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:
|Treatment-naïve patients with genotype 1 or 4 CHC||Sovaldi + peginterferon alfa + ribavirin||12 weeks|
|Patients with genotype 2 CHC||Sovaldi + ribavirin||12 weeks|
|Patients with genotype 3 CHC||Sovaldi + ribavirin||16 weeks*|
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 CanadaAs 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:
- 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.
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:
- Sovaldi + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia, and anemia
- Sovaldi + ribavirin combination therapy were fatigue and headache
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.