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European Commission approves 12-week regimen of Daklinza/Sovaldi for HCV genotype 3

Bristol-Myers Squibb announced the European Commission has approved an updated label for Daklinza to be used in combination with Sovaldi for the treatment of chronic hepatitis C virus genotype 3 infection for 12 weeks, according to a press release.

The update indicates that Daklinza (daclatasvir, Bristol-Myers Squibb) can now be used in combination with Sovaldi (sofosbuvir, Gilead Sciences) for 12 weeks in patients without cirrhosis in all states of the European Union and without the administration of ribavirin. The original label included treating genotype 3 patients, including those with or without compensated cirrhosis and/or treatment-experienced, with daclatasvir and sofosbuvir plus ribavirin for 24 weeks, according to the release.

Daclatasvir is an NS5A complex inhibitor and was previously looked upon favorably by the Committee for Medicinal Products for Human Use of the European Medicines Agency based on data from multiple studies with other HCV agents, including sofosbuvir.

The European Commission approved daklinza to be used in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic HCV infection in adults in August 2014, according to the release.

“The burden of hepatitis C – and genotype 3, specifically – remains significant in many parts of Europe,” Graham R. Foster, FRCP, PhD, professor of Hepatology at the Blizard Institute, Queen Mary University of London, United Kingdom, said in the release. “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.”

The FDA approved daclatasvir in July as the first drug to demonstrate safety and efficacy in genotype 3 HCV infections without requiring co-administration of interferon or ribavirin.

Disclosures: Healio.com/Hepatology was unable to confirm relevant financial disclosures of Foster at the time of publication.