Newly approved HCV treatment regimen available in the UK

Following a European Marketing Authorization last week, Viekirax plus Exviera, with or without ribavirin, is now available in the United Kingdom for the treatment of chronic hepatitis C genotype 1 and 4 infections, 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.

“New treatments, such as AbbVie's triple combination regimen containing three directly acting anti-virals, offer both naive and treatment experienced patients, including those with cirrhosis, a very high likelihood of clearing hepatitis C virus,” Geoffrey Dusheiko, MD, MB, BCh, professor of medicine at UCL Institute of Liver and Digestive Health and Royal Free Hospital, London, said in the release. “Such highly efficacious, better tolerated and shorter treatments irrevocably change the field from interferon-based care.”

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 a previous release. Patients with HIV-1 coinfection, those undergoing opioid substitution therapy and liver transplant recipients can also be treated with the regimen.

“AbbVie is committed to making a meaningful contribution to addressing the personal, societal and economic burden of hepatitis C,” Matt Regan, general manager of AbbVie UK, said in the release. “The licensing of viekirax and exviera in the UK, and the launch of AbbVie Care in hepatitis C, brings us much closer to making this a reality and to making a positive difference in the lives of people living with and affected by hepatitis C.”

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.