December 16, 2013
Health Canada Issues Notice of Compliance for Sovaldi™ (Sofosbuvir) for the Treatment of Chronic Hepatitis C
– Sovaldi Receives Marketing Authorization for Patients with Genotypes 1, 2, 3 or 4 HCV –
– High Cure Rates (SVR 12) and Therapy Shortened to Just 12 Weeks for Many Patients –
|Treatment-naïve patients with genotype 1 or 4 CHC||
Sovaldi + peginterferon alfa
|Patients with genotype 2 CHC||Sovaldi + ribavirin||12 weeks|
|Patients with genotype 3 CHC||Sovaldi + ribavirin||16 weeks*|
* 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
“I believe sofosbuvir has the potential to transform HCV treatment in
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
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
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
- 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.
- 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 Programin
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
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.
Most common (≥20%, all grades) adverse reactions for:
- Sovaldi + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia, and anemia
- Sovaldi + ribavirin combination therapy were fatigue and headache
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.
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
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
For more information on
Gilead Sciences, Inc.
Patrick O’Brien, Investors
Cara Miller, Media