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Post# of 252995
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Thursday, 10/16/2014 9:43:32 AM

Thursday, October 16, 2014 9:43:32 AM

Post# of 252995
Norvir as a potential anchor on AbbVie HCV sales??

I suspect this has been discussed before, but to what degree do you think the liver a/e's reported for Norvir will affect AbbVie's ability to market their HCV combo?

From the Novir label -

5.2 Hepatic Reactions
Hepatic transaminase elevations exceeding 5 times the upper limit of normal, clinical hepatitis, and jaundice have occurred in patients receiving NORVIR alone or in combination with other antiretroviral drugs (see Table 3). There may be an increased risk for transaminase elevations in patients with underlying hepatitis B or C. Therefore, caution should be exercised when administering NORVIR to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis. Increased AST/ALT monitoring should be considered in these patients, especially during the first three months of NORVIR treatment T[see Use In Specific Populations T(8.6)T]T.

There have been postmarketing reports of hepatic dysfunction, including some fatalities. These have generally occurred in patients taking multiple concomitant medications and/or with advanced AIDS.
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