Health Canada has granted the treatment Daklinza (daclatasvir) a Notice of Compliance (NOC) for treating adult patients with hep C genotypes 1 and 2 with compensated liver disease, including cirrhosis, and a Notice of Compliance with conditions (NOC/c) for the treatment of genotype 3 patients with compensated liver disease.
Notice of Compliance and Notice of Compliance with Condition
Receiving a Notice of Compliance allows a treatment to be sold in Canada with official approval. If a drug has a Notice of Compliance a doctor may prescribe the drug – but at this stage the new drug combination is still not available on public drug plans, like BC PharmaCare. Private insurers each decide company coverage of the new drug (i.e. what percentage of the drug costs they will cover).
A Notice of Compliance with conditions (NOC/c) is issued when Health Canada allows a drug to be marketed in Canada, with the condition that the manufacturer of the treatment undertakes additional studies to verify the treatment’s efficacy (how well it works). In this case, it was issued pending the submission of final clinical study results from the clinical trial ALLY-3.
Daklinza (daclatasvir) with Sovaldi (sofosbuvir)
Daklinza is now approved for use with Sovaldi (sofosbuvir). It may be combined with other drugs for different results in the future.
Daklinza with Sovaldi is a treatment for those with chronic hep C genotype 1, 2, or 3, including those with cirrhosis. It is an all-oral, short-course (12 or 24 weeks), interferon-free, possibly ribavirin-free treatment. A sustained viral response (SVR12), or ”cure”, has been achieved by more than 90% of the patients who have been treated with Daklinza and Sovaldi.
Patients prescribed Daklinza will be supported by Bristol-Myers Squibb Canada’s Claire Patient Support Program. More information about the program will follow shortly.
“This is another important milestone for hepatitis C patients across genotypes. But the significance of this approval is the impact it will have on the one in five patients who have genotype 3 and are being treated but not achieving cure rates like we’re seeing with those living with other genotypes. This gives them a chance to hear the very same words that many of us are being told – you are cured.” –Joan King, Vice President of a hepatitis C patient group in Canada