US-based AbbVie has received marketing authorisation from European Commission (EC) for its all-oral, short-course, interferon-free treatment of Viekirax (ombitasvir / paritaprevir / ritonavir tablets) and Exviera (dasabuvir tablets) to treat patients with chronic hepatitis C.
Approval was granted with or without ribavirin (RBV) to treat patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis HIV-1 co-infection, patients on opioid substitution therapy and liver transplant recipients.
The drug also received approval for use with RBV in genotype 4 (GT4) chronic hepatitis C patients.
AbbVie board chairman Richard Gonzalez said: "The approval of AbbVie’s hepatitis C treatment in the European Union, following the recent approvals in the US and Canada, offers patients across Europe a new and effective treatment to cure this serious disease.
"We are committed to working with local governments and healthcare systems to support broad access to Viekirax and Exviera."
Approval was based on a clinical development programme, designed to evaluate safety and efficacy of the regimen in 2,300 enrolled patients across 25 countries.
The programme comprised six pivotal Phase III trials, which demonstrated Viekirax and Exviera cured 95%-100% of hepatitis C patients with GT1 HCV infection who received the recommended regimen, with less than 2% of patients experiencing virologic failure, noted AbbVie.
AbbVie chief scientific officer Michael Severino said: "With the approval of Viekirax and Exviera in the European Union, we are offering a treatment that achieved high cure rates for people living with GT1 and GT4 chronic hepatitis C."
According to AbbVie, Viekirax and Exviera are the first products that received approval as a combination treatment of three direct-acting antivirals, with distinct mechanisms of action and non-overlapping resistance profiles to target hepatitis C at multiple steps in the viral lifecycle.
Image: Electron micrographs of hepatitis C virus purified from cell culture. Photo: courtesy of Maria Teresa Catanese, Martina Kopp, Kunihiro Uryu and Charles Rice.
