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Fax To:



From:
Professor Sir Liam Donaldson - Chief Medical Officer - Department of Health

Date:



24 July 2007



Reference
CEM/CMO/2007/16

Category:
NON URGENT (cascade within 48 hours)




Title:
UPDATE TO HIV POST-EXPOSURE PROPHYLAXIS (PEP) GUIDANCE FROM THE EXPERT ADVISORY GROUP ON AIDS (EAGA) FOLLOWING THE RECENT RECALL OF VIRACEPT


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To: Directors of Public Health of PCTs and Medical Directors of NHS Trusts to forward to:

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Dear Colleague,

UPDATE TO HIV POST-EXPOSURE PROPHYLAXIS (PEP) GUIDANCE FROM THE EXPERT ADVISORY GROUP ON AIDS (EAGA) FOLLOWING THE RECENT RECALL OF VIRACEPT (GATEWAY REFERENCE 8562)

1. The recall of the antiretroviral Viracept (nelfinavir) 1 from the European market in June 2007 has implications for PEP, since Viracept is the currently recommended protease inhibitor component of PEP starter packs.2 EAGA has therefore recommended an update to its HIV PEP guidance, as an interim measure pending a complete update of the guidance, which is in preparation.

2. EAGA recommends that Kaletra (lopinavir/ritonavir) tablets be substituted for Viracept in PEP starter packs. In preliminary discussions regarding changes to the recommended PEP starter pack, EAGA had already concluded that Kaletra (tablet formulation) should be the preferred protease inhibitor (see below). Thus, the recommended regimen for PEP starter packs is:


3. Prescribers need to be aware of the greater potential for drug interactions between Kaletra and other prescription and non-prescription medicines and advise patients accordingly.

4. At the end of 2005, EAGA considered all available protease inhibitors as possible substitutes for Viracept. EAGA’s primary consideration was that the PEP regimen should reflect standard of care for first-line therapy in established HIV infection and unboosted protease inhibitors were no longer recommended for first-line treatment. Kaletra has better gastrointestinal tolerability than Viracept and is effective against viral strains with protease inhibitor resistance mutations. The tablet formulation of Kaletra causes fewer side effects, does not require refrigeration and has a reduced pill burden.

5. As with other antiretrovirals, PEP is not a licensed indication for Kaletra, and responsibility for the patient's welfare rests with the prescribing doctor. Information on stability and shelf life of Kaletra in PEP starter packs can be found on the EAGA website at www.advisorybodies.doh.gov.uk/eaga/publications.htm




Yours sincerely
SIR LIAM DONALDSON
CHIEF MEDICAL OFFICER

1 MHRA Class 1 Drug Alert - Nelfinavir recall

2 UK Health Departments. HIV Post-Exposure Prophylaxis: Guidance from the UK Chief Medical Officers’ Expert Advisory Group on AIDS. Revised February 2004.
PHL HIV letter 24 07 07.rtf

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