10 September 2015 - Bristol-Myers Squibb Company announced today that the European Commission has approved an updated label for Daklinza for the treatment of genotype 3 chronic hepatitis C (HCV). The update allows the use of Daklinza in combination with sofosbuvir for 12 weeks in patients without cirrhosis in all 28 Member States of the European Union, and marks the first time these patients with genotype 3 HCV have a once-daily, all-oral treatment regimen of this shorter duration.

“The burden of hepatitis C – and genotype 3, specifically – remains significant in many parts of Europe,” said Graham R. Foster, FRCP, Ph.D., Professor of Hepatology, Blizard Institute, Queen Mary University of London, London, United Kingdom. “Despite advances in therapy, genotype 3 HCV patients are still some of the most challenging to treat with direct-acting antivirals. The cure rates achieved by Daklinza in combination with sofosbuvir for 12 weeks represent a positive step forward for genotype 3 patients without cirrhosis.”

Daklinza is contraindicated in combination with medicinal products that strongly induce CYP3A and P-glycoprotein transporter, as this may lead to lower exposure and loss of efficacy of Daklinza. Daklinza must not be administered as a monotherapy.

For more details, go to: http://news.bms.com/press-release/updated-label-daklinza-daclatasvir-12-week-treatment-non-cirrhotic-patients-chronic-he