Idenix Pharmaceuticals (IDIX)

[DewDiligence]

New black-box warning for Baraclude:

The Baraclude FDA label has been updated with a new black-box warning against use in HIV/HBV co-infected patients not being treated with a standard anti-HIV cocktail.

Excerpt from FDA letter for updated label:
http://www.fda.gov/cder/foi/appletter/2007/021797s003,%20021798s003ltr.pdf

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These submissions amend the labeling to include safety information related to the use of entecavir (ETV) in patients with human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfection who are not receiving simultaneous highly active antiretroviral therapy (HAART). Specifically, a recommendation against the use of BARACLUDE in HIV/HBV co-infected patients who are not also receiving adequate therapy for their HIV is added to the Boxed Warnings and WARNINGS sections.
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Actual black-box text from updated Baraclude label:
http://www.fda.gov/cder/foi/label/2007/021797s003,021798s003lbl.pdf

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Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if BARACLUDE is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated. Therapy with BARACLUDE is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART).
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Tyzeka has no antiviral activity against HIV and hence it does not incur the risk of producing HIV mutations that are resistant to therapy. Advantage: IDIX.