Health Canada approves Daklinza for HCV

Health Canada announced it has approved Daklinza for the treatment of chronic hepatitis C virus infection, according to a press release.

Daklinza (daclatasvir, Bristol-Myers Squibb), a potent, pan-genotypic NS5A replication complex inhibitor, was approved for use in combination with Sovaldi (sofosbuvir, Gilead Sciences). The approval includes a Notice of Compliance (NOC) for genotypes 1 and 2 with compensated liver disease and cirrhosis and a NOC with conditions (NOC/c) for genotype 3 with compensated liver disease and cirrhosis. The NOC/c was issued based on final clinical study results of the ALLY-3 study. This condition makes daclatasvir the first all-oral regimen without interferon and ribavirin to be approved for the treatment of genotype 3 patients, according to the release.

Daclatasvir is indicated as a 12-week regimen in combination with sofosbuvir for the treatment of genotype 1 and genotype 3 patients without cirrhosis and indicated as a 24-week regimen in genotype 2 patients and for genotype 1 and 3 patients with cirrhosis, according to the release.

“Patients with genotype 3 hepatitis C infection, which make up about one in five cases of hepatitis C infection in Canada, have proven difficult to treat with existing therapies,” Paul Marotta, MD, FRCPC, medical director of liver transplantation, London Health Sciences Centre and associate professor, University of Western Ontario, London, said in the release. “Having the new daclatasvir and sofosbuvir combination, which has shown very positive results in studies in this population, is a very encouraging development in moving towards the ultimate elimination of the infection in most patients.”

Nawal Peacock, president and general manager at Bristol-Myers Squibb Canada said in the release: “Bristol-Myers Squibb Canada is very pleased to contribute to the revolution of treatment outcomes for hepatitis C patients with the approval in Canada of Daklinza. This approval will provide an exciting new option to address an unmet need for patients with hepatitis C to benefit from therapy.”

According to the release, HCV genotype 1 accounts for 64% of patients, genotype 2 accounts for 14% and genotype 3 accounts for 20% of all HCV infections in Canada.

The FDA approved daclatasvir in combination with sofosbuvir for the treatment of chronic HCV genotype 3 infections in July.

Disclosures: Peacock reports being employed by Bristol-Myers Squibb Canada. Healio.com/Hepatology was unable to confirm relevant financial disclosures of Marotta at the time of publication.