AbbVie Updates U.S. Labels for VIEKIRA PAK, TECHNIVIE Following Consultation With FDA

In consultation with the U.S. Food and Drug Administration (FDA), the U.S. Product Inserts (USPI) for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and TECHNIVIE™ (ombitasvir, paritaprevir, and ritonavir tablets) 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. Because post-marketing events are reported voluntarily during clinical practice, estimates of frequency cannot be made and a causal relationship between treatment and these events has not been established. VIEKIRA PAK with and without ribavirin (RBV) remains indicated for genotype 1 (GT1) HCV patients with compensated cirrhosis, including Child-Pugh A. The safety and efficacy of VIEKIRA PAK, with and without RBV, has been studied in Phase 3 trials in more than 2,300 patients and is one of the recommended regimens in the AASLD guidelines for these patients. TECHNIVIE in combination with RBV is indicated for genotype 4 (GT4) HCV patients without