Tag Archives: notice of compliance

Sunvepra (asunaprevir) Approved in Canada

Sunvepra (asunaprevir) Approved in CanadaSunvepra (asunaprevir) has been approved as a hepatitis C treatment in Canada!* Health Canada granted the treatment a Notice of Compliance (NOC) for the treatment of chronic hepatitis C, genotype 1 or 4, in adult patients with compensated liver disease, including liver cirrhosis (liver scarring).

Health Canada has stated that Sunvepra is to be taken in combination with other hep C direct-acting antivirals/treatments. It has also stated that:

  • Treatment with Sunvepra should be initiated and monitored by a physician experienced in treating hep C.
  • Sunvepra must not be administered by itself.
  • Treatment length depends on the viral genotype and subtype.
  • Sunvepra has not been studied in treatment experienced patients who have tried to treat their hep C already with a treatment regimen that included Sunvepra or other hep C protease inhibitors.
  • Sunvepra should not be taken by those with moderate or severe hepatic impairment (Child-Pugh B or C, score 7 or greater) and by patients with decompensated liver disease.

For more information, please see Sunvepra’s product monograph, available through Health Canada, or Health Canada’s Summary Basis of Decision (SBD) document for Sunvepra.

What a Notice of Compliance (NOC) Means for Sunvepra (asunaprevir)

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 it – but at this stage the new drug is still not available on public drug plans, like BC PharmaCare, just private insurers. Private insurers each decide company coverage of the new drug (i.e. what percentage of the drug costs they will cover).

Sunvepra (asunaprevir)

Sunvepra (asunaprevir) is prescribed in combination with other treatments/direct-acting antivirals (DAAs) for patients with chronic hepatitis C genotypes 1 or 4 and compensated liver disease, including cirrhosis.

Sunvepra in combination with Daklinza, peginterferon, and ribavirin, was tested on those with hep C genotype 1 or 4 who were prior non-responders (patients who tried treatment but it failed to achieve SVR/cure) and succeeded with great results. High SVR12 rates were achieved with genotype 1 (93.2%) and genotype 4 (100%) patients. (Health Canada)

*Health Canada granted Sunvepra a Notice of Compliance (NOC) on March 9th, 2016. A CADTH Common Drug Review for Sunvepra began in 2015 and patient input was sent in by Canadian patient groups, including the Pacific Hepatitis C Network, for this review then. After the input was sent, the review was temporarily suspended as the manufacturer, Bristol Myers Squibb Canada Inc., requested time to provide additional information. This temporary suspension was lifted in early 2016.

Zepatier Approved in Canada

ZepatierZepatier (grazoprevir / elbasvir) is now an approved hepatitis C treatment in Canada! Health Canada has granted the treatment a Notice of Compliance (NOC) for the treatment of chronic hepatitis C (genotype 1, 3, or 4) in adult patients who have or don’t have liver cirrhosis (liver scarring).

When Zepatier will be prescribed to patients, the treatment’s regimen will depend on the genotype/type of hepatitis C virus one has, whether or not one has liver cirrhosis, and one’s treatment history (whether or not treatment has already been tried without success).

See Zepatier (grazoprevir / elbasvir) Facts for more information about Zepatier.

What a Notice of Compliance (NOC) Means for Zepatier

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 it – but at this stage the new drug is still not available on public drug plans, like BC PharmaCare, just private insurers. Private insurers each decide company coverage of the new drug (i.e. what percentage of the drug costs they will cover).

For more information about Zepatier (grazoprevir / elbasvir), or any other new and emerging hep C treatments, please visit PHCN’s Hepatitis C Treatment Information Project or email.

Galexos Sovaldi Combination Earns Notice of Compliance

Galexos Sovaldi pictureThe combination of Janssen’s Galexos (simeprevir) and Gilead’s Sovaldi (sofosbuvir), for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease, has received  a notice of compliance.

the news

Receiving a notice of compliance allows the 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. At this stage private insurers each decide company coverage of the new drug (ie. what percentage of the drug costs they will cover).

Janssen’s Galexos has also been issued non-conditional approval for use in combination with peginterferon alfa and ribavirin for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease.

For more information about currently approved hep C treatments in BC, new and emerging drugs, the drug approval process in Canada and BC, or hep C support programs, please visit PHCN’s Hepatitis C Treatment Information Project or email hepctip@pacifichepc.org.