PROTOCOL FOR THE MANAGAMENT OF SEXUAL EXPOSUE TO HIV, HBV AND HCV: POST EXPOSURE PROPHYLAXIS FOR HIV (PEPSE) AND HEPATITIS B

Transcription

1 PROTOCOL FOR THE MANAGAMENT OF SEXUAL EXPOSUE TO HIV, HBV AND HCV: POST EXPOSURE PROPHYLAXIS FOR HIV (PEPSE) AND HEPATITIS B Printed copies must not be considered the definitive version DOCUMENT CONTROL PROTOCOL NO. PROT005 MANAGAMENT OF SEXUAL EXPOSURE TO HIV, HBV Protocol AND HCV: POST EXPOSURE PROPHYLAXIS FOR HIV (PEPSE) AND HEPATITIS B Author Justine McCuaig Version no. 1.0 Reviewer Dr David Breen Implementation date Scope (Applicability) All Health Protection Staff, GP Practices, OHSS January 2011 Status Approved Next review date January 2013 Approved by HPT and ICT Last review date: November 2009

2 CONTENTS Page 1. INTRODUCTION 3 2. AIM 3 3. POST EXPOSURE PROPHYLAXIS FOR HIV INFECTION FOLLLOWING 3 SEXUAL EXPOSURE 3.1 Risk of HIV transmission Calculating the risk of HIV transmission Recommendations for prescribing PEPSE Testing PEPSE drugs Choice of drugs GUM referral Advise for exposed persons 9 4. POST EXPOSURE PROPHYLAXIS FOR HEPATITIS B (HBV) FOLLOWING SEXUAL EXPOSURE Sexual partners of individuals with known HBV infection Sexual partners of high risk individuals with unknown HSsAg status Victims of sexual assault with perpetrator of unknown HBsAg status Follow up MANAGEMENT OF EXPOSURE TO HEPATITIS C (HCV) FOLLOW UP 12 TABLES Table1 Risk that the source is positive 4 Table 2 Risk of HIV transmission following an exposure from a known 5 HIV positive individuals Table 3: Examples of estimated risk calculations 5 Table 4: Situations in which PEPSE would be recommended 6 or considered APPENDICES APPENDIX 1 Post Exposure Prophylaxis Patient Information Leaflets 13 APPENDIX 2 Flow Chart Guidance for those prescribing PEP 14 APPENDIX 3 GUM Referral Form 15 APPENDIX 4 List of Useful Contacts in Dumfries and Galloway 16

3 1. INTRODUCTION This document provides advice and action to be followed to prevent bloodborne virus infection following sexual exposure. The main concerns associated with sexual exposure are the potential risks for transmission of bloodborne viruses such as Human Immunodeficiency Virus (HIV) and Hepatitis B (HBV). Hepatitis C (HCV) may occasionally be a consideration. Sexual exposure can also place a person at risk of other sexually transmitted infections and pregnancy. The need for emergency contraception should be assessed and if required administered or arranged. Follow up screening for other sexually transmitted infections and pregnancy testing should be advised. 2. AIM The aim of this policy is to ensure that appropriate, prompt advice, treatment and follow-up is available to individuals following sexual exposure to potential bloodborne infection. 3. POST EXPOSURE PROPHYLAXIS FOR HIV FOLOWING SEXUAL EXPOSURE This area remains controversial. In 2006 the British Association for Sexual Health and HIV (BASHH) published guidelines for the use of post exposure prophylaxis for HIV following sexual exposure 1. Unless otherwise stated, the following recommendations are based upon these guidelines. The use of PEPSE following potential sexual exposure to HIV 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. 3.1 The risk of HIV Transmission The risk of an individual acquiring HIV following an exposure is dependant upon the risk that the source is HIV positive. Where unknown the risk can be calculated using the table (Table 1) and the risk of the exposure (Table 2). Risk of HIV transmission = Risk that the source is HIV positive x Risk of type of exposure. All risk probabilities are for unprotected sexual exposure; it is assumed that similar risks will exist where condom failure has occurred.

4 Table 1: Risk that the source is positive (HPA Data until end 2006 Supplementary data tables of unlinked Anonymous Prevalence Monitoring Programme. Community Group HIV Seroprevalence % < All ages MSM (Men who London have sex with Elsewhere in England men) Wales and NI attending GUM clinics Scotland Heterosexuals attending London GUM clinics Male Female Heterosexuals attending GUM clinics elsewhere in England, Wales and NI Male 0.34 Female 0.58 Heterosexuals attending GUM clinics in Scotland Male Female Attendees at GUM clinics in England, Wales and NI (region of birth)* MSM Heterosexual Male Heterosexual Female All exposed categorie s Europe North America Central and South America Caribbean North Africa and Middle East Sub Saharan Africa South Asia East and South East Asia Australasia Injecting drug users Males Females London Rest of England, Wales and NI Health Protection Agency. Supplementary data tables of unlinked anonymous prevalence monitoring programme For exposure outside the UK or to individuals recently moved to the UK see

5 Table 2: Risk of HIV transmission following an exposure from a known HIV positive individual (complied from BASHH guidance) Type of exposure Estimated risk of HIV transmission per exposure (%) Receptive anal intercourse Insertive anal intercourse 0.06 Receptive vaginal intercourse Insertive vaginal intercourse Receptive oral sex (fellatio) Mucous membrane exposure 0.09 (CI ) 3.2 Calculating the Risk of HIV Transmission Table 3 provides examples of estimates an individual s risk of HIV transmission if the source is known to be HIV positive or of unknown status according to the type of exposure. Complied from BASHH guidance with use of HPA data (see table 1). Table 3: Examples of estimated risk calculations (modified from BASHH with use of HPA seroprevalence data used in table 1) Community Group Unprotected receptive anal intercourse from MSM (residing in London and age unknown) Unprotected receptive anal intercourse from MSM (residing in Scotland and age unknown) Receptive vaginal intercourse with heterosexual man (residing in Scotland) Estimated risk of HIV transmission Source status unknown Source known HIV Positive 23% x (0.1 to 3%) = to 0.69% 1/144 to 1/ % x (0.1 to 3%) = to 0.114% 1/877 to 1/ % x (0.1 to 0.2%)= to % 1/ to 1/ x (0.1 to 3%)= 0.1 to 3% 1/33 to 1/ x (0.1 to 3%) = 0.1 to 3% 1/33 to 1/ x ( 0.1 to 0.2%) = 0.1 to 0.2% 1/500 to 1/1000 A sexual health advisors role is crucial for those presenting for PEPSE. Areas to discuss include: the need for support during the following 12 weeks to 6 months (depending on HIV status of source and use of PEPSE, see section 3.8 for more details) the need for repeat HIV tests during and at the end of the relevant follow-up period the need for safe sex until all results are available and negative the need to avoid blood donation until all results are available and negative the side effects of the drugs and support available to help adherence issues around disclosure coping strategies A sexual health advisor is available at the GUM clinic at DGRI.

6 3.3 Recommendations for Prescribing PEPSE A risk benefit analysis should be undertaken for every individual presenting following an exposure and a decision to initiate PEP made on a case by case basis. This should consider both the risk of transmission according to the coital act (as in Table 2) and the risk the source being positive (as in Table 1). Consideration should be given to the presenting individual already been infected with HIV and the ability to adhere to and tolerate the proposed regime. The potential exposure to other STIs and appropriate management for this, needs to be considered alongside consideration of PEPSE. The wishes of the individual should be considered at all times. Although there is a lack of conclusive data for the efficacy of PEPSE animal studies, human studies involving occupational exposure, and studies to reduce vertical transmission and prospective data from sites were PEPSE has been evaluated suggest PEP may be protective. The following should be discussed with individuals presenting for PEPSE: the rationale for PEPSE the lack of conclusive data for the efficacy of PEPSE the potential risks and side effects the arrangement for early follow-up with an HIV and GUM clinician

7 Table 4: Situations in which PEPSE would be recommended or considered Partner Presenting for PEPSE Receptive anal sex Insertive anal sex Receptive vaginal sex Insertive vaginal sex Fellatio with ejaculation (partner giving fellatio is presenting for PEPSE) Splash of semen into eye Fellatio without ejaculation Cunnilingus Source individual is known to be HIV positive Source individual is of unknown status (see below) Source individual is Source individual is not from a group or area from a group or area of of high HIV high HIV prevalence prevalence Recommended Recommended Considered Recommended Considered Not recommended Recommended Considered Not recommended Recommended Considered Not recommended Considered Considered Not recommended Considered Not recommended Not recommended Not Not recommended Not recommended recommended Not Not recommended Not recommended recommended Where the table states consider the threshold for recommending PEPSE could be lower in the context of factors that may increase the risk of transmission. For example: a high plasma viral load in the source (this may be particularly relevant during primary HIV infection). the presence of breeches in the mucosal barrier such as mouth or genital ulcer disease, genital trauma including that which may be experienced during sexual assault or first sexual intercourse menstruating or other bleeding may also facilitate transmission the presence of concurrent sexually transmitted infections

8 Source individual of unknown status Attempt should be made, where possible, to establish the HV status of the source individual 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 urgent HIV testing of that partner with appropriate guidance on HIV testing and consent, as early as possible. High prevalence groups are those where there is a significant likelihood of the source individual being HIV positive. Within the UK at present, this is likely to be MSM and individuals who have migrated to the UK from areas of high HIV prevalence (particularly sub-saharan Africa). At the present time it also appears that in the UK there are significant geographical variations in the HIV seroprevalence rates within the MSM community, for example a London resident MSM is 6 times more likely to be HIV positive than a Glasgow MSM resident. This information may influence the decision to offer PEPSE. 3.4 Testing Individuals for whom PEPSE is provided must undertake an HIV test. A 5-10ml clotted sample should be taken. The laboratory request form should clearly state the name of the exposed individual their date of birth full details of the exposure including time of exposure, and whether the source is known. Any additional information about the source should also be included in the request form e.g., name of source Results must be obtained as soon as possible after initiating therapy. Future management of undiagnosed HIV infection may be severely compromised by short course anti-retroviral therapy: PEPSE not offered or PEPSE is offered and patient declines If a patient after counselling is not offered PEPSE, or is offered but the patient declines PEPSE, a 5-10 ml clotted blood sample should be taken and the Bacteriology Laboratory request form should be marked; Blood for storage - not for testing - for the attention of the Consultant Bacteriologist patient counselled but not given/declines PEPSE The baseline blood sample may assist the investigation of subsequent illness in the injured person. 3.5 PEPSE drugs The anti retroviral drugs provided in PEP packs in NHS Dumfries and Galloway are Combivir and Kaletra. Metoclopramide and Loperamide are also included in the pack. (see appendix 1 for further information). In situations such as sexual assault, little if any information will be available about source, making it difficult to tailor antiretroviral therapy increasing the risk of a drug resistant strain of HIV. This is more likely if adherence to PEP regime is sub optimal. The likelihood of adherence to regime should be a factor in the decision to offer PEP. Timing of the first dose of PEP. The use of PEPSE following potential sexual exposure to HIV is only recommended where the individual presents within 72

9 hours of exposure. Within that time frame, it is recommended that PEPSE (if given) should be administered as early as possible Where appropriate in a high risk situation, an initial dose of PEP can be given immediately pending further risk assessment and counselling. An urgent pregnancy test should be offered to all women of child bearing age before PEP is commenced. If a the exposed person is under 16 contact a paediatrician for further advise (see appendix 2). PEP treatment is four weeks. PEP packs will be available containing a three day course which is sufficient to cover weekends and bank holidays and are available in: o Emergency Department, Dumfries & Galloway Royal Infirmary o Accident & Emergency Department, Galloway Hospital Stranraer o Minor injuries Unit Newton Stewart Hospital o Thomas Hope Hospital, Langholm o Minor Injuries Unit, Castle Douglas Hospital If PEPSE is offered blood must be taken for a HIV, HBV, HCV screen. FBC, U&E s, LTF s, lipids and blood glucose should also be checked. Syphilis serology is also recommended. It is not necessary to wait for results of blood tests before commencing PEP. Results of tests should be monitored and acted on accordingly. 3.6 Choice of Drugs If source patient is unknown, standard pack should be given. When the exposed presents with the source determine (if possible from source or source s notes) the source s viral load, current anti-retroviral therapy and resistance patterns. If the source is known to have no resistance and an undetectable viral load then given standard PEP pack. If the source is local and known to have resistance or a detectable viral load seek advice from an infectious disease consultant at the time either here or elsewhere. (see appendix 2 and 4 for contact details). Do not delay administration of standard PEP unduly, consider administering standard PEP whilst seeking further advise. If the source is from outwith the region and reports either resistance or detectable viral load, advice needs to be sought from source's infectious disease unit at the time. If this is not possible then advice should be sought from local consultant or one on call elsewhere (eg Gatnavel). Do not delay administration of standard PEP unduly, consider administering standard PEP whilst seeking further advise. All anti-viral agents have side effects. Ensure side effects are discussed. Interactions with other medication including herbal remedies can occur, a check should be made on and discuss further with pharmacy if concerned. Consider anti emetic and anti motility drugs (metroclopramide and loperamide are included in pack). The dosages, side

10 effects and contraindications of these drugs are listed in Appendix 1. Ensure that patient information cards are provided to those receiving PEP. The prescriber must arrange for the receiver of PEP to be seen by Dr G A Jones or Sister Murray within 7 days. Dr Jones secretary should be on contacted ( ) stating clearly when a patient needs to be seen. The referral form in the PEP pack should also be faxed to Ensure that extra PEP drugs are provided from pharmacy if a patient is not likely to seen for more than three days e.g. the beginning of a weekend or around the time of public holidays. 3.7 Gum Referral Referral to the Department of Sexual Health Genito-urinary Medicine (GUM) clinic is recommended whether or not PEP has been administered. The GUM clinic can offer screening for other sexually transmitted infections commencing two weeks post exposure. If the patient has not been referred to Dr Jones, Consultant in Infectious Diseases (as a consequence of either not being offered or declining PEP) the GUM clinic can perform follow up serology for between 12 weeks to 6 months post exposure (duration of follow up depends on HIV status of source and use of PEPSE, see section 3.8 for more details) The exposed patient should be advised to contact or attend a drop in clinic within 2 weeks following exposure. They should be asked to consent to the GUM clinic making contact with them (see Section 6). Referral to GUM clinic should be made using form in PEP pack see appendix Advise for exposed persons Exposed persons should be followed up as follows: Source known to be HIV positive irrespective of whether PEPSE given to exposed follow up 6 months post exposure Source status unknown and PEPSE given to exposed follow up 12 weeks after completion of PEPSE Source status unknown and PEPSE not given to exposed follow up 12 weeks post exposure Exposed persons should seek medical advise about any acute illness which occurs during the follow up period regardless of whether PEP has been given. Illnesses characterised by fever,rash, myalgia, fatigue, malaise and lymphadenopathy may represent a seroconversion illness or a side effect of the medication. Advise patient to contact Dr Jones secretary if unwell Tel All exposed persons should be offered condoms and strongly advised to use these or abstain from intercourse (oral, vaginal and anal) until all post exposure results are available and negative at the end the relevant follow-up period. In addition, females on hormonal contraception (oral, transdermal or implant) should be advised of the reduced efficacy of these methods for the four weeks of treatment and a further four weeks post treatment due to liver enzyme induction. The metabolism of depot medroxyprogesterone acetate is unaffected by the use antiretroviral drugs and can continue to be used without the loss of contraceptive efficacy. Blood donation should also be avoided until all post exposure results are reported as negative at the end of the follow-up period.

11 4. POST EXPOSURE PROPHYLAXIS FOR HEPATITIS B (HBV) FOLLOWING SEXUAL EXPOSURE Significant exposure to Hepatitis B includes: Unprotected oral, vaginal and anal intercourse Oro-anal contact. 4.1 Sexual partners of individuals with known HBV infection. Advice based on the Department of Health, Immunisation against Infectious Disease Department of Health. Immunisation against infectious disease Acute Infection Sexual partners of individuals suffering from acute Hepatitis B, and who are seen within one week of last contact, should be offered protection with Hepatitis B immunoglobulin (HBIG) and an accelerated course* of HBV vaccine. Ideally both vaccination and (HBIG) should be given within 48 hours of exposure, although they could still be considered a week after exposure. Vaccination theoretically will provide some protection from disease when started up to six weeks after exposure. 3 Blood should taken to determine if they have already been infected. Contacts shown to be HBsAg, anti-hbs or anti-hbc positive do not require further immunisation. Chronic Infection Sexual contacts of an individual with newly diagnosed chronic Hepatitis B should be offered an accelerated course* of vaccine: HBIG may be added if unprotected sexual contact occurred in the past week. Blood should be taken at the time of first vaccine to determine if they have already been infected. Contacts shown to be HBsAg, anti-hbs or anti-hbc positive do not require further immunisation. Vaccination theoretically will provide some protection from disease when started up to six weeks after exposure Sexual partners of high risk individuals with unknown HSsAg status HBV vaccine is recommended as routine for all men who have sex with men (MSM), sex workers, those with sexual partners from high prevalence areas#, and sexual partners of injecting drug users. Where vaccine status is uncertain and person has been exposed to someone from the above risk groups commence an accelerated course of HBV vaccine. Some MSM and injecting drug users may have been previously vaccinated. Most members of the general public will not. If course is incomplete, finish course. Vaccination theoretically will provide some protection from disease when started up to six weeks after exposure Victims of sexual assault with perpetrator of unknown HBsAg status An accelerated course*of vaccine should be offered following sexual assault with a perpetrator of unknown HBsAg status. Vaccination theoretically will provide some protection from disease when started up to six weeks after exposure. 3 Dosage *An accelerated course of vaccination consists of doses spaced at zero, seven and 21 days. A booster dose should be given at 12 months. ENGERIX B should

12 be used. This product has been granted a licence to allow for a rapid immunisation schedule. Twinrix combined Hepatitis A/B vaccine is recommended for men who have sex with men, Twinrix can also be given at 0,7 and 21 days with a booster at 12 months. # countries where Hepatitis B is more common: sub- Saharan Africa, most of Asia and the Pacific Islands, Amazon, southern parts of Eastern and Central Europe, the Middle East and the Indian sub-continent. Unless there is clear documented evidence of vaccine status, offer vaccination. If patient counselled but not given/declines immunisation and /or immunoglobulin a blood sample should still be taken and the bacteriology request form should be marked: Blood for storage not for testing for the attention of the consultant bacteriologist. Patient counselled but not given/declines post exposure immunisation and /or immunoglobulin for Hepatitis B. 4.4 Follow Up Referral to GUM clinic is recommended for administration for further doses of vaccine under an accelerated schedule (day 0, 7, 21 and booster at 12 months). The GUM clinic can also screen for other sexually transmitted infections. See section 6 for more information on referral to GUM service. The exposed patient should be advised to have follow-up serology at 6 weeks, 3 months and 6 months post exposure irrespective of whether immunisation and /or immunoglobulin administered. The exposed patient should be advised to contact or attend a drop in clinic within 7 days following exposure. They should be asked if they consent to the GUM clinic making contact with them (see Section 6). All exposed persons should be offered condoms and strongly advised to use these or abstain from intercourse (oral vaginal or anal) until all post exposure results are available and negative 6 months after exposure. Blood donation should also be avoided until all post exposure results are reported negative at 6 months after exposure. The exposed patient should be advised to seek medical advice from GP or GUM clinic about the development of symptoms such as flu like illness, jaundice, anorexia, nausea, malaise and ache in the right upper abdomen which may suggest Hepatitis B infection. 5. MANAGEMENT OF EXPOSURE TO HEPATITIS C (HCV) There is no available post exposure prophylaxis for Hepatitis C. People who have had exposure to a sexual partner who is or is suspected HCV infected should be offered testing, on presentation and at 6 weeks, 3 & 6 months post exposure. Referral to the GUM service is advised to offer screening for other sexually transmitted infections, ideally first visit at 2 weeks post exposure The exposed patient should be advised to contact or attend a drop in GUM clinic within 2 weeks following exposure. They should be asked if they consent to the GUM clinic making contact with them (see Section 6).

13 The exposed patient should be advised to have follow-up serology at 6 weeks, 3 and 6 months post exposure (also available at the GUM clinic). The exposed persons should be offered condoms and strongly advised to use these or abstain from intercourse (oral vaginal or anal) until all post exposure results are available and negative 6 months after exposure. Blood donation should also be avoided until all post exposure results are reported negative at 6 months after exposure. The exposed patient should be advised to seek medical advice from GP or GUM clinic about the development of symptoms such as flu like illness, jaundice, anorexia, nausea, malaise and ache in the right upper abdomen which may suggest Hepatitis C infection. 3 Clinical Effectiveness Group British Association of Sexual Health band HIV. United Kingdom National Guideline on the Management of the Viral Hepatitides A,B & C FOLLOW UP Where a Casualty Officer has managed a patient following sexual exposure the patient should be counselled as to whether he wishes his or her GP to be informed of the attendance and action taken. If the patient consents then the Casualty Officer should write to the exposed individual s GP stating the following information: What has happened. What action has been taken. The recommended follow-up (on clinical grounds). When an exposed person does not consent to GP being notified of the attendance then GUM clinic involvement is even more crucial and the exposed person should be counselled accordingly. GUM clinic attendance should be considered routine apart from the most exceptional of circumstances. All patients should be seen by the GUM service within 2 weeks of exposure (sooner if patient requires 2 nd dose of an accelerated Hepatitis B vaccination). GUM service follow-up is important to: Administer further doses of Hepatitis B vaccination under an accelerated course (0, 7 days, 21 days and 12months) Follow up serology of blood borne virus Screening for other sexually transmitted infections (commencing 2 weeks post exposure) Offer guidance to help minimise risk of further exposure The exposed patient should be advised to contact or attend a drop in clinic within 2 weeks (7 days if requires 2 nd dose of the Hepatitis B accelerated schedule) following exposure. They should be asked if they consent to providing two forms of contact in order for the GUM clinic to make contact with them. GUM Clinic Times No appointments necessary 5.30 to 7pm Mondays or 2.30 to 4pm Fridays Bay 2 of Out-Patients DGRI and Wednesdays to 1.30pm Galloway Community Hospital

14 Post Exposure Prophylaxis Patient Information Leaflets APPENDIX 1

15 Appendix 2

16 Appendix 3

17 APPENDIX 4 LIST OF USEFUL CONTACTS IN DUMFRIES AND GALLOWAY DGRI Main Switch Board Tel Casualty Officer, Emergency Department DGRI Available through DGRI switchboard Accident and Emergency Department Galloway Community Hospital Tel Minor Injuries Unit, Newton Stewart Hospital Thomas Hope Hospital Langholm Minor Injuries Unit, Castle Douglas Hospital Duty Consultant Microbiologist, DGRI Consultant Physician and Infectious Disease Specialist, DGRI Available through DGRI switchboard Duty Infectious Diseases Physician, Brownlee Centre, Gartnavel Hospital, Glasgow Blood Transfusion, DGRI Blood Transfusion, Galloway Community Hospital Tel Tel Tel Available through DGRI switchboard Tel Tel Tel Tel Tel Ext.4596 GUM Service (contact Department of Sexual Health Direct dial Tel Tel Bloodborne Virus Team, Health Protection Tel