Less than a month after getting the green light in the USA, AbbVie has secured approval in Europe for its all-oral, interferon-free
hepatitis C regimen Viekirax plus Exviera.

The European Commission has granted marketing authorisations for its all-oral, short-course, interferon-free treatment of Viekirax (ombitasvir/paritaprevir/ritonavir), plus Exviera (dasabuvir) approved in the USA as Viekira Pak. The treatment has been approved with or without ribavirin for patients with genotype 1 chronic HCV infection, including those with compensated liver cirrhosis, HIV-1 co-infection, patients on opioid substitution therapy and liver transplant recipients; additionally, Viekirax has been approved with ribavirin in genotype 4 patients.

The approvals follow a review under accelerated assessment by the European Medicines Agency. Approximately nine million people in the Old Continent are infected with chronic HCV.

AbbVie chief executive Richard Gonzalez said the approval “offers patients across Europe a new and effective treatment to cure this serious disease”. It will compete with Gilead Science’s Harvoni, which combines the mega-blockbuster Sovaldi (sofosbuvir), a nucleotide analogue polymerase inhibitor, with the NS5A inhibitor ledipasvir, for HCV genotype 1 and 4 infection.

While these new HCV drugs are being lauded for their stunning efficacy, there  is concern over the very high cost of these life-saving, highly-innovative treatments, not least in Europe. Mr Gonzalez added that “we are committed to working with local governments and healthcare systems to support broad access to Viekira + Exviera”.