Hepatitis C combination treatment approved in Europe
The all oral drug regimen should be launched in the UK in the coming month
A new combination hepatitis C drug therapy has been given the green light by the European Commission, adding to a glut of new treatments for the disease.
The treatment, ombitasvir/paritaprevir/ritonavir (Viekirax, AbbVie) plus dasabuvir (Exviera, AbbVie), is an all-oral interferon-free treatment.
It is now approved across the EU with or without ribavirin for patients with genotype 1 chronic hepatitis C virus infection.
That includes patients with compensated liver cirrhosis, HIV-1 co-infection, patients on opioid substitution therapy and liver transplant recipients.
Additionally, ombitasvir/paritaprevir/ritonavir has also been approved on its own for use with RBV in genotype 4 chronic hepatitis C patients.
The latest Phase III trials for the treatment enrolled 2,300 enrolled patients across 25 countries.
In all this consisted of six pivotal Phase III studies, which showed the combination cured 95-100 per cent of hepatitis C patients with GT1 HCV infection who received the recommended regimen, with less than two percent 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.
The specific licence is 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.
Exviera consists of dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice daily taken with or without ribavirin, dosed twice daily.
The combination treatment is taken for 12 weeks with or without ribavirin, except in GT1a patients with cirrhosis, who should take it for 24 weeks.