Post Exposure Prophylaxis (PEP) Following Occupational & Non-Occupational Exposure of
Adults & Adolescents to HIV; A Trustwide Clinical Guideline
Summary statement: How does the
document support patient care?
This policy provides guidelines for the risk assessment
and subsequent management of occupational and nonoccupational exposures to HIV and the use of postexposure prophylaxis.
Staff/stakeholders involved in
development:
Job titles only
Consultants & Associate specialists in GU & HIV
Medicine
Consultants in reproductive & sexual health
Consultant in Emergency Medicine
Consultants in Occupational Health
Occupational Health Manager
HIV pharmacist
Sexual Health Advisors
General Manager Medicine
Division:
Trustwide
Department:
Trustwide
Responsible Person:
Jeannie Baumann, Director of Clinical Services Women
and Child Health
Author:
Dr Emma Rutland, Consultant in Genitourinary & HIV
Medicine
For use by:
All staff
Purpose:
To provide guidance to WSHT staff who assess
patients or members of staff for post exposure
prophylaxis following exposure to HIV.
To reduce the risk of HIV transmission to WSHT staff or
patients following exposure to HIV
To outline the processes to be taken by WSHT staff in
the event that they are potentially exposed to HIV at
work.
This document supports:
Standards and legislation
DoH guidance:
HIV post-exposure prophylaxis: Guidance from the UK
Chief Medical Officers’ Expert Advisory Group on AIDS.
Department of Health. Revised September 2008.
National guidelines:
Clinical Effectiveness Group (British Association of
Sexual Health and HIV). United Kingdom Guideline For
The Use Of Post-Exposure Prophylaxis For HIV
Following Sexual Exposure. Int J STD & AIDS 2006;
17: 81–92
Key related documents:
1 of 53
WSHT Blood Borne Virus (BBV) Policy (including
management of sharps exposure incidents) April 2010
Consent Policy December 2009
Approved by:
Divisional Governance/Management
Group
Women and Child Health Divisional clinical Governance
Review Meeting
Management Board
Approval date:
28 October 2011 / May 2012
Ratified by Board of Directors/
Committee of the Board of Directors
n/a
Ratification Date:
n/a
Expiry Date:
January 2015
Review date:
28 October 2014
If you require this document in another format such as Braille, large print, audio or another
language please contact the Trusts Communications Team
Reference Number:
To be added by the Library
Version
date
Author
Status
1.0
28/10/11
Tracey Rose,
Operational
Manager on behalf
of Dr Emma
Rutland
draft
2.0
3.0
4.0
2 of 53
Comment
Post Exposure Prophylaxis (PEP)
Following Occupational & Non-Occupational Exposure of
Adults & Adolescents to HIV:
A Trust-wide Policy
To complement existing Western Sussex Hospitals Trust
Policy Blood Borne Virus (BBV) Policy (including
management of sharps exposure incidents) April 2010
3 of 53
Contents
1. Introduction
2. Roles and Responsibilities of The Trust, It’s Employees and Departments
involved in managing persons exposed to HIV
3. Initial management
4. HIV exposure risk assessment
5. Post Exposure Prophylaxis (PEP)
6. Investigations
7. Other Blood Borne Viruses
8. Follow-Up
9. Availability of the Guidance
10. Specialist Contacts
11. Development of the Guidance
12. Implementation
13. References
Appendices:
Appendix A - HIV PEP following Occupational Exposure Consultation Record
Sheet
Appendix B - HIV PEP following non occupational (Sexual / community
needlestick / bite) Exposure Consultation Record Sheet
Appendix C - PEP (occupational exposure) pathway
Appendix D - PEP (non occupational exposure) pathway
Appendix E - PEP prescription form
Appendix F - PEP consent form
Appendix G - Prevalence of HIV in community groups
Appendix H - Example of risks from single exposure HIV
Appendix I - Letter for source day-case patients
Appendix J - Information for prescribers
Appendix K - Information for patients
Appendix L - flow chart for emergency contraception
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1.0 Introduction
1.1 Scope
This document should be read in conjunction with the Western Sussex Hospitals
NHS Trust blood borne virus (BBV) policy. The BBV policy provides clear guidelines
on the management of occupational exposures to blood borne viruses including the
initial aspects of dealing with an exposure to HIV and assessment for the use of post
exposure prophylaxis (PEP) for HIV. These guidelines focus on the use of PEP for
HIV and have been produced for the benefit of clinical staff working in Western
Sussex Hospitals NHS Trust who assess patients or members of staff following
potential exposure to HIV. This includes staff working in Accident & Emergency
Departments, Occupational Health and Sexual Health / HIV Departments.
In some cases the exposure will have been occupational. In others the exposure will
have been non-occupational, sometimes linked to lifestyle. The guidelines will
address risk assessment and subsequent management of exposures to HIV and the
use of post-exposure prophylaxis following exposures to HIV.
1.2 Background
Healthcare workers (HCW) exposed to blood and body fluids have a low but
measurable risk of acquiring blood-borne virus infection through their work. Although
the risk of acquiring hepatitis B infection is around 30%, most healthcare workers
have now been vaccinated against this infection. The risk of acquiring hepatitis C
infection, based on cases reported to the HPA, is 1.6%. The estimated risk from
patients with documented HIV is about 0.3% for percutaneous exposure (i.e.
accidents where the skin is pierced/broken by a needle or to other sharps incident)
and about 0.1% for significant exposure to mucous membranes or non-intact skin
(e.g. splashes to the eyes or splashes to areas of the skin that are already broken
because of scratches or due to a skin condition). Exposure to intact skin is not
considered to pose a risk [1].
1.3 Rationale for PEP following percutaneous exposure
A U.S. case control study concluded that the administration of zidovudine
monotherapy as prophylaxis to health care workers occupationally exposed to HIV
was associated with an 80% reduction in the risk for occupationally acquired HIV
infection. [2] Four factors were associated with increased risk of HIV infection:
1)
2)
3)
4)
Deep injury
Visible blood on the device which caused the injury
Injury with a needle which had been placed in a source patient's artery or vein
Terminal HIV-related illness in the source patient
It was estimated that the risk for HIV transmission after percutaneous exposures
involving larger volumes of blood, particularly if the source patient's viral load was
likely to be high, exceeds the average risk of 3 per 1,000.
In established HIV infection, the use of combinations of antiretroviral drugs is more
potent than zidovudine alone in suppressing viral replication. This, together with the
increased prevalence of zidovudine resistance amongst HIV infected people, has led
to the introduction of combination antiretroviral drug prophylaxis following
occupational exposure to HIV.
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Results from animal studies suggest that HIV PEP is most likely to be efficacious if
started within the hour
1.4 Rationale for PEP following sexual exposure
Rationale for the use of PEP following non occupational sexual exposure (PEPSE) is
largely based on data from PEP following percutaneous exposure, a few animal and
2 small prospective studies in humans.
Animal studies demonstrate a reduction in HIV seroconversion with the use of
antiretroviral drugs following sexual exposure to HIV [3]
The use of postnatal AZT given to neonates who were delivered vaginally to HIV
positive mothers not on antiretroviral therapy in a subset of the ACTG 076 study
demonstrated a protective effect [4]
Prospective data on the use of PEPSE is available for men who have sex with men.
Two Brazilian studies demonstrated a reduction in HIV seroconversion rates in men
utilising PEPSE following high risk HIV exposures [5,6].
2.0 Roles and Responsibilities of The Trust, It’s Employees and Departments
involved in managing persons exposed to HIV
The Trust has a duty of care to ensure, so far as reasonably practicable, the health,
safety and welfare at work of their employees. It also has a duty to safeguard the
health and well-being of patients/clients.
The Trust accepts responsibility to protect staff and patients through the development
and maintenance of arrangements for:

2.1
Good management of occupational and non-occupational exposure to HIV
Overall
It is the responsibility of the CEO and Board to ensure that policies, procedures and
practices meet the national requirements for management of exposure to HIV.
It is the responsibility of the Consultant GUM/HIV at St Richard’s Hospital to
champion this policy.
The responsibilities of healthcare workers are detailed in the Blood Borne Virus
Policy.
2.2 The role of A&E
In view of the need for very prompt treatment and the serious consequences of HIV
seroconversion, significant occupational exposure to known or possible sources of
HIV constitutes a medical emergency. Outside normal working hours, the A&E
Department has the responsibility for assessment of occupational exposure and
requirement for PEP, and will be the first point of contact for any such exposure,
whether or not this arose in the hospital [1].
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Similarly due to the need for prompt treatment with PEP following non occupational
sexual exposures to HIV, A&E has the responsibility for assessment for the
requirement of PEPSE outside normal working hours [2].
The Trust has a responsibility to ensure that staff in the A&E department are aware
of, and have accepted their responsibility to provide cover for PEP where appropriate
[1].
For monitoring purposes, PEP consultations will be coded by A&E, Occupational
Health and GUM/HIV departments.
2.3 The role of Occupational Health
In working hours Occupational Health at WaSH and SRH has the responsibility for
assessment of occupational exposure and requirement for PEP for WSHT HCWs.
Occupational health at Worthing has the responsibility for assessment of
occupational exposure and requirement for PEP for community HCW’s
Bank and agency staff who are employed by the organisation should be assessed by
occupational health following occupational exposure in working hours.
Occupational Health staff to complete PEP consultation sheet and assess the
indications for prescribing PEP
Occupational Health should also follow up HCWs who do not commence PEP
following potential occupational exposure for repeat BBV screening as necessary.
Occupational Health should see all HCWs who do commence PEP following
potential occupational exposure on at least one occasion for reporting and monitoring
requirements.
Occupational Health should report confidentially all potential exposures to HIV
(regardless of whether PEP was initiated) to the Occupational Exposure Surveillance
Team, HIV/STI Department, HPA Centre for Infections, 61 Colindale Avenue, London
NW9 5EQ (Tel. 020 8327 7095).
In certain circumstances (usually a ‘dangerous occurrence’) it may be necessary to
report the event to the Health and Safety Executive under the Reporting of Injuries,
Diseases and Dangerous Occurrences (RIDDOR) Regulations 1995. Cases of HIV
infection resulting from exposure in the health care setting will also normally be
reportable as diseases within the scope of RIDDOR.
Occupational health will be responsible for assessment and further management of
Hepatitis B prevention following occupational exposure as per the Trust BBV
guidelines.
2.4 The role of the GUM/HIV department
In clinic hours all non occupational exposures to HIV will be assessed and managed
through the Fletcher unit (SRH) or Warren Browne unit (WaSH).
The GUM department will provide assessment and further management of Hepatitis
B prevention following potential sexual exposure.
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The GUM / HIV specialist will be available to give telephone advice on the
recommendations for PEP / PEPSE provision in complicated cases during and
outside of working hours through the on call GUM / HIV specialist. The GUM / HIV
specialist will also be available to give telephone advice on HIV testing source
patients in special circumstances.
The GUM/HIV departments will follow up all patients commenced on PEP / PEPSE.
Source patients of occupational exposures will be tested through their clinical teams.
The GUM/HIV department Health advisors will provide support to staff in other areas
of the Trust in seeking informed consent for HIV testing. The departments can offer
confidential testing under a GUM number if the source patient prefers. They will also
provide HIV pre-test discussion for source patients identified following needlestick
injuries in day surgery or endoscopy (see section 5.2.3).
The GUM / HIV specialists will also take an active role in providing specific training to
staff involved in the assessment and provision of PEP / PEPSE. This would include
the following staff groups:
 Medical and nursing staff in A&E
 Medical and nursing staff in the Department of HIV/GUM
 Medical and nursing staff in the Department of Occupational Health
3.0 Initial management after possible exposure to HIV
3.1 HCWs sustaining a risk incident

Remove the hazard to ensure the incident is not repeated.

The source patient should be identified if possible.

Establish incident details - date, time, source, nature of injury and any known
information about the Source patient (name, DoB, Hospital No., BBV risk
factors and status if already known).

It is the responsibility of the injured employee to report it immediately to the
area manager (e.g. ward sister).

Complete an accident / incident / Datix following assessment in Occ health /
A&E
3.2 Attend appropriate site for assessment
3.2.1 Following occupational exposure

Ring the Sharps injury “hotline” (SRH 01243 788122 x 2405) (WASH 01903
205111 x3037 ) immediately and follow the instructions given.
SRH
 Normal working hours - attend Occupational Health without delay (unless the
“hotline” instruction states otherwise)
 Out of hours - attend Accident and Emergency Department immediately
WaSH
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 Normal working hours - attend Occupational Health without delay (unless the
“hotline” instruction states otherwise)
 Out of hours - attend Accident and Emergency Department immediately
Community staff (non WaSH / SRH)
 Normal working hours - attend Occupational Health (WaSH) without delay
(unless the “hotline” instruction states otherwise)
 Out of hours - attend Accident and Emergency Department immediately
3.2.2 Following non occupational / sexual exposure



Patients requesting PEP following sexual exposure should be referred to the
Fletcher unit, Chichester or Warren Browne unit, Worthing during clinic hours
Out of hours patients should attend Accident and Emergency Department for
assessment.
Members of the public presenting with community needlesticks / bites should
be assessed in the local A&E departments (if not already assessed in primary
care)
4.0 HIV exposure risk assessment
A risk assessment needs to be made urgently by someone other than the exposed
individual. If indicated PEP should be started without delay and ideally within 1
hour of exposure. WSHT staff will be assessed by occupational health, during
opening hours, and A&E staff at other times. The risk assessment will assess the
need to commence PEP and whether reliance on the standard PEP starter pack is
appropriate, or whether a modified prescription is required.
It may not be possible to attain immediately all the information required to decide
whether PEP is indicated (particularly regarding the source individual). A more
thorough risk assessment can be performed later as more information becomes
available (including results of HIV test from the source person) to inform a decision
whether to change or discontinue the regimen. Starting PEP, where appropriate
should not be delayed to await the result of source patient testing.
If there is a delay before the exposed person presents for PEP, it is usual practice to
offer PEP up to 72 hours after exposure. However its efficacy is likely to fall with
increasing delay.
Decisions on initiation of PEP more than 72 hours after an occupational exposure
should made on individual basis in discussion with the exposure recipient and a
GUM/HIV specialist and in full knowledge of the lack of evidence of efficacy [1].
The baseline risk assessment must be documented on an ‘HIV PEP Consultation
Record Sheet’ (Appendix A&B) These are available in:



St Richards Hospital: A&E, Occupational Health, Fletcher unit
Worthing hospital: A&E
Southlands: Occupational Health, Warren Browne unit
The risk of transmission of HIV depends on the:
 type of exposure
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


4.1
the nature of the body fluid involved
the volume of body fluid involved
the source person
Type of exposure
The risk of HIV transmission following an exposure from a known HIV positive
individual is shown below [7].
Type of exposure
Blood transfusion (one unit)
Receptive anal intercourse
Receptive vaginal intercourse
Insertive vaginal intercourse
Insertive anal intercourse
Receptive oral sex (fellatio)
Insertive oral sex (receiving fellatio)
Needle–stick injury
Sharing injecting equipment
Mucous membrane exposure
Estimated median (range) risk of
transmission per exposure
90-100%
1.11% (0.042-3.0%)
0.1% (0.004-0.32%)
0.082 (0.011-0.38%)
0.06% (0.06-0.065%)
0.02% (0-0.04%)
0%
0.3% (95% CI 0.2%-0.5%)
0.67%
#0.63% (95% CI 0.018%-3.47%)
HIV
# derived from a single study including only small numbers of health care workers exposed to HIV
following mucous membrane exposures. This is likely to significantly over estimate the risk.
4.2
Type of Fluid
Body Fluids which may pose a risk of HIV Transmission if significant occupational
exposure occurs:
High Risk Body Fluid
Amniotic Fluid
Blood
Cerebrospinal Fluid
Human Breast Milk
Pericardial Fluid
Peritoneal Fluid
Pleural Fluid
Saliva in association with dentistry (which is likely to be
contaminated with blood even when not visibly so)
Semen
Synovial Fluid
Unfixed Tissues or Organs
Vaginal Secretions
Any other body fluid which is visibly bloodstained.
Exudative or other tissue fluid from burns or skin lesions
Laboratory cultures and isolates of HIV
4.3 Volume of Fluid
The following increase the risk of HIV transmission:
1. Visible blood on the device which caused the injury.
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No Risk Body Fluid
(unless visibly blood stained)
Faeces
Saliva
Urine
Vomit
2. Injury with a needle which has been placed in a source patient’s artery or vein.
3. Injury involving wide bore needle or extensive laceration.
4.4
Source Person
There may be increased risk of HIV transmission if the source person is:
1. Known HIV positive
 Risk is further increased if the patient has a high plasma HIV viral load / is
seroconverting
 An undetectable plasma HIV viral load in a patient taking antiretroviral therapy
reduces the risk
 Sexually transmitted infections enhance HIV transmission in epidemiological
studies and increase HIV shedding from the genital tract.
 Menstruation or other bleeding may also facilitate transmission
2. Known source but unknown HIV status with recognisable risk factors
(see table below):
 Man who has had sex with men
 Current or ex-injecting drug use.
 Lived in, or received blood/blood products in areas of high HIV prevalence e.g.
Sub-Saharan Africa, Eastern Europe and Central Asia.
 Multiple transfusion of blood/blood products in the UK (before 1985) or elsewhere
 HIV indicator disease e.g. PCP pneumonia
3. Is a sexual contact of any of the above.
Risk that source is HIV positive [7] – (Based upon HPA 2008 data)
Population Group (aged >15 years)
Men who have sex with men
UK
London
Elsewhere in UK
Brighton
Heterosexuals (region of birth)
UK
Rest of Europe
North America
Central and South America
Caribbean
North Africa and Middle East
Sub-Saharan Africa
South Asia
East and South Asia
Australasia
Injecting drug users
UK
London
Elsewhere in UK
11 of 53
HIV Prevalence (%)
Male
5.2
10.5
3.4
13.7
Female
-
0.4
1.2
1.1
1.9
1.2
0.5
6.1
0.5
1.1
0.3
0.3
0.6
0.2
1.1
1.0
0.4
10.3
0.5
0.8
0.2
0.3
0.8
0.2
0.3
0.3
0.3
4.5 The Unknown Source
In the event of a potential exposure to an untraceable source (e.g. a needlestick
injury from a rubbish bag) it is very usually difficult to justify PEP.
PEP is not indicated for discarded needles in the community.
In secondary care a risk assessment should be made considering the circumstances
of the exposure (eg Known HIV positive patient on ward). Discuss with Occupational
Health or GUM/HIV specialist if in doubt.
4.6 Assessing the risk
PEP is not a licensed indication for antiretroviral therapy; further information on the
indications, benefits and risks of PEP can be found in national guidelines [1,7]
In circumstances where the risk of HIV exposure is low and PEP is not
recommended the person seeking PEP should be advised that the potential risks of
toxicity PEP outweigh the negligible risk of HIV transmission.
Appendix H gives an example of risks of HIV transmission after a single episode.
Cofactors such as STIs, viral load and bleeding may affect the risk estimate [7]
4.6.1 Recommendations for prescribing PEP after non occupational including
sexual exposure to HIV (PEPSE) [7]
PEPSE is only recommended where the individual presents within 72 hours of
exposure. Within that time frame, it is recommended that PEPSE (if given) should be
administered as early as possible.
See tables in ‘HIV PEP following non occupational (Sexual / community needlestick /
bite) Exposure Consultation Record Sheet’ (Appendix B) for situations for which PEP
is recommended
Attempt should be made, where possible, to establish the HIV status of the source
individual (according to appropriate guidance on HIV testing and consent) as early as
possible. It is recommended that strong efforts be made to encourage the individual
to notify their partner where possible, and to arrange urgent HIV testing of that
partner, as early as possible.
• Source individual is known to be HIV positive
In this scenario attempts should be made at the earliest possible stage to determine
the viral load, resistance profile and treatment history in the source individual. Where
the viral load is undetectable it is assumed that the risk of transmission will be
significantly reduced. The majority of supporting evidence is derived from
heterosexual discordant couples although there are some data among MSM. There
are anecdotal reports of transmission where the source is thought to have an
undetectable plasma viral load.
• Source individual is of unknown status
Attempts should be made, where possible, to establish the HIV status of the source
individual (according to appropriate guidance on HIV testing and consent) as early as
possible. There is growing evidence to suggest that significant cases of PEP can be
averted through assertive HIV testing of the source individual. It is therefore
recommended that strong efforts be made to encourage the individual to notify their
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partner where possible, and for the clinic to arrange urgent HIV testing of that
partner, with appropriate guidance on HIV testing and consent, as early as possible.
Within the UK at present sources from a group or area of high HIV prevalence
include men who have sex with men and individuals who have immigrated to the UK
from areas of high HIV prevalence particularly sub-Saharan Africa. (see Appendix G
for HIV prevalence rates)
Other circumstances:
Sexual Assault:
It is believed that transmission of HIV is likely to be increased following aggravated
sexual intercourse, such as that experienced during sexual assault. Clinicians may
therefore consider recommending PEPSE more readily in such situations.
Needle-stick injuries in the community:
It is not uncommon for individuals to request PEP following a needle-stick injury with
a discarded needle in the community. In general PEP is not recommended following
these exposures as it is usually not possible to determine i) whether the needle has
been used or not and for what purpose, ii) the HIV status of the source and iii) the
interval between the needle being used and the exposure. Once blood has dried, HIV
dies within a couple of hours. However viable HIV has been shown to persist in
syringes and needles up to 30 days depending on temperature and the size of
syringe/needle. However there is no data on the transmissibility of this virus.
In studies where only small amounts of blood are in the syringe viable HIV
cannot be detected after 24 hours
Human bites:
Requests for PEP following human bites have been reported. In general PEP is not
recommended following these exposures as although the risk of transmission
following a bite is unknown it is likely to be extremely small.
Other considerations regarding PEPSE
 HIV testing is strongly recommended before commencing PEP or as soon as
possible thereafter.
 Following sexual exposure it is important to consider emergency contraception
(Appendix L).
 Sexual exposure can also place a person at risk of other sexually transmitted
infections (including hepatitis B).
5.0
Post Exposure Prophylaxis (PEP)
5.1
Indications
If there is a delay before the exposed person presents for PEP, it is usual practice to
offer PEP up to 72 hours after exposure. However its efficacy is likely to fall with
increasing delay.
Decisions on initiation of PEP more than 72 hours after an occupational exposure
should made on individual basis in discussion with the exposure recipient and a
GUM/HIV specialist and in full knowledge of the lack of evidence of efficacy [1].
13 of 53
5.1.1

if the patient had a significant exposure to blood or another high-risk body fluid
from a source either
- known to be HIV infected, or
- considered to be at high risk of HIV infection, but where the result of an HIV
test has not or cannot be obtained, for whatever reason [1].
5.1.2





PEP is recommended if:
PEP is not recommended:
after exposure to low-risk materials (e.g. urine, vomit, saliva, faeces) unless they
are visibly bloodstained (e.g. saliva in association with dentistry).
where testing has shown that the source is HIV negative, or
if risk assessment has concluded that HIV infection of the source is highly unlikely
PEP is not indicated for discarded needles in the community.
PEP would only be indicated in cases of human bites in very exceptional
circumstances (eg where an HIV+ individual with a detectable viral load with
blood in their mouth bites another individual where the teeth have broken the
skin)
Exceptionally, PEP may be indicated following a negative test if there is reason to
suspect the source may be seroconverting (i.e. in the window period) [1].
5.2
Standard PEP
A standard course of PEP must be taken for 28 days as in the following table:
Starter pack: days 1-5
Drug
Truvada
Kaletra
Strength & Form
Combined
tablet:
Tenofovir 300mg &
Emtricitabine 200mg
Combined
tablet:
Lopinavir 200mg &
Ritonavir 50mg
Dose
ONE (1) tablet ONCE a day
Duration
Days 1-5
TWO (2) tablets TWICE a day
With or without food
Days 1-5
In addition an anti-emetic and an anti-diarrhoeal agent is routinely prescribed:
Domperidone
10mg Tablet
ONE(1) tablet THREE times a Pack of 10
day when needed for nausea
or vomiting
Loperamide
2mg Tablet
TWO (2) tablets at the first Pack of 12
sign of diarrhoea or loose
bowel motion then ONE(1)
tablet when needed thereafter.
Maximum of 8 tablets in 24 hrs
Then: Days 6-28 (prescribed by Doctor from Fletcher unit / Warren Browne unit)
Drug
Truvada
14 of 53
Strength & Form
Dose
Combined
tablet: ONE (1) tablet ONCE a day
Tenofovir 300mg &
Emtricitabine 200mg
Duration
Days 6-28
Combined
tablet: TWO (2) tablets TWICE a day
Lopinavir 200mg & With or without food
Ritonavir 50mg
Kaletra
Days 6-28
Although PEP should be continued for 28 days, the exposed person may be advised
to stop taking PEP after further information is obtained (e.g. the source tests
negative). It is unlikely that all the necessary information will be available when you
initially prescribe PEP.
Full adherence to PEP is critically important; the patient will need careful flow up and
support in achieving this. Symptom control is an important element of this follow up.
A Patient Information Leaflet is included with each drug in the starter pack (Appendix
K). These drugs are not licensed for PEP, however, the Department of Health
recommends them for this indication. These drugs can be prescribed for PEP only on
an 'off-label' basis since their use in this context is outside approved indications.
A prescription sheet is included for use in all starter packs. (Appendix E)
5.3
PEP Starter Packs and Location
Starter packs of PEP will be available in each of the following locations:



St Richards Hospital
Worthing hospital
Southlands hospital
A&E
Emergency Drug Cupboard
Fletcher
Pharmacy
A&E
Emergency
Pharmacy
Drug
unit
Cupboard
Emergency Drug Cupboard
Pharmacy
Warren Browne unit
Each area will be responsible for ensuring PEP stock available, intact and in date.
Starter packs of PEP contain enough medication for 5 days of treatment. During this
time the patient will be followed up by the HIV/GUM Department. Patients requiring
PEP should be given a starter pack from one of these areas, the balance of the
medication will be prescribed at the follow up visit.
Rarely it may be necessary to issue 2 packs e.g. to cover a long weekend. The full 1
month course of PEP should not be prescribed at the time when PEP is initiated.
5.4 Consent to PEP
The PEP Starter Pack also contains an Information Sheet. It is important that the
information on the sheet is understood by the exposed person and that they give
verbal informed consent before starting PEP. This consent must be documented on
the consultation sheet.
5.5 Variations to standard PEP
Advice from a GUM/HIV Specialist Consultant should be sought before deviating
from standard PEP. Uncertainty regarding the optimal combination should not be
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allowed to delay initiation of PEP. If in doubt start standard PEP as soon as possible
and then seek further advice.
Information about the virus present in the source patient, previous and current
antiretroviral therapy and drug resistance may be relevant when the GUM/HIV
specialist chooses alternative PEP drugs.
5.6 PEP: Special Considerations
5.6.1 Paediatric Patients (<16 years of age)
This document applies to adults. Specific guidelines on the paediatric management
of potential exposure to HIV should be referred to when the exposed person is less
than 16 years of age and advice taken from a Paediatric HIV consultant.
Children and adolescents under 16 years of age presenting for consideration of PEP,
either following needlestick injury or sexual exposure (consensual and following
assault) should be referred to the Paediatric Consultant.
Paediatric PEP Regimen Outline (following discussion with Paediatric Consultant /
advice from the Paediatric Infectious Disease Consultant at St George’s Hospital,
London, available via St Georges Hospital switchboard 020 8672 1255): Children
who weigh < 40kg should NOT receive Tenofovir (i.e. Truvada) containing PEP but
should be offered Kaletra, lamivudine and zidovudine at doses appropriate to their
weight and surface area.
Adolescents weighing 40kg and above can be treated with the adult PEP regimen.
Follow up:
 All patients under 16 years of age considered for PEP (whether prescribed or
not) should be referred for follow up.
 It is appropriate that patients considered for PEP following sexual exposure
should be followed up by the Paediatric Consultant and/or GUM/HIV
specialist
 Following assessment a completed Consultation Record Sheet (see adult
proforma) should be faxed to the Consultant Paediatrician and/or GUM/HIV
specialist
 Children prescribed PEP will be followed up by the Consultant Paediatrician
5.6.2 Drug History




A full history of current or recent (in the preceding 2 weeks) medication taken by
the exposed person (including prescription, OCP, non-prescription, over-thecounter, recreational drug use and herbal preparations) should be taken prior to
prescribing PEP.
A list of important potential drug interactions is provided in the PEP pack along
with instructions for prescribers (Appendix J)
The contraceptive effect of oestrogens and progestogens is reduced by Kaletra
If in doubt, advice should be sought from the HIV specialist pharmacist during
clinic hours, from the on-call pharmacist out of hours or online at www.hivdruginteractions.org/ [8]
16 of 53
5.6.3
Hepatitis B infection in the exposed patient
If the exposed patient is HBsAg positive there is a risk of flare of hepatitis after
Truvada has been stopped. Therefore baseline Hepatitis B serology should be taken
in all patients starting PEP and the GUM /HIV specialist will consider withdrawal of
Truvada / change in regimen in these patients when reviewed in clinic.
5.6.4 HIV seroconversion illness or established HIV infection in the exposed
patient
PEP is not recommended in the context of HIV seroconversion illness or established
HIV infection in the exposed patient.
5.6.5
Pregnancy and breast feeding
Pregnancy does not preclude the use of HIV PEP. The possibility of pregnancy
should always be considered. Urgent pregnancy testing should be arranged for any
female worker who cannot rule out the possibility of pregnancy, as part of the
assessment consultation.
The antiretroviral in pregnancy register has shown no increased risks to the babies of
HIV-infected women who have become pregnant whilst taking the drugs used in the
PEP starter packs. National guidelines exist for the prescription of antiretroviral
therapy in pregnancy [9].
A pregnant health care worker who has experienced an occupational HIV exposure
should be counselled about the risks of HIV transmission as per any other health
care worker. If started on PEP she will receive extra information about the risks for
transmission to her baby, and about what is known and not known about the potential
benefits and risks of antiretroviral therapy for her and her baby when she attends the
appointment with the HIV specialist.
If the exposed person is pregnant or suspects pregnancy then seek specialist advice
from an HIV Consultant. If the woman is breast feeding specialist advice from an HIV
Consultant should be sought.
5.6.6
Viral drug resistance
If the source patient is known to be HIV+ve, exposure to drug resistant HIV should be
considered. The resistance profile of HIV from the source will depend on the source’s
drug history and may sometimes influence the choice of antiretrovirals used in PEP.
Specialist advice from an HIV specialist is required. Starting standard PEP should
not be delayed; Truvada/ Kaletra should be started and specialist advice
sought thereafter.
The GUM/HIV specialist may recommend that blood samples should be taken from
the source at baseline (with the patient’s consent) and sent as a high priority for
analysis for viral drug resistance genotype. Interpretation of the results and any
modifications to the PEP regimen should only be made on advice from an HIV
specialist.
5.6.7
HIV exposures in laboratory staff
Knowledge about the source virus and originating patient is very important. Specialist
advice from an HIV specialist should be sought. Starting standard PEP should not
17 of 53
be delayed; Truvada/ Kaletra should be started and specialist advice sought
immediately thereafter.
6.0
Investigations
1. Investigations for the exposed person
2. Investigations for the source person
6.1
Investigations for the exposed person
If PEP is not prescribed, consent should be sought for the following:



10ml blood sample for ‘Serum Save’ and sent to virology for storage for 2 years
Hepatitis B serology as appropriate (see Trust policy on BBV section 5.7)
Testing for HIV and other sexually transmitted infections should be
recommended after sexual exposure
If PEP is commenced consent should be sought for the following:





HIV antibody testing - at earliest opportunity on follow up with GUM/HIV.
Hepatitis B serology - all patients
FBC
U&E, LFTs, glucose, calcium and phosphate
Testing for all other sexually transmitted infections should be recommended after
sexual exposure
Ensure request for copy to be sent to Fletcher unit, Chichester / Warren
Browne unit, Worthing
6.1.1 HIV antibody testing
After occupational exposures
In patients commencing PEP HIV antibody testing should be recommended at or
near baseline. This will be carried out at first follow up with sexual health at the
Fletcher unit / Warren Browne unit which should be at the earliest opportunity the
next working day. Confidential testing will be offered.
After non-occupational exposures
HIV antibody testing is strongly recommended after sexual exposure (PEPSE).
Ideally this should be done before commencing PEP although unnecessary delay in
commencing PEP should be avoided
If the Fletcher unit / Warren Browne unit is closed at the time of commencing PEPSE
patients should attend for testing at their follow up appt with sexual health on the next
working day.
6.2
Investigations for the source person
This depends on the HIV status of the source person:
6.2.1
Source person known to be HIV+ve
18 of 53
Important information about the source’s virus can be gained from blood tests. It is
important that these are taken near to the time of exposure (i.e. within a few days at
most).
After all significant exposures the GUM/HIV specialist will organise any viral load
and resistance tests as required.
6.2.2
Source person of unknown to HIV status: HIV-Ab testing
Testing of the source patient is only necessary after a significant exposure.
The named Consultant for the source patient or a delegated team member should
approach the patient and ask for their informed agreement to HIV testing.
This approach should not be undertaken by the exposed worker. In the event of the
exposed worker being the Consultant him/herself the approach may be made by a
Consultant colleague within the same department or by making arrangements with
the GUM / HIV specialist.
If the HIV status of the source cannot be established, the exposed person will have
the opportunity to consider whether or not to take or continue PEP when followed up
in GUM/HIV departments.
6.2.2.1 Pre-test discussion
This should include [1]:
 Details of the incident and the reason for requesting for a test. Wherever possible
the identity of the health care worker should not be disclosed.
 The difficulties of the exposed health care worker's situation should be discussed
either in terms of the worker not missing the opportunity to benefit from PEP, or
conversely not being subjected unnecessarily to its potentially unpleasant short
term and unknown long term side effects.
 Consent to disclose the test result to the exposed health care worker and
Occupational Health.
The source person’s right to refuse testing must be respected. The source patient
may wish to test confidentially at the Fletcher unit / Warren Browne unit; if so this can
be arranged by contacting the relevant department.
If the patient has been sedated or has recently had a general anaesthetic the validity
of such consent would be open to challenge (see section 5.2.2.4 below).
6.2.2.2 Requesting urgent HIV serology





HIV testing available from Monday to Friday.
A single 7-10 ml clotted blood sample (no anti-coagulant)
Yellow microbiology request form stating exposure incident and stating the name
of the exposed HCW.
Request: HIV Ag/Ab test plus HepBSag / HCV Ab
This should be sent to the microbiology lab and requested as urgent. Results will
normally be available on the day of receipt as long as it is received in the lab by
2PM, (or later by arrangement).
19 of 53
6.2.2.2 Results
In all cases the result of HIV testing should be communicated to the source patient
without delay (and before it is communicated to the exposed worker). The clinical
team (Consultant or delegated member of the team) who requested HIV testing
should have access to the result from the laboratory and give the result to the patient
without delay.
The exposed health care worker should have the results communicated to them and
receive appropriate advice from occupational health or the GUM/HIV specialist
following up their case.
If the source tests negative (with no known risk in last 3 months), then PEP can be
stopped and HIV testing of the exposed person is not necessary. If the source
reported recent possible HIV exposure (window period) PEP may still be
recommended [1].
If the source patient tests HIV positive s/he should be referred to the HIV team within
24 hours for ongoing medical care and support. The exposed person should be
complete the course of PEP.
6.2.2.3 Patients lacking capacity to consent
Where a source patient lacks capacity to consent (e.g. because they are
unconscious), his/her tissue etc can only lawfully be tested for serious communicable
diseases if it is reasonably held to be in his/her best interests in accordance with the
Mental Capacity Act 2005 [1] and the Trust’s Consent Policy.
These cases can be discussed with the HIV specialist.
6.2.2.4 Exposures where the source patient is a day case who has been
sedated or had a general anaesthetic
When a day case patient has been sedated or had a general anaesthetic and a
potential exposure incident has occurred no attempt should be made to seek consent
for HIV-AgAb testing on the day of the procedure. Given that the patient has been
recently sedated the validity of such consent would be open to challenge.







The patient should be given a simple, brief but clear verbal explanation of the
incident
If necessary a translator should be employed
Refer the patient to the Fletcher unit, Chichester or Warren Browne unit, Worthing
for follow up the next working day.
Complete the information on the standard letter in Appendix H and take a
photocopy
Give the original to the source patient with a brief explanation of its contents
Ensure that the patient’s contact details (including home and mobile telephone
numbers) and GP are up to date.
Fax and/or post the copy of the letter to Fletcher unit or Warren Browne unit
At the Fletcher unit / Warren Browne unit the health advisor or nursing staff will:

Provide pre-test discussion and seek informed consent for HIV testing
20 of 53




Provide confidential testing which will not form part of their main hospital medical
record
Give the source patient their results as soon as possible
Seek the consent of the source patient for release of results to the exposed HCW
Actively recall patients who fail to attend
6.2.2.5 Deceased patients
In the event of a deceased patient being the source of a needlestick injury and whose
HIV status is unknown, the taking and testing of samples requires consent in
accordance with the Human Tissue Act 2004. Assuming the deceased did not give
consent (or refuse it) while alive, this can be obtained from a “nominated
representative” (if appointed) or by a person in a “qualifying relationship” to the
deceased [1]. If the testing shows that the patient was a carrier of a virus, seek
advice from an HIV specialist before giving the information to the patient’s close
contacts.
7.0 Other Blood Borne Viruses
Guidelines for management of HCWs exposed to other blood borne viruses is
outlined in the Trust BBV policy
Following all significant exposures the source patient should also be approached
regarding testing for hepatitis B and C infection.
7.1 Follow-Up
7.2 HCW not receiving PEP
HCW who are not receiving PEP will be followed up by the Occupational Health
Department.
If initially assessed in A&E the HCW will be given a copy of their assessment /
consultation record sheet to take to the appropriate Occupational Health Department
and the A&E department will leave a message on the appropriate Occupational
Health Departments answer phone with the staff members details.
7.3 HCW receiving PEP
HCW receiving PEP will be advised to attend the Fletcher unit, Chichester, or Warren
Browne unit, Worthing, at the earliest opportunity the next working day. HCWs should
also be advised to contact Occupational Health on the next working day.
The Consultation Record Sheet completed by A&E / Occupational Health should be
faxed to the Fletcher unit / Warren Browne unit and if out of hours a message should
be left on the Fletcher unit / Warren Browne units answer phone with the staff
members details.
If patient fails to attend Fletcher unit / Warren Browne unit the Health Advisors will
make all efforts to contact the HCW.
21 of 53
7.4.1 Patients commencing PEP following sexual / non occupational exposure
in A&E
Patients who commence PEPSE in A&E will be advised to attend the Fletcher unit /
Warren Browne unit at the earliest opportunity the next working day.
If assessed in A&E the Consultation Record Sheet completed by A&E should be
faxed to the Fletcher unit / Warren Browne unit and a message should be left on the
Fletcher unit / Warren Browne units answer phone with the patients details.
If patient fails to attend the Health Advisors will make all efforts to contact the patient
7.4.2 Patients not commencing PEP following non occupational exposure in
A&E
Patients following sexual exposure should be advised to attend the Fletcher unit /
Warren Browne unit for an STI screen.
Patients following community needlestick exposures / bites etc should be followed up
in primary care as per normal practice.
7.5 Tests for BBV following potential exposure / PEP
7.5.1 Persons taking PEP
Follow up tests will be undertaken by the GUM/HIV units managing the patients as
outlined in their follow up protocols.
7.5.2 HCW not taking PEP
These people will be followed up in the Occupational Health department.
 Hepatitis B serology / management as per Trust policy on BBV
 3 months – 4th Generation HIV Ag/Ab test
 6 months – HCV Ab test
7.6 HIV seroconversion
During the follow up period patients should seek medical advice about any acute
illness. Illnesses characterised by fever, rash, myalgia, fatigue, malaise or
lymphadenopathy may represent a seroconversion illness. Some of these symptoms
may, however, be side effects of antiretroviral medication [1]. Advice is available from
the HIV team.
If HIV infection is diagnosed, health care worker should be advised and managed in
line with DoH recommendations [10].
8.0
Availability of the Guidance
This Guidance should be available in all wards and departments and on the Trust
intranet.
22 of 53
9.0
Specialist Resources
Sharps hotline:
SRH 01243 788122 x 2405
WASH 01903 205111 x3037/01273 446037
**On the back of each staff member ID card
GUM & HIV Medicine: St Richards Hospital
Consultant: Dr Emma Rutland – extension 3660 or contact via switchboard
Associate Specialist: Sam Gamalath - extension 3660 or contact via switchboard
Health advisors: Barbara Hayman and Sandie Parker – 3669
GUM & HIV Medicine: Worthing / Southlands Hospital
Consultant: Dr Andrew Nayagam – extension 3681 or contact via switchboard
Associate specialist: Dr Vasu Selvadurai – extension 3681 or contact via switchboard
Speciality Doctor: Dr Ruwani Jayaweera – extension 3681 or contact via switchboard
Health Advisor: Richard Williams – ext 3681
Specialist HIV Pharmacy
David Moore:
On Monday, Tuesday am and Friday: Southlands Hospital
Extension: 3750 (office) or ext 3413 (dispensary)
On Wednesday and Thursday am: Sexual Health clinic, Crawley
Hospital 01293 600300 ext 4007
Mobile: 07790295575, if fail to contact using above numbers
Kin Ing:
On Mondays pm and Thursday am: Fletcher Unit, (SRH) - ext
3660
Tuesdays all day, Wednesdays am, Fridays am: Warren Browne
unit (Southlands), ext 3681 (reception) or Bleep 908
Other times: Beeding House, ext 3750 (Southlands site) or Bleep
908
work mobile: 07876 031464, if fail to contact using above
numbers.
Occupational Health Department, St Richards Hospital
Reception: 01243 788122 x2403; direct dial 01243 831478
Sharps Hotline: 01243 788122 x2405
Occupational Health department, Southlands/Worthing Hospital
23 of 53
Telephone:
Fax:
Sharps Hotline:
01273 446056
01273 446027
01273 446037
10.0 Development of Guidance
The sources of reference on which this guidance is based are shown below. In
addition the guidance reflects current practice within the Trust (where this does not
conflict with published evidence and expert opinion) combined with information about
good practice from other NHS Trusts.
A draft version of the guidance was circulated to consultants, associate specialists
and health advisers within the Department of HIV/ GUM for their approval. In addition
specific consultation was sought with senior medical staff in the Accident and
Emergency Department, Department of Occupational Health and Microbiology. The
Guidance was then submitted for approval to the Trust Policies Committee .
Amendments were made as necessary before the final guidance was submitted for
ratification.
11.0 Implementation
12.1 Dissemination of the Guidance
The Guidance will be sent to all Consultants, Ward Managers, Out Patient
Department, Theatres, Imaging Departments and Laboratories. The manager in each
of these areas will be responsible for disseminating copies of the Guidance to
relevant staff and ensuring that copies of the Guidance are available for immediate
reference in the event of a potential HIV exposure.
12.2 Staff Induction and Training of Non-Specialist Staff
In line with the Blood Borne Virus Policy training on the correct use of sharps and
what to do in the case of an inoculation incident is provided to relevant staff on the
health and safety update day and in accordance with the Learning and Development
Policy.
To minimise delay in seeking advice about PEP all Trust staff must be aware of how
to avoid occupational exposure, possible risks from occupational exposure to HIV
and action to be taken following possible exposure including immediate first aid and
how to report an exposure, and to whom and reasons why this is important
Responsibility for this rests with the line manager for any given staff group.
Basic information about PEP must form a part of the Trust Induction Programme for
new staff [1].
12.3 Training of Staff Involved in Assessment and Administration of PEP
The following groups of staff will require specific training regarding assessment of the
need to access immediate expert advice and about supplying an initial dose of PEP
and awareness of current protocols:


Medical and nursing staff in A&E
Medical and nursing staff in the Department of HIV/GUM
24 of 53

Medical and nursing staff in the Department of Occupational Health
This will involve regular teaching conducted at a frequency determined by the rate of
turnover and training needs of each staff group.
12.4
Monitoring
In line with section 3.0 of the Blood Borne Virus Policy:
 Sharps injuries and other body fluid exposure incidents: A quarterly
occupational health report is presented to the Health and Safety Committee.
 Staff attendance at training is monitored in accordance with the Learning and
Development policy.
12.5
Audit
The recommendations within the Guidance will be audited. Auditable outcomes may
include:





Proportion of PEPSE prescriptions that fit within recommended indications:
(target 90%)
Proportion of PEPSE prescriptions administered within 72 hours of risk
exposure: (target 90%)
Proportion of patients started on PEP referred to GUM / HIV unit (target 100%)
Proportion of patients prescribed PEP completing 28 day course (target 75%)
Proportion of individuals completing 12 week post-PEP HIV antibody test (target
60%)
13.0
References
1. HIV post-exposure prophylaxis: Guidance from the UK Chief Medical Officers’
Expert Advisory Group on AIDS. Department of Health. Revised September
2008.
2. Cardo DM, Culver DH, Ciesielski CA, Srivastava PU, Marcus R, Abiteboul D,
Heptonstall J, Ippolito G, Lot F, McKibben PS, Bell DM. A case-control study
of HIV seroconversion in health care workers after percutaneous exposure.
Centers for Disease Control and Prevention Needlestick Surveillance Group.
N Engl J Med. 1997; 337: 1485-1490.
3. 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;74:9771–5
4. Wade NA, Birkhead GC, Warren BL, et al. Abbreviated regimens of
zidovudine prophylaxis and perinatal transmission of the human
immunodeficiency virus. N Engl J Med 1998;339:1409–14
5. Praca Onze Study Team. Behavioural impact, acceptability, and HIV
incidence amongst homosexual Men with access to postexposure
chemoprophylaxis for HIV. J Acquir Immune Defic Syndr 2004;35:519
6. Schecter M. Occupational and sexual PEP – benefit/risk? 6th International
Conference on Drug Therapy in HIV Infection, 2002. Glasgow, UK (abstr. PL
6.1)
7. Clinical Effectiveness Group (British Association of Sexual Health and HIV).
United Kingdom Guideline For The Use Of Post-Exposure Prophylaxis For
HIV Following Sexual Exposure. Int J STD & AIDS 2006; 17: 81–92 reference
new guideline**
25 of 53
8. Website of Liverpool HIV Pharmacology Group, Department of Pharmacology
and Therapeutics, University of Liverpool, UK.
9. British HIV Association and Children’s HIV Association guidelines for the
management of HIV infection in pregnant women 2008. HIV Medicine 2008;
9: 452–502.
10. HIV infected Health Care Workers : Guidance on Management and Patient
Notification.
Department
of
Health
2005.
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/do
cuments/digitalasset/dh_4116416.pdf
14.0
Glossary
A&E
AIDS
BASHH
BBV
CDSC
DoH
DNA
EAGA
FBC
GMC
GUM/HIV
HAART
HBV
HCV
HCV-Ab
HCW
HIV
HIV-AgAb
HPA
LFT
MSM
NHS
PCR
PEP
PEPSE
PHLS
STI
U.S.
U&E
26 of 53
Accident and Emergency
Acquired Immunodeficiency Syndrome
British Association for Sexual Health and HIV
Blood-borne virus
Communicable Disease Surveillance Centre
Department of Health
Deoxyribonucleic acid
Chief Medical Officer’s Expert Advisory Group on AIDS
Full Blood Count
General Medical Council
Sexual Health Service
Highly Active Anti-Retroviral Therapy (Combination of drugs)
Hepatitis B virus
Hepatitis C virus
Hepatitis C antibody
Health care worker
Human Immunodeficiency Virus
HIV antigen antibody
Health Protection Agency
Liver function tests
Men who have Sex with Men
National Health Service
Polymerase Chain Reaction
Post-exposure prophylaxis
PEP after sexual exposure
Public Health Laboratory Service
Sexually transmitted infection
United States of America
Urea and Electrolytes
Appendix A
HIV PEP following Occupational Exposure Consultation Record Sheet
Prompt Assessment Is Important: PEP Is Most Effective If Started Within the Hour
Contacted sharps hotline number? YES / NO
If NO: contact sharps hotline (SRH 01243 788122 x 2405 or WASH 01903 205111 x3037)
Part 1: About the Person Requesting PEP (to be completed by HCW)
Name of exposed person:
____________________
WSHT Staff?
Yes  No 
DOB:
____________________
Sex:
Male/ Female
Patient sticker (A&E)
Today’s date
__/__/____
Time now:
___:___
Date of incident
__/__/____
Time of incident
___:___
Part 2: Information about the Source Person (to be completed by HCW)
a) Is the source unknown and unidentifiable:
YES  Go to part 4
Is the source known:
YES 
Give any identifying information e.g. name, hospital number, ward & Consultant:
b) Is the source:
Known to be HIV+ve:
Unknown or uncertain HIV status:
 Go to part 3A
 Go to part 3B
Part 3A: The HIV+ve Source Person (to be completed by HCW)
Is any of the following information immediately available?
If not PEP should not be delayed to collect more information about the source. PEP
can be altered later if necessary (after discussion) if more information does become
available
a) Most recent HIV viral load:
copies/ml
Date: __/___/__
b) Is the source currently on antiretroviral treatment? If yes which drugs?
c) Has the source previously taken any/ any other antiretroviral treatment? If yes which
drugs?
27 of 53
d) Is there any known HIV drug resistance?
(now go to part 4)
Part 3B. Identified source of unknown or uncertain HIV status
a) Does the source have a known HIV risk behaviour?

Man who has sex with men

Current/ ex IVDU

Born or recently arrived from area of high HIV prevalence
(see attached HIV prevalence data / Appendix G))

Recipient of multiple blood transfusions or blood products pre 1985

Sexual partner of person with risk factor(s) above
b) Date of last HIV test? __/__/__

Never had HIV test
(now go to part 4)
Part 4: About the Exposure (to be completed by HCW)
A: Material involved (tick all that apply):
 Blood

Saliva in association with dentistry
 Amniotic Fluid

Vaginal Secretions / Semen
 Cerebrospinal Fluid

Unfixed Tissues or Organs
 Human Breast Milk

Pericardial / peritoneal / pleural Fluid
 Exudative or other tissue fluid from burns or skin lesions
 Other body fluid which is visibly bloodstained
B: Type of exposure:
I.
Was there a sharps injury:
Superficial (surface scratch)

Moderate (Skin penetrated)

Deep (penetrating injury)

II.
Was there exposure of non intact skin? (e.g. abrasions, cuts, eczema etc):

III.
Was there mucous membrane exposure?

C: Was an instrument involved:
Was the instrument:
28 of 53
No

Hollow bore needle

Solid needle

Other instrument

Visibly contaminated with blood

Previously in an artery or vein

(Now go to part 5)
Part 5 is PEP indicated? – (to be completed by A&E nurse/Dr)
***Note PEP is not indicated if the source is unknown or cannot be identified go to Part 8
HIV Risk Assessment Table
Use the following risk assessment table to determine whether HIV post-exposure prophylaxis
(PEP) is indicated.
Risk assessment of injury
Score
Nature of exposure
Splash to broken or mucosal membrane
1
Percutaneous penetration
2
Non bloody fluid excluding faeces, saliva, urine, vomit
0
Blood or blood stained fluid
2
Solid
0
Hollow
1
Suture / IM / subcutaneous
0
IV / arterial access
1
Superficial (scratch/graze)
1
Moderate (penetrated skin)
2
Deep
3
Material exposed to
Type of sharp
Sharp use
Wound description
Risk factors for HIV (source patient) (see part 3b)
Enter score
Score
Low risk factors / unknown
1
High risk factors
5
Known HIV positive
6
TOTAL SCORE
□ Total score 10 or more PEP recommended – Go to Part 6 & refer to A&E Dr
□ Total score below 10 do not give PEP – Go to Part 7
29 of 53
Part 6: PEP Indicated – Other medical details required ( to be completed
by A&E doctor)
a) Past medical history:
b) Medication History:
Current medication or in preceding 2 weeks (including Oral contraceptive pill); Check for
any interactions with PEP on information for prescribers sheet provided / Appendix J)
c) Allergies (to Truvada (tenofovir, emtricictabine) or Kaletra (lopinavir, ritonavir)
d) If female: LMP
If possible pregnancy do urinary Pregnancy test.
Result:
**IF SOURCE PATIENT IS KNOWN HIV POSITIVE / DRUG INTERACTIONS ARE
HIGHLIGHTED OR PATIENT IS PREGNANT CONTACT HIV CONSULTANT WHO
WILL ADVISE WHETHER ANY CHANGES SHOULD BE MADE TO PEP REGIME
**If none of the above continue to provide PEP starter pack as below
a) Having read the PEP information sheet (Appendix K) does the patient understand:
 how to take PEP
 potential side effects
 drugs licensed to treat HIV but not PEP; however recommended by
national guidelines
 Importance of follow-up
b) Does the patient consent to PEP (sign consent form Appendix F)
Yes
No


Continue below…
Why:
c) Provide PEP starter pack and complete prescription sheet in PEP pack (Appendix
E):
Truvada 1 tablet once a day & Kaletra 2 tablets twice a day for 5 days
Date of first dose: __/__/__
Time of first dose: ___:___
d) Discuss following issues:

Safer sex / condom use for 3 months

Safe injecting practice (if appropriate)

No Blood / semen donation for 3/12
30 of 53
Now go to part 7 below
Part 7. Hepatitis B/C Management
All cases of occupational exposure must be referred to Occupational Health regardless
of level of risk.
Hepatitis B management (as per BBV policy)
If known HepBsAg positive source or known non responder to vaccine (see shaded
boxes consider HBIG).
If not refer to occupational health next working day for ongoing management.
HBV prophylaxis for reported exposure incidents
Significant exposure
Non-significant exposure
HBV status of person HBsAg
Unknown
HBsAg
negative Continued risk
No further risk
exposed
positive
source
source
source
< 1 dose HB vaccine
HBIG × 1
Accelerated
Initiate course of HB Initiate course of HB No
HBV
pre-exposure
course of HB vaccine
vaccine
prophylaxis.
Accelerated
vaccine*
Reassure
course of HB
vaccine*
> 2 doses HB vaccine
One dose of HB One dose of HB Finish course of HB Finish course of HB No
HBV
pre-exposure
vaccine
vaccine
vaccine
vaccine
prophylaxis.
(anti-HBs not known)
followed
by
second
dose
Reassure
one month later
Known responder to Consider
Consider
Consider
booster Consider
booster No HBV prophylaxis
HB vaccine
booster dose of booster dose of dose of HB vaccine
dose of HB vaccine
(anti-HBs > 10mIU/ml)
HB vaccine
HB vaccine
Reassure
Known non-responder HBIG
×
1 HBIG
×
1 No HBIG Consider No HBIG
No
HBV
to HB vaccine
Consider
Consider
booster dose of HB
prophylaxis.
(anti-HBs < 10mIU/ml
booster dose of booster dose of vaccine
Consider
booster
2–4
months
post- HB vaccine.
HB vaccine
dose of HB vaccine
Reassure
immunisation)
2nd dose of 2nd dose of
HBIG should be HBIG should be
given at one given at one
month
month
*An accelerated course of vaccine consists of doses spaced at zero, one and two months. A booster dose may be given at 12 months
to those at continuing risk of exposure to HBV.
Source: PHLS Hepatitis Subcommittee (1992).
Hepatitis C (HCV) Management
There is no vaccine / prophylaxis for Hepatitis C.
All cases of occupational exposure to hepatitis C must be referred to occupational health for
follow up and further management.
Part 8. Baseline Bloods
All exposed patients: Serum store & HepBsAb will be taken by the Occupational Health
department on the next working day (clotted samples)
If starting PEP:
31 of 53
FBC
U&Es, LFTs, Glucose, Calcium, phosphate
Full Hepatitis B & C serology
 (EDTA)
 (Yellow top)
 (clotted sample)
**HIV testing will be done at first follow up in GUM/HIV dept
**Please request copy to Fletcher unit, Chichester or Warren Browne unit, Worthing
Tests for the source person will be arranged with his/ her consent of by the Clinical
team responsible for their care if WSHT patient
Part 9. Follow - Up Arrangements
a) WSHT staff not commencing PEP: Patient must attend occupational health on next
working day
Ring occupational health and leave a message with
exposed staff members details
Give a copy of paperwork to exposed staff member
to take to occupational health
b) Patients commencing PEP:
Patient must attend Fletcher unit / Warren Browne
unit on next working day in addition to attending
occupational health.
Please fax all sheets in this form with A&E front
sheet to the GUM/HIV Department (Fletcher unit on:
fax number 01243831606 or Warren Browne unit on:
fax number 0173446049)**
AND
Telephone Fletcher unit on 01243831607 or Warren
Browne unit on 01273446049 to inform them of
referral (leave message on answer phone out of
hours)
**Health advisors from Fletcher unit / Warren Browne unit will contact patients who do not
attend according to the contact details you fax to them. Please ensure that these are
accurate.
Signed:________________Print name:_______________ Date: __/__/__
32 of 53
Appendix B
HIV PEP following non occupational (Sexual / community needlestick /
bite) Exposure Consultation Record Sheet
Prompt Assessment Is Important: PEP Is Most Effective If Started Within the Hour
Person completing form:
__________________________
Part 1: About the Person Requesting PEP
Name of exposed person:
____________________
DOB:
____________________
Sex:
Male/ Female
Patient sticker
Today’s date
__/__/____
Time now:
___:___
Date of incident
__/__/____
Time of incident
___:___
Part 2: Information about the Source Person
a) Is the source unknown and unidentifiable:
Is the source known:
b) Is the source:
YES  Go to part 4
YES 
Known to be HIV+ve:
Unknown or uncertain HIV status:
 Go to part 3A
 Go to part 3B
Part 3A: The HIV+ve Source Person
Is any of the following information immediately available?
If not PEP should not be delayed to collect more information about the source. PEP
can be altered later if necessary (after discussion) if more information does become
available
e) Most recent HIV viral load:
f)
copies/ml
Date: __/___/__
Is the source currently on antiretroviral treatment? If yes which drugs?
g) Has the source previously taken any/ any other antiretroviral treatment? If yes which
drugs?
h) Is there any known HIV drug resistance?
33 of 53
(now go to part 4)
Part 3B. Identified source of unknown or uncertain HIV status
a) Does the source have a known HIV risk behaviour?

Man who has sex with men

Current/ ex IVDU

Born or recently arrived from area of high HIV prevalence
(see attached HIV prevalence data / Appendix G)

Recipient of multiple blood transfusions or blood products pre 1985

Sexual partner of person with risk factor(s) above
b) Date of last HIV test?
__/__/__

Never had HIV test
(now go to part 4)
Part 4: About the Exposure
A) Sexual exposure:
Sexual partner:
Male
/
Female
Contactable
/
Uncontactable
Was there sexual assault?
Yes
/
No
Tick appropriate box(es) for sexual exposure and condom use. Leave blank if any
information for an exposure is not known.
Types of
Type of sex?
sex
Anal
Receptive
Insertive
Vaginal
Receptive
Insertive
Oral
Receptive
Insertive
B) Discarded needle:
Describe injury:
C) Bite:
Describe injury:
34 of 53
Condom Used?
Condom
Internal
Break?
Ejaculation?
Has the person requesting PEP ever had an HIV test?
Yes : date of last HIV test (approx.): _____________
Since last HIV test has patient had any of the following risks for HIV infection:
No  has the patient ever had any of the following risks for HIV infection:




unprotected anal/vaginal sex with known HIV+ve person
man having unprotected anal sex with unknown man
IVDU
originates from / unprotected sex in HIV endemic area (see HIV
prevalence sheet in appendix)
(Sexual health unit only: Consents to HIV antibody test?:
(Now go to part 5)
35 of 53
Yes 
No )
Part 5 is PEP indicated?
**PEP is not indicated for exposures over 72 hours ago – go to part 7
Use the table to help decide whether PEP is indicated.
Type
Of Source Known HIV +ve
Unprotected
Viral
load Viral
load
Sexual Exposure detectable
/ undetectable
unknown
Receptive
anal Recommended
Recommended
sex
Insertive anal sex Recommended
Not recommended
Source HIV Status Unknown
Source
High Source not High
Risk#
Risk#
Receptive vaginal
sex
Insertive vaginal
sex
Fellatio
with
ejaculation
Fellatio
without
ejaculation
Cunnilingus
Recommended
Not recommended
Considered
Not recommended
Recommended
Not recommended
Considered
Not recommended
Recommended
Not recommended
Considered
Not recommended
Considered
Not recommended
Not recommended
Not recommended
Not recommended Not recommended
Not recommended
Not recommended
Not recommended Not recommended
Not recommended
Not recommended
Not recommended
Not recommended
Not recommended
Not recommended
Considered
Not recommended
Not recommended
Not recommended
Not recommended
Not recommended
Not recommended
Splash of semen Considered
into eye
Sharing injecting Recommended
drug equipment
Human bite
*Not
recommended
Needlestick from
discarded needle
in the community
# Within the UK at present this is men who have sex with men and individuals who have immigrated to
UK from areas of high HIV prevalence particularly sub-Saharan Africa
*This may be considered in exceptional circumstances where an HIV+ individual with a detectable viral load
with blood in their mouth bites another individual where the teeth have broken the skin
 No, PEP is not recommended
Advise patient that the potential side effects and toxicity of taking PEP outweigh the
negligible risk of transmission posed by the type of exposure because it is considered
insignificant, whether or not the source patient is known or considered likely to be
HIV infected.
Continue to Part 7
 Yes, PEP indicated; continue to Part 6
 PEP is considered – discuss with HIV Specialist
36 of 53
Part 6: PEP Indicated – Other medical details required
e) Past medical history:
f) Medication History:
Current medication or in preceding 2 weeks (including Oral contraceptive pill); Check for
any interactions with PEP on information for prescribers sheet provided / Appendix J)
g) Allergies (to Truvada (tenofovir, emtricictabine) or Kaletra (lopinavir, ritonavir)
h) If female: LMP
If possible pregnancy do urinary Pregnancy test.
Result:
**IF SOURCE PATIENT IS KNOWN HIV POSITIVE / DRUG INTERACTIONS ARE
HIGHLIGHTED OR PATIENT IS PREGNANT CONTACT HIV CONSULTANT WHO
WILL ADVISE WHETHER ANY CHANGES SHOULD BE MADE TO PEP REGIME
**If none of the above continue to provide PEP starter pack as below
i)
Having read the PEP information sheet (Appendix K) does the patient understand:
 how to take PEP
 potential side effects
 drugs licensed to treat HIV but not PEP; however recommended by
national guidelines
 Importance of follow-up
j)
Does the patient consent to PEP (sign consent form Appendix F)
Yes

Continue below…
No

Why:
k) Provide PEP starter pack and complete prescription sheet (Appendix E) in PEP
pack:
Truvada 1 tablet once a day & Kaletra 2 tablets twice a day for 5 days
Date of first dose: __/__/__
l)
Time of first dose: ___:___
Discuss following issues:



For sexual exposures: 
37 of 53
Safer sex / condom use for 3 months
Safe injecting practice (if appropriate)
No Blood / semen donation for 3/12
Consider emergency contraception
Now go to part 7 below
Part 7. Hepatitis B/C Management
Hepatitis B management
If high risk exposure to a known HepBsAg positive source consider HBIG (Discuss with
GUM/HIV specialist on call). Otherwise further assessment and management of Hepatitis B
prevention following sexual exposure will be carried out by GUM/HIV unit or following nonsexual exposure by primary care.
Hepatitis C (HCV) Management
There is no vaccine / prophylaxis for Hepatitis C. All cases of sexual exposure will be referred
to Fletcher unit / Warren Browne unit for follow up and further management.
Part 8. Baseline Bloods
Patients not starting PEP: No bloods in A&E. Patients will be advised to have follow up in
GUM/HIV service or primary care (see below)
If starting PEP:
FBC
U&Es, LFTs, Glucose, Calcium, phosphate
Full Hepatitis B serology
 (EDTA)
 (Yellow top)
 (clotted sample)
Baseline HIV testing will be carried out at first follow up visit at
Fletcher unit / Warren Browne unit next working day
**Please request copy to Fletcher unit, Chichester or Warren Browne unit, Worthing
Tests for the source person will be arranged with his / her consent by the GUM/HIV unit
Part 9. Follow - Up Arrangements
a) Patients not commencing PEP:
i) Sexual exposures: Patient should be advised to attend Fletcher unit / Warren Browne unit
for STI screening / Hep B/C follow up. Ask patient to ring for appt / details of walk in service.
Please fax all sheets in this form with A&E front sheet to the GUM/HIV Department (Fletcher
unit on: fax number 01243831606 or Warren Browne unit on: fax number 0173446049)**
ii) Non sexual exposures: Patient can be followed up in Primary care
b) Patients commencing PEP:
Patient must attend Fletcher unit / Warren Browne unit on next working day**
Please fax all sheets in this form with A&E front sheet to the GUM/HIV Department (Fletcher
unit on: fax number 01243831606 or Warren Browne unit on: fax number 0173446049)**
AND telephone Fletcher unit on 01243831607 or Warren Browne unit on 01273446049 to
inform them of referral (leave message on answer phone out of hours)
**Health advisors from Fletcher unit / Warren Browne unit will contact patients who do not
attend according to the contact details you fax to them. Please ensure that these are
accurate.
38 of 53
Signed:_________________Print name:_______________Date: __/__/__
APPENDIX C
Post exposure prophylaxis (occupational exposure) pathway
Staff Member (patient) presents with occupational exposure
Occupational Health (working hours)
o
o
o
o
A&E (out of hours)
o
o
Complete risk assessment form
Do serology for Hep B
Do save serum (with consent)
Consider need for HBIG / Hep B
vaccination
Complete risk assessment form
Consider need for HBIG
Low risk (score <10)
No PEP required
High risk (score >10)
PEP recommended
PEP declined


Arrange follow up
If assessed in A&E: Ensure follow up
arranged with occupational health,
leave message on occupational health
answer phone and give copy of
paperwork to exposed staff member
F/U: (Occupational health)
- HepB serology results
- HIV AgAb 3/12
- HepC Ab 6/12
PEP accepted
PEP accepted.
 Information leaflet given to patient
 Consent form signed by patient and prescribing
medical officer
 5 day PEP pack given to patient to start asap
 Do baseline FBC, U&E, LFT, calcium and phosphate,
Hepatitis B serology (request copy to Fletcher / WBU)
 Refer to GUM clinic next working day & leave
telephone message at GUM
 Copy of assessment notes faxed to GUM/HIV unit
 If assessed in A&E: Ensure follow up arranged with
occupational health, leave message on occupational
health answer phone and give copy of paperwork to
exposed staff member
GUM/HIV Clinics
Chichester – Fletcher Unit SRH
WaSH – Warren Browne Unit
Tel:01243831607
Tel:01273446075
Fax:01243831606
Fax:01273446049
Occupational Health Departments
Chichester: 01243 788122 x2403; direct dial 01243 831478 Sharps Hotline: x2405
39 of 53
Worthing/Southlands Hospitals:
Hotline: 01273 446037
Telephone: 01273 446056; Fax 01273 446027; Sharps
APPENDIX D
Post exposure prophylaxis following
exposure: pathway for out of hours
non
occupational
Patient presents with sexual / community needlestick / bite
exposure
o
o
A&E (out of hours)
Complete risk assessment form
Consider HBIG if high risk exposure to known HepBsAg+ve source (D/W
GUM/HIV specialist)
PEP not recommended
PEP considered – discuss with
GUM/HIV specialist on call via
switchboard
PEP not
recommended /
declined
PEP recommended
PEP
recommended
and accepted
PEP declined
Arrange follow up



Sexual exposures: strongly advise
follow up arranged with GUM/HIV
Ensure risk assessment form
faxed to relevant unit
Non sexual exposures: follow up
in primary care
PEP accepted.






GUM/HIV Clinics
Chichester – Fletcher Unit SRH
WaSH – Warren Browne Unit
40 of 53
PEP accepted
Tel:01243831607
Tel:01273446075
Information leaflet given to patient
Consent form signed by patient and prescribing
medical officer
5 day PEP pack given to patient to start asap
Do baseline FBC, U&E, LFT, Hepatitis B
serology (request copy to Fletcher unit / WBU)
Refer to GUM clinic next working day & leave
telephone message at GUM
Copy of assessment notes faxed to GUM/HIV
unit
Fax:01243831606
Fax:01273446049
APPENDIX E
Prescription for HIV Post Exposure Prophylaxis (PEP)
Date: __/__/____
Name of exposed person or GUM clinic number:
_____________
DOB:
_____________
Hospital/ A&E no:
_____________
Type of exposure:
Occupational
Sexual
Post code
Please Supply PEP pack containing:

Truvada 1 tablet o.d. for 5 days
(5 tablets)

Kaletra 2 tablets b.d. for 5 days
(20 tablets)

Domperidone 10mg t.d.s as required
(10 tablets)

Loperamide 4mg q.d.s as required
(12 tablets)
Prescriber’s signature
Name
Date:
Please ensure the patient receives the patient information leaflet:
"HIV Post Occupational Exposure Prophylaxis".
Please file in A&E notes and fax with consultation sheet to Fletcher unit,
Chichester or Warren Browne unit, Worthing
41 of 53
Appendix F
Consent Form
HIV Post Exposure Prophylaxis
Truvada (Tenofovir + Emtricitabine) and Kaletra (Lopinavir + Ritonavir) have been
recommended for the prevention of transmission following exposure to HIV by the
Department of Health and Specialist HIV organisations. Their efficacy and long term
toxicity are not known. However, their use may prevent HIV transmission.
Because these drugs are not licensed for this indication, it is necessary to obtain your
written consent to receive treatment.
******************************
I wish / do not wish* to receive Truvada® and Kaletra® for prophylaxis.
I have read and received a copy of "HIV Post Exposure Prophylaxis" and my consent
is based on this written information.
Signature of person at risk ........................................................................................
Name of person at risk ..................................... Contact tel. No. .............................
(Block capitals)
Date ...........................................................................................................................
* delete as necessary
42 of 53
Appendix G
Risk that source is HIV positive [7]
Population Group (aged >15 years)
Men who have sex with men†
UK†
London†
Elsewhere in UK†
Brighton*
Heterosexuals (region of birth)‡
UK
Rest of Europe
North America
Central and South America
Caribbean
North Africa and Middle East
Sub-Saharan Africa
South Asia
East and South Asia
Australasia
Injecting drug users†
UK
London
Elsewhere in UK
HIV Prevalence (%)
Male
5.2
10.5
3.4
13.7
Female
-
0.4
1.2
1.1
1.9
1.2
0.5
6.1
0.5
1.1
0.3
0.3
0.6
0.2
1.1
1.0
0.4
10.3
0.5
0.8
0.2
0.3
0.8
0.2
0.3
0.3
0.3
† Prevalence numerator is derived from MPES estimates for 2008 (published 2009), Health Protection Agency. Prevalence
denominator is derived from multiplying ONS mid-2008 population estimates by the estimated proportion of UK population
reporting homosexual partners or injecting non-prescribed drugs in past five years, as relevant (Johnson et al.Lancet 2001).
‡HIV
prevalence
among
GUM
clinic
attendees
by
work
region
of
birth
in
2008.
http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1226046271991 Contemporaneous prevalence estimates can be
obtained at: http://www.hpa.org.uk/infections/topics_az/hiv and sti
*Dodds JP, Johnson AM, Parry JV, Mercey DE. A tale of three cities: persisting high HIV prevalence, risk behaviour and
undiagnosed infection in community samples of men who have sex with men. Sex Transm Infect. 2007; 83(5): 392–396
Areas of high Hepatitis B prevalence
Areas shaded dark green =
prevalence >8%
Saharan and sub-Saharan Africa
East and South East Asia
Tropical South America
Romania
Saudi Arabia
Northern Canada (Inuits) and
Greenland
Areas shaded dark green = prevalence >8%
Areas shaded light green = prevalence 2-8% (From WHO, 2006)
43 of 53
Appendix H
Estimate of Risk of HIV Acquisition from a single exposure
= risk of source having HIV x risk of exposure
Examples:
Needlestick injury from local intravenous drug user.
Risk = 0.3% X 0.3% = approximately 1/111,111
Needlestick injury from SSA man of unknown status
Risk = 6.1% x 0.3% = approximately 1 in 5,464
Needlestick injury from UK born heterosexual man of unknown status
Risk = 0.4% x 0.3% = approximately 1 in 83,333
Sharing drug injecting equipment with a known HIV positive
Risk = 100% X 0.67% = approximately 1 in 149
Unprotected receptive anal sex with HIV positive MSM.
Risk = 100% x 1.11% = approximately 1 in 90
Unprotected receptive anal sex with local MSM of unknown status.
Risk = 3.4% x 1.11% = approximately 1 in 925 to 1 in 2650
Unprotected insertive anal sex with local MSM of unknown status.
Risk = 3.4% x 0.06% = approximately 1 in 49,020
Unprotected receptive oral sex (giving fellatio) with MSM of unknown status.
Risk = 3.4% X 0.02% = approximately 1 in 147,049
Unprotected receptive vaginal sex with known HIV positive man.
Risk = 100% x 0.1% = approximately 1 in 1000
Unprotected receptive vaginal sex with African man of unknown status.
Risk = 6.1% X 0.1% = approximately 1 in 16,393
Unprotected insertive vaginal sex with African woman of unknown status
Risk = 10.3% X 0.082% = approximately 1 in 1/11,840
Unprotected receptive vaginal sex with UK born man of unknown status
Risk = 0.4% X 0.1% = 1/250,000
Based on seroprevalence data from the Health Protection Agency, 2008
44 of 53
Appendix I
Information For Day Case Patients
A Member of Staff Has Been Accidentally Exposed to Your Body Fluids
What You Need to Know; Why We Need Your Help
Today’s date: __/__/____
Patient Details
Name of patient:
_____________
Hospital no.:
_____________
DOB: _____________
Male/ Female
Patient’s address:
Patient’s day time tel. no.:
_____________
Mobile tel. no.: _____________
Brief explanation of event:
Appointment in GUM/HIV clinic: Date: _____________Time:
_____________
Where:
Hospital
Tel:
Why Have You Been Given This Letter?
This letter is to help you remember some important information given to you after your
procedure. A member of staff will have given you a full explanation.
Today you have had an investigation or treatment at Western Sussex Hospitals NHS Trust.
During this treatment a member of our staff became accidentally exposed to your blood or
another of your body fluids.
This has not placed you at any risk and there will be no effect on your future health.
Why We Need Your Help
When healthcare workers (nurses, doctor etc.) are accidentally exposed to body fluids in
certain circumstances there may be a risk to their health.
45 of 53
If this risk is high it can be reduced if the healthcare worker takes a special treatment for a
month. The treatment is effective but can be difficult to take and cause side effects.
However in order to assess how high the risk is for them extra information is needed from
the patient who they were treating
If the risk turns out to be low the healthcare worker can stop the treatment and be greatly
reassured. Unfortunately it is the uncertainty about their future health that many healthcare
workers find so distressing. They find themselves placed at risk simply because they were
doing their job caring for patients.
Western Sussex Hospitals NHS Trust cares for its employees. Therefore in line with
guidelines from the Department of Health we routinely try to get as much of this important
information as we can in these situations. However we can only do this with your consent
and help.
Therefore we need your help
At the top of this letter there is an appointment for you to see a nurse at the GUM/HIV clinic’
When you come to the clinic the nurse will



Explain more about why we need your help
Answer any questions you may have
Ask your permission to take a blood sample for testing
If you agree to the blood sample the nurse will arrange to see you with your results as soon
as possible
Nothing you tell us in the clinic will go in your hospital notes or be told to anyone outside the
clinic (including other hospital staff or GP and even the effected healthcare worker) without
your consent.
The clinic uses separate notes which never leave the clinic. The staff working there are
bound to keep strict confidentiality by law.
We will understand if you do not feel you can help us. However if this is the case we would
value the opportunity to meet you. Even if you do not want to have a blood sample taken you
may be able to give us some information which will reassure the member of staff affected.
Where to get further information
St Richards Hospital
Fletcher unit, St Richards Hospital, extension ……………
Worthing and Southlands Hospital
Warren Browne unit, Southlands Hospital, extension……………
Signed:_______________ Print name:_________________
46 of 53
Date: __/__/__
APPENDIX J
Information for prescriber on HIV post exposure prophylaxis
Prophylaxis, if required, must be commenced as soon as possible after the incident, ideally within 1-2 hrs.
1)
The Regimen
Truvada [combination of Tenofovir disoproxil 245mg and Emtricitabine 200mg] – one tablet every day orally,
and
Kaletra [combination of Lopinavir 200mg & Ritonavir 50mg] – two tablets every 12 hours orally
Currently no anti-retroviral is licensed for HIV post exposure prophylaxis however, the Department of Health
recommends them for this indication. These drugs can be prescribed for PEP only on an ‘off-label’ basis since their
use in this context is outside approved indications.
2)
Administration, Side-Effects and Warnings
NB: The majority of the side effects occur after LONG TERM use (> 4 weeks)
Truvada
Administration:-
one tablet every day
Common side effects:-
headache, dizziness, diarrhoea, vomiting, nausea, abdominal pain, allergic
reaction, skin rash, pain, asthenia, insomnia, abnormal dreams, dyspepsia,
flatulence, hyperglycaemia, hypertriglycerideamia, hypophosphataemia, raised
serum lipase, amylase, raised liver enzymes, neutropenia, hyperbilirubinaemia,
raised creatine kinase,
Rare side effects:-
anaemia, lactic acidosis, pancreatitis, renal impairment,
Caution:-
renal impairment: monitor renal function;
pregnancy and breast-feeding
Kaletra
Administration: -
two tablets every 12 hours
Common side effects: -
diarrhoea, nausea, vomiting, headache, flatulence, abdominal pain, rash, pruritis,
lipodystrophy, asthenia, raised triglycerides, raised total cholesterol, raised γGT
Rare side effects: -
bleeding problems in haemophiliacs, pruritis, myalgia, exacerbation of or
manifestation of diabetes mellitus, hepatitis, hyperglycaemia, pancreatitis,
abnormal liver function tests, leucopenia, anaemia,
Drug interactions: -
Metabolised by CYP450 enzymes; (see interaction pages)
Caution: -
impaired hepatic function.
Pregnancy and breast-feeding
haemophilia
diabetes
concomitant use with medicines that prolong QT interval
Domperidone Anti – emetic
As all three medicines can cause nausea, an anti-emetic, Domperidone, is prescribed with the prophylaxis. The
dose is 10mg orally, every 12 hours, before taking the HIV medicines.
See BNF for cautions and side effects.
47 of 53
Loperamide Anti-diarrhoeal
As diarrhoea is a common side-effect with Kaletra, an anti-diarrhoeal is prescribed with the prophylaxis. The dose
is 2 capsules at the onset of diarrhoea and one capsule to be taken after each subsequent bowel movement up to
a maximum of eight capsules in 24 hours.
See BNF for cautions and side-effects.
Important drug interactions
All drug/dose changes must be made on an individual patient basis. Contact HIV pharmacy / HIV specialist
on-call for more information.
Drug interactions can also be checked on-line using the University of Liverpool’s HIV Drug interaction
website wwww.hiv-druginteractions.org
Drug
Simvastatin (Zocor™)
Problem
Contraindicated therefore stop at
once. Large increase in simvastatin
levels – greatly increased risk of
myopathy inc rhabdomyolysis
Alternative
Atorvastatin – start 10mg
prescribing opportunity.
Atorvastatin
(Lipitor™)
Rosuvastatin (Crestor™)
The levels of atorvastatin
rosuvastatin are increased
Piroxicam (Feldene™)
Inhaled/Intranasal
corticosteroids;
Fluticasone
(Flixotide™,
Flixonase™, Seretide™)
Increased risk of toxicity from
piroxicam
High
systemic
absorption
of
corticosteroid.
Advise patient to
stop using if possible (i.e. only if no
risk of severe asthma)
Use low dose of statin and monitor for toxicity
or consider stopping statin for the duration of
PEP
Any other NSAID e.g. diclofenac
Budesonide
(Rhinocort
Aqua™,
Pulmicort™,
Symbicort ™)
Diazepam, midazolam,
Zolpidem
Erythromycin
Clarithromycin
.
Levels of hypnotic/anxiolytic likely
to be increased
Potential for increase in levels of
these agents – may prolong QT
interval
St John’s Wort
Enzyme inducer therefore will
reduce Kaletra levels.
Induction
effect will persist for approx 2 weeks
after cessation.
Enzyme inducer – will reduce
Kaletra levels. Induction effect will
persist for approx 2 weeks after
cessation; co-administration causes
hepatotoxicity.
Will get increase in rifabutin levels
and may require dose reduction
Rifampicin
Rifabutin
Amiodarone
and
antiarrhythmics
Calcium channel
blockers (diltiazem,
verapamil)
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and
other
Contraindicated – likely to get
increase in levels of anti-arrhythmic
drug – risk of serious and/or life
threatening reactions such as
cardiac arrhythmias.
Increased levels – increased risk
of heart block
OD
at
next
Beclomethasone (e.g. Becotide™ inhalers,
Beconase™ nasal spray)
Please note compound preparations e.g.
(Seretide TM, Symbicort) also include
bronchodilators (salmeterol, formoterol). The
bronchodilators will need to be prescribed
separately to the steroid inhalers.
Warn patient re potential interaction: avoid
concomitant use or decrease dose
Advise patient to stop if short course or
reduce dose if possible.
Consider switch to azithromycin to finish
antibiotic course if appropriate.
Don’t issue Kaletra® – prescribe
Truvada ® one tablet OD + Zidovudine
250mg BD
Don’t issue Kaletra® – prescribe
Truvada ® one tablet OD + Zidovudine
250mg BD
Don’t issue Kaletra® – prescribe
Truvada ® one tablet OD + Zidovudine
250mg BD or consider reduction in rifabutin
dose (e.g. to 150mg 3x/week) for duration of
PEP
Don’t issue Kaletra® – prescribe
Truvada ® one tablet OD + Zidovudine
250mg BD
Consider using alternative third
PEP drug*. Alternatively liaise with
GP/cardiologist re dose adjustment
Digoxin
Initial acute increase in digoxin
levels – could lead to toxicity.
Anticonvulsants
(phenytoin,
phenobarbitone,
carbamazepine)
Enzyme inducers – will reduce
Kaletra levels. Induction effect will
persist for approx 2 weeks after
cessation.
Other anticonvulsants probably safe.
Increased risk hypotension
Propranolol
Antipsychotics/neuroleptics
Pimozide, Clozapine
Antipsychotics/Neuroleptics
:Quetiapine,haloperidol,
risperidone,thioridazine
Increase in levels and potential for
life threatening arrhythmias
Increase in levels may result in
serious
haematological
abnormalities
PIs may increase the drug levels
of these agents
Antidepressants
(especially SSRIs and
Related antidepressants,
mirtazepine)
May get increase in drug levels of
antidepressants
Immunosuppressants
(ciclosporin,
tacrolimus,
sirolimus)
Methadone
Significant interaction to increase
levels of immunosuppressants
Oral contraceptives and
depot
contraceptive
injections
Effectiveness likely to be reduced
Warfarin
Levels (and therefore INR) can be
increased or decreased
Prednisolone,
dexamethaxone
Levels likely to be increased
Recreational drugs:
Ecstasy (MDMA),
gammahydroxybutyrate
(GHB), methamphetamine
Erectile dysfunction agents
(sildenafil,
vardenafil,
tadalafil)
Levels
of
ecstasy,
gammahydroxybutyrate (GHB) and
methamphetamine
may
be
significantly increased by ritonavir.
Significant increase in drug levels
and effect/side effects of erectile
dysfunction agents
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Potential for decrease in methadone
levels. Methadone levels are likely to
be affected from Day 7-10 on
starting Kaletra.
Don’t issue Kaletra® – prescribe
Truvada ® one tablet OD + Zidovudine
250mg BD
Don’t issue Kaletra® – prescribe
Truvada ® one tablet OD + Zidovudine
250mg BD
Continue at same dose but counsel patient
regarding potential hypotension
Don’t issue Kaletra® – prescribe
Truvada ® one tablet OD + Zidovudine
250mg BD
Dose reduction may be required
(liaise with GP or psychiatrist) or
prescribe Truvada ® one tablet OD +
Zidovudine 250mg BD
Consider dose reduction and monitor for
toxicity. Alternatively prescribe Truvada ® one
tablet OD + Zidovudine 250mg BD
(especially
with
high
doses
of
antidepressants)
Don’t issue Kaletra® – prescribe
Truvada ® one tablet OD + Zidovudine
250mg BD
Counsel patient; monitor and increase dose
only if pt complains of withdrawal symptoms.
On completion of PEP, methadone dose may
need to be reviewed, especially if any dose
adjustments have been made. Discuss with
substance misuse service
Counsel patient – use barrier method of
contraception (e.g.condom) as well whilst on
PEP and for 4 weeks after (N.B. also risk of
transmission) with no pill break.
According to indication for warfarin
– monitor INR closely or prescribe
Truvada ® one tablet OD + Zidovudine
250mg BD
In long-term use decrease dose of steroid
whilst on PEP (consider reducing dose of
prednisolone by approx 30%)
Individuals should be advised that
co-administration should be avoided.
Avoid co-administration where possible. If
given use with caution at low doses, do not
exceed maximum doses (see below) and
increase monitoring for adverse
events
Maximum doses:
sildenafil 25mg every 48 hours,
tadalafil 10mg every 72 hours,
vardenafil 2.5mg every 72 hours
NB: Advice regarding safer sex for the
duration of PEP
APPENDIX K
HIV Post Exposure Prophylaxis
Information for Patient
March 2011
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HIV Post Occupational Exposure Prophylaxis Information
Information for patients
1) Introduction
You have been involved in an incident that might have put you at risk of HIV infection. It is important that you read the
following information before deciding whether or not to take preventative treatment (post exposure prophylaxis: PEP).
Background information for healthcare workers
The risk of acquiring HIV infection following occupational exposure to HIV-infected blood and body fluids is low. Taking
PEP may significantly reduce the risk of you acquiring HIV.
The estimated risk from source patients with documented known HIV infection is about 3 in 1000 for percutaneous
exposure (i.e. accidents where the skin is pierced/ broken by a needle or to other sharps incident) and about 1 in 1000 for
significant exposure to mucous membranes or non-intact skin (e.g. splashes to the eyes or splashes to areas of the skin
that are already broken because of scratches or due to a skin condition). It has been considered that there is no risk of
HIV transmission where intact skin is exposed to HIV-infected blood.
Although preventing exposure remains vital, recent evidence suggests that when significant exposure occurs prompt
treatment with anti-HIV drugs decreases the risk of HIV infection. A case-control study of HIV infection in health care
workers following percutaneous exposure to HIV infected material has shown that prophylaxis with Zidovudine (AZT) is
associated with a 79% decrease in risk of HIV transmission. Over the years the use of combined anti-HIV drugs has
proved to be more effective than AZT alone in suppressing viral replications in people with HIV.
The Department of Health has issued guidelines on post-exposure prophylaxis (PEP) for persons exposed to HIV.
However, knowledge about the efficacy and toxicity of drugs used for PEP are limited.
Background information for people exposed to HIV outside of work
People may be exposed to HIV through vaginal or anal sex (either without a condom or when the condom broke or fell
off), through sharing equipment for injecting drugs or through sexual assault. The risk of HIV infection associated with
each such exposures are approximately 0.5-3% for unprotected anal sex between men, 0.1% for unprotected vaginal sex
and 0.7% for needle sharing. However these risks vary widely among individuals.
Minimising your risk of HIV exposure through safer sex (especially correct use of condoms for penetrative sex) and safer
drug use (especially avoiding sharing of needles and other equipment) is the most important factor in avoiding HIV
infection.
There is research evidence that healthcare workers exposed to HIV infected blood have a low but measurable risk of
acquiring HIV infection. Taking PEP significantly reduces this risk but cannot eliminate it. There is some research
demonstrating a reduction in HIV transmission in persons taking PEP after exposure in other situations (especially after
sexual exposure).
2) The Prophylactic Regimen
Truvada [combination of Tenofovir disoproxil 245mg and Emtricitabine 200mg] – one tablet every day orally,
and
Kaletra [combination of Lopinavir 200mg & Ritonavir 50mg] – two tablets every 12 hours orally
Currently no anti-retroviral is licensed for HIV post exposure prophylaxis however, the Department of Health recommends
them for this indication. These drugs can be prescribed for PEP only on an ‘off-label’ basis since their use in this context
is outside approved indications.
Prophylaxis, if required, must be commenced as soon as possible after the incident, ideally within 1-2 hrs (Can
be up to 72 hours)
3) Administration, Side-Effects, interactions with other medicines and Warnings
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Before taking the PEP regimen please inform the doctor about:
 All other drugs that you are taking, including any that you buy over the counter in a community pharmacy,
any herbals medicines or any illicit substances that you may take.
 Any previous allergy to any medicines
 If you have ever have liver or kidney disease
 If you are diabetic
 If you have ever had any bone disease
 If you are pregnant or thinking about becoming pregnant
Please note: The majority of the side effects of these medications result after LONG TERM use (> 4 weeks)
Truvada
Administration: One tablet every day at the same time with or after food for 28 days
Side effects:


Tenofovir, like all other medicines has some side effects. The most common (incidence of
more than 1 in 100 patients) are:
Diarrhoea, nausea and vomiting, problems with digestion resulting in discomfort after meals,
stomach pain, flatulence, dizziness, fatigue (lack of energy), headache, rash or changes in skin
colour, difficulty sleeping.
Please read the manufacturers ‘patient information leaflet’ for a full list of possible side-effects
Other medications and Truvada:
Truvada is removed from the body by the kidneys. It is important to tell the prescribing doctor
about any medication that you take, especially any of the following:

Kaletra
Aminoglycosides (for bacterial infection), Amphotericin B (for fungal infection), Cidofovir (for viral
infection), Foscarnet (for viral infection), Ganciclovir (for viral infection), Interleukin-2 (to treat
cancer), Pentamidine (for infections), Vancomycin (for bacterial infection)
Administration: Two tablets every 12 hours (twice a day) for 28 days
Side effects:


Kaletra, like all other medicines has some side effects. The most common (incidence of
more than 1 in 100 patients) are:
Diarrhoea, headache, nausea and vomiting, dry mouth, flatulence, stomach pain, difficulty
sleeping, fatigue (lack of energy), rash
Please read the manufacturers ‘patient information leaflet’ for a full list of possible side-effects
Other medications and Kaletra:
Kaletra is metabolised (processed in the body) by the liver. Some other medicines are metabolised in
the same way. That is why is important to tell the doctor about any medicines that you take even
occasionally. Examples of some medicines/drugs that should not be taken with Kaletra include:

Simvastatin, piroxicam, inhaled corticosteroids (fluticasone, budesonide), rifampicin, rifabutin,
antiarrhythmics (amiodarone, digoxin), anticonvulsants (phenytoin, carbamazepine, phenobarbital),
antipsychotics (pimozide, clozapine), immunosuppressants (ciclosporin, tacrolimus, sirolimus), St.
Johns wort, Erectile dysfunction agents (sildenafil, vardenafil, tadalafil), recreational drugs, ecstasy,
GHB, methamphetamine.

Other examples of medicines that are metabolised in the same way and may need to have the dose
or medicine changed are: atorvastatin, rosuvastatin, diazepam, midazolam, zolpidem, antibiotics
(erythromycin, clarithromycin), heart medications (calcium channel blockers such as diltiazem,
verapamil, nifedipine), propranolol, antipsychotics/neuroleptics (quetiapine, haloperidol, risperidone),
antidepressants (fluoxetine, paroxetine, sertraline, mirtazepine), methadone, oral contraceptive pills
and depot injections, warfarin, prednisolone, dexamethasone.
Anti-sickness
As all three medicines can produce nausea, an anti-sickness, domperidone, is prescribed with the
prophylaxis. The dose is one tablet orally, every 12 hours, before taking the HIV medicines .
Anti-diarrhoeal
As diarrhoea is a common side-effect with Kaletra, an anti-diarrhoeal, loperamide, is prescribed with
the prophylaxis. The dose is 2 capsules at the onset of diarrhoea and one capsule to be taken after
each subsequent bowel movement up to a maximum of eight capsules in 24 hours
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Appendix L
Patient identified as at risk of pregnancy from assault
1. Enquire about current/recent method of contraception, compliance with method, or any other
reason current method not effective contraceptive cover for this assault
2. Enquire about day of last menstrual period, normality, cycle length and variation
a. Establish day of cycle sexual assault (s) took place
3. Estimate likely date of ovulation and risk of pregnancy
2.
Exclude established pregnancy or risk of pregnancy other than assault, exclude contra-indications to EC and use of interacting
medications (especially liver enzyme-inducing drugs)
Did 1st assault occur within the previous 120 hours?
NO
YES
If assault is first UPSI since LMP,
refer for emergency IUD if no
more than 5 days since earliest
calculated date of ovulation
If UPSI within <72hrs, offer option of
Levonelle 1500 or emergency IUD. If
IUD fit planned, encourage use of
Levonelle 1500 now, as interim measure
If 2 or more episodes of UPSI earlier in
cycle did patient take Levonelle 1500
within 72 hrs or ellaOne with 120 hours?
NO
If all episodes of UPSI occurred no more than 5
days since earliest calculated date of ovulation,
refer for emergency IUD. For patients declining
emergency IUD and requesting Levonelle or
ellaOne, explain not recommended as risk of
pregnancy earlier in cycle.
If within 72 -120 hrs of assault and
assault is 1st UPSI, offer option of
ellaOne or emergency IUD. If IUD fit
planned, encourage use of ellaOne now,
as interim measure
YES
Patient at higher risk of pregnancy therefore refer for
emergency IUD. For patients declining emergency IUD and
requesting Levonelle or ellaOne, explain not recommended
and efficacy / failure rates unknown with subsequent doses.
NB ellaOne can only be taken once in cycle.
EXPLAIN:
- Mode of action, efficacy and risk of pregnancy (possibility of ectopic) of different types of emergency contraception.
-Negative pregnancy test at the time of request of EC does not rule out conception that may have occurred earlier in the menstrual
cycle if a woman has had unprotected intercourse more than 72 hours ago, including second or subsequent act(s) of unprotected
intercourse in the same menstrual cycle, unless the first episode was more than 21 days ago and a pregnancy test is negative.
-Explain how to take oral emergency contraception, low side-effect profile, what to do if vomits within 3 hours, and possible effects on
menstrual cycle.
-Ulipristal (ellaOne) is not recommended to be used more than once per cycle as the safety and efficacy of repeated exposure has not
been assessed.
-If hormonal contraception is continued after administering ulipristal, barrier contraception should be used until the next
period or withdrawal bleed.
-Option of emergency IUD should be discussed with all women as use of on-going contraception.
-Need for effective contraception or abstinence for rest of cycle and need for follow-up if next period >7 days late or abnormal.
-Offer STI screening to all women and discuss long-term contraceptives and refer as appropriate
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