Sunvepra (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) 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.