< br>The European Commission ( EC ) 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 Ribavirin in genotype 4 ( GT4 ) chronic hepatitis C patients.
The approvals follow a review under accelerated assessment by the European Medicines Agency ( EMA ), designated to new medicines of major public health interest.
The approval of Viekirax plus Exviera is supported by a robust clinical development program designed to study the safety and efficacy of the regimen in more than 2,300 enrolled patients across 25 countries. The program consisted of six pivotal phase 3 studies, which have demonstrated that Viekirax plus 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. Additionally, more than 98% ( n=2011/2053 ) of patients in clinical trials completed a full course of therapy.
Most common ( more than 20% ) adverse reactions for Viekirax plus Exviera with Ribavirin were fatigue and nausea.
The approval of Viekirax plus Exviera is also based on the results from phase 2 clinical trials in GT1 chronic HCV infected patients, which showed that Viekirax plus Exviera cured 97% ( n=33/34 ) of liver transplant recipients, 92% ( n=58/63 ) of patients co-infected with HIV-1 and 97% ( 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 Ribavirin achieved 100% SVR12.
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 plus Exviera is taken for 12 weeks with or without Ribavirin, 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 Ribavirin, dosed twice daily.
Approximately 9 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% of cases worldwide.
In Europe, the most prevalent sub-genotype is 1b ( 47% ).
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. ( Xagena )
Source: Abbvie, 2015