Bristol-Myers Squibb (BMS), the maker of Daklinza, gave notice on September 27 2018 that as of November 29 2019, BMS will no longer distribute Daklinza in Canada.
Daklinza (daclatasvir) – General Information (PDF)
Targeted Genotype: 1-3 (BC PharmaCare only covers it for GT3 or 1b with Sunvepra)
Approved by Health Canada and Covered by BC PharmaCare: Yes
Treatment Description: Daklinza (daclatasvir) is a direct acting antiviral (DAAs), a hep C drug, that works against hep C in combination with other DAAs. Daklinza is a treatment that can’t be taken alone. It may be prescribed with Sunvepra against hepatitis C genotype 1a or Sovaldi (sofosbuvir) with or without ribavirin (RBV).
Usage Warning: If you have ever had hepatitis B, the hepatitis B virus could become active again during and after taking Daklinza. Patients with Bradycardia taking amiodarone can not take Sovaldi (sofosbuvir) in any combination. There have been reports of severe heart issues. Tell your doctor if you are taking CYP3A inhibitors or P-gp, OATP 1B1, 1B3, BCRP, phenytoin, carbamazepine, rifampin, or St. John’s wort (Hypericum perforatum) as they limit Daklinza’s effectiveness.
Daily Dose: 2 pills +/- Ribavirin
SVR: 89% – 100%
Length of Treatment:
|Treatment regimens for genotype 3 hepatitis C adult patients:||# of Weeks|
|Treatment-naïve and treatment-experienced with no liver cirrhosis||12 weeks in combination with sofosbuvir|
|Treatment-naïve and treatment-experienced with compensated liver cirrhosis or decompensated cirrhosis||12 weeks in combination with sofosbuvir and RBV|
|Treatment-naïve and treatment-experienced liver transplant recipients with no cirrhosis or with compensated cirrhosis||12 weeks in combination with sofosbuvir and RBV|
Common Side Effects:
- Tiredness (fatigue)
- Information about what Daklinza and Sovaldi are and how they work
- Daklinza Clinical Trial Results
- Daklinza and Sovaldi’s BC PharmaCare Decision
BC’s PharmaCare Eligibility for Daklinza
Daklinza is a limited coverage drug. To qualify for treatment coverage a patient must have ALL of the following:
- A prescription from a hepatologist, a gastroenterologist, an infectious disease specialist or other physician experienced with treating hepatitis C;
- Lab-confirmed hepatitis C genotype 3;
- Lab-confirmed hepatitis C test done within the previous 12 months;
- NOT currently being treated with another hepatitis C direct-acting antiviral drug;
- A liver fibrosis stage F2 or greater OR less than F2 with the following:
- Co-infection with HIV or hepatitis B virus
- Post organ transplant (liver and/or non-liver organ transplant)
- Extra-hepatic manifestations5
- Chronic kidney disease stage 3, 4 or 5 as defined by National Kidney Foundation Kidney Disease outcomes Quality Initiative6
- Co-existent liver disease with diagnosis evidence for fatty liver disease (e.g., non-alcoholic steatohepatitis)7
- Diabetes receiving treatment with anti-diabetic drugs
- Women who are planning pregnancy within the next 12 months
Talk to your healthcare provider for more information or to start the treatment process.
Bristol-Myers Squibb Canada’s CLAIRE Program
Canadians prescribed Daklinza (daclatasvir), Sovaldi (sofosbuvir), and in some cases ribavirin, can request to be enrolled in the CLAIRE patient support program. The CLAIRE patient support program was designed to help patients seek coverage and provide access to a customized list of services. It was designed so that one person will take care of each patient through the program’s duration. For more information, contact your doctor, nurse, or contact the program at: 1-844-HCV-2559 (phone number), 1-844-FAX-2559 (fax number), firstname.lastname@example.org (email address).