– VEMLIDY is a Once-Daily Treatment that Demonstrated Similar Efficacy with Improved Renal and Bone Laboratory Safety Parameters Compared to VIREAD® –
MISSISSAUGA, ON, June 19, 2017 /CNW/ - Gilead Sciences Canada, Inc. (Gilead Canada) today announced that Health Canada has granted a Notice of Compliance (NOC) for VEMLIDY™ (tenofovir alafenamide, TAF) 25mg tablets, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.
VEMLIDY is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of Gilead's VIREAD® (tenofovir disoproxil fumarate, TDF) 300mg. Data show that because VEMLIDY has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to VIREAD, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. As a result, VEMLIDY improved renal and bone laboratory safety parameters compared to VIREAD.
"Chronic hepatitis B is a life-threatening disease, requiring prolonged and often lifelong antiviral therapy. While there are a small number of antiviral agents available for hepatitis B, long-term treatment can be associated with side effects in some patients," said Dr. Scott Fung, Hepatologist at Toronto General Hospital and Assistant Professor of Medicine at the University of Toronto. "Clinical trials have demonstrated that VEMLIDY is highly effective in terms of viral suppression with normalization of liver enzymes and has shown improved renal and bone safety compared to VIREAD, representing a significant advance in treatment for many patients living with this chronic liver disease."
The approval of VEMLIDY is supported by 48-week data from two international Phase 3 studies (Studies 108 and 110) among 1,298 treatment-naïve and treatment-experienced adult patients with chronic HBV infection. Study 108 randomized and treated 425 HBeAg-negative patients with either VEMLIDY or VIREAD, and Study 110 randomized and treated 873 HBeAg-positive patients with either VEMLIDY or VIREAD. Both studies met their primary endpoint of non-inferiority to VIREAD based on the percentage of patients with chronic hepatitis B with plasma HBV DNA levels below 29 IU/mL at 48 weeks of therapy.
In an integrated analysis of both studies, patients receiving VEMLIDY demonstrated improvements in certain bone and renal laboratory parameters compared to those treated with VIREAD. Patients in the VEMLIDY arm also experienced numerically higher rates of normalization of blood serum alanine aminotransferase (ALT) levels.
"Chronic hepatitis B can be effectively controlled through medication but patients must take it for life. This type of prolonged treatment, while protecting the liver, can lead to other health complications," said Dr. Morris Sherman, Chairperson, Canadian Liver Foundation and Hepatologist at Toronto General Hospital. "The more options physicians have to customize treatment and lower doses with improved safety to meet their patients' needs, the better the outcomes will be over the long term."
"Gilead Canada continues its commitment to improve and simplify care for people living with chronic hepatitis B, as we have in hepatitis C and HIV/AIDS," said Kennet Brysting, General Manager, Gilead Canada. "VEMLIDY is the first medication approved to treat chronic HBV infection in nearly a decade, and we are excited to offer this new, effective option to help advance long-term care for patients. Gilead Canada will also launch a new patient support program for those who are treated with VEMLIDY or VIREAD to access medicine and provide optimal care."
Important Safety Information
VEMLIDY has serious warnings in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment severe acute exacerbation of hepatitis B. For important safety information for VEMLIDY, including contraindications and additional warnings and precautions, please see the Canadian Product Monograph at www.gilead.ca.
Gilead Sciences, Inc. (Gilead) 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. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California. Gilead Sciences Canada, Inc. is the Canadian affiliate of Gilead Sciences, Inc. and was established in Mississauga, Ontario, in 2005.
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 that physicians and patients may not see the advantages of VEMLIDY over other therapies and may therefore be reluctant to prescribe the product. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, 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 VEMLIDY™ is available at www.gilead.ca.
VEMLIDY™ and VIREAD® are trademarks 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.
SOURCE Gilead Sciences, Inc.
For further information: FOR MORE INFORMATION IN CANADA, CONTACT: Karen M. Chow, National Stakeholder Relations and Communications, Gilead Sciences Canada, Inc., (905) 363-8083