Post-Exposure Prophylaxis ( PEP ) Guidelines - Community Exposure to Possible HIV
|Publication: 01/10/2010 --|
|Last review: 08/05/2019|
|Next review: 02/05/2022|
|Approved By: Trust Clinical Guidelines Group|
|Copyright© Leeds Teaching Hospitals NHS Trust 2019|
This Clinical Guideline is intended for use by healthcare professionals within Leeds unless otherwise stated.
Post-Exposure Prophylaxis (PEP) Guidelines - Community Exposure to Possible HIV
- Background and Purpose
- Provision of PEP
- Evidence for the use of PEP
- Assessing the need for PEP
- PEP and Other Considerations
- Information / Advice to Patients
- PEP Follow Up
- PEP Patient information
- Proforma for patients requesting HIV Post Exposure Prophylaxis (PEP)
Following sexual or percutaneous exposure to HIV it may take up to 48-72 hrs before HIV can be detected in lymph nodes and up to 5 days before it can be detected in the blood. Therefore, there is a window of opportunity for preventing established HIV infection after sexual exposure or sharing IV equipment by using PEP. A circular from the Chief Medical Officer in 2006 stated that PEP should be made available in every locality. PEP is best given early, preferably within 2 hours of the exposure, so the decision whether to initiate PEP is an urgent one, and first doses should not be delayed once a need is identified.
This local guideline seeks to ensure that PEP is provided in Leeds Teaching Hospitals’ Trust in line with the British Society of Sexual Health and HIV (BASHH) national guidelines (2015) and Department of Health advice.
During clinic hours Monday-Thursday 08.00-20.00, Friday 08.00-17.00 and Saturday 09.00- 13.00, anyone requesting PEP should be sent directly to Leeds Sexual Health where they will be seen on a walk-in basis in the Merrion Centre site (balcony level). Please note the last patient will be admitted half an hour before closing and up to date information on clinic closures is available online www.leedssexualhealth.com Health Care Professionals can speak to a clinician via the secretaries in office hours (0113 3920304 ) or Health Advisors (0113 3920325). Outside of these hours the Emergency Departments in Leeds will provide PEP, and specialist advice can be obtained from the GU/ID registrar on call via switch.
The use of PEP is now widespread and there is evidence that it is effective in preventing sexually acquired HIV infection. However, this was from non-randomised studies so there is lack of conclusive data.
The decision to initiate PEP should be made on a case by case basis on the balance of risk versus benefit using the included flowchart.
Initiation beyond 72 hours after exposure is not recommended.
Where the exposure is classed as ‘consider’, PEP should be prescribed if there are additional risk factors that may increase the likelihood of transmission e.g. sexual assault, presence of an STI, the ‘donor’ is thought to have acute HIV infection.
If in any doubt, we would recommend starting PEP.
Undetectable = untransmittable
For people living with HIV who have an undetectable HIV viral load and are stable on treatment, there is effectively no risk of sexual transmission, supported by strong RCT evidence. Cohort studies have recorded no sexual transmissions from over 10000 exposures. PEP is not required in these circumstances. However, if there is any doubt over the source’s viral load or treatment history then PEP should be started whilst confirmation is sought.
Contact the oncall GU/ID registrar via switch for further discussion if required
An HIV test, U&E and LFT should be performed in all patients before PEP is commenced. If the baseline HIV test is positive please contact Leeds Sexual Health for advice.
Clotted sample (red / yellow ring)
The recommended duration of PEP is 28 days (unless source-testing after initiation of PEP determines that the ‘donor’ is HIV negative or if it transpires that the recipient is, unknowingly already infected).
PEP is initially provided in a standard ‘starter’ pack containing a 5 day supply of:
- Emtricitabine 200/Tenofovir DF 245 one tablet po once daily
- Raltegravir 400mg tablets po twice daily
All patients commenced on PEP should be advised to attend Leeds Sexual Health for follow-up before the ‘starter’ pack runs out. See patient information leaflet for contact details or leedssexualhealth.com.
Emtricitabine 200/Tenofovir DF 245 is a tablet containing a combination of two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) tenofovir and emtricitabine. It may cause mild nausea and vomiting but routine antiemetics are not necessary at baseline. It can also be associated with renal impairment although these effects are more commonly associated with long term use.
Raltegravir is an integrase inhibitor. It is well tolerated with minimal side effects. Myopathy and rhabdomyolysis have been reported rarely so caution is advised in individuals with a history of these conditions.
Drug interactions are rare with Truvada and raltegravir but calcium, magnesium and iron containing drugs can affect the absorption of raltegravir so should not be co-administered with it but taken separately a few hours later. However, a full drug history should be taken including herbal/over the counter medications. Interactions can be checked on www.hiv-druginteractions.org or with medicines information on 0113 3965377, or the pharmacist or GUM/ID Specialist Trainee on-call.
Being pregnant is not a contraindication to prescribing PEP but pregnant women will need further discussion regarding the possible effects of antiretrovirals on the pregnancy/foetus before PEP is prescribed. Therefore all women should be assessed regarding their risk of pregnancy and should be discussed with the GUM/ID Specialist Trainee on-call before PEP is given.
II) Hepatitis B
Consider hepatitis B post exposure prevention by vaccinating.
Emergency contraception: If suitable for emergency contraception they should be given levonorgestrel 1.5mg if within 72 hours of last unprotected sex (3mg advised if weigh >70kg) or ellaOne® can be used up to 5 days. There are no drug drug interactions with the current standard PEP regime.
Ongoing contraception: There are no interactions with hormonal contraceptives (pills, patches or implants), however women taking PEP should be advised to use condoms during the duration of PEP and until they have had their final HIV test result.
IV) In patients with ≥CKD Grade 3 renal impairment Tenofovir DF should not be used. An alternative regimen should be discussed with the GUM/ID Specialist Trainee on-call. If the standard regimen is not being used due to renal impairment then the standard starter pack cannot be prescribed. If during opening hours, a prescription can be taken to outpatient pharmacy. If out of hours the on-call pharmacist will need to be contacted.
V) Return from abroad with a PEP regime different from UK prescription: Patients can some times present requesting review or further prescription of PEP after being commenced abroad. If the regime is different from that normally prescribed in the UK, contact the GUM/ID Specialist Trainee on-call for advice or direct to Merrion clinic in opening hours.
VI) Information about ‘donor’ / source patient: if the source patient is definitely HIV positive and there is evidence that they may have failed treatment in the past or have a resistant strain of virus then it may be necessary to alter the drugs from the standard PEP regimen. However DO NOT DELAY COMMENCING PEP. Consider administering initial doses of standard PEP whilst further information / expertise is being sought. The initial regimen may be modified in the light of emerging information at early review by Leeds Sexual Health.
I) Patients should be aware that there is no guarantee that PEP will work and that it should not be considered to be an alternative to safer sex practices. Patients who present repeatedly requesting PEP must be referred to Leeds Sexual Health and in some cases PEP may be refused. Such individuals will require intensive counselling regarding safer sex practices.
II) Take the PEP at regular intervals:
- Emtricitabine 200/Tenofovir DF 245 - one tablet daily (take at the same time every day with or after food).
- Raltegravir - 400mg tablet in the morning and 400mg tablet in the evening (take 12 hours apart at the same times every day with or without food).
The first dose of both medications should be taken as soon as possible within the department. The timing for the second raltegravir tablet can then be brought forward to less than 12 hours, to allow achievable timings from the second day of taking (eg 9am, 9pm).
If there are any problems with taking PEP then the patient should be advised to either attend Leeds Sexual Health during clinic opening hours or if out of hours to contact the GUM/ID Specialist Trainee on-call via the LTHT switchboard.
III) Protected sex, blood donation and pregnancy
Anyone considered for / commenced on PEP after a high-risk sexual exposure should be advised to avoid having unprotected sex or donating blood until they have had a negative HIV test at 2 months after completing PEP. Women should be advised to avoid conception during the same time period.
IV) Side effects of PEP:
- PEP can cause some side effects including nausea, vomiting, headaches and rash which are usually mild but if problematic, the patient should be advised to either attend Leeds Sexual Health during clinic opening hours or if out of hours to contact the GUM/ID Specialist Trainee on-call via the LTHT switchboard.
- PEP may occasionally cause problems such as abnormalities in liver/kidney function. For this reason blood tests are taken before starting and during PEP to look for any potential complications associated with the treatment. All of these problems settle down after stopping PEP.
- PEP can interact with other drugs including ‘recreational drugs’ or herbal remedies. Patients taking calcium, magnesium or iron containing drugs (such as mineral supplements or within antacids), can have reduced absorption of raltegravir so should dose apart 2 hrs before or 6 hours after.
Inform patients that they need to attend Leeds Sexual Health for follow-up before the starter pack runs out. A walk-in service for emergencies such as PEP operates in working hours, Monday-Thursday 08.00-20.00, Friday 08.00-17.00 and Saturday 09.00- 13.00, with last patient admitted half an hour before closing. Leeds Sexual Health can be contacted for professional advice 0900-1700 weekdays (0113 3920304 or 0113 3920325). The GUM/ID Specialist Trainee on-call can be contacted via switchboard for advice between 1700 and 0900.
All patients should be given the following PEP information leaflet.
|Target patient group:|
|Target professional group(s):||Secondary Care Doctors
Secondary Care Nurses
Trust Clinical Guidelines Group
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