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Appendix 2
Information for Staff
Instructions and advice after exposure to a known or suspected HIV positive
donor:
These instructions must be read if you have had an injury or contact, involving known
or suspected HIV infected blood or blood contaminated body fluid.
By the time you read this, you should have cleaned the wound or site of
contamination thoroughly and reported to your immediate local senior person. If the
patient is not known to be HIV-infected, but there are reasons to believe he/she may
be, you should discuss the advisability of taking antiretroviral (anti-HIV) therapy with
someone on the named key people list.
You need to consider the following questions/points:
1. What are the chances of becoming infected?
The risk of becoming infected with HIV is low.
Information from follow-up studies of exposed health care workers suggests that the
overall rate of transmission from a single percutaneous (eg needle stick) exposure to
HIV-infected blood is around 0.32% (1 in 319). The risk is thought to be greatest after
an injury with a blood filled hollow needle. This compares with a transmission risk of
around 1 in 3 for an unvaccinated person who has an equivalent exposure to
hepatitis B e antigen positive individual and a risk of around 1 in 30 after an
equivalent exposure to hepatitis C. The risk of seroconversion after a
mucocutaneous exposure to HIV infected blood is estimated to be around 0.03% (1
in 3000) which is much lower. Transmission through intact skin is not known to occur.
2. Information on post exposure prophylaxis drugs
Antiretroviral agents from three classes of drug are currently licensed for first-line
treatment of HIV infection, namely:



Nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs).
Non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Protease inhibitors (PIs).
However as no antiretroviral drug has been licensed for PEP, they can only be
prescribed for PEP on an ‘off-label’ basis. In HIV-infected patients, triple therapy has
proved more effective than mono- or dual-therapy in suppressing HIV replication and
avoiding the emergence of viral resistance. A potent three-drug regimen is preferred
because resistance to antiretroviral drugs is found at significant levels in both treated
and untreated infected individuals in the UK.
Information about the virus present in the source patient will be relevant when
choosing appropriate PEP drugs. Similarly, information about the source patient’s
previous and current antiretroviral therapy may also be important. Any information
available in the source patient’s medical record about antiretroviral drug resistance
should be used to inform the choice of PEP drugs after discussion with the infectious
disease consultant and the microbiologist.
After due consideration of storage/stability issues, side-effect profiles, drug
interactions, drug resistance and regimen simplicity (i.e. reduced pill burden and food
restrictions), the following regimen is now recommended for PEP starter packs:


One Truvada tablet (245mg tenofovir and 200mg emtricitabine) once a day,
plus
Two Kaletra film-coated tablets (200mg lopinavir and 50mg ritonavir/per
tablet) twice a day.
There are no food restrictions associated with this regimen and the PEP pack can be
stored at room temperature.
This new regimen is also consistent with the generic regimen of two NRTIs plus a
boosted PI recommended for PEP following non-occupational exposure.
Inclusion of an NNRTI in PEP regimens is not recommended. Both of the NNRTI
licensed for treatment of HIV infection in UK (efavirenz and nevirapine) are
associated with short-term toxicity. Nevirapine has the potential to cause severe
rashes and sometimes Stevens-Johnson syndrome; efavirenz is associated with
neurological side effects and is also contraindicated in pregnancy, but it has a lower
incidence and severity of rash than nevirapine.
GOSH recommends a combination antiretroviral drugs for individuals who are
occupationally exposed to HIV in line with the DH "HIV Post-Exposure Prophylaxis"
guidance issued September 2008.
The drugs for post exposure prophylaxis (PEP) aim to prevent HIV seroconversion. However, all drugs can have side effects therefore it is necessary to
weigh the potential benefits (i.e. a reduced likelihood of becoming HIV infected)
against the potential risks (i.e. side effects). These combinations may change from
time to time as we are constantly reviewing the optimum prophylaxis.
PEP therapy will usually last four weeks. The drugs used, or the time over which they
are given, may require modification. If you experience severe side effects over the
weekend please seek advice from your GP, or you can access urgent telephone
medical advice by contacting the on-call Mortimer Market doctor.
If you are pregnant we do not recommend the use of the triple drug combination.
However, if more than 14 weeks pregnant use of zidovudine alone, or Combivir
(zidovudine and lamivudine) can be considered, but this should only be done after
careful consultation.
3. What are the pros and cons of taking antiretroviral therapy?
Pros
1. These drugs inhibit HIV replication and reduce risk of HIV sero-conversion.
2. These drugs have a simple regimen with better tolerability.
Cons
1. All drugs have side effects, and some antiretroviral drugs have contraindications with other medications. The long-term side effects of taking these
drugs in HIV negative people are unknown. See Appendix 7.
2. There is considerable research data and information about the effective use
of zidovudine in HIV pregnant women. Therefore this is the favoured drug we
would consider in pregnant health care workers who are occupationally
exposed. Further advice should be sought in the presence of resistant virus
and for high-risk injuries in pregnant women from a specialist in HIV medicine.
3. Although we cannot be sure that antiretroviral PEP will prevent you becoming
HIV infected, we have good reason to believe that it will reduce the risk, and
should ideally be started as soon as possible after the injury (within one to
two hours of the injury).
Taking antiretroviral drugs may reduce the risk of you acquiring HIV infection after
occupational exposure. For this reason, we have made this starter pack available.
However, these drugs may cause you some side effects.
Because it is best if the drugs are started straight away, if you are still in doubt we
recommend you start the drugs now, and on the first week day following the incident
when you report to the Occupational Health Department, discuss the advisability of
continuing the drugs. You will be referred to the duty HIV Physician at the Mortimer
Market Centre if further management is indicated.
The PEP basic starter pack has only enough drugs for three days, therefore you
must be seen by GOSH Occupational Health Department on the first week day
following the incident.
The combination and dosage of the drugs recommended for PEP and starter pack
are:

Truvada (emtricitabine 200mg and tenofovir 245mg) one tablet once a day.
Take with or after meals to minimise possible nausea.

Kaletra tablets (Lopinavir 200mg and Ritonavir 50mg). Two tablets twice a
day. Take with or after food to minimise nausea.
Other drugs that may be used or prescribed for PEP are in Appendix 3
Please note: once a day (OD) doses should be taken at the same time each day,
whether morning or night. Twice a day (BD) dosing should be taken about 12 hours
apart, three times a day (TID) roughly eight-hourly - this is to maintain therapeutic
drug levels in the blood. If you weigh less than 60kg some of the above drug doses
may be reduced.
4. Other information
Safer sex using a condom is important because it will protect your partner in the
unlikely event of you becoming infected through this accident. Again you will be fully
advised about this when you talk to the HIV physician. In all cases you should
arrange for a serum sample to be taken and sent to the Department of Virology (for
"save" serum).
You should have counselling regarding other blood-borne infections (eg Hepatitis B
and C) and are advised to have further HIV tests. The timing and reason for these
repeat tests will be discussed at Occupational Health and/or the Mortimer Market
Centre with you. If you opt to take antiretroviral prophylaxis additional investigations
for example a full blood count/liver function test will need to be done on a regular
basis.
Consent form for blood borne virus screening (PDF)