FDA alerts require Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets) and Technivie (ombitasvir, paritaprevir and ritonavir tablets) label changes due to hepatic decompensation and liver failure- AbbVie

In consultation with the FDA, the US prescribing information 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 changes reflected a FDA drug safety communication about post-market reports of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking the drugs. There have been 26 cases in the FDA Adverse Event Reporting System (FAERS) of hepatic decompensation since Viekira and Technivie's launches in December 2014 and July 2015, respectively, and at least 10 cases have resulted in liver transplantation or death. Most cases occurred in patients receiving Viekira who had evidence of advanced cirrhosis before starting treatment.