EU approves Viekirax + Exviera for treatment of Hepatitis C- Abbvie

AbbVie has announced that the European Commission has granted marketing authorizations for its all-oral, short-course, interferon-free treatment of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets). The treatment has been approved with or without ribavirin (RBV) for 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. Additionally,Viekirax has been approved for use with RBV in genotype 4 (GT4) Chronic Hepatitis C patients. The approvals follow a review under accelerated assessment by the European Medicines Agency, designated to new medicines of major public health interest.

Genotype 1 is the most prevalent form of Hepatitis C in Europe, accounting for 60 percent of cases worldwide. In Europe, the most prevalent sub-genotype is 1b (47 percent). Genotype 4, most common in the Middle East, sub-Saharan Africa and Egypt, is becoming increasingly prevalent in several European countries, including Italy, France, Greece and Spain. AbbVie's treatment is now licensed for use in all 28 member countries of the European Union, as well as in the U.S., Canada, Switzerland, Iceland, Liechtenstein and Norway.

Comment: Viekirax + Exviera will join Solvadi (sofosbuvir) and Harvoni (sofosbuvir + ledispavir) from Gilead as oral, revolutionary therapies in the treatment of Chronic Hepatitis C, replacing the pegylated interferon injectable drugs that carried serious side effects. The new drugs carry impressive cure rates of 90% or more in patients after 8 weeks or 12 weeks of treatment contrasting with the 65%-70% cure rates with the pegylated interferons. Viekirax + Exviera showed 96% of patients gaining SVR 12 ( clearance) in the SAPPHIRE 1 and SAPPHIRE 2 trials with low discontinuation rates.The only problem for this combination is its high pill burden compared to once a day Sovaldi and Harvoni. Price may be a determinant factor in the success of the AbbVie combination.