Post Exposure Prophylaxis
(PEP/oPEP)
Dr Don Ajith Karawita
MBBS (PERA), PgD Ven (COL), MD Venereology (COL)
(Senior Registrar in Venereology)
National STD/AIDS Control Programme
CDC Guidelines 2001.
CDC
headquarters
in Atlanta
Standard Precautions
1. Hand washing
7. Occupational health and
blood borne pathogens
2. Gloves
– Handling of sharps
3. Personal protective
– Prevention of mucous
equipment (PPE)
membrane exposures
4. Patient care equipments
– Management of needle
– Cleaning of instruments
5. Environmental control
– Management of spills
6. Linen management
stick accident or mucous
membrane exposure
– Collection and transport of
specimens
8. Patient isolation
Additional Precautions
1. Transmission based precautions
–
–
–
Airborne precautions (droplet nuclei < 5µm)
Droplet precautions (droplet nuclei > 5µm)
Contact precautions / isolation
2. Strict isolation
3. Aseptic precautions
•
•
Cleaning of entry site of the body
Hands of the staff must be disinfected and
gloved.
Choice of method
RISK GROUP
High risk (Critical)
Direct contact with a
break in skin or mucous
membrane or entering a
sterile body area.
Intermediate risk
(Semi-critical)
Direct contact with
mucous membranes or
non-intact skin
EXAMPLES
CHOICE OF
PROCESSING
Surgical instruments,
Needles, Syringes,
cystoscopes,
Laparoscopes, Surgical
dressings.
Must be sterile
Heat sterilization
(autoclaving), chemical
sterilants
Endoreacheal tubes,
Gastroscopes & other
endoscopes.
High level disinfection
acceptable, liquid
chemicals.
Low risk (Non-critical) Stethoscopes, BP
Low level disinfection
Items in contact with intact apparatus, bed pans,
urinals
skin.
or through cleaning with
detergent acceptable
Disinfectant / Antiseptic
• Alcohol
– Surgical spirit
(60% isopropyl
alcohol)
– 70% ethyl alcohol
– Alcohol hand rub
(Isopropyl alcohol with
glycerol)
• Aldehydes
– Cidex
(2% glutaraldehyde
solution)
• Chlorhexidines
– Hibisol
(0.5% chlorhexidine in
70% alcohol
– Hibitane
(4% chlorhexidine
gluconate
– Hibiscrub
(4% chlorhexidine
gluconate with a
detergent)
Disinfectant / Antiseptic
• Chlorine releasing
agents
– TCL, Bleaching powder
(Calcium hypochiorite 35%
w/w of available chlorine)
– Sodium hypochlorite
liquid form
•
•
•
•
5% stock solution
1% (10,000ppm)
0.1%(1000ppm)
0.01% (125ppm) Milton
• Iodophors
– Betadine, Wokadine
(10% solution, available
iodine 1%)
– Betadine scrub,
Wokadine scrub (7.5%
Povidone iodine scrub,
avilable iodine 0.75%
• Peracetic acid
– Perasafe (Peracetic
acid)
• Phenolic disinfectants
– Lysol (2%, 5%
solutions)
Hospital waste
Hazardous waste
1. Sharps
General or Nonhazardous waste
1. Infectious waste
(incinaration/ Burial)
2. Pathologicl waste
(incinaration/ Burial)
Dispose to
common
garbage site/bin
3. Chemical waste
(Returned to supplier/ MSD)
4. Pharmaceutical waste
(Returned to supplier/ MSD)
5. Radioactive waste
(Keep for radioactive
decay→Dispose as non
hazardous waste)
Collected by local
authorities
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV),
and Human Immunodeficiency Virus (HIV)
•
•
•
•
Bloodborne viruses
Can produce chronic infection
Transmissible in healthcare settings
Data from multiple sources (e.g.,
surveillance, observational studies,
serosurveys) used to assess risk of
occupational transmission
Risk of Bloodborne Virus Transmission after
Occupational Percutaneous Exposure
Source
Risk
HBV
HBeAg +
HBeAg -
22.0-30.0%
1.0-6.0%
HCV
1.8%
HIV
0.3%
Evaluation - Occupational exposure to
infectious materials
Patient
Percutaneous
Severe, Less
severe
1.Exposure
Mucous
membrane/Non
intact skin
3. Determine
Infectious Status
of Source
2. Exposure
Substance
Blood, Bloody fluid,
OPIM
Small volume,
Large volume.
Health care worker 4. Determine
Susceptibility of
(HCW)
Exposed Person
Elements of Postexposure Management
• Wound management & Exposure
reporting → Step 1
• Risk Assessment → Step 2
– (1) blood borne infection status of source
person
– (2) Infectious material
– (3) type and severity of exposure
– (4) Susceptibility of HCW
• Appropriate treatment → Step 3
• Follow-up, and counseling → Step 4
Step 1 Provide immediate care to the
exposure site
• Post exposure Wound Management:
– Wash wounds and skin 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
• Inform authorities → Infection control unit.
Management of sharps accidents
WHO / SEAR 1999
WHO / SEAR 1999
Elements of Postexposure Management
• Wound management & Exposure
reporting → Step 1
• Risk Assessment → Step 2
– (1) blood borne infection status of source
person
– (2) Infectious material
– (3) type and severity of exposure
– (4) Susceptibility of HCW
• Appropriate treatment → Step 3
• Follow-up, and counseling → Step 4
Postexposure Management:
Risk Assessment (Seek expert advice)
Infectious status of the source
person (SC)
– presence of HBsAg
– presence of HCV antibody
– presence of HIV antibody
– if source unknown, assess
epidemiologic and clinical
evidence (Do not test discarded
needles)
Body substance
– blood
– bloody fluid
– Other potentially infectious
materials (OPIM)
(semen, vaginal secretions
and CSF, synovial, pleural,
peritoneal, pericardial and
amniotic fluids) or tissue
Type of exposure (EC)
–
–
–
–
percutaneous
mucous membrane
non-intact skin
bites resulting in blood
exposure
Determine susceptibility of
exposed person (HCW)
– Hepatitis B vaccine status
– HBV immune status if
vaccine response status
in unknown
– Anti-HCV and ALT
– HIV antibody
Elements of Postexposure Management
• Wound management & Exposure
reporting → Step 1
• Risk Assessment → Step 2
– (1) blood borne infection status of source
person
– (2) Infectious material
– (3) type and severity of exposure
– (4) Susceptibility of HCW
• Appropriate treatment → Step 3
• Follow-up, and counseling → Step 4
Step 3 Give PEP for exposures posing
risk of infection transmission
• HBV
– Give oPEP as soon as possible within 24 hours.
– PEP can be given to pregnant women
• HCV
– PEP not recommended
• HIV
– Initiate PEP within hours of exposure (2-72 Hours)
– Offer pregnancy testing to all women of child bearing age
not known to be pregnant.
– Seek expert consultation if viral resistance suspected.
– Administer PEP for 4 weeks if tolerated.
oPEP
Hepatitis B
Infection
Concentration of HBV in Body Fluids
High
Moderate
Low/Not
Detectable
Blood
Serum
Wound exudates
Semen
Vaginal Fluid
Saliva
Urine
Feces
Sweat
Tears
Breast Milk
Vaccination and
antibody response
status of exposed
worker*
Unvaccinated
Treatment when source is found to be:
HBsAg positive
HBsAg
negative
Source unknown
or not available
for testing
HBIG x1 and initiate
Hepatitis B vaccine
series.
Initiate
hepatitis B
vaccine
series
Initiate hepatitis B
vaccine series
Known responder
No treatment
No treat.
No treatment
Known nonresponder
HBIGx1 and initiate revaccination or HBIGx2
No
treatment
If known high risk source,
treat as if source were
HBsAg positive
Antibody response
unknown
Test exposed person for No
anti-HBs
treatment
1. If adequate, no
treatment.
2. If inadequate,
HBIGx1 and vaccine
booster.
Test exposed person for
anti-HBs: 1. If adequate,
no Treatment
2. If inadequate, vaccine
booster and recheck titer
in 1-2 months.
Previously vaccinated
• Persons who have previously been infected with HBV are
immune to reinfection and do not require PEP.
• Hepatitis B immunoglobulin: dose 0.06ml/kg im
• A responder is a person with adequate levels of serum
antibody to HBsAg (i.e. anti-HBs > 10mIU/ml): a nonresponder is a person with inadequate response to
vaccination (i.e. serum anti-HBs antibody< 10mIU/ml)
• The option of giving one dose of HBIG and reinitiating the
vaccine series is preferred for non-responders who have
not completed a second 3-dose vaccine series. For those
who previously completed a second vaccine series but
failed to respond, 2doses of HBIG are preferred. Give one
dose at time of exposure, and the second dose one month
later.
Efficacy of HBV PEP*
Regimen
Prevention of HBV Infection
Multiple doses of HBIG alone
when 1st dose initiated within 1
week
70-75%
Hepatitis B vaccine series alone
70-75%
Combination of HBIG and vaccine
series
85-95%
* Estimated for adults, based on perinatal data
Hepatitis B Vaccine: Long-Term Efficacy
• Anti-HBs titers decline to <10 mIU/mL in 3050% of adults within 8-10 years after
vaccination
• Exposure to HBV results in anamnestic antiHBs response that prevents clinically
significant HBV infection
• Immune memory remains intact for at least 20
years after immunization
• Chronic HBV infection rarely documented
among vaccine responders
• Booster doses currently not recommended
oPEP
Hepatitis C
Infection
oPEP
Hepatitis C Infection
Not recommended
oPEP
HIV Infection
Overview of the HIV clinical disease
AIDS
HIV
Seroconversion
illness
Clinical
stage 4
33%
Clinical
stage 2
75%
Clinical stage 1
1-4wks 3wks
8 to 12 years
Clinical
stage 3
AIDS Defining
illnesses
Natural History of HIV Infection
Percutaneous injuries
Infection status of the source
HIV-positive,
class 1
Aymptomatic
HIV infection or
known low viral
load (e.g.
<1500)
HIV-positive,
class 2
Symptomatic HIV
infection, AIDS,
Acute
seroconversion,
or known high
viral load
Source of
unknown HIV
status
(e.g deceased
source person
with no samples
available for HIV
testing)
Unknown
source
(e.g. a
needle
from a
sharps
disposal
container)
HIV
negat
ive
Less severe (e.g.
solid needle,
superficial injury)
Recommend
basic 2-drug
PEP
Recommend
expanded 3-drug
PEP.
Generally, no
PEP
Generally,
no PEP
No
PEP
More severe
(e.g. large-bore
hollow needle,
deep puncture,
visible blood on
device or needle
used in patient’s
artery or vein)
Recommend
expanded 3drug PEP.
Recommend
expanded 3-drug
PEP.
Generally, no
PEP
Generally,
no PEP
No
PEP
Exposure
type
Mucous membrane exposures and non-intact skin
exposures.
Infection status of the source
HIV-positive,
class 1
Asymptomat
ic HIV
infection or
known low
viral load
(e.g. <1500)
HIV-positive,
class 2
Symptomatic
HIV infection,
AIDS, acute
seroconversion
, or known high
viral load
Source of
unknown HIV
status
(e.g. deceased
source person
with no samples
available for
HIV testing)
Unknown
HIVsource
Negativ
(e.g. splash e
from
inappropriat
ely
disposed
blood)
Small
volume
(e.g. few
drops)
Consider
basic 2-drug
PEP
Recommend
basic 2-drug
PEP
Generally, No
PEP
Generally,
No PEP
No
PEP
Large
volume
(e.g. major
blood
splash)
Recommend Recommend
basic 2-drug expanded 3PEP
drug PEP
Generally, No
PEP
Generally,
No PEP
No
PEP
Exposure
type
• If drug resistance is a concern, obtain expert consultation.
Initiation of PEP should not be delayed pending expert
consultation and, because expert consultation alone cannot
substitute for face-to-face counseling, resource should be
available to provide immediate evaluation and follow-up care for
all exposures.
• The designation “consider PEP” indicates that PEP is optional
and should be based on as individualized decision between the
exposed person and the treating clinician. However, consider
basic 2-drug PEP for a source with HIV risk factors, or occurs in
a setting where exposure to HIV-infected persons is likely.
• If PEP is offered and taken, and the source is later determined
to be HIV negative, PEP should be discontinued.
• For skin exposures, follow-up is indicated only if there is
evidence of compromised skin integrity (e.g. dermatitis,
abrasion, or open wound)
Considerations When Using PEP
Risk of Transmission
PEP
Risk of Adverse
Effects
Postexposure Management: HIV PEP
Basic Regimen
Basic Regimen
Zidovudine (ZDV)
Lamivudine (3TC)
200 mg tid (300 mg PO bid)
150 mg bid
Alternate Basic Regimens
Didanosine (ddI)
Stavudine (d4T)
200 mg bid (125 mg bid if <60 kg)
40 mg bid (30 mg bid if <60 kg)
Stavudine (d4T)
Lamivudine (3TC)
40 mg bid (30 mg bid if <60 kg)
150 mg bid
Postexposure Management: HIV
Expanded Regimen
Expanded Regimen
Basic regimen plus one of the following
Indinavir (IDV)
800 mg q8h
Nelfinavir (NFV)
750 mg tid or 1250 mg bid
Efavirenz (EFV)
600 mg daily
Abacavir (ABC)
300 mg bid
Elements of Postexposure Management
• Wound management & Exposure
reporting → Step 1
• Risk Assessment → Step 2
– (1) blood borne infection status of source
person
– (2) Infectious material
– (3) type and severity of exposure
– (4) Susceptibility of HCW
• Appropriate treatment → Step 3
• Follow-up, and counseling → Step 4
Step 4 Perform follow up testing and provide counseling
HBV Infection
HCV infection
HIV Infection
Advice exposed persons to seek
medical evaluation for any acute
illness occurring during follow-up
Advice exposed persons
to seek medical
evaluation for any acute
illness occurring during
follow-up
Perform HIV antibody testing for
illness compatible with an acute
retroviral syndrome.
Test for anti-HBs 1-2 months after
last dose of vaccine if only
vaccine given. (anti-HBs response to vaccine
Perform testing for antiHCV and ALT 4-6
months after exposure
cannot be ascertained if HBIG received in the previous
3-4 months)
Evaluate exposed persons taking
PEP within 72 hours after
exposure and monitor for drug
toxicity for at least 2 weeks.
Follow-up not indicated if exposed Perform HCV RNA
person immune to HBV or received testing at 4-6 weeks if
HBIG PEP
earlier diagnosis of HCV
infection desired
Perform HIV-antibody testing for
at least 6 months postexposure
(e.g. at baseline, 6 weeks, 3
months, and 6 months)
Prevent secondary transmission
on during the follow-up period.
Refrain from donating blood,
plasma, organs, tissue, or semen.
No need for: modification of sexual
practices or patient care, refraining
from conception
Prevent secondary
transmission on during the
follow-up period.
Confirm repeatedly
reactive anti-HCV EIA
with supplemental test
Preventing Transmission of
Blood borne Viruses
in Healthcare Settings
Frequency of Percutaneous Injury in
Healthcare Personnel
• Based on CDC estimates, 384,325 (95% CI
311,091-463,922) percutaneous injuries are
sustained by healthcare personnel in US
hospitals annually*
• The number of injuries sustained outside of
hospital settings is unknown
• Frequency of percutaneous injury varies by
occupational group and healthcare setting
* Panlilio, AL, et. al. Estimate of the Annual Number of
Percutaneous Injuries in U.S. Healthcare Workers. 4th Decennial
Conference, March 5-9, 2000
Preventing Transmission of Bloodborne Viruses
in Healthcare Settings
• Promote hepatitis B vaccination
• Treat all patients as potentially
infectious
• Use barriers to prevent
blood/body fluid contact
• Prevent percutaneous injuries