The FINANCIAL — 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, according to AbbVie.
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 cirrhosis.
The USPIs for VIEKIRA PAK and TECHNIVIE were updated following post-marketing reports of hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, in patients receiving AbbVie’s HCV treatment, with or without RBV. Most patients with these severe outcomes had evidence of advanced cirrhosis prior to initiating therapy.
AbbVie will issue a Dear Health Care Provider letter to inform US healthcare providers of the updates.