Post Exposure Prophylaxis (PEP)



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 |This policy provides guidelines for the risk assessment and subsequent management |

|care? |of occupational and non-occupational exposures to HIV and the use of post-exposure |

| |prophylaxis. |

|Staff/stakeholders involved in development: |Consultants & Associate specialists in GU & HIV Medicine |

|Job titles only |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: |DoH guidance: |

|Standards and legislation |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: |WSHT Blood Borne Virus (BBV) Policy (including management of sharps exposure |

| |incidents) April 2010 |

| |Consent Policy December 2009 |

|Approved by: |Women and Child Health Divisional clinical Governance Review Meeting |

|Divisional Governance/Management Group |Management Board |

|Approval date: |28 October 2011 / May 2012 |

|Ratified by Board of Directors/ Committee of the Board of |n/a |

|Directors | |

|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 |Comment |

|1.0 |28/10/11 |Tracey Rose, Operational |draft | |

| | |Manager on behalf of Dr Emma | | |

| | |Rutland | | |

|2.0 | | | | |

|3.0 | | | | |

|4.0 | | | | |

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

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

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) Deep injury

2) Visible blood on the device which caused the injury

3) Injury with a needle which had been placed in a source patient's artery or vein

4) 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.

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:

• Good management of occupational and non-occupational exposure to HIV

2.1 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].

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.

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

• 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

• the nature of the body fluid involved

• the volume of body fluid involved

• the source person

4.1 Type of exposure

The risk of HIV transmission following an exposure from a known HIV positive individual is shown below [7].

|Type of exposure |Estimated median (range) risk of HIV transmission per exposure |

|Blood transfusion (one unit) |90-100% |

|Receptive anal intercourse |1.11% (0.042-3.0%) |

|Receptive vaginal intercourse |0.1% (0.004-0.32%) |

|Insertive vaginal intercourse |0.082 (0.011-0.38%) |

|Insertive anal intercourse |0.06% (0.06-0.065%) |

|Receptive oral sex (fellatio) |0.02% (0-0.04%) |

|Insertive oral sex (receiving fellatio) |0% |

|Needle–stick injury |0.3% (95% CI 0.2%-0.5%) |

|Sharing injecting equipment |0.67% |

|Mucous membrane exposure |#0.63% (95% CI 0.018%-3.47%) |

# 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 |No Risk Body Fluid |

| |(unless visibly blood stained) |

|Amniotic Fluid |Faeces |

|Blood |Saliva |

|Cerebrospinal Fluid |Urine |

|Human Breast Milk |Vomit |

|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.

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) |HIV Prevalence (%) |

|Men who have sex with men |Male |Female |

|UK |5.2 |- |

|London |10.5 |- |

|Elsewhere in UK |3.4 |- |

|Brighton |13.7 |- |

|Heterosexuals (region of birth) | | |

|UK |0.4 |0.3 |

|Rest of Europe |1.2 |0.6 |

|North America |1.1 |0.2 |

|Central and South America |1.9 |1.1 |

|Caribbean |1.2 |1.0 |

|North Africa and Middle East |0.5 |0.4 |

|Sub-Saharan Africa |6.1 |10.3 |

|South Asia |0.5 |0.5 |

|East and South Asia |1.1 |0.8 |

|Australasia |0.3 |0.2 |

|Injecting drug users | | |

|UK |0.3 |0.3 |

|London |0.8 |0.3 |

|Elsewhere in UK |0.2 |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 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].

5.1.1 PEP is recommended if:

• 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 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 |Strength & Form |Dose |Duration |

|Truvada( |Combined tablet: Tenofovir 300mg |ONE (1) tablet ONCE a day |Days 1-5 |

| |& Emtricitabine 200mg | | |

|Kaletra( |Combined tablet: Lopinavir 200mg |TWO (2) tablets TWICE a day |Days 1-5 |

| |& Ritonavir 50mg |With or without food | |

In addition an anti-emetic and an anti-diarrhoeal agent is routinely prescribed:

|Domperidone |10mg Tablet |ONE(1) tablet THREE times a day when needed for |Pack of 10 |

| | |nausea or vomiting | |

|Loperamide |2mg Tablet |TWO (2) tablets at the first sign of diarrhoea |Pack of 12 |

| | |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 |Strength & Form |Dose |Duration |

|Truvada( |Combined tablet: Tenofovir 300mg |ONE (1) tablet ONCE a day |Days 6-28 |

| |& Emtricitabine 200mg | | |

|Kaletra( |Combined tablet: Lopinavir 200mg |TWO (2) tablets TWICE a day |Days 6-28 |

| |& Ritonavir 50mg |With or without food | |

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 A&E

Emergency Drug Cupboard

Fletcher unit

Pharmacy

• Worthing hospital A&E

Emergency Drug Cupboard

Pharmacy

• Southlands hospital 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 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 ( ................
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