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Re: DewDiligence post# 196244

Thursday, 10/22/2015 6:55:58 PM

Thursday, October 22, 2015 6:55:58 PM

Post# of 252176
ABBV’s PR on V-Pak label change:

http://finance.yahoo.com/news/abbvie-updates-u-labels-viekira-222100117.html

In consultation with the U.S. Food and Drug Administration (FDA), the U.S. Product Inserts for VIEKIRA PAK and TECHNIVIE have been updated from 'not recommended in Child Pugh B patients' to a contraindication in patients with Child-Pugh B cirrhosis. Patients classified as Child-Pugh C will remain contraindicated as they have been since approval.

The updated USPI for VIEKIRA PAK also includes a recommendation for physicians to assess evidence of hepatic decompensation prior to treatment and during treatment in cirrhotic patients.

Technivie is ABBV/ENTA’s 2-DAA product for GT4 patients; it is a subset of the constituents in Viekira Pak.

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