The European Commission has granted marketing authorizations for AbbVie's 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.1
"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," said Richard Gonzalez, chairman of the board and chief executive officer, AbbVie. "We are committed to working with local governments and healthcare systems to support broad access to Viekirax + Exviera."
The approvals follow a review under accelerated assessment by the European Medicines Agency, designated to new medicines of major public health interest. Approximately nine million people in Europe are infected with chronic hepatitis C, a major cause of liver cancer and liver transplantation. Genotype 1 is the most prevalent form of hepatitis C in Europe, accounting for 60 per cent of cases worldwide. In Europe, the most prevalent sub-genotype is 1b (47 per cent). 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 US, Canada, Switzerland, Iceland, Liechtenstein and Norway.
"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," said Stefan Zeuzem, M.D., professor of medicine and chief of the department of medicine I, J.W. Goethe University Hospital, Frankfurt, Germany. "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."
Treating hepatitis C is complex because the virus mutates and replicates rapidly. Viekirax + Exviera are the first products to be approved 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.
"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," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This is an important part of our ongoing commitment to advancing public health by applying innovative science to the development of promising medicines."
The approval of Viekirax + Exviera is supported by a robust clinical development programme designed to study the safety and efficacy of the regimen in more than 2,300 enrolled patients across 25 countries. The programme consisted of six pivotal Phase 3 studies, which demonstrated that Viekirax + Exviera cured 95-100 per cent of hepatitis C patients with GT1 HCV infection who received the recommended regimen, with less than 2 per cent of patients experiencing virologic failure. Additionally, more than 98 per cent (n=2,011/2,053) of patients in clinical trials completed a full course of therapy. Most common (>20 per cent) adverse reactions for Viekirax + Exviera with RBV were fatigue and nausea.
The approval of Viekirax + Exviera is also based on the results from phase 2 clinical trials in GT1 chronic HCV infected patients, which showed that Viekirax + Exviera cured 97 per cent (n=33/34) of liver transplant recipients, 92 per cent (n=58/63) of patients co-infected with HIV-1 and 97 per cent (n=37/38) of patients on opioid substitution therapy. Patients who achieve a sustained virologic response (SVR12) are considered cured of hepatitis C.
Approval of Viekirax in GT4 chronic hepatitis C was based on a phase 2 study in which patients treated with Viekirax with RBV achieved 100 per cent SVR12.1
Viekirax + Exviera is approved for the treatment of genotype 1 chronic hepatitis C virus infection, including patients with compensated cirrhosis. Viekirax consists of the fixed-dose combination of paritaprevir 150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir 25mg (NS5A inhibitor), dosed once daily, and Exviera consists of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily taken with or without ribavirin, dosed twice daily. Viekirax + Exviera is taken for 12 weeks with or without RBV, except in GT1a patients with cirrhosis, who should take it for 24 weeks.
For the treatment of genotype 4 chronic hepatitis C patients, AbbVie's treatment consists of Viekirax dosed once daily taken with RBV, dosed twice daily.
Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C protease inhibitors and regimens that include protease inhibitors. Paritaprevir has been developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of chronic hepatitis C.
Viekirax is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. Exviera is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories.