Replies to post #59658 on Biotech Values

[DewDiligence]

New FDA recommendation for Ziagen/Epzicom screening:

The FDA now recommends genetic testing prior to a patient’s taking Ziagen or any combination pill containing it such as Epzicom. This recommendation comes on the heels of a recommendation from NIAID to switch certain Epzicom patents to Truvada (#msg-27222444).

The new recommendation for genetic testing ought to expedite the irrelevance of Ziagen and Epzicom and further cement the hegemony of Atripla and Truvada-based regimens in the HIV market in both the US and Europe.

Ziagen (abacavir) is sold by GSK as a standalone drug and as a component of Epzicom (a Truvada competitor consisting of Ziagen+Lamivudine) and Trizivir (a rarely used 3-in-1 pill consisting of Ziagen+Lamivudne+AZT).

http://www.fda.gov/cder/drug/InfoSheets/HCP/abacavirHCP.htm

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Information for Healthcare Professionals
Abacavir (marketed as Ziagen) and Abacavir-containing Medications

FDA ALERT [7/24/2008]: Serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701. Abacavir HSR is a multi-organ syndrome characterized by 2 or more clinical signs or symptoms that can include fever, rash, gastrointestinal symptoms, respiratory symptoms and constitutional symptoms.

FDA has reviewed data from 2 studies that support the recommendation for pre-therapy screening for the presence of the HLA-B*5701 allele and the selection of alternative therapy in positive subjects. Genetic tests for HLA-B*5701 are already available and all patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with abacavir or abacavir-containing medications. Avoidance of abacavir therapy in HLA-B*5701 positive patients will significantly decrease the risk of developing clinically-suspected abacavir HSR. For HLA-B*5701-positive patients, treatment with an abacavir-containing regimen is not recommended and should be considered only under exceptional circumstances when the potential benefit outweighs the risk.

Development of clinically-suspected abacavir HSR requires immediate and permanent discontinuation of abacavir therapy in all patients, including patients negative for HLA-B*5701. This new safety information will be reflected in updated product labeling.
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