Simeprevir (GALEXOS) is also now covered on the Quebec formulary, according to CATIE, the Canadian AIDS Treatment Information Exchange.
However, it is only available to those who have already failed
conventional treatment with interferon and ribavirin. It is available
only to genotype 1 patients who do not have the Q80K mutation and not
co-infected with HIV.
MUST MEET ALL THESE QUALIFICATIONS TO GET REIMBURSED FOR SIMEPREVIR:
– to be used in association with ribavirin and pegylated interferon alfa– for treatment of persons suffering from chronic hepatitis C
– genotype 1 only
– without a Q80K mutation
– not HIV-1 infected, and
– have already experienced a therapeutic failure with a combination of ribavirin / pegylated interferon alfa;
Authorization for simeprevir is granted for a period of 12
weeks. The total duration of treatment, including the concomitant and
subsequent taking of the combination of ribavirin / pegylated interferon
alfa, will be 48 weeks if the viral load (HCV-RNA) is undetectable on treatment week 24.
The drugs in question, Sovaldi and Galexos, are currently being reviewed by the province of Nova Scotia.
More than 200 people have written
letters or signed petitions calling on the province to immediately add
two new drugs to treat hepatitis C to the P.E.I. Pharmacare Formulary.
Kathleen Critch, one of those
involved in efforts to bring these drugs to P.E.I., says those efforts
are ongoing and others are expected to add their voice to the call for
provincial authorities to act.
Critch, whose mother has hepatitis C, says Islanders deserve access to these drugs.
GALEXOS™* is the first treatment for chronic hepatitis C to be approved
for once-daily use in combination with pegylated interferon and
TORONTO, Nov. 20, 2013 /CNW/ – Janssen Inc. announced today that Health
Canada has approved GALEXOS™ (simeprevir) for the treatment of chronic
hepatitis C (CHC) genotype 1 infection, in combination with
peginterferon alfa and ribavirin in adults with compensated liver
disease, including cirrhosis, who are treatment-naïve or who have
failed previous interferon therapy (pegylated or non-pegylated) with
ribavirin.1 GALEXOS™ was approved following Priority Review and is the first
treatment for chronic hepatitis C to be approved for once-daily
administration with pegylated interferon and ribavirin in Canada.2
GALEXOS™ is a protease inhibitor that works by blocking the protease
enzyme that enables the hepatitis C virus (HCV) to replicate in host
cells.3 GALEXOS™ is administered by oral capsule, once daily for 12 weeks in
combination with pegylated interferon and ribavirin, followed by
pegylated interferon and ribavirin alone for an additional 12 or 36