HCV treatment regimen approved by European Commission

The European Commission granted marketing authorizations for Viekirax plus Exviera, with or without ribavirin, for the treatment of chronic hepatitis C genotype 1 and 4 infection, according to a press release.

The viekirax (ombitasvir/paritaprevir/ritonavir, AbbVie) and exviera (dasabuvir, AbbVie) combination is an all-oral, interferon-free regimen consisting of a fixed-dose combination of the protease inhibitor ritonavir, at 100 mg/150 mg, co-formulated with 25 mg ombitasvir, administered once daily, along with 250 mg dasabuvir with or without ribavirin, administered twice daily.

The combination regimen should be taken for 12 weeks with or without ribavirin, except in HCV genotype 1a patients with cirrhosis, who should take it for 24 weeks. For patients with chronic HCV genotype 4, the regimen should consist of viekirax dosed once per day with ribavirin dosed twice daily, according to the release. Patients with HIV-1 coinfection, undergoing opioid substitution therapy and liver transplant recipients can also be treated with the regimen.

“With the approval of [viekirax plus 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,” Michael Severino, MD, executive vice president of research and development and chief scientific officer of AbbVie, said in the release. “This is an important part of our ongoing commitment to advancing public health by applying innovative science to the development of promising medicines.”

The regimen was looked upon favorably based on data from multiple phase 3 studies — SAPPHIRE-I, SAPPHIRE-II, PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II. More than 2,300 patients have been included in the studies with the direct-acting antiviral regimen, and the treatment has been generally well tolerated.

The European Committee for Medicinal Products for Human Use granted a positive opinion for the regimen in November 2014.