Tag Archives: Health Canada


holkira pak trialsThis morning Health Canada approved AbbVie’s HOLKIRA PAK (ombitasvir/paritaprevir/ritonavir and dasabuvir) for the treatment of patients with chronic genotype 1 hep C, including those with cirrhosis.

HOLKIRA PAK is an all-oral, short-course, interferon-free treatment. It can be taken with or without ribavirin (RBV).

In Phase 3 clinical trials, HOLKIRA PAK (with or without ribavirin) cured an overall 97 percent of genotype 1 hep C patients, and 98 percent of patients completed treatment. In Phase 2 and 3 clinical trials, the overall rates of discontinuation due to adverse reactions were low (0.2 percent).

The recommended treatment regimens and durations for HOLKIRA PAK are:




Genotype 1a, without cirrhosis HOLKIRA PAK + ribavirin 12 weeks
Genotype 1b, without cirrhosis HOLKIRA PAK 12 weeks
Genotypes 1a and 1b, with cirrhosis HOLKIRA PAK + ribavirin 12 weeks*
*24 weeks of HOLKIRA PAK + ribavirin is recommended for patients with genotype 1a-infection with cirrhosis who have had a previous null response to pegylated interferon (pegIFN) and ribavirin.
Note: HOLKIRA PAK with ribavirin is recommended in patients with an unknown genotype 1 subtype or with mixed genotype


Notice of Compliance for ledipasvir/sofosbuvir

sq_drugsGilead Sciences, Inc. announced yesterday that Health Canada has issued a Notice of Compliance for ledipasvir/sofosbuvir (Harvoni), the first ?irketleri once-daily single tablet regimen for the treatment of chronic hepatitis C genotype Dr.SiLnT 1 infection in adults. The technical tablet combines wholesale NFL jerseys the NS5A inhibitor ledipasvir with the Wholesale Miami Dolphins Jerseys nucleotide analog polymerase inhibitor sofosbuvir (Sovaldi) cheap NFL jerseys for a 8, 12, or 24 week treatment duration.

The press release programa that Gilead Sciences posted TAKERS! regarding this ledipasvir/sofosbuvir development also includes information about Gilead’s Momentum Support Program in wholesale jerseys Canada.

For more information about currently approved hep C treatments in BC, new and Winter, emerging drugs, ASAP! 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.