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Transcript
My Child Found a Needle and...
Management of Potential
Nonoccupational Exposures to
Blood Borne Viruses
Sheryl L. Henderson, MD., Ph.D.
Pediatric Infectious Disease
Emory University School of Medicine
July 20. 2005
Case 1
The needle in the pocket
• 8 year old boy
• Received a used pair of jeans 3 hours
before presentation to ED,
• Put his hand in the pocket and…
Postexposure evaluation and
management
• Blood borne viruses-- HIV, HBV, HCV
• Causes of chronic infection
• HIV and HBV--prophylaxis available
Risk of Bloodborne Virus Transmission
after
Occupational Percutaneous Exposure
Source
HBV
HBeAg +
HBeAg -
Risk
22.0-30.0%
1.0-6.0%
HCV
1.8%
HIV
0.3%
HIV Postexposure evaluation and
management
• HIV -- most anxiety producing,
• No controlled trials evaluating transmission
risk,
• Data from multiple sources (e.g., surveillance,
observational studies, registrys, serosurveys)
used to assess risk of transmission.
Antiretroviral Postexposure
Prophylaxis After Sexual,
Injection-Drug Use, or Other
Nonocccupational Exposure to
HIV in the United States
MMWR 54: No. RR-2, January 21,
2005
Efficacy of HIV Prophylaxis
• Animal Studies (macaque model)
• Postexposure prophylaxis in the newborn
• Occupational exposures
Macaque studies
• PMPA (tenofovir) most effective when given
within 24 hours and continued for 28 days
after intravenous inoculation with SIV. (Tsai et.
al., J Virol, 1998)
• Animals inoculated vaginally with HIV-2 were
protected by PMPA given up to 72 hours.
(Otten et. al, J Virol, 1999)
• Small numbers of animals in the studies.
Human Studies of HIV PEP:
Prevention of Perinatal Transmission
• ZDV administered during pregnancy, labor,
and delivery reduced transmission by 67%
(Connor EM, et al. N Engl J Med 1994;331:1173-80.)
• Protective effect observed when ZDV given
only to newborn within the first 48-72 hours of
life (Wade NA, et al. N Engl J Med 1998;339:1409-14.)
• PACTS mutlicenter study demonstrated
reduced perinatal transmission by 48% when
only infant prophylaxis within 24 hours.
(Bulterys, et. al., 1999
Timing and Duration
• Studies suggest there is a period of hours
before the virus is fully integrated during
which time infection can be interrupted with
the use of postexposure prophylaxis.
• Duration of treatment, more effective, the
longer administered. (28 days)
Postexposure Management:
Wound Care
• Clean wounds with soap and water
• Flush mucous membranes with water
• No evidence of benefit for:
– application of antiseptics or disinfectants
– squeezing (“milking”) puncture sites
• Avoid use of bleach and other agents
caustic to skin
• Evaluate tetanus immune status
Considerations When Using PEP
Risk of
Transmission
PEP
Risk of Adverse
Effects
Factors to consider in evaluating
risk
• Potential that the source fluid is infected,
• Timing of the exposure,
• Nature of the exposure (e.g., blood-mucous
membrane)?
• Amount of bodily fluid exposed to,
• Risk of transmission based on the nature of
the exposure.
Factors to consider in evaluating
risk
• Potential that the source fluid is infected,
• Timing of the exposure,
• Nature of the exposure (e.g., blood-mucous
membrane)?
• Amount of bodily fluid exposed to,
• Risk of transmission based on the nature of
the exposure.
Assessing the source
• Source-known or unknown?
• If known, what is the HIV infection status?
• If unknown, what is the likelihood of
infection?
– HIV test (rapid or EIA) if source is present
Postexposure Management:
Unknown or Untestable Source
• Consider information about exposure
– where and under what circumstances
– prevalence of HIV in the population group or
the environment
• Testing of needles and other sharp instruments
not recommended
– unknown reliability and interpretation of
findings
– hazard of handling sharp instrument
Factors to consider in evaluating
risk
• Potential that the source fluid is infected,
• Timing of the exposure,
• Nature of the exposure (e.g., blood-mucous
membrane, deep or superficial)?
• Amount of bodily fluid exposed to,
• Risk of transmission based on the nature of
the exposure.
Timing
• Viability of virus
– How long has the body fluid been present on
object before exposure?
– 8% viability in syringe at room temp for 3
weeks, and <1% at higher temps for 1 week
(Abdala et. al, Subst Use and Misue, 2000)
• Efficacy of prophylaxis
Factors to consider in evaluating
risk
• Potential that the source fluid is infected,
• Timing of the exposure,
• Nature of the exposure (e.g., blood-mucous
membrane, deep or superficial)?
• Amount of bodily fluid exposed to,
• Risk of transmission based on the nature of
the exposure.
Risk of Occupational Percutaneous
Exposure
• CDC surveillance--1,440 HCW with
percutaneous exposures to HIV+ blood
(0.28% seroconversion)
• 23 aggregate studies 20 of 6,202 (0.32%)
seroconversion.
Risk of Occupational Percutaneous
Exposure
• Case-control study of HIV seroconversion in
HCW (33 cases/665 controls) in U.S, U.K.,
Europe
• Use of zidovudine (ZDV) was associated with
an 81% decrease in the risk for HIV infection
– limitations include a small number of cases,
and that cases and controls came from
different cohorts (Cardo et al, NEJM 1997;337:1485-90.)
• Evaluation of risk factors
Risk Factors for HIV Transmission After
Percutaneous Exposure to HIV-Infected Blood:
CDC Case-Control Study*
Risk Factor
Adjusted OR ratio (95% CI)
Deep injury
Visible blood on device
Procedure involving needle
placed in artery or vein
Terminal illness in source patient
Postexposure use of zidovudine
15 (6.0-41)
6.2 (2.2-21)
4.3 (1.7-12)
5.6 (2.0-16)
0.19 (0.06-0.52)
*Cardo et al., New Engl J Med 1997;337:1485-90.
Factors to consider in evaluating
risk
• Potential that the source fluid is infected,
• Timing of the exposure,
• Nature of the exposure (e.g., blood-mucous
membrane, deep or superficial)?
• Amount of bodily fluid exposed to,
• Risk of transmission based on the nature of
the exposure.
Estimated per-act risk for acquisition of HIV
by exposure route.
Exposure Route
Blood transfusion
Needle-sharing IDU
Risk per 10,000
exposures to infected
source
9,000
67
Receptive anal intercourse
50
Percutaneous needle stick
30
Receptive penile-vaginal intercourse
10
Insertive penile-vaginal intercourse
5
Receptive oral intercourse
1
MMWR 54:no.RR-2, 2005
Risks of Sexual HIV
Transmission
• Studies of risk evaluation of HIV discordant
couples.
• Risks evaluated include type of sex act,
frequency and use of condoms.
• Mathematical modeling of studies was used
to quantify per act risk on the basis of
choice of partner, sex act, and condom use.
(Varghese et. al., Sex Transm Dis 2002:29:38-43)
Estimated per-act risk for acquisition of HIV
by exposure route.
Exposure Route
Blood transfusion
Needle-sharing IDU
Risk per 10,000
exposures to infected
source
9,000
67
Receptive anal intercourse
50
Percutaneous needle stick
30
Receptive penile-vaginal intercourse
10
Insertive penile-vaginal intercourse
5
Receptive oral intercourse
1
MMWR 54:no.RR-2, 2005
HIV Risk after Sexual Assault
• Studies in women—higher rates of genital
trauma relative to consensual sex acts,
• Men and boys also victims of rape,
• Three documented cases of HIV
serconversion after sexual assault in
literature among women,
• In children (1998) 26 with AIDS and h/o
sexual assault (Lindegren, Pediatrics 1998:102:e46)
Risks after found needle
exposure
•
•
•
•
•
Source of needle often unknown
Unknown period of time
Small bore needle
Small amounts of fluid, if any
Likely low risk of HIV transmission
Decision Algorithm for
Management of nonoccupational
HIV exposures
MMWR 54:No. RR-2,
January 21, 2005
Case 1--needle found in pocket
• More information gathered
• Blood visible in needle
• Family member stated they would be
concerned that this was from an IDU
• No further information on the source, or
length of time needle had been in the
pocket.
Considerations When Using PEP
Risk of
Transmission
PEP
Risk of Adverse
Effects
Antiretroviral Medications have
significant side effects
• Important to counsel patient about side effects,
• Most common side effects, occurring in >50% of
patients on some of the regimens:
–
–
–
–
Nausea
Fatigue
Diarrhea
Anorexia
• Among HCW <50% complete Px
Reported Cases of Toxicity Associated
with Nevirapine for PEP*
• Fulminant liver failure (one requiring liver
transplantation) and hypersensitivity reaction
have been reported in healthcare personnel
taking nevirapine for PEP
• FDA has received 22 reports of serious adverse
events related to nevirapine taken for PEP
– hepatotoxicity (12 cases)
– skin rash (14 cases)
– rhabdomyolysis (1 case)
*MMWR 2001;49:1153-1155
Nevirapine not used as PEP
• Recent FDA updates that nevirapine not be
started as initial therapy in HIV-infected
individuals with relatively good immune
systems.
Important Concepts about HIV PEP
• Determining which and how many agents to
use for PEP is largely empiric
• Professional judgement should be used
based on local knowledge and experience in
treating HIV
• Regimens should be tolerable to the
exposed person
HIV PEP
• Depending on risk of transmission, some
experts may decide to use 2 vs. 3
medications (never monotherapy).
• If there is information about an HIV
positive source, prophylaxis may be
selected based on the source’s medication
regimen and viral resistance pattern.
Antiretroviral medications
• Continued increase in the number of
medications available for treatment and
prophylaxis
• Select medications that are readily available.
• 3 drug regimen available at CHOA:
AZT/3TC=Combivir
PLUS
Lopinavir/Ritonavir=Kaletra
Kaletra/Combivir
Once a day regimens
Postexposure Management:
HIV Postexposure Counseling
• Side effects of PEP
drugs
• Signs and symptoms
of acute HIV
infection
– fever
– rash
– flu-like illness
• Prevention of secondary
transmission
– sexual abstinence or
condom use
– no blood/tissue
donation
No work restriction indicated
Management of Exposure
• Obtain baseline HIV EIA, HBV sAg and
HBV sAb (to determine if vaccine
responder), HCV Ab.
• If sexual assault, w/u for STD’s, pregnancy
in women (prior to initiating PEP).
Re-evaluation of HIV-Exposed Person
Consider re-evaluation of the exposed person
within 72 hours
– additional information about the source
person may become available
– if the source person has a negative HIV
antibody test, stop PEP
Postexposure Management:
Follow-up HIV Testing of Exposed Person
• If source HIV positive or unknown, test at 6
weeks, 3 months, 6 months
– EIA standard test
– direct virus assays not recommended
• Testing of CBC and Chemistry panel at 2
weeks to assess for side effects of
medications.
Elements of Postexposure Management
• Wound management
• Assessment of infection risk
• Baseline testing
• Appropriate treatment, follow-up,
and counseling
Resources
Emory Pediatric Infectious Disease
First Call Pager: PIC #50174
Office: (404) 727-5642
HIV PEPline
• National Clinicians’ Post-Exposure
Prophylaxis Hotline (PEPline)
• Free consultation for clinicians treating
occupational exposures to HIV and other
bloodborne pathogens.
• 24 hours a day
• 7 days a week
• 1-888-HIV-4911
• http://www.ucsf.edu/hivcntr/
•
a joint program of UCSF/SFGH CPAT / EPI Center
supported by HRSA and CDC
CASE 2
THE BITE
CASE 2
• 11 year old in PMD office
• He had bitten another boy 24 hours
before
• Child bitten is known HIV+
CASE 3
Look Mom,
A Balloon!!
CASE 3
• 6 year old boy
• Found a recently used condom in a
public place 2 hours before,
• Blowing balloons
Updated U.S. Public Health Service
Guidelines for the
Management of Occupational
Exposures to HBV, HCV, and HIV
and Recommendations for
Postexposure Prophylaxis
CDC. MMWR 2001;50(RR-11)
http://www.cdc.gov/mmwr/PDF/rr/rr5011.pdf
Risk of Bloodborne Virus Transmission
after
Occupational Percutaneous Exposure
Source
HBV
HBeAg +
HBeAg HCV
Risk
22.0-30.0%
1.0-6.0%
1.8%
HIV
0.3%
Concentration of HBV in Body Fluids
High
Moderate
Blood
Serum
Wound exudates
Semen
Vaginal Fluid
Saliva
Low/Not
Detectable
Urine
Feces
Sweat
Tears
Breast Milk
Postexposure Management:
Baseline HBV Testing of Exposed* Person
• Test for anti-HBs if person has been
vaccinated, but vaccine response is
unknown
• Baseline testing not necessary if exposed
person has not been vaccinated or vaccine
response is known
* Source HBsAg positive or status
unknown
Efficacy of HBV PEP*
Regimen
Prevention of HBV Infection
Multiple doses of HBIG
alone when 1st dose
initiated within 1 week
Hepatitis B vaccine series
alone
Combination of HBIG and
vaccine series
* Estimated for adults, based on perinatal data
70-75%
70-75%
85-95%
Recommended Postexposure Management: PEP for
Exposure to HBV
Vaccination and
antibody status of
exposed person
Treatment when source is
HBsAg positive
Unvaccinated
HBIG x 1 and initiate hepatitis B
vaccine series
Previously vaccinated
Known responder
No treatment
Known nonresponder
HBIG x 1and initiate revaccination or
HBIG x 2
Antibody response
unknown
Test exposed person for anti-HBs
• If adequate, no treatment
• If inadequate, HBIG x 1
and vaccine booster
Recommended Postexposure Management:
PEP for Exposure to HBV
Vaccination and antibody
status of exposed person
Treatment when source is not
tested or status unknown
Unvaccinated
Initiate hepatitis B vaccine series
Previously vaccinated
Known responder
No treatment
Known nonresponder
If known high-risk source treat as if
source were HBsAg positive
Antibody response
unknown
Test exposed person for anti-HBs
1. If adequate, no treatment
2. If inadequate, vaccine booster
and recheck titer in 1-2 mos
Postexposure Management:
Follow-up HBV Testing of Exposed Person
• Perform follow-up anti-HBs testing in
exposees who receive hepatitis B vaccine
– test for anti-HBs 1-2 months after last dose
– anti-HBs response to vaccine cannot be
ascertained if HBIG received in the
previous 3-4 months