Gilead Sciences, Inc. (Nasdaq: GILD) today announced that Health Canada
has issued a Notice of Compliance for Sovaldi™ (sofosbuvir) 400 mg
tablets, a once-daily oral nucleotide analog polymerase inhibitor for
the treatment of chronic hepatitis C (CHC) infection. Sovaldi is
indicated for use in adult patients with compensated liver disease,
including cirrhosis, for the treatment of genotype 1 or 4 CHC in
combination with pegylated interferon and ribavirin, and for the
treatment of genotype 2 or 3 CHC in combination with ribavirin. The
recommended dose and treatment duration for Sovaldi combination therapy
is as follows:
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Treatment
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Duration
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Treatment-naïve patients with genotype 1 or 4 CHC
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Sovaldi + peginterferon alfa
+ ribavirin
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12 weeks
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Patients with genotype 2 CHC
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Sovaldi + ribavirin
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12 weeks
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Patients with genotype 3 CHC
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Sovaldi + ribavirin
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16 weeks*
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* Consideration should be given to extending the duration of therapy
beyond 16 weeks and up to 24 weeks guided by an assessment of the
potential benefits and risks for the individual patient (these factors
may include cirrhosis status and treatment history).
Treatment regimen, duration and response to Sovaldi are dependent on
viral genotype and patient population, and associated baseline factors.
Sovaldi must not be administered as monotherapy. The Canadian Product
Monograph is available at www.Gilead.ca.
Gilead submitted the marketing application for Sovaldi in Canada on May
17, 2013 and was granted Priority Review by Health Canada. Gilead is
awaiting federal and provincial reimbursement review for Sovaldi under
the Canadian Common Drug Review process. Gilead anticipates that Sovaldi
will be available to patients in Canada early next year. Sovaldi
was approved in the United States on December 6, 2013 and applications
are pending in the European Union, Australia and New Zealand,
Switzerland and Turkey.
“I believe sofosbuvir has the potential to transform HCV treatment in
Canada as it addresses many unmet patient needs,” said Jordan Feld, MD,
MPH, Staff Hepatologist, Toronto Western Hospital, Department of
Medicine, Division of Gastroenterology. “The high cure rates, shortened
treatment duration, and potential to eliminate or reduce interferon
injections give us our best opportunity to successfully treat Canadians
with hepatitis C.”
An estimated 250,000 Canadians are living with chronic hepatitis C virus
(HCV), but because the disease can progress for many years without
causing noticeable symptoms, about 35 percent of these individuals do
not know they are infected. HCV disproportionately impacts “baby
boomers,” individuals born between 1945 and 1965, and the Canadian Liver
Foundation now recommends that all Canadian baby boomers be tested for
the virus. The current standard of care for HCV in Canada involves up to
48 weeks of therapy with a pegylated interferon (peg-IFN)/ribavirin
(RBV)-containing regimen, which may not be suitable for certain types of
patients.
The marketing authorization is supported primarily by data from four
Phase 3 studies, NEUTRINO, FISSION, POSITRON and FUSION, which evaluated
12 or 16 weeks of treatment with Sovaldi combined with either RBV or RBV
plus peg-IFN. Three of these studies evaluated Sovaldi plus RBV in
genotype 2 or 3 patients who were either treatment-naïve (FISSION),
treatment-experienced (FUSION) or peg-IFN intolerant, ineligible or
unwilling (POSITRON). NEUTRINO evaluated Sovaldi in combination with
peg-IFN/RBV in treatment naïve patients with genotypes 1, 4, 5 or 6.
Patients who achieve SVR12 are considered cured of HCV. Trial
participants taking Sovaldi-based therapy achieved SVR12 rates of 50-90
percent. For full study details, see the Clinical Studies section of the
Product Monograph.
Sovaldi combination therapy was well tolerated in clinical studies.
Adverse events were generally mild and there were few treatment
discontinuations due to adverse events. The most common adverse reaction
occurring in at least 5 percent of patients receiving Sovaldi in
combination with ribavirin was fatigue. Among patients receiving Sovaldi
in combination with RBV and peg-IFN, the most common adverse reactions
occurring in at least 5 percent of patients were fatigue, anemia,
neutropenia, insomnia, headache and nausea. See below for Important
Safety Information regarding contraindications, warnings and
precautions, adverse reactions and drug interactions.
Patient Assistance Program in Canada
As part of its commitment to ensuring that people with hepatitis C can
access Sovaldi, Gilead Sciences Canada has developed the Momentum
Support Program™, which will launch on January 6, 2014. The program is
designed to provide an integrated offering of support services for
patients and healthcare providers, including:
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Access to dedicated case managers to help patients and their providers
with insurance-related needs, including identifying alternative
coverage options such as federal and provincially-insured programs.
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The Sovaldi Co-pay assistance program, which will provide financial
assistance for eligible patients who need help paying for
out-of-pocket medication costs.
For more information regarding Sovaldi or the Momentum Program in
Canada, please call the Gilead Sciences Canada medical information line
at 1-866-207-4267.
About Sovaldi
Sovaldi is an oral nucleotide analog inhibitor of the HCV NS5B
polymerase enzyme, which plays an essential role in HCV replication.
Sovaldi is a direct-acting agent, meaning that it interferes directly
with the HCV life cycle by suppressing viral replication. Treatment
regimen and duration for Sovaldi are dependent on both viral genotype
and patient population. Treatment response varies based on baseline host
and viral factors. Sovaldi must not be administered as monotherapy.
IMPORTANT SAFETY INFORMATION
Contraindications
Sovaldi combination treatment with ribavirin or with peginterferon alfa
plus ribavirin is contraindicated in women who are pregnant or may
become pregnant and men whose female partners are pregnant because of
the risk for birth defects and fetal death associated with ribavirin.
Contraindications to ribavirin or with peginterferon alfa plus ribavirin
also apply to Sovaldi combination treatment. Refer to the Product
Monographs of peginterferon alfa and ribavirin for a list of their
contraindications.
Warnings and Precautions
Sovaldi must not be administered as a monotherapy and must only be used
in combination with either peginterferon alfa/ribavirin or ribavirin for
the treatment of hepatitis C infection.
Pregnancy: Use with Ribavirin or Peginterferon Alfa/Ribavirin: Ribavirin
therapy should not be started unless a report of a negative pregnancy
test has been obtained immediately prior to initiation of therapy.
Female patients of childbearing potential and their male partners must
use two forms of non-hormonal contraception during treatment and for at
least 6 months after treatment has concluded. Routine monthly pregnancy
tests must be performed during this time. Refer to the prescribing
information for ribavirin.
Use with Potent P-gp Inducers: Rifampin and St. John’s wort should not
be used with Sovaldi as they may significantly decrease sofosbuvir
plasma concentration, reducing its therapeutic effect.
Adverse Reactions
Most common (≥20%, all grades) adverse reactions for:
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Sovaldi + peginterferon alfa + ribavirin combination therapy were
fatigue, headache, nausea, insomnia, and anemia
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Sovaldi + ribavirin combination therapy were fatigue and headache
Drug Interactions
In addition to rifampin and St. John’s wort, coadministration of Sovaldi
is not recommended with carbamazepine, modinafil, oxcarbazepine,
phenobarbital, phenytoin, and rifabutin. Such coadministration is
expected to decrease the concentration of sofosbuvir, reducing its
therapeutic effect.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company’s mission is to advance the care of patients suffering
from life-threatening diseases worldwide. Headquartered in Foster City,
California, Gilead has operations in North and South America, Europe and
Asia Pacific.
About Gilead Sciences Canada, Inc.
Gilead Sciences Canada, Inc. is the Canadian affiliate of Gilead
Sciences, Inc. and was established in Mississauga, Ontario in 2006.
Forward-Looking Statement
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the risk
Sovaldi may not be available to patients in Canada in the currently
anticipated timelines. In addition, physicians and patients may not see
advantages of Sovaldi over other therapies and may therefore be
reluctant to prescribe the product, and the risk that public payers may
be reluctant to approve or provide reimbursement for the product.
Further, pending marketing applications for Sovaldi in the European
Union and other territories may not be approved in the currently
anticipated timelines or at all, and marketing approval, if granted, may
have significant limitations on its use. These risks, uncertainties and
other factors could cause actual results to differ materially from those
referred to in the forward-looking statements. The reader is cautioned
not to rely on these forward-looking statements. These and other risks
are described in detail in Gilead’s Quarterly Report on Form 10-Q for
the quarter ended September 30, 2013, as filed with the U.S. Securities
and Exchange Commission. All forward-looking statements are based on
information currently available to Gilead, and Gilead assumes no
obligation to update any such forward-looking statements.
Canadian Product Monograph for Sovaldi is available at www.Gilead.ca.
U.S. full prescribing information for Sovaldi is available at www.Gilead.com.
Sovaldi is a trademark of Gilead Sciences, Inc., or its related
companies.
For more information on Gilead Sciences, please visit the company’s
website at www.Gilead.com,
follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
Copyright Business Wire 2013