POST-EXPOSURE PROPHYLAXIS (HIV, HEP B, HEP C)

POST-EXPOSURE PROPHYLAXIS (HIV, HEP B, HEP C) www.hiv-druginteractions.org No major changes to this protocol since last reviewed in 2014 Reference should also be made to the NHSGGC document on management of occupational and non-occupational exposures to blood-borne viruses (April 2013). This guideline and supporting documentation can be downloaded from www.nhsggc.org.uk/phpu. Sandyford employees are advised to refer to the above policy from the Health Board in relation to the management of occupational exposure. Management of Occupational Exposure to HIV Apply first aid as below. Report to supervisor Contact occupational health First Aid Encourage bleeding of puncture wounds by gentle squeezing. Do not suck the area. Wash the affected area with soap and warm running water, but do not scrub Treat mucosal surfaces (e.g. mouth or conjunctiva) by rinsing with warm water or saline (do not swallow). Assessing the incident Needle-stick injuries: The overall risk of HIV transmission is estimated to be 0.3%. The following factors determine risk in any given situation Hollow needle Large gauge needle (>18g) Visible blood in/on device Procedure involved artery or vein Gloves not used Deep injury (see definitions below) Contamination of an established cut/abrasion/scratch/burn or other skin lesion. This would require contact with infected blood, serum or plasma. Contamination of mucosal surfaces (such as the eye or mouth). This would require contact with infected blood, serum or plasma. The risk is lower than that of needle-stick, at 0.1%. Injuries where the skin is punctured by, for example, a human bite. POST-EXPOSURE PROPHYLAXIS: CEG DECEMBER 2015 Page 1 of 10

Only one documented case worldwide. Dealing with the source patient In the case of hospital-acquired injury, the team caring for the source patient should approach the source patient to conduct a risk assessment (this is currently under review within Glasgow where it is hoped source assessment will be conducted by senior local nursing staff). Within Sandyford, risk assessment of the source patient will be undertaken by the lead nurse for the site. Ensure privacy. The injured healthcare worker should ideally not be the person who has to deal with the following procedure. Inform that an accident involving an employee has occurred with their blood Ask routine risk questions (see Source Patient Assessment Tool PART A) If the injury was felt to be significant and the source patient is considered to have any risk of infection with HIV/Hepatitis B or C, proceed as below After full pre-test discussion (see HIV testing), take blood for testing If patient anxious/high risk of HIV infection, refer to Sexual Health Adviser or nurse with Sexual Health Adviser competencies for pre-test counselling If patient unconscious/intoxicated, assess risk as fully as possible, but do not take blood without consent Determining risk (please refer to PEPSE protocol if further information required) Risk is determined by three variables: - Type of injury - Prevalence of infection in population to which the source patient belongs and - Transmission characteristics of blood-borne virus concerned Table 1 Population Group HIV Prevalence % Men MSM- UK 4.4 London 8.1 Glasgow 4.6 Heterosexual (place of birth)- Sub-Saharan Africa 3.1 Rest of UK 0.5 IVDU- London 0.9 Scotland 0.5 Examples of estimated risk calculations are given here: Women - - - 6.2 0.3 - POST-EXPOSURE PROPHYLAXIS: CEG DECEMBER 2015 Page 2 of 10

Table 2 Exposure Population Group Risk of HIV Transmission (source unknown status) Risk of HIV Transmission (source HIV Positive) Sharing Injecting Equipment IVDU in London 0.009 x 0.67%=0.006% 1x0.67%=0.67% IVDU in Scotland 1/16,667 0.005 x 0.67%=0.0033% 1/149 1/30,303 Try and establish the HIV status of the source individual (according to appropriate guidance on HIV testing and consent) as early as possible. PEP can be averted through assertive HIV testing of the source individual. Treatment with PEP All patients or staff requiring PEP for HIV must be discussed with the consultant on-call If source patient known to be HIV infected or is judged to be at significant risk and definite high risk exposure: Table 3 (modified from PEPSE guidance) Source HIV Positive- Detectable Viral Load HIV Positive- Undetectable Viral Load Unknown Status from High Prevalence Group/ Area Unknown Status from Low Prevalence Group/ Area Splash of risk body fluid into eye Consider Sharing injecting equipment/sharps injury Recommended Consider Human bite Needlestick from discard needle in the community - - POST-EXPOSURE PROPHYLAXIS: CEG DECEMBER 2015 Page 3 of 10

Offer post-exposure prophylaxis (PEP), ideally within one hour of the injury (up to 72 hours). If uncertain, PEP is better started and the need for continuation considered once more information (e.g. HIV result) is available. If PEP is to be commenced blood for the following, should be sent by the prescribing doctor before PEP is commenced: U&Es FBC LFT For the consider category; seek senior advice. Key questions: Is the patient pregnant or at risk of pregnancy? Is there an existing medical condition (eg renal dysfunction)? Is there potential for interaction with other medications that the patient is taking inc. contraception? Could the virus be resistant to one or more of the drugs? Is there a history of recreational drug use what agents? IT IS THE RESPONSIBILITY OF THE PRESCRIBING CLINICIAN TO CHECK FOR ANY DRUG INTERACTIONS This can be done at www.hiv-druginteractions.org. Pharmacists based at the Brownlee can also be contacted for advice Mon Fri 9 5 on 53383 If a drug interaction exists please discuss this with the GUM consultant on-call, an alternative course of PEP may be available. Informed Consent for PEP Informed consent should be obtained from the exposed person prior to prescribing PEP. The exposed person s understanding of the following should be documented: The need for PEP and agreement with the risk assessment That PEP is an unlicensed use of these drugs that have been licensed for treatment of established HIV infection Known side effects of the drugs to be prescribed (skin rash. renal dysfunction and mood changes) The importance of close adherence which may improve any efficacy and reduce the risk of infection with drug-resistant HIV, should infection supervene despite PEP Arrangements for follow up Symptoms and signs which may be associated with HIV seroconversion. Practice safer sex and avoid blood donation whether or not on PEP POST-EXPOSURE PROPHYLAXIS: CEG DECEMBER 2015 Page 4 of 10

Table 4 PEP Regimen by Expert Advisory Group on AIDS Drug Dose es Truvada This is made up of two drugs combined into ONE tablet Tenofovir disoproxil (245 mg ) Emtricitabine (200 mg) Raltegravir 400mg (Isentress ) Take ONE tablet, ONCE a day, preferably every 24 hours Take ONE tablet, TWICE a day, preferably every 12 hours Truvada and Raltegravir can be taken at the same time. Take with or just after food or a meal. It does not matter if you take these tablets before or after food or on an empty stomach Starter pack of 5 days is supplied by the clinic. A prescription will be required for additional supplies of PEP. Consider drug interactions with these medicines. Further information can be obtained from www.bnf.org and www.hiv-druginteractions.org/. Follow up Truvada / Raltegravir is well tolerated. PEP should normally be continued for 4 weeks. Published evidence shows that less than 50% of patients complete PEP. Patients starting PEP need to be seen in any of the urgent care clinics within Sandyford Central or Sandyford Renfrewshire before the end of the starter pack for a further 23 day supply.. They do not need to be referred to the Brownlee. All health care workers occupationally exposed to HIV should have follow-up counselling, post-exposure testing and medical evaluation whether or not they have received PEP. Exposed persons should seek medical advice about any acute illness which occurs during the follow up period. Illnesses characterised by fever, rash, myalgia, fatigue, malaise or lymphadenopathy may represent a seroconversion illness, or a side effect of the medication. In the absence of seroconversion, health care workers need not be subject to any modification of their working practices. The HIV test should be done 8 weeks after completion of PEP BASHH/EAGA statement on HIV window period Nov 14 A health care worker who has acquired HIV infection because of exposure to HIV infected material in the workplace may be able to claim Industrial Injuries Disablement Benefit. POST-EXPOSURE PROPHYLAXIS: CEG DECEMBER 2015 Page 5 of 10

Reporting Of Occupational Exposures To HIV Occupational exposure to HIV should be reported (in complete confidence) to the Communicable Disease Surveillance Centre (CDSC) or, in Scotland, to the Scottish Centre for Infection & Environmental Health (SCIEH) In the event of exposure to HIV, employers may be required to report the event to Health and Safety Executive (HSE) under the Reporting of Injuries, Diseases and Dangerous Occurrences (RIDDOR) Regulations 1995. Management Of Other Suspected Exposure To HIV No data exist on the efficacy of antiretroviral post-exposure prophylaxis following exposure to HIV other than for occupational exposure in a health care setting. Hence due to lack of any evidence of efficacy, at present the Expert Advisory Group on AIDS (EAGA) cannot recommend in favour of, or against its use The risk of acquiring HIV in this context is so low that it outweighs the risk of toxicity from antiretroviral drugs. Management Of Exposure To Hepatitis B CATEGORY Known Responder Non-Responder AFTER A SIGNIFICANT NEEDLESTICK OR SIMILAR INJURY RECOMMENDATION If source blood is confirmed HBsAg positive Give one booster dose of hepatitis B vaccine. Otherwise no action required Give HBIG based on risk assessment If source known to be HBsAg positive or highly likely to be, consider adding rapid course of HBV vaccine Immunised but Response Unknown Immunised but incomplete course Previously unvaccinated Give booster dose based on risk assessment. Check antibody titre now and if necessary in 2-3 months. If source known to be HBsAg positive or highly likely to be, consider adding HBIG. Give booster dose and complete the course. Check antibody titre now and if necessary in 2-3 months. If source known to be HbsAg positive or highly likely to be, consider adding HBIG if only one dose of course previously given Give rapid course of vaccine and add HBIG based on risk assessment Follow up Repeat serology at 3 and 6 months Avoid unprotected sex & blood donation until follow-up serology Contact clinic if symptoms of hepatitis POST-EXPOSURE PROPHYLAXIS: CEG DECEMBER 2015 Page 6 of 10

Management Of Exposure To Hepatitis C There is no available post exposure prophylaxis for Hepatitis C. Baseline testing at presentation Follow-up: Repeat serology at 4 weeks post exposure antigen test Avoid unprotected sex & blood donation until follow-up serology. Contact clinic if symptoms of hepatitis Reference British Association for Sexual Health and HIV. (2011). UK Guideline for the use of post exposure prophylaxis for HIV following sexual exposure. NHS Greater Glasgow & Clyde. (2013).Management of Occupational and Non Occupational Exposures to Bloodborne Viruses www.nhsggc.org.uk/phpu Expert Advisory Group on AIDS. Change to regimen for post-exposure prophylaxis (PEP). Sept 2014 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/351633/chang e_to regimen_for_pep_starter_pack_final.pdf POST-EXPOSURE PROPHYLAXIS: CEG DECEMBER 2015 Page 7 of 10

HIV POST EXPOSURE PROPHYLAXIS (PEP) PATIENT INFORMATION SHEET What is my risk of acquiring HIV? The risk of acquiring HIV following a skin puncture with HIV-infected blood is about 0.3% (3 in 1000). The risk of acquiring HIV after unprotected sex with a known HIV positive person can be up to 3% (3 in 100), but it depends on a lot of things including the type of sex and how infectious the HIV positive person is. Can anything be done to reduce this risk? After HIV gets into the body, it takes a few days for the infection to get established. We can use this window to give you anti-hiv medication to reduce the risk of the virus taking hold. This is called Post-Exposure Prophylaxis, or PEP for short, as it is trying to prevent infection after you have been exposed. There are clear guidelines in NHS Greater Glasgow and Clyde (NHSGGC) about when to prescribe PEP. The medication itself has side-effects and can make you unwell. It is only worth prescribing this medication if the risk of HIV infection is high. You will need to tell the staff looking after you some basic facts about your exposure so they can accurately assess your risk of contracting HIV. What is the treatment? From December 2012 NHSGGC has changed what drugs we give people to try and prevent HIV infection. The new drugs have less side-effects. We need to give three active agents to combat HIV, but two of these are combined into a single tablet. Drug Dose es Truvada This is made up of two drugs combined into ONE tablet Tenofovir (245 mg ) Emtricitabine (200 mg) Raltegravir 400mg (also called Isentress ) Take ONE tablet, ONCE a day, preferably every 24 hours Take ONE tablet, TWICE a day, preferably every 12 hours Take with or just after food or a meal. It does not matter if you take these tablets before or after food or on an empty stomach Truvada and Raltegravir can be taken at the same time. When should it be started? The quicker PEP is started after exposure the better within hours. The longer the wait the more chance it won t work. After 72 hours PEP isn t given because it won t work. POST-EXPOSURE PROPHYLAXIS: CEG DECEMBER 2015 Page 8 of 10

How long is therapy for? PEP treatment is given for 28 days. Initially you will be given a FIVE day supply of the medication. You will be seen for follow-up by a specialist at a Sandyford service or at the Brownlee Centre, Gartnavel General Hospital before this runs out. If the specialist recommends that you continue on PEP, a further 23-day supply will be arranged for you from Gartnavel General Hospital Pharmacy. It is important that you take all of your medication as directed. Does PEP have side effects? The newer HIV treatments we use have less side-effects than previously. Common nuisance side effects include flatulence (passing wind) and nausea (feeling sick). These do not usually require extra treatments. More serious side effects include: Skin rash: If you notice a rash you MUST contact the clinic you are attending for follow-up. If this is closed you should contact NHS24. Do NOT take further doses of your PEP treatment until you have been assessed. Kidney problems: One of the agents in Truvada can affect the way your kidneys work. You will have tests to make sure your kidneys are working normally when you start treatment. Mood change & sleep disturbance: Raltegravir can rarely cause problems sleeping and mood changes. If you feel the tablets are affecting you in this way you must discuss this with the doctor who prescribed your PEP. If you experience any unexplained symptoms during your treatment please contact the pharmacist or clinic you are attending for follow-up (see Further Information section). What about other medical conditions and medications? It is important that you tell us about any medical conditions you have and particularly any prescribed medication you are taking. Kidney or liver problems, Hepatitis B, previous pancreatitis, stomach conditions and TB treatment are very important to know about as these conditions might affect the way in which PEP is prescribed or monitored. It is ESSENTIAL that any medicine, supplement, herbal remedy or recreational drug use is disclosed to the doctor prescribing your PEP. Pregnancy and contraception If you think you might be pregnant, tell your doctor as this may influence the frequency of blood tests while receiving PEP. Truvada/Raltegravir PEP will not affect your contraception method, but you should use male or female condoms to reduce the risk of transmitting HIV until you are clear of the window period and have a negative HIV test. After completing the course will I be HIV negative? PEP does not always prevent HIV infection. It can fail because some anti-hiv drugs don t work against some strains of HIV and it s more likely to fail if it s not taken properly or soon enough. POST-EXPOSURE PROPHYLAXIS: CEG DECEMBER 2015 Page 9 of 10

It is very important that you attend for any follow-up for HIV testing, and testing for other infections as needed. Please report any unexpected symptoms, particularly fever or rash to your doctor or pharmacist. Further Information If you have any questions about this medication please contact the HIV specialist pharmacists at Gartnavel General Hospital Gartnavel General Pharmacy 0141 211 3383/3317/3322 9am to 5pm Mon Fri and 9am to 12 noon on a Saturday morning (ask for an HIV pharmacist). Sexual Health Advisors, Sandyford 0141 211 8634 www.sandyford.org.uk www.pepscotland.org POST-EXPOSURE PROPHYLAXIS: CEG DECEMBER 2015 Page 10 of 10