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«© ASHM 2013 Apart from any fair dealing for the purpose of research or study, criticism or review, as permitted under the Copyright Act 1968, no ...»

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Post-Exposure Prophylaxis after

Non-Occupational and

Occupational exposure to HIV

National Guidelines

National guidelines

for post-exposure

prophylaxis after


and occupational

exposure to HIV

© ASHM 2013 Apart from any fair dealing for the purpose of research or study, criticism or review, as permitted

under the Copyright Act 1968, no part of this book may be reproduced by any process without

Published by: written permission. Direct enquiries to the Australasian Society for HIV Medicine.

ASHM Effort has been made to get permission from copyright owners for use of copyright material.

We apologise for any omissions or oversight and invite copyright owners to draw our attention LMB 5057 Darlinghurst NSW 1300 to them so that we may give appropriate acknowledgment in subsequent reprints or editions.

T +61 2 8204 0700 The statements or opinions that are expressed in this book reflect the views of the contributing F +61 2 9212 2382 authors and do not necessarily represent the views of the publisher. Every care has been taken E ashm@ashm.org.au to reproduce articles as accurately as possible but the publisher accepts no responsibility for W www.ashm.org.au errors, omissions or inaccuracies contained therein or for the consequences of any action taken by any person as a result of anything contained in this publication.

ABN: 48 264 545 457 The National PEP Guidelines were developed with financial assistance from the Australian Published December 2013 Government, Department of Health and Ageing.  The Department of Health and Ageing does ISBN (online): 978-1-920773-31-1 not endorse the content contained in the PEP Guidelines.

Contents Introduction 4 Assessment of the risk of HIV transmission 5

1. What is the HIV transmission risk/exposure? 5

2. What is the HIV status of the source individual? 6

3. What is the HIV status of the exposed individual? 7 Prescribing PEP 8 Immediate management of an individual with known or suspected exposure to HIV 10 Clinical assessment and follow-up 11 Laboratory assessment and follow-up 12 Which regimen? 13 Management of possible exposure to other conditions 15 Additional clinical management issues 16 Information for clinicians 18 Information for patients 18

–  –  –

Introduction National guidelines for post-exposure prophylaxis after non-occupational and occupational exposure to HIV These guidelines outline the management of individuals who have been exposed (or suspect they have been exposed) to HIV in occupational and non-occupational settings. There are currently no data from randomised controlled trials of the use of post-exposure prophylaxis (PEP), and there are many gaps in the scientific data. Accordingly, assumptions are made about the direction of management.

Every presentation for PEP should be assessed on a case-by-case basis, balancing the potential harms and benefits of treatment.

These National PEP guidelines are:

• replacing the National guidelines for Non-Occupational Post-Exposure Prophylaxis to HIV (DoHA 2006) and the HIV component of the Management of Exposure to Blood/Body Fluids in an Occupational Health Setting, ANCAHRD Bulletin No 29 September 2002 • produced by the Australasian Society for HIV Medicine (ASHM) • located at www.ashm.org.au/pep-guidelines • funded by the Commonwealth Department of Health and Ageing (DoHA) • endorsed by the Australasian College for Emergency Medicine November 2013 • to be reviewed through ASHM, for advice to DoHA supported by a literature review1 and other documents • at www.ashm.org.au/pep-guidelines.

The advice provided is necessarily general. Any unusual or complex presentation should be discussed with an expert in HIV medicine before deciding whether or not PEP should be prescribed.

Specific implementation details in response to regional differences are available through state, territory and local agencies.

Assessment of the risk of HIV transmission

The risk of HIV transmission through a single exposure is determined by:

• The nature of the exposure with its estimated risk/exposure (Table 1) • The risk that the source is HIV positive, if their status is unknown (Table 2) • Factors associated with the source and exposed individuals.

–  –  –

1. What is the HIV transmission risk/exposure?

All sexual risk estimations are for unprotected sexual contact. It is assumed that a similar risk is incurred when a condom fails.

Table 1: Exposure and transmission risk/exposure with known HIV positive source See Literature Review1 section Transmission risks associated with different exposures for further information.

–  –  –

Many factors modify the risk of HIV transmission and should be considered in the risk assessment.

Factors that may increase the risk of HIV transmission include:

• a high plasma viral load (a high load when seroconverting or with advanced disease) • a sexually transmissible infection in the source or exposed individual, especially genital ulcer disease and symptomatic gonococcal infections • a breach in genital mucosal integrity (eg trauma, genital piercing or genital tract infection) • a breach in oral mucosal integrity when performing oral sex • penetrating, percutaneous injuries with a hollow bore needle, direct intravenous or intra-arterial injection with a needle or syringe containing HIV infected blood • the uncircumcised status of the insertive HIV negative partner practising IAI or IVI.

*Early initiation of antiretroviral therapy, compared with delayed therapy, resulted in a relative reduction of 96% in the number of linked HIV transmissions in serodiscordant heterosexual couples. Therefore the transmission risk for vaginal intercourse with an HIV positive partner with an undetectable viral load may be estimated to be decreased by a factor of 20.

2. What is the HIV status of the source individual?

Provision of PEP should not be delayed while establishing the source status.

• Ideally, active attempts should be made to contact the source and ask them to have an urgent HIV test; however, the often anonymous nature of exposures makes this impractical.

• If the source discloses they are HIV positive, consent should be gained to seek treatment details from their doctor. At the very least it is useful to know if they are on treatment or not and if their viral load is undetectable.

• In cases where the source refuses to disclose their HIV status or have an HIV test, it should be assumed (for the purposes of PEP prescription) that they are HIV positive.

• If the source cannot be contacted, the seroprevalence data (see Table 2) will assist in determining the need for PEP.

–  –  –

HIV seroprevalence in overseas populations The seroprevalence overseas varies widely, with a High Prevalence Country (HPC) being defined as having a prevalence of 1% in the general population. However, variance is not only between countries but also in different risk groups. Highest seroprevalence is in Southern Africa (up to 25%) and in injecting drug users in South East Asia (up to 40% in Thailand and Indonesia). For seroprevalence for individual countries go to www.unaids.org/en/dataanalysis/datatools/aidsinfo/

3. What is the HIV status of the exposed individual?

All candidates for PEP require baseline HIV antibody testing. Where possible, the results should be followed up within 24 hours of the specimen being collected. Urgent testing should be made available to individuals who are identified as at high risk for HIV.* Initiation of PEP should not be delayed while determining the HIV status of the exposed individual.

* It is recognised that not all areas can provide test results within 24 hours.

Prescribing PEP Ultimately, the decision to prescribe PEP needs to be made on a case-by-case basis considering all the variables. These guidelines are not prescriptive, but put forward cases where PEP is recommended and the benefit of treatment is likely to exceed harm. Situations where there is greater uncertainty or complexity should be discussed with a physician experienced in this area.

PEP should be prescribed as soon as possible after the exposure and within 72 hours.

Adverse effects caused by antiretrovirals and their impact on adherence are well recognised, Individuals receiving PEP should be informed of the potential adverse effects of treatment and possible drug interactions; particularly if protease inhibitors are prescribed. Drug choice is determined by considering antiretroviral treatment history, viral load and resistance patterns of the source case and the medical history of the exposed individual.

As for the number of drugs recommended for treatment, there is no direct evidence to support the greater or lesser efficacy of 3 over 2 drug preventative regimens. It is an extrapolation of any possible benefit conferred by increased numbers/classes of drugs for HIV treatment whilst also taking into account potential side effects, toxicity, adherence and cost effectiveness of adding a third drug.

–  –  –

PEP recommendations after occupational exposure to a source with unknown HIV status In the occupational setting, the source is usually able to be identified and tested for HIV, and PEP is usually only prescribed for those who have definitely been exposed to HIV. The risks carried by exposures that occur in the occupational setting are outlined in the Table 5. If the source is unable to be identified or tested, then the risk of the source being HIV positive must be assessed from any epidemiological or other information available. When the source is unknown, the use of PEP should be decided on a case-by-case basis, and it is recommended that an expert always be consulted in this situation.

Immediate management of an individual with known or suspected exposure to HIV • Do not douche the vagina or rectum after sexual exposure.

• After oral exposure, spit out blood/body fluids and rinse with water.

• Wash wounds and skin sites that have been in contact with blood or body fluids.

• Irrigate mucous membranes and eyes (remove contact lenses) with water or saline.

• Do not inject antiseptics or disinfectants into wounds.

Clinical assessment and follow-up In making a clinical assessment health practitioners should consider the gender, culture, behaviour, language and literacy level of the patient, and their intellectual capacity.

The following details should be documented in the patient’s history:

1. The time of the assessment and first dose, if prescribed

2. Details of the exposure (when, with whom, what, and where) a. time of exposure b. details of source c. exact mode and details of exposure (including contributory factors) blood or body fluid involved, trauma, first aid measures applied.

d. place of exposure

3. Information about the exposed person a. most recent HIV test and result b. potential exposures within the last 3 months (and earlier as indicated) c. previous post-exposure prophylaxis and history of this treatment d. evaluation of current STIs; hepatitis B* and C infection e. pregnancy risk, contraception and lactation, consider emergency contraception f. medical history, all medications and drug allergies g. psychiatric history h. drug and alcohol history i. their knowledge of the source (if unavailable for interview)

4. Information about the source Provision of PEP should not be delayed whilst obtaining this information.

a. HIV status and other relevant demographic features

b. if HIV positive:

(i) plasma viral load and CD4 (ii) antiretroviral treatment history (has resistance been an issue, if so with which drugs?) (iii) recent HIV resistance genotyping c. current or past STIs; hepatitis B and C status

5. PEP discussion An explanation of PEP and its indications and effectiveness, risks and benefits are provided to all potential candidates. Discussion of HIV, including risk assessment, is part of clinical assessment (see 2011 National HIV testing policy10).

6. Follow-up Individuals found to be HIV positive or indeterminate on baseline testing, or during follow-up, require immediate referral. PEP should be ceased if the baseline test is positive.

* Patients with serology consistent with chronic/active hepatitis B and on a regimen containing lamivudine, tenofovir or emtricitabine should have hepatitis B viral load measured. Advice from a specialist in the management of viral hepatitis should be sought when the PEP course is completed.

Laboratory assessment and follow-up After potential exposure to HIV, individuals should have baseline and follow-up testing for HIV and other infections (depending on mode of exposure).

The table below sets out the recommended schedule of testing for individuals who are prescribed PEP (adapted from 2005 CDC guidelines11). Follow-up HIV testing is no longer recommended at 6 months. The management of an exposed patient who seroconverts is not included. The symptoms of seroconversion should be explained to all patients, with advice to present if these, or any other symptoms occur.

–  –  –

E = exposed individual a Individuals with evidence of previous immunity to hepatitis B (HBsAb positive) will require no further follow-up.

Non-immune individuals require immunisation and follow-up (to 6 months). See also section Management of possible exposure to other conditions for more information.

b Depends upon mode of exposure.

c Repeat testing for chlamydia and gonorrhoea.

d Repeat syphilis serology after sexual exposure.

e Baseline and where clinically indicated.

f If raltegravir prescribed there should be a baseline measurement of serum creatine kinase with at least one other measurement during the course of treatment if myalgias or weakness develop along with clinical examination for proximal muscle weakness.

Which regimen?

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