Determine HIV Status of source, when possible
4.
Dispense PEP if indicated
5.
Educate and Counsel Exposed Patient
6.
Documentation
1. Assess Risk
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Percutaneous injury
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Contact of mucous membrane
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Contact non-intact skin
1. Assess Risk: Blood or Body Fluid
Fluids with Risk:
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Blood or visibly bloody fluid
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Semen
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Vaginal secretions
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Cerebrospinal fluid
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Synovial fluid
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Pleural fluid
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Pericardial fluid
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Amniotic fluid
Community Needlestick Injuries
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Consider:
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HIV prevalence in the community or facility
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Surrounding prevalence of injection drug use
Do not test discarded needles for HIV
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False negatives
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Risk
1. Assess Risk, cont.
Non-risky Fluids*
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Saliva, sputum or nasal
secretions
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Tears
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Sweat
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Urine
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Stool
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Emesis
*Unless there is visible blood
Bites
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~250,000 bites annually in U.S.
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HIV levels in saliva very low
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Documented transmission by blood-tinged
saliva1,2
Consider PEP when:
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Blood exposure to biter and/or bitten person
(e.g. source has bleeding gums or lesions)
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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.
PEP of Non-Occupational Exposures
PEP recommended if source HIV+,
high-risk, unknown (e.g. sexual assault)
PEP NOT recommended
Unprotected
Kissing,
vaginal/anal
intercourse (receptive or insertive)
Unprotected
receptive penileoral contact with ejaculation
Oral-vaginal
contact with blood
exposure

Needle-sharing
Injury

with blood exposure
needlestick, bite, accident
Hivguidelines.org
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
2. Exposure Management
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Wash immediately w/ soap and water
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Flush mucous membranes with water
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No evidence that use of antiseptics or expressing fluid
reduces potential transmission
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Antiseptics not indicated; caustic agents (bleach) not
recommended
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“Milking the wound” may increase risk
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increases local inflammation
3. Source HIV Status
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Source HIV status unknown
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Voluntary HIV testing
Document if source unwilling or unable to consent
Rapid HIV testing +/- HIV RNA viral load
test recommended
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OSHA regulations require rapid testing for
occupational exposures
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HIV RNA if recent potential HIV exposure to source
Rapid test result positive
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Give result to source; confirm by HIV Western blot
3. Source HIV Status
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Obtain preexisting HIV test results
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Obtain consent for release of HIV information, or
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Contact source’s physician for documentation of
results (patient consent not required)
If source known HIV-, no PEP
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Consider HIV RNA viral load testing to rule out
acute HIV infection
3. Source HIV Status
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Known HIV Infection
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Stage of infection (early, late or end stage)
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CD4, viral load testing, resistance testing
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Current and previous antiretroviral therapies
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Consider involvement of HIV Specialist
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Don’t delay PEP while waiting for results
Risk Behavior
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PEP recommended
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Isolated exposure (sexual, needle, trauma)
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Lapse in risk-reduction practices
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Interest in behavioral change
Repeated high-risk behavior or
presentation for repeat courses of PEP
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Intensify education & prevention
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Behavioral change
4. PEP Recommendations
NYS DOH Guidelines
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PEP ASAP, ideally within 2 hrs, no
later than 36 hrs from exposure
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HAART (3 antiretroviral drugs) x 4
weeks
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Baseline HIV serology of exposed
person within 72 hours of initiating
PEP
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HIV specialist follow-up within 72
hours
4. PEP Recommendations
Beyond 36 Hours?
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“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
4. PEP Recommendations
Selection of HIV PEP Regimen
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PEP regimen usually empiric
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If source known HIV+:
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consider HIV resistance
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genotype/phenotype/past antiretroviral drug history
NYS: Preferred PEP Regimen
Zidovudine (AZT) 300 mg po bid Combivir 1 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
Truvada 1 po qd
May substitute stavudine for AZT, nelfinavir or lopinavir for tenofovir; dosing by weight in children
4. PEP Recommendations
CDC: Basic HIV PEP Regimen
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zidovudine (ZDV) + lamivudine (3TC) or
emtricitabine (FTC)
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ZDV 300 mg BID; 3TC 300 QD or 150 BID; FTC 200
QD
tenofovir (TNF) + lamivudine (3TC) or
emtricitabine (FTC)
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TNF 300 mg QD// 3TC 300 QD or 150 BID; FTC 200 QD
4. PEP Recommendations
CDC: Preferred Expanded PEP Regimen
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Basic regimen
plus
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lopinavir/ritonavir (LPV/RTV) (or efavirenz
[nPEP]
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LPV/RTV: 400/100 mg = 2 tablets twice daily with food
5. Education and Counseling
Explain to patient:
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Potential exposure risk
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Risks and benefits of PEP
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To report signs and symptoms of acute
(primary) HIV infection
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Prevention of secondary transmissions
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Acknowledge fear/anxiety commonly
encountered by exposed health care workers
and offer counseling services
Medication Side Effects
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Nausea
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Vomiting
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Fatigue
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Headache
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Loss of appetite
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Diarrhea
Emperically give ant-emetic like Reglan and anti-diarrheal
Immodium
5. More Education and Counseling
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What prescribed person needs to know:
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Knowledge about efficacy of PEP is limited
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ZDV best shown to prevent HIV transmission
in humans
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No data on combination therapy, but experts
recommend multiple drugs to increase potency
and overcome potential drug-resistant virus
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Any or all drugs for PEP may be declined by
the HCW
6. PEP Follow-up
Monitoring Recommendations After Initiation of PEP
(www.hivguidelines.org)
Visit
Baseline
Week 1
Week 2
Week 3
Month 1
Month 3
Month 6
X
X
X
X
X
CBC/diff Met/LFT HIV Ab*
X
X
X
X
X
X
(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
Longitudinal Care
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Recommend barrier protection for 3-6 months,
while monitoring for PEP is ongoing
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Avoid breastfeeding for 3-6 months
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Women preferring to breastfeed between 3-6 months
should carefully weigh risks/benefits
Failure of Post-Exposure
Prophylaxis
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Failure documented with zidovudine (AZT;
Retrovir) monotherapy and with combination
therapies
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Potential explanations:
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Viral resistance
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Large inoculum
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Delay in PEP
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Lack of adherence to PEP
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Infection at a time other than the known potential
exposure
AIDS 2001;1593:430, Arch Int Med
1999;159:2361-3
Occupational Blood-borne Exposures
Relative Risk of Seroconversion with
Percutaneous Injury
Seroconversion %
50
50%
40
30
30%
20
10
2%
0.3%
0
HIV
HCV
.
From:
CDC. MMWR 2001;50 (RR11):1-42.
HBsAg+
HBeAg-
HBsAg+
HBeAg+
Hepatitis B
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Management depends on:
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Source hepatitis B surface antigen status
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Whether exposed person vaccinated
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Whether exposed person has immunity
Recommended PEP for Hepatitis B Virus
Vaccination/Ab
response status of
exposed patient
Treatment when source patient is:
HBsAg
positive
HBsAg
negative
Source unknown or not
available for testing
HBIG ×1;
initiate HB
vaccine series
Initiate HB
vaccine series
Initiate HB vaccine series
Previously
No treatment
vaccinated, known
responder
No treatment
No treatment
Previously
HBIG ×1 and
vaccinated, known initiate
non-responder
revaccination
or HBIG ×2
No treatment
No treatment unless high-risk
source; if high-risk source, treat as
if source were HBsAg positive
Previously
Single vaccine
vaccinated,
booster dose
response unknown
No treatment
No treatment unless high-risk
source; if high-risk source, treat as
if source were HBsAg positive
Unvaccinated/
non-immune
Still undergoing
vaccinated
Complete
HBIG ×1;
complete series series
Complete series
Hepatitis C
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No vaccine or treatment will prevent
infection
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Immune globulin not recommended; does not
work
Early infection effectively treated with
Peg-interferon +/- ribavirin
Exposure to Hepatitis C
HCV Ab
Baseline
(source
HCV+ or
unknown)
1 month
3 months
6 months
Increase in
ALT in 1st 24
wks
X
LFTS
HCV RNA
X
X
X
X
If source HCV
+
X
X
X
X
X
nPEP Case
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JW, 21 year old WM presents to CCC, West
Village on 7/15/10 for PEP. Reports going online 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
nPEP Case
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History of poly-substance abuse starting at age 16
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Cocaine, crystal meth (now reports IV use for last 4-6
months)
SW visit
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Unemployed, moved to NYC to get away from drug scene
Referred to drug treatment programs (Realization Center,
Andres Hoyas at Center)
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Assisted in applying for Medicaid, food stamps and Waverly Job
Center
nPEP Case
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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
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nPEP Case
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PE reveals exudative pharyngitis (L tonsil)
Repeat Labs are Drawn:
DNA PCR: 690 copies
 HIV Elisa and WB are positive
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