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.