HIV, Hepatitis B and Hepatitis C – Management of Health Care Workers Potentially
Exposed
Summary
The purpose of this Policy Directive is to assist health services to appropriately assess and
manage a health care worker following an occupational exposure in order to prevent
disease transmission.
Document type
Policy Directive
Document number
PD2017_010
Publication date
04 May 2017
Author branch
Health Protection NSW
Branch contact
(02) 9391 9192
Replaces
PD2017_009
Review date
04 May 2022
Policy manual
Not applicable
File number
16/2631
Status
Active
Functional group
Clinical/Patient Services - Incident Management, Infectious Diseases
Personnel/Workforce - Occupational Health and Safety
Population Health - Communicable Diseases, Infection Control
Applies to
Affiliated Health Organisations, Board Governed Statutory Health Corporations, Chief
Executive Governed Statutory Health Corporations, Community Health Centres, Dental
Schools and Clinics, Environmental Health Officers of Local Councils, Government Medical
Officers, Local Health Districts, Ministry of Health, NSW Ambulance Service, NSW Health
Pathology, Private Hospitals and day Procedure Centres, Public Health System Support
Division, Public Health Units, Public Hospitals, Specialty Network Governed Statutory
Health Corporations
Distributed to
Divisions of General Practice, Environmental Health Officers of Local Councils,
Government Medical Officers, Ministry of Health, NSW Ambulance Service, Private
Hospitals and Day Procedure Centres, Public Health System, Tertiary Education Institutes
Audience
All clinical staff
Policy Directive
Secretary, NSW Health
This Policy Directive may be varied, withdrawn or replaced at any time. Compliance with this directive is mandatory
for NSW Health and is a condition of subsidy for public health organisations.
POLICY STATEMENT
PD2017_010
Issue date: May-2017
Page 1 of 2
HIV, HEPATITIS B AND HEPATITIS C MANAGEMENT OF HEALTH
CARE WORKERS POTENTIALLY EXPOSED
PURPOSE
Human immunodeficiency virus (HIV), hepatitis B and hepatitis C may be transmitted
by significant percutaneous or mucosal exposure to infective blood or other infective
body substances. Occupational exposure is defined as an incident that occurs during
the course of a person’s employment and involves direct contact with blood or other
body substances. Such exposures may put the person at risk of acquiring a blood
borne virus infection. The purpose of this Policy Directive is to assist Health Services
to appropriately assess and manage a health care worker following an occupational
exposure in order to prevent disease transmission.
MANDATORY REQUIREMENTS
All health facilities within the NSW public health system are required to implement
this Policy Directive. It is also recommended that licensed private health care
facilities have regard to this Policy Directive.
Facilities must ensure that:
An efficient local system is established for reporting and managing potential
exposures of HCWs (including non-LHD, non-hospital based health staff or
volunteers) to blood borne viruses
HCWs (including non-LHD, non-hospital based health staff or volunteers) and
source patients have access to blood borne virus testing, as appropriate,
following an occupational exposure
Confidentiality is maintained for all testing and reporting relating to
occupational exposures
All staff are aware of whom to contact for advice regarding occupational
exposures
Expert advice is available to all HCWs (including non-LHD, non-hospital
based health staff or volunteers) 24 hours a day following a potential BBV
occupational exposure to enable rapid assessment and, if needed, timely
administration of prophylaxis
All occupational exposures are reported to SafeWork NSW as required under
the Work Health and Safety Act (s35 and 36) and Work Health and Safety
Regulation (cl699) (Refer to SafeWork NSW Factsheet
http://www.safework.nsw.gov.au/media/publications/health-and-safety/when-
to-notify-blood,-body-fluid-and-needlestick-exposure-incidents)
HCWs are able to obtain the support to which they are entitled, including
access to an Employee Assistance Program or workers compensation if
appropriate as documented in NSW Policy Directive Employee Assistance
Program (PD2016_045)
POLICY STATEMENT
PD2017_010
Issue date: May-2017
Page 2 of 2
The local Public Health Unit is notified in the rare event that hepatitis B or
hepatitis C is transmitted from a patient to a health care worker.
Health care workers must ensure that:
All exposures to blood and body substances are reported as per local
protocols.
IMPLEMENTATION
Sections 2 to 5 describe the procedures to be followed by health care workers and
health facilities in the event that a health care worker is potentially exposed to a
blood borne virus following an occupational exposure.
REVISION HISTORY
Version
Amendment notes
May 2017
(PD2017_010)
Formatting changes.
April 2017
(PD2017_009)
HIV testing and post exposure prophylaxis
recommendations have been updated. A requirement
for health facilities to notify their local public health
unit in the rare event of blood borne virus
transmission to a health care worker has been
added. Evidence relating to occupational
transmission of BBV has been updated.
January 2005
(PD2005_311)
Minor amendments.
June 2003
Circular 2003/839
Updates regarding to use of newer antiretroviral
therapies.
1998
Circular 1998/11
New circular.
ATTACHMENTS
1. HIV, Hepatitis B and Hepatitis C Management of Health Care Workers
Potentially Exposed: Procedures.
PD2017_010
Issue date: May-2017
Contents page
HIV, Hepatitis B and Hepatitis C Management of
Health Care Workers Potentially Exposed
PROCEDURES
Issue date: May-2017
PD2017_010
HIV, Hepatitis B and Hepatitis C Management of
Health Care Workers Potentially Exposed
PROCEDURES
PD2017_010
Issue date: May-2017
Contents page
CONTENTS
1 BACKGROUND ........................................................................................................................ 1
1.1 About this document ......................................................................................................... 1
1.2 Key abbreviations and definitions ..................................................................................... 1
1.3 Legal and legislative framework ....................................................................................... 2
2 IMMEDIATE CARE OF THE EXPOSED HEALTH CARE WORKER .................................... 2
3 RISK ASSESSMENT OF THE EXPOSURE ............................................................................ 2
4 MANAGEMENT OF EXPOSURES WITH NO RISK OF BLOOD BORNE VIRUS
TRANSMISSION ...................................................................................................................... 4
5 MANAGEMENT OF EXPOSURES WITH POTENTIAL FOR BLOOD BORNE VIRUS
TRANSMISSION ...................................................................................................................... 4
5.1 Post exposure prophylaxis ............................................................................................... 4
5.2 Risk assessment of the source patient ............................................................................ 5
5.2.1 Source negative for HIV, HBV and HCV .............................................................. 6
5.2.2 Source with unknown infectious status and source unable to be tested ............. 6
5.2.3 Source positive or potentially positive for HIV ...................................................... 7
5.2.4 Source positive or potentially positive for HBV .................................................. 10
5.2.5 Source positive or potentially positive for HCV .................................................. 11
5.3 Testing of the exposed HCW .......................................................................................... 13
5.4 Special situation: when a patient is exposed to the blood or body fluids of a HCW ..... 13
6 REFERENCES ........................................................................................................................ 15
APPENDIX A: MANAGEMENT OF THE EXPOSED HCW FOLLOWING AN
OCCUPATIONAL EXPOSURE .............................................................................................. 18
APPENDIX B: RECOMMENDED LABORATORY TESTING FOR THE EXPOSED HCW .. 19
APPENDIX C: HIV PEP RECOMMENDATIONS ................................................................... 20
APPENDIX D HEPATITIS B PEP RECOMMENDATIONS ................................................... 21
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1 BACKGROUND
1.1 About this document
Human immunodeficiency virus (HIV), hepatitis B and hepatitis C may be transmitted by
significant percutaneous or mucosal exposure to infective blood or other infective body
substances. Occupational exposure is defined as an incident that occurs during the
course of a person’s employment and involves direct contact with blood or other body
substances. Such exposures may put the person at risk of acquiring a blood borne virus
infection.
Adherence to infection prevention and control practices as outlined in the current version
of the NSW Infection Control Policy remains the first line of protection for health care
workers (HCWs) against occupational exposure to HIV, hepatitis B and hepatitis C. The
policy and guidelines for the NSW Health Service on prevention of sharps injuries are
documented in the NSW Policy Directive Sharps Injuries Prevention in the NSW Public
Health System (PD2007_052). The current version of the NSW Policy Directive
Occupational Assessment, Screening and Vaccination Against Specified Infectious
Diseases mandates that health staff directly involved in patient care and/or the handling
of human tissue, blood or body fluids complete the full course of hepatitis B vaccination
and provide their post vaccination serology result.
This policy directive outlines the procedures that should be followed in the event of an
occupational exposure including:
The immediate care to be taken by the exposed HCW
An assessment of the risk of blood borne virus transmission
Management of the exposed HCW including blood borne virus testing and post
exposure prophylaxis.
1.2 Key abbreviations and definitions
Appropriately skilled officer means a medical practitioner or nurse with expertise in
the assessment of the risk of blood borne virus transmission and the management of the
exposed HCW following an occupational exposure
anti-HBs antibody to hepatitis B surface antigen
BBV blood borne virus. Refers to HIV, hepatitis B and hepatitis C viruses.
HBV hepatitis B virus
HBIG hepatitis B immunoglobulin
HBsAg hepatitis B surface antigen
HCW health care worker. Refers to all persons working in healthcare settings who have
the potential for exposure to infectious/potentially infectious body fluids. This also
includes non-LHD, non-hospital based health staff and volunteers.
HCV hepatitis C virus
HIV human immunodeficiency virus
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PCR polymerase chain reaction
PEP post exposure prophylaxis
Source - person from whom blood or body fluids originated
Window period refers to the time after a person has been exposed and is the
maximum time it takes for a test to give an accurate result
1.3 Legal and legislative framework
Health Services have obligations under the Work Health and Safety Act 2011 (NSW) and
the Public Health Act 2010 (NSW) and their associated regulations.
2 IMMEDIATE CARE OF THE EXPOSED HEALTH CARE WORKER
After exposure to blood or other body substances the exposed HCW should as soon as
possible do the following:
Wash the exposure site with soap and water
Undertake appropriate care of any wound(s)
If eyes are contaminated then rinse them, while they are open, gently but
thoroughly with water or normal saline
If blood or other body substances get in the mouth, spit them out and rinse the
mouth with water several times
If clothing is contaminated remove clothing and shower if necessary
Inform their line manager so they can immediately be relieved from duty and notify
the appropriately skilled officer who is designated to conduct an urgent risk
assessment on potentially exposed staff (as per local reporting procedures) to
ensure that necessary further action is undertaken.
Sections 2 to 5 outline the procedures to be followed by health care workers and health
facilities following an occupational exposure. Refer to Appendix A for a summary of these
procedures and Appendix B for a summary of recommended laboratory testing.
3 RISK ASSESSMENT OF THE EXPOSURE
In the event of an occupational exposure, appropriately skilled officer/s should conduct a
risk assessment immediately. The first step in the risk assessment is to establish the type
of injury (see Table 1). Following this, consideration should be given to the body fluid
involved (see Table 2).
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Table 1: Risk of transmission of blood borne viruses from an infectious bodily fluid, by
injury type (based on UK guidelines
1
)
Level of risk
Injury type
Higher risk injury
Deep percutaneous injury
Visible blood on sharps
Needle used on source’s blood vessels
Lower risk injury
Superficial injury, exposure through broken
skin, mucosal exposure (usually splashes
to eye or mouth)
Old discarded sharps
No visible blood on sharps
Needle not used on blood vessels e.g.
suturing, subcutaneous injection needles
Injury with no risk
Skin not breached
Contact of body fluid with intact skin
Needle (or other sharp object) not used on
a patient before injury
Table 2: Body fluids and risk for blood borne virus transmission (based on UK
guidelines
1
)
Level of risk
Body fluid
Infectious (good evidence of BBV
transmission following occupational
exposure)
Blood
Visibly bloody body fluids
Potentially infectious (risk of BBV
transmission following occupational
exposure unknown)
(In alphabetical order):
Amniotic fluid
Cerebrospinal fluid
Human breast milk
Pericardial fluid
Peritoneal fluid
Pleural fluid
Saliva in association with dentistry (likely to
be contaminated with blood even when not
visibly so)
Semen
Synovial fluid
Tissue fluid from burns or skin lesions
Vaginal secretions
Not infectious (unless visibly blood
stained)
Nasal secretions
Saliva (non-dentistry associated)
Sputum
Stool
Sweat
Tears
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Urine
Vomit
Where the exposed HCW is uncertain about actions to be taken, the Blood and Body
Fluid Exposure Phoneline (formerly the NSW Needlestick Hotline) may assist. The Blood
and Body Fluid Exposure Phoneline is an information, support and referral service for
NSW based health care workers who sustain needlestick injuries and other blood/body
fluid exposures during the course of their work. The line is answered by an on-call nurse
7 days a week from 7am to 11pm and can be contacted on free call 1800 804 823 within
NSW. The Exposure Phoneline is not a reporting or surveillance service.
4 MANAGEMENT OF EXPOSURES WITH NO RISK OF BLOOD
BORNE VIRUS TRANSMISSION
Occupational exposures are not considered to have the potential for blood borne virus
transmission if either the injury is classified as no risk (Table 1) or the body fluid is not
infectious (Table 2). For such exposures, no further action with respect to the health
worker is required other than an opportunistic assessment of his/her protection against
hepatitis B in accordance with the current NSW Policy Directive Occupational
assessment, screening and vaccination against specified infectious diseases. Post
exposure prophylaxis (PEP) is not indicated and testing of the source patient is not
required. Such workers should be advised that the potential side effects and toxicity of
taking HIV PEP outweigh the negligible risk of transmission posed by this exposure
regardless of the HIV status of the source patient. No HCV or HIV testing of the exposed
HCW is required.
A risk assessment of the incident should be conducted and local documentation
procedures should be followed after each potential exposure.
5 MANAGEMENT OF EXPOSURES WITH POTENTIAL FOR BLOOD
BORNE VIRUS TRANSMISSION
An occupational exposure has the potential for blood borne virus (BBV) transmission if
the injury carries a risk (see table 1) and the body fluid is infectious/potentially infectious
(see table 2). Following all such exposures a risk assessment of the incident should be
conducted.
5.1 Post exposure prophylaxis
Post exposure prophylaxis (PEP) is available following exposure to HIV and hepatitis B. It
is recommended for all higher risk injuries involving an infectious/potentially infectious
body fluid. It should be considered for lower risk injuries involving an infectious/potentially
infectious body fluid (see Tables 1 and 2).
Greater efficacy is achieved the earlier prophylaxis is administered (ideally within 1-2
hours of exposure). The initiation of PEP should not be delayed while awaiting laboratory
testing of either the source patient or the health care worker. The continuation of PEP
should be reconsidered once laboratory results become available. Further information on
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PEP is found in section 5.2.3 (for HIV) and 5.2.4 (for HBV). Prophylaxis can be
commenced up to 72 hours post exposure.
5.2 Risk assessment of the source patient
Following occupational exposures that carry a risk of BBV transmission, officer/s
conducting the risk assessment should seek information on the BBV status of the source
patient as soon as is practicable.
If the blood borne virus status of the source patient at the time of the incident is unknown,
the staff conducting the risk assessment should arrange for the source patient to be
tested as soon as practicable for HIV, HBV and HCV infection (refer to Table 3). Results
of source testing will better inform the exposed HCW about the risk of transmission and
where PEP has been initiated, inform the need for continuation. Informed consent for
testing must be obtained from the source patient. The exposed HCW should not
approach the source patient for consent. If the patient does not provide consent, testing
cannot occur. Consent should also be sought for the results of testing to be provided to
the exposed HCW.
Occupational exposures occurring during autopsies should be managed as set out in
section 5.2.2.
Note that testing of the source patient for HBV infection is not required if the exposed
HCW has previous documented evidence of immunity to hepatitis B (anti-HBs level ≥10
mIU/mL at any time or HBcAb positive). Viral load should be measured for source
patients who are known, or discovered, to be infected with HIV, HCV or HBV. The
source should be offered immediate referral to a specialist service if a previously
undiagnosed blood borne virus is detected.
Table 3: Recommended testing of source patient
#
Combined HIV antigen and antibody immunoassay (fourth generation HIV test)
Hepatitis B surface antigen (not required if HCW has hepatitis B immunity)
Hepatitis C antibody*
#
Viral load should be measured for source patients who are known, or discovered, to be infected with
HIV, HCV or HBV
*Consider qualitative hepatitis C RNA testing if individual is at risk of hepatitis C infection as may be
antibody negative in acute infection and remain negative for up to 12 months if immunocompromised.
Source potentially in the window period
If the source patient tests negative for BBV infection but reports a recent (within previous
three months for HIV or six months for HBV and HCV) risk behaviour that places them at
high risk for infection, he/she should be advised to seek medical attention if they develop
signs and/or symptoms of primary infection. For their own health benefit, they should also
be advised to undergo testing for that BBV six weeks and 12 weeks after the exposure. If
the source is at risk of a recent hepatitis B or C infection final tests should be done at 24
weeks after exposure.
Follow up and documentation of source testing is not required by staff managing the
occupational exposure as it will not influence the care of the exposed HCW (due to timing
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of results). Until such time as infection can be excluded in the source, the exposed HCW
should be managed as for exposure to a positive source.
The risk assessment of the source patient is outlined in Table 4.
Table 4: Risk assessment of source patient (based on UK guidelines
1
)
Level of risk
Source
Higher risk source
Known to be infected with one or more blood borne viruses
(viral load and treatment status unknown)
Known to have a detectable viral load for one or more blood
viruses
Unknown viral load but known to have advanced or untreated
blood borne infection
Blood borne virus status unknown and known risk factors*
Lower risk source
Infected with a blood borne virus but known to have a fully
supressed viral load
Unknown viral load but receiving long term antiviral treatment
for blood borne virus with good adherence and known to be
stable
Blood tests at/near to the time of the incident were negative for
all three blood borne viruses but source reports ongoing risk
factors for blood borne viruses
Blood borne virus status unknown but had no known risk
factors for such viruses
Source with minimal or
no risk
Recent blood test that was negative for all three blood borne
viruses and no recent risk behaviours reported
* Example of risk factor may include intravenous drug use, men who have sex with men, origin or unprotected
sexual intercourse with a sexual partner from high prevalence area
1
for either HIV infection, or hepatitis B or
hepatitis C.
5.2.1 Source negative for HIV, HBV and HCV
In the event that the source undergoes testing and is found to be negative for HIV, HBV
and HCV and does not report recent behaviour that may place them at risk of a blood
borne virus then no further action is required. PEP, if commenced, should be
discontinued. If there is reason to suspect the self-reported risk history of the source may
unreliable or incomplete, the exposed HCW should be managed as per exposure to a
positive source (refer to sections 5.2.3 to 5.2.5).
5.2.2 Source with unknown infectious status and source unable to be tested
If the status of the source is not known then the risk of the source being positive for HIV,
HBV and HCV must be assessed from the available information relating to risk factors
1
Countries with population prevalence over 1% are considered to have a high prevalence of HIV. High
prevalence areas include the Caribbean, Sub-Saharan Africa, South East Asia and Papua New Guinea.
For the HIV seroprevalence for individual countries go to http://aidsinfo.unaids.org/. Areas reporting high
hepatitis C prevalence are sub-saharan Africa, North Africa and the Middle East, central, south and east
Asia and Eastern Europe. Areas of high hepatitis B endemicity include most of East and Southeast Asia
(except Japan), Pacific island groups, parts of central Asia and the Middle East, the Amazon Basin, and
sub-Saharan Africa. Refer to the Travelers’ Health section of the Centers of Disease Control and
Prevention website for further detail.
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known to be associated with BBVs (e.g. intravenous drug use, male homosexual sex and
origin or sexual partner from a high prevalence area). If there is a risk of the source being
infected with HIV, HBV or HCV then the exposed HCW should be managed as per
exposure to a positive source (refer to sections 5.2.3 to 5.2.5).
5.2.3 Source positive or potentially positive for HIV
Risk of HIV transmission from positive source patient
The overall risk of acquiring HIV infection following occupational exposure to HIV is low.
The average risk of HIV transmission (without prophylaxis) after a percutaneous
exposure to HIV infected blood has been estimated to be 0.3% (95% confidence interval
(CI): 0.2-0.5%).
2
The risk of seroconversion following mucous membrane exposure is
estimated to be 0.09% (95 % CI: 0.006%-0.5%) and the risk following non-intact skin
exposure is estimated to be even lower.
2
A case control study conducted by the US Centers for Disease Control and Prevention
showed that significant risk factors for HIV infection were deep injury (odds ratio (OR) =
15, 95% CI: 6.0-41), injury with a device that was visibly contaminated with the source
patient's blood (OR= 6.2, 95% CI: 2.2-21), a procedure involving a needle placed in the
source patient's artery or vein (OR =4.3, 95% CI 1.7-12), and exposure to a source
patient who died of the acquired immunodeficiency syndrome within two months
afterward (OR=5.6; 95 %CI: 2.0-16)
3
.
There have been no confirmed cases of HIV infection in a HCW following an
occupational exposure in NSW since 1994 and nationally since 2002. Only one
confirmed case of occupational HIV acquisition (involving a laboratory technician working
with a live HIV culture) has been reported in the US since 1999
4
. There has only been
one other case report of occupational HIV transmission in the developed world published
since 2005. In this instance, a nurse acquired HIV following a needle stick injury from a
patient (not previously known to have HIV) with a high viral load
5
. Due to delayed
reporting of the incident, PEP was not given. Table 5 shows a summary of the
occupational exposure registry reviews published in the international literature since
2005.
Table 5: Evidence of HIV transmission following occupational exposure
Country
Time
period
No. of HCW
exposures
to HIV
No. HIV
sero-
conversions
(rate)
Notes
Australia
6
2000-2003
13
0 (0%)
Includes percutaneous and mucous
membrane exposures. All given PEP
Brazil
7
1997-2009
80
0 (0%)
Includes only percutaneous injuries. No
information provided on PEP
Denmark
8
19992012
276
0 (0%)
Includes percutaneous and mucous
membrane exposures. All given PEP
Germany
9
2010-2012
51
0 (0%)
Includes only percutaneous injuries. PEP (3
drugs, mean time to start 75 mins >
exposure) given to 35/51 and for other 16
cases the source patient was known to have
a viral load <20 copies/mL at time of incident.
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Netherlands
10
2003-2010
60
0 (0%)
Includes only percutaneous injuries. No
information provided on PEP
Thailand
11
19962014
84
0 (0%)
Includes percutaneous, mucous membrane
and non-intact skin exposures. All offered
PEP, completed in 62/84 instances.
United
Kingdom
12
2004-2013
1478
0 (0%)
Includes percutaneous, mucous membrane
and non-intact skin exposures. 1135 (77%)
given PEP.
Post exposure prophylaxis (PEP)
Based on evidence from animal models and what is known about primary HIV infection,
there is a window of opportunity following exposure to HIV, during which antiviral
medication may prevent infection. However, the evidence for efficacy of PEP in
preventing HIV acquisition is limited
13,14
. A small US case-control study of HIV
seroconversion in HCWs after percutaneous exposure published in 1997 provided the
first evidence in humans that PEP seemed to be protective against infection
3
. This study
found that zidovudine PEP was associated with an 81% reduction in the odds of infection
after adjustment for relevant exposure risk factors. There have been 24 reports of PEP
failure following occupational needle stick exposures in the literature
15
. In over three
quarters of these instances, zidovudine only was used; only six instances of PEP failure
in the context of occupational needle stick injury have been reported with multi-drug
regimens with three of these occurring after 1999. Factors that may have contributed to
the failure of the combination drug PEP include drug resistance (in 3 cases the HCW was
found to be infected with a strain resistant to the PEP regimen), exposure to a high HIV
viral load and delayed initiation of PEP.
16,17,18,19
Multi-drug regimens are now prescribed to prevent HIV infection following exposure.
However, there is no definitive evidence to support a two versus a three-drug regimen.
Instead, the additional benefit of a third drug must be weighed against the cost and
potential harms.
While newer HIV antiretrovirals are less toxic and better tolerated than the older HIV
drugs, adverse effects still occur. In addition, serious drug interactions can occur when
antiretroviral agents are used with certain other drugs. More commonly reported side
effects include nausea, vomiting, diarrhoea and fatigue. Rare, but important side effects
of tenofovir include acute renal failure and proximal renal tubolopathy (Fanconi’s
syndrome). There is a small risk of rhabdomyolysis with raltegravir.
The need for HIV PEP depends on an assessment of the risk of transmission and
consideration of the potential adverse effects. Where possible, information concerning
the source’s stage of HIV infection, viral load, resistance testing and history of therapy
and medication adherence should be ascertained so that the most appropriate therapy
and counselling can be offered. While the evidence supports a significantly lower risk of
HIV transmission following sexual exposure to a source with an undetectable viral load,
such evidence does not exist for occupational exposures. While it is assumed there is
also an extremely low risk of HIV transmission, it is still reasonable for a healthcare
worker who has had a higher risk exposure to a source who is HIV positive but with an
undetectable viral load to complete the course of PEP. The recommended PEP regimen
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is outlined in Table 6. Refer to Appendix C for the antiretroviral drug regimens
recommend by the Australasian Society of HIV Medicine.
Table 6: PEP recommendations following occupational exposure to HIV positive source
Injury type
Source viral load known to
be undetectable
Source not on treatment or on
treatment with detectable or
unknown viral load
Needlestick injury or other sharps
exposure
Consider 2 drugs
3 drugs
Mucous membrane or non-intact
skin exposure
Consider 2 drugs
Consider 3 drugs
Any medical officer can prescribe a PEP starter pack (lasting 3 to 7 days). The
recommended course of PEP is 28 days. A prescription for the remainder of the PEP
course must be obtained from a clinician experienced in the administration of drugs for
the treatment of HIV.
Where there is a risk that a woman may be pregnant, undertake a serum beta HCG
urgently. If possible, contact an HIV experienced Infectious Disease or Sexual Health
Physician before starting HIV prophylaxis for a woman who is pregnant or at risk of
pregnancy. Where it is not immediately possible and the risk of contracting HIV appears
to outweigh any potential risk for the pregnancy commence prophylaxis and advise
making an appointment with an HIV experienced physician for the next working day.
Truvada
®
and Combivir
®
are category B3 drugs which means that there is limited data
relating to safety in pregnancy but no human evidence of harm.
Exposed HCW testing recommendations
It is recommended that 4
th
generation HIV antibody/antigen testing be conducted at 6
weeks. A negative test at 6 weeks is likely to exclude infection but the exposed HCW
should be retested at 12 weeks to definitively exclude infection. HIV viral load tests have
the capacity to detect early HIV infection before antibody development and should be
considered following higher risk exposures to a higher risk source. Longer follow up with
additional testing may also be indicated in complex cases (e.g. possibility of coinfection)
as directed by an expert clinician.
Advice for the exposed HCW during follow up period
During the follow up period the exposed HCW should be advised:
Not to donate plasma, blood, body tissue, breast milk or sperm
To protect sexual partners by adopting safe sexual practices (use of condoms)
To seek expert medical advice regarding pregnancy and/or breastfeeding
To seek medical attention about any acute illness (i.e. fever, rash, myalgia,
fatigue, malaise, lymphadenopathy, anorexia).
Modification to work practices (including avoidance of exposure prone procedures) is not
required on the basis of an occupational HIV exposure.
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5.2.4 Source positive or potentially positive for HBV
Susceptibility of the exposed HCW to HBV infection
In accordance with the current NSW Policy Directive Occupational Assessment,
Screening and Vaccination Against Specified Infectious Diseases all staff who have
direct contact with patients, deceased persons, blood, body substances or infectious
material or surfaces/equipment that might contain these must complete a full course of
hepatitis B vaccination and/or provide serological evidence of protection.
If the exposed HCW has a documented protective response (anti-HBs level ≥10 mIU/mL)
at any time following completion of the vaccination course, then he/she is considered
immune to hepatitis B and no further action (i.e. testing of the source patient or post
exposure prophylaxis) is required regardless of the exposure. If the response to previous
vaccination is unknown, the anti-HBs level of the exposed HCW should be determined as
quickly as possible. If immunity status cannot be determined quickly then the HCW
should be managed as a susceptible person until such time that evidence of immunity is
available.
The following provisions relate only to those who are presumed susceptible to HBV
infection (those with anti-HBs level <10 mIU/mL and who are hepatitis core antibody
negative).
Risk of HBV transmission from positive source patient
The probability of infection following exposure to a susceptible person depends on a
number of factors including the volume and infectiousness of the body fluids and the
route of the exposure. Occupational HBV transmission primarily occurs via percutaneous
and mucosal exposure to blood. Of viral parameters, the risk of infection best correlates
with viral load (HBV DNA) rather than hepatitis B serology. The presence of hepatitis B e
antigen (HBeAg) is a surrogate marker for high viral load.
In studies of hepatitis B susceptible HCWs who sustained injuries from needles
contaminated with blood containing HBV, the risk for developing clinical hepatitis if the
blood was both HBsAg-positive and HBeAg-positive was 22%31%, and the risk for
developing serologic evidence of HBV infection was 37%62%. By comparison, the risk
for developing clinical hepatitis from a needle contaminated with HBsAg-positive, HBeAg-
negative blood was 1%6%, and the risk for developing serologic evidence of HBV
infection was 23%-37%.
17
Post exposure prophylaxis (PEP)
Where indicated (see Section 5.1) HBV post exposure prophylaxis with hepatitis B
immunoglobulin and vaccine should be offered to non-immune and non-infected
individuals in accordance with the recommendations in the current edition of the
Australian Immunisation Handbook (refer to Appendix D). Requests for hepatitis B
immunoglobulin should be directed to the local hospital blood bank.
Source testing recommendations
If a source is known or found to be HBsAg positive, then HBeAg and quantitative HBV
DNA testing of the source patient should be performed, with the consent of the source,
so that the exposed HCW can be counselled appropriately about the risk of transmission.
Exposed HCW testing recommendations
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The exposed susceptible HCW should undergo HBsAg testing at 6 weeks, 12 weeks and
24 weeks. In the rare event that an exposed HCW is newly diagnosed with HBV infection,
the local Public Health Unit should be notified. Post-vaccination serological testing is
recommended 4 to 8 weeks after completion of the vaccination course.
Advice for the exposed HCW during follow up period
During the follow up period the exposed HCW should be advised:
Not to donate plasma, blood, body tissue, breast milk or sperm
To seek medical attention if they develop signs and/or symptoms of acute hepatitis
(i.e. anorexia, vague abdominal discomfort, nausea and vomiting, fatigue and/or
jaundice)
The exposed HCW is not required to modify sexual practices provided that HBV PEP has
been administered on time. Ideally the HCW should refrain from becoming pregnant until
completion of the vaccination course. There are no restrictions regarding breastfeeding.
Modifications to work practices (including avoidance of exposure prone procedures) are
not required on the basis of an occupational HBV exposure.
5.2.5 Source positive or potentially positive for HCV
Risk of HCV transmission from positive source patient
Overall, the risk of HCV transmission following an occupational exposure is low. The
probability of infection following exposure depends on a number of factors including the
volume and infectiousness of the body fluids and the route of the exposure. The average
incidence of anti-HCV seroconversion after accidental percutaneous exposure from a
HCV-positive source is estimated at 1.8% (range 0-7%)
20
.
The risk of transmission
increases significantly if the source has a high viral load. A review of the recent published
evidence of HCV transmission following occupational exposures is summarised in Table
7.
A case control study on the risk factors for HCV transmission in HCW based on UK data
collected from 1997 to 2007, found that all HCV seroconversions followed percutaneous
injuries
21
.
As had been previously shown
22
, the depth of injury was significantly
associated with seroconversion and the majority of exposures involved hollow bore
needles from a vein or artery contaminated with blood or blood stained fluid.
Transmission rarely occurs from mucous membrane exposures to infective blood and
there are only two published reports to date of HCV transmission to a HCW via non-intact
skin exposure
23,24
.
Post exposure prophylaxis (PEP)
Currently, there is no vaccination or post exposure prophylaxis that is effective in the
prevention of hepatitis C transmission. However, treatment of acute hepatitis C infection
is now highly effective. Early identification of infection is necessary to enable prompt
referral and treatment.
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Table 7: Evidence of HCV transmission following occupational exposures
Country
Time period
Number of exposures
involving HCW and HCV
positive source
Number of HCV
seroconversions
Rate
Australia
6
2000-2003
64
#
0
0%
Austria
21
1995-2009
150*
0
0%
Brazil
7
1997-2009
38
#
2
5%
Denmark
22
2003-2012
62
0
0%
Germany
9
2010-2012
44*
1
2.3%
Italy
23
2004-2006
26
0
0%
Korea
24
2004 -2008
327
3
0.9%
Netherlands
10
2003-2010
53
1
1.9%
United Kingdom
12
2004-2013
2566
9
0.4%
*All percutaneous injuries with source known to be HCV PCR positive
#
All percutaneous injuries involving large bore catheter needles
Source testing recommendations
If the source is known or found to be HCV antibody positive, then quantitative hepatitis C
RNA testing of the source patient should be performed with the consent of the source, so
that the exposed HCW can be counselled appropriately about the risk of transmission.
Exposed HCW testing recommendations
The exposed HCW should undergo qualitative HCV PCR testing at 6 weeks and HCV
antibody testing at 6 weeks and 12 weeks. If results are negative at that time the HCW
can be advised that the risk of transmission is negligible but an antibody test at 24 weeks
post exposure should still be undertaken to confirm that transmission has not occurred.
Given its low specificity, liver function testing is not recommended. In the rare event that
an exposed HCW is newly diagnosed with HCV infection, the local PHU should be
notified.
Advice for the exposed HCW during follow up period
During the follow up period the exposed HCW should be advised:
not to donate plasma, blood, body tissue or sperm
to seek medical attention if they develop signs and/or symptoms of acute hepatitis
(i.e. anorexia, vague abdominal discomfort, nausea and vomiting, fatigue and/or
jaundice)
The exposed HCW is not required to modify sexual practices. In most circumstances the
HCW should refrain from becoming pregnant until HCV infection is excluded. There are
no restrictions regarding breastfeeding. Modifications to work practices (including
avoidance of exposure prone procedures) are not required on the basis of an
occupational HCV exposure.
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5.3 Testing of the exposed HCW
The exposed HCW should have baseline testing for HIV, HBV and HCV infections as
detailed in Table 8. If the exposed HCW is known to be infected with one or more of
these BBVs, then baseline testing for those BBVs is not required. Note that a HCW with
previous HCV infection who has been successfully treated or who has cleared the virus
spontaneously remains susceptible to HCV re-infection.
Informed consent must be obtained before testing can proceed. The exposed HCW
needs to be informed that baseline testing:
Determines whether they were infected before the exposure and can be done up
to a few days after the exposure (there is no need for after-hours testing)
Does not have to be done at the workplace. The HCW can seek testing at their GP
or other offsite service but the reason for the test (i.e. following occupational
exposure) should be documented.
Although not urgent, is important in case of a worker’s compensation claim in the
rare event of seroconversion
If the HCW is not immune and not previously vaccinated against HBV, or not currently
infected with HBV, then he/she should be vaccinated as outlined in The Australian
Immunisation Handbook and in accordance with the current NSW Policy Directive
Occupational assessment, screening and vaccination against specified infectious
diseases.
The HCW should be offered immediate referral to a specialist service if a previously
undiagnosed blood borne virus is detected. Refer to current version of the NSW Policy
Directive HIV, Hepatitis B or Hepatitis C Health Care Workers Infected. Immediate
consultation with a HIV specialist is required in the event that the exposed HCW who had
commenced HIV PEP is found to be HIV positive on baseline testing.
All occupational exposure incidents should be documented according to local
procedures.
Table 8: Baseline testing of the HCW
HCW hepatitis B status unknown
HCW previously shown to be hepatitis B
immune
Hepatitis B surface antigen, hepatitis B
surface antibody, hepatitis B core
antibody
Combined HIV antigen and antibody
immunoassay (fourth generation HIV test)
Hepatitis C antibody
Combined HIV antigen and antibody
immunoassay (fourth generation HIV test)
Hepatitis C antibody
5.4 Special situation: when a patient is exposed to the blood or body fluids
of a HCW
In some instances, when a HCW is exposed to potentially infectious fluids from a patient,
there is also exposure of the patient to the HCWs blood. For example, this might occur if
the HCW experiences a used sharps injury and blood from the sharps injury comes into
contact with the patient’s open wound or mucous membrane. In this situation, in addition
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to the risk of BBV transmission to the HCW, there is also a potential risk of BBV
transmission from the HCW to the patient. In such circumstances, the HCW should be
managed as per Sections 2 to 5 as a potential source for the patient. The patient and
their treating medical team must be informed of the incident as soon as possible after the
exposure. Injuries to patients must be reported in the Incident Information Management
System.
The Australian National Guidelines for the Management of Health Care Workers Known
to be infected with Blood Borne Viruses minimize the risk that a patient will be exposed to
the blood of an infected health care worker. In the event of an occupational exposure
incident involving a HCW known to be infected with a BBV, refer to the NSW Policy
Directive, HIV, Hepatitis B or Hepatitis C Health Care Workers Infected.
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6 REFERENCES
1 Riddell A, Kennedy I, Tong CY. Management of sharps injuries in the health care
setting. BMJ. 2015 Jul 29;351:h3733.
2 Kuhar DT, Henderson DK, Struble KA, Heneine W, Thomas V, Cheever LW,
Gomaa A, Panlilio AL; US Public Health Service Working Group.Updated US Public
Health Service guidelines for the management of occupational exposures to human
immunodeficiency virus and recommendations for postexposure prophylaxis.Infect
Control Hosp Epidemiol. 2013 Sep;34(9):875-92.
3 Cardo DM, Culver DH, Ciesielski CA, Srivastava PU, Marcus R, Abiteboul D,
Heptonstall J, Ippolito G, Lot F, McKibben PS, Bell DM; Centers for Disease Control
and Prevention Needlestick Surveillance Group. A case-control study of HIV
seroconversion in health care workers after percutaneous exposure. N Engl J Med.
1997 Nov 20;337(21):1485-90.
4 Joyce M, Kuhar D, Brooks J. Notes from the Field: Occupationally Acquired HIV
Infection among Health Care Workers United States, 19852013 Morbidity and
Mortality Weekly Report (MMWR). January 9, 2015 / 63(53): 1245-1246.
5 Gibellini D, Borderi M, Bon I, Biagetti C, De Crignis E, Re MC. HIV-1 infection of a
nurse from a newborn with an unknown HIV infection: a case report. J Clin Virol.
2009 Dec;46(4):374-7.
6 Peng Bi, Tully PJ, Boss K, Hiller JE. Sharps injury and body fluid exposure among
health care workers in an Australian tertiary hospital. Asia-Pacific Journal of Public
Health. 20(2):139-47, 2008.
7 Medeiros WP, Setúbal S, Pinheiro PY, Dalston MO, Bazin AR, de Oliveira SA.
Occupational hepatitis C seroconversions in a Brazilian hospital. Occup Med
(Lond). 2012 Dec;62(8):655-7.
8 Lunding S, Katzenstein TL, Kronborg G, Storgaard M, Pedersen C, Mørn B,
Lindberg JÅ, Kronborg TM, Jensen. The Danish PEP Registry: Experience with the
use of post-exposure prophylaxis following blood exposure to HIV from 1999-2012.
J.Infect Dis (Lond). 2016;48(3):195-200.
9 Himmelreich H, Rabenau HF, Rindermann M, Stephan C, Bickel M, Marzi I, Wicker
S.
The management of needlestick injuries. Dtsch Arztebl Int. 2013 Feb;110(5):61-7.
10 Frijstein G, Hortensius J, Zaaijer HL. Needlestick injuries and infectious patients in a
major academic medical centre from 2003 to 2010. Neth J Med. 2011
Oct;69(10):465-8.
11 Wiboonchutikul S, Thientong V, Suttha P, Kowadisaiburana B, Manosuthi W.
Significant intolerability of efavirenz in HIV occupational postexposure prophylaxis. J
Hosp Infect. 2016 Apr;92(4):372-7.
12 Woode Owusu M, Wellington E, Rice B, Gill ON, Ncube F & contributors. Eye of the
Needle United Kingdom Surveillance of Significant Occupational Exposures to
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Bloodborne Viruses in Healthcare Workers: data to end 2013. December 2014.
Public Health England, London.
13 Black RJ. Animal studies of prophylaxis. Am J Med 1997;102:3944. 14 Tsai CC,
Emau P, Follis KE, et al. Effectiveness of postinoculation (R)-9-(2-phos-
phonylmethoxypropyl) adenine treatment for prevention of persistent simian
immunodeficiency virus SIVmne infection depends critically on timing of initiation
and duration of treatment. J Virol 1998;72:426573.
14 Otten RA, Smith DK, Adams DR, et al. Efficacy of postexposure prophylaxis after
intravaginal exposure of pig-tailed macaques to a human-derived retrovirus (human
immunodeficiency virus type 2). J Virol 2000;74:97715.
15 Beekmann SE, Henderson DK. Prevention of human immunodeficiency virus and
AIDS: postexposure prophylaxis (including health care workers). Infect Dis Clin
North Am. 2014 Dec;28(4):601-13.
16 Hawkins DA1, Asboe D, Barlow K, Evans B. Seroconversion to HIV-1 following a
needlestick injury despite combination post-exposure prophylaxis. J Infect. 2001
Jul;43(1):12-5.
17 Panlilio AL, Cardo DM, Grohskopf LA, Heneine W, Ross CS. Updated U.S. Public
Health Service guidelines for the management of occupational exposures to HIV
and recommendations for postexposure prophylaxis. MMWR Recomm Rep. 2005;
54:117.
18 Camacho-Ortiz A. Failure of HIV postexposure prophylaxis after a work-related
needlestick injury. Infect Control Hosp Epidemiol. 2012; 33:6467.
19 Borba Brum MC, Dantas Filho FF, Yates ZB, Vercoza Viana MC, Martin Chaves
EB, Trindade DM. HIV seroconversion in a health care worker who underwent
postexposure prophylaxis following needlestick injury. Am J Infect Control. 2013;
41:4712.
20 Updated U.S. Public Health Service Guidelines for the Management of
Occupational Exposures to HBV, HCV, and HIV and Recommendations for
Postexposure Prophylaxis MMWR June 29, 2001/50(RR11);1-42
21 Tomkins SE, Elford J, Nichols T, Aston J, Cliffe SJ, Roy K, Grime P, Ncube FM.
Occupational transmission of hepatitis C in healthcare workers and factors
associated with seroconversion: UK surveillance data.J Viral Hepat. 2012
Mar;19(3):199-204.
22 Yazdanpanah Y, De Carli G, Migueres B, Lot F, Campins M, Colombo C, Thomas
T, Deuffic-Burban S, Prevot MH, Domart M, Tarantola A, Abiteboul D, Deny P, Pol
S, Desenclos JC, Puro V, Bouvet E.
Risk factors for hepatitis C virus transmission to health care workers after
occupational exposure: a European case-control study. Clin Infect Dis. 2005 Nov
15;41(10):1423-30.
23 Beltrami EM, Kozak A, Williams IT, Saekhou AM, Kalish ML, Nainan OV, Stramer
SL, Fucci MC, Frederickson D, Cardo DM. Transmission of HIV and hepatitis C
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virus from a nursing home patient to a health care worker. Am J Infect Control. 2003
May;31(3):168-75.
24 Toda T, Mitsui T, Tsukamoto Y, Ebara T, Hirose A, Masuko K, Nagashima S,
Takahashi M, Okamoto H. Molecular analysis of transmission of hepatitis C virus in
a nurse who acquired acute hepatitis C after caring for a viremic patient with
epistaxis. J Med Virol. 2009 Aug;81(8):1363-70.
25 Michael Strasser, Elmar Aigner, Ilse Schmid, Andreas Stadlmayr, David Niederseer,
Wolfgang Patsch and Christian Datz (2013). Risk of Hepatitis C Virus Transmission
from Patients to Healthcare Workers: A Prospective Observational Study. Infection
Control & Hospital Epidemiology, 34, pp 759-761
26 Eskandarani HA, Kehrer M, Christensen PB.No transmission of blood-borne viruses
among hospital staff despite frequent blood exposure. Dan Med J. 2014
Sep;61(9):A4907.
27 Davanzo E, Frasson C, Morandin M, Trevisan A. Occupational blood and body fluid
exposure of university health care workers. Am J Infect Control. 2008
Dec;36(10):753-6.
28 Ryoo SM, Kim WY, Kim W, Lim KS, Lee CC, Woo JH. Transmission of hepatitis C
virus by occupational percutaneous injuries in South Korea.J Formos Med Assoc.
2012 Feb;111(2):113-7.
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APPENDIX A: MANAGEMENT OF THE EXPOSED HCW FOLLOWING
AN OCCUPATIONAL EXPOSURE
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APPENDIX B: RECOMMENDED LABORATORY TESTING FOR THE
EXPOSED HCW
BBV status of the
source patient
#
Time (in weeks) following BBV exposure
6 weeks
12 weeks
24 weeks
HIV positive
Combined HIV
antigen and antibody
(fourth generation HIV
immunoassay)
Combined HIV
antigen and antibody
(fourth generation HIV
immunoassay)
HBV positive*
Hepatitis B surface
antigen
Hepatitis B surface
antigen
Hepatitis B surface
antigen
HCV positive
Hepatitis C antibody,
qualitative HCV PCR
Hepatitis C antibody
Hepatitis C antibody
#
If BBV testing of the source patient at the time of the incident is negative but there is the
possibility of being in the window period or BBV status of the source is unknown and there is a
risk of being infected then follow up as per positive source.
* If the HCW is immune (i.e. anti-HBs level ≥10 mIU/mL or HBcAb positive) no further HBV
testing is required regardless of the exposure or status of the source patient.
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APPENDIX C: HIV PEP RECOMMENDATIONS
HIV PEP starter packs may very between facilities. The Australasian Society for HIV
Medicine (ASHM) recommendations are provided here.
Recommendations for PEP following occupational exposure to HIV
2
2-drug regimens*
Tenofovir 300mg with lamivudine 300mg (daily) *(TGA approved generic lamivudine may be used
to reduce cost)
OR
Tenofovir disoproxil fumarate/emtricitabine 300mg/200mg (daily)
*
Zidovudine, in combination with lamivudine, can be used in two-drug PEP combinations. The benefits of
cheaper zidovudine cost are offset by the need for a twice-daily treatment regimen, higher incidences of
gastrointestinal side effects, myalgia and headaches in comparison to the recommended regimens.
3-drug regimens
The preferred 2 drug-regimen PLUS
dolutegravir 50mg (daily)
OR
raltegravir 400mg (bd)
OR
rilpivirine 25mg (daily with food)
Note: Refer to Post Exposure Prophylaxis after Non-Occupational and Occupational Exposures: Australian
National Guidelines 2nd Edition for cautions in relation to specific antiretroviral medications
2
Taken from the Post Exposure Prophylaxis after Non-Occupational and Occupational Exposures:
Australian National Guidelines 2
nd
Edition
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APPENDIX D HEPATITIS B PEP RECOMMENDATIONS
Management of non-immune HCWs following occupational exposure to a positive/likely
positive HBsAg source
3
Type of exposure
Hepatitis B Immunoglobulin
Vaccine
Percutaneous, ocular or
mucous membrane
Single dose of 400IU by IM
injection within 72 hours of
exposure
1ml recombinant antigen by IM
injection within 7 days* of
exposure, repeated at 1 month
and again 6 months post first
dose
*The 1st dose can be given at the same time as HBIG, but should be administered at a separate site.
Administration as soon as possible after exposure is preferred.
3
Taken from the Australian Immunisation Handbook, 10
th
Edition