AbbVie scores EU recommendation for shorter treatment of Viekirax in hepatitis C

pharmafile | July 25, 2016 | News story | Research and Development, Sales and Marketing |  EU, Gilead, Viekirax, hepatitis C 

AbbVie has received an EU recommendation for a shorter treatment duration of Viekirax (ombitasvir/paritaprevir/ritonavir) plus ribavirin in genotype 4 chronic hepatitis C virus infected adult patients with compensated cirrhosis.

Chronic hepatitis C virus affects more than 160 million people worldwide, with 34 million living with the genotype 4 form of the virus. This genotype is becoming increasingly common across Mediterranean countries, especially, where prevalence rates from 10 to 24% have been reported.

Currently approved on a 24 week regimen, this new recommendation has taken a positive stance on a 12 week treatment duration for Viekirax plus ribavirin. This opinion is supported by data from the Phase III AGATE-I study where 97% of patients achieved sustained virologic response at 12 weeks post-treatment.

Michael Severino, chief scientific officer at AbbVie, says: “Through optimising the use of Viekirax, AbbVie strives to meet the needs of patients and physicians, including a shortened treatment duration. This milestone is progress toward an approval that would allow us to provide the opportunity for a cure with just 12 weeks of our regimen to genotype 4 patients with or without compensated cirrhosis in Europe.”

Tarik Asselah, lead study author, adds: “Until recently people living with genotype 4 chronic hepatitis C had limited treatment options. If approved, this 12-week treatment would mark another step forward in the cure for GT4 patients, allowing difficult-to-cure patients with compensated cirrhosis to be treated in half the time with Viekirax, representing a significant benefit for both them and their patients.”

Sean Murray