May 24, 2016 – Daklinza (daclatasvir), taken for 12 weeks (in combination with Sovaldi and with or without ribavirin), has been approved by Health Canada for the treatment of patients with chronic hepatitis C (genotype 1, 2, or 3) and with HIV co-infection, advanced liver cirrhosis, or post-liver transplant hep C recurrence.
This approval is good news as due to potential drug interactions between hep C treatments and HIV treatments or anti-rejection drugs for post-transplant, patients who are co-infected or have had liver transplants have been historically difficult to treat. This difficulty hasn’t been good news as, for example, approximately 20% of Canadians with HIV also have hep C (HCV). When patients have both infections, hep C progresses much faster than it does in those infected with just HCV–progresses much faster to the point where HCV related liver disease is the leading cause of death for those who are co-infected. (BMS Canada)
These new Health Canada approvals, or treatment indications, were based on data from the clinical trials ALLY-1 and ALLY-2.
Daklinza (daclatasvir) with Sovaldi (sofosbuvir)
Daklinza taken in combination with other hep C antivirals, such as Sovaldi, was approved for Canadian use in August 2015.
Daklinza with Sovaldi and with or without ribavirin is a treatment for those with chronic hep C genotype 1, 2, or 3, including those with cirrhosis, and now with HIV co-infection, advanced cirrhosis, or post-liver transplant hep C recurrence. It is an all-oral, short-course (12 or 24 weeks), interferon-free, possibly ribavirin-free, treatment.
“With this expanded label for Daklinza, we are proud to provide an option that helps bridge what has been a challenging treatment gap for these patients.” –Dr. Nawal Peacock, President and General Manager, Bristol-Myers Squibb Canada.