The European Commission has granted marketing authorizations for AbbVie’s all-oral, interferon-free, short-course treatment with VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets). This treatment was recently approved with or without ribavirin (RBV) for patients suffering from chronic hepatitis C virus (HCV) infection with genotype 1 (GT1), including those with HIV-1 co-infection, compensated liver cirrhosis, liver transplant recipients and patients on opioid substitution therapy. Furthermore, VIEKIRAX has been approved to be used in patients suffering from chronic hepatitis C patients with RBV in genotype 4 (GT4).
Richard Gonzalez, from AbbVie, said in a press release: “The approval of AbbVie’s hepatitis C treatment in the European Union, following the recent approvals in the U.S. 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 + EXVIERA.”
The European Medicines Agency approved this review under accelerated assessment as a new therapeutic that represents a major interest in public health. About 9 million people in Europe have chronic hepatitis C infection – a leading cause of liver transplantation and liver cancer. Across Europe, the most prevalent form of hepatitis C is genotype 1, as it represents 60 percent of hepatitis C cases worldwide. In particular, sub-genotype 1b is the most prevalent strain, and it represents 47 percent of the cases. Genotype 4 is the most common HCV strain in the Middle East, Egypt and sub-Saharan Africa and it has been noted to be increasing in Italy, Spain and Greece. AbbVie’s treatment is licensed in all 28 countries of the European Union, United States, Switzerland, Canada, Iceland, Norway and Liechtenstein.
Stefan Zeuzem, a medicine’s professor from Germany, said in a press release: “Hepatitis C is a complex disease, with multiple genotypes and special patient populations that need to be considered when determining the right treatment for an individual patient. In clinical trials, AbbVie’s treatment achieved high cure rates with low rates of discontinuation across a variety of patient populations, making it an important addition to the class of therapies that is changing the way hepatitis C is being treated.”
This is a complex disease since the hepatitis virus mutates and replicates quickly. VIEKIRAX + EXVIERA are the first products approved to treat the 3 direct-acting mechanisms that target the virus.
Michael Severino, from AbbVie, adds: “With the approval of VIEKIRAX + 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 (…) This is an important part of our ongoing commitment to advancing public health by applying innovative science to the development of promising medicines.”