Gilead receives approval in Canada for EPCLUSA™ (sofosbuvir/velpatasvir)

Gilead receives approval in Canada for EPCLUSA™ (sofosbuvir/velpatasvir), the first once-daily pan-genotypic (genotypes 1-6) single tablet regimen for the treatment of chronic hepatitis C

-- 12-Week Treatment with EPCLUSA Provides High Cure Rates (SVR12)
For All Six Hepatitis C Genotypes --

MISSISSAUGA, ON, July 14, 2016 /CNW/ - Gilead Sciences Canada, Inc. (Gilead Canada) has received a Notice of Compliance (NOC) from Health Canada for EPCLUSA (sofosbuvir 400 mg/velpatasvir 100 mg), the first once-daily, pan-genotypic single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.  EPCLUSA - for 12 weeks - is for use in patients without cirrhosis or with compensated cirrhosis, and in combination with ribavirin (RBV) for patients with decompensated cirrhosis. EPCLUSA is the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for RBV. Health Canada had previously granted EPCLUSA a Priority Review, which is given to a medication that offers a significant advance in treatment over existing options for a serious, life-threatening or severely debilitating condition.

"This newly-approved treatment represents an important step forward in how we treat HCV," said Dr. Jordan Feld, Hepatologist and Research Director, Francis Family Liver Clinic, Toronto Centre for Liver Disease, Toronto General Hospital.  "We can now cure the majority of HCV-infected patients with a simple, safe and effective 12-week treatment, regardless of genotype or treatment history."

The approval of EPCLUSA is supported by data from four international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotype 1-6 chronic HCV infection, without cirrhosis or with compensated cirrhosis (Child-Pugh A) received 12 weeks of EPCLUSA.  The ASTRAL-4 study randomized 267 patients with genotype 1-6 chronic HCV infection, with decompensated cirrhosis (Child-Pugh B) to receive 12 weeks of EPCLUSA with or without RBV or 24 weeks of EPCLUSA.  The primary endpoint for each study was sustained virologic response 12 weeks after completing therapy (SVR12).

Of the 1,035 patients treated with EPCLUSA for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 per cent) achieved SVR12.  In ASTRAL-4, patients with decompensated cirrhosis receiving EPCLUSA with RBV for 12 weeks achieved a high SVR12 rate (94 per cent) compared to those who received EPCLUSA for 12 weeks or 24 weeks without RBV (83 per cent and 86 per cent, respectively).  The most common adverse events in the four ASTRAL studies were headache, fatigue and nausea, and were comparable in incidence to the placebo group included in ASTRAL-1.

"Canada, and other countries, have committed to eliminating hepatitis C by 2030, and to accomplish this goal, we need to significantly increase treatment rates," said Dr. Morris Sherman, Chairperson, Canadian Liver Foundation and Hepatologist at Toronto General Hospital.  "Having a therapy that works for all genotypes will make treatment easier for both patients and physicians to manage, but it must be accessible regardless of where someone lives or their ability to pay."

"At Gilead, we continue to be motivated by the urgent need to develop medicines and transform and simplify care for people living with HCV," said Ed Gudaitis, General Manager, Gilead Canada.  "We are committed to working with drug plans across the country to help ensure EPCLUSA is accessible to patients who need treatment for this life-threatening disease."

Patient Support Program

To assist eligible HCV patients in Canada with access to EPCLUSA, Gilead Canada has added EPCLUSA to the Gilead Momentum Support Program^®, which provides information to patients and healthcare providers to help ensure patient access to medication.  

For more information regarding the Momentum Support Program^® in Canada, please call 1-855-447-7977.

Important Safety Information 

• When used in combination with RBV, the contraindications to RBV are applicable to the combination regimen.
• Data to support the treatment of patients with decompensated cirrhosis who are infected with HCV genotype 2 or 4 are limited, and there are no data for genotype 5 and 6 HCV-infected patients with decompensated cirrhosis. The indication for treatment of these patients is based on extrapolation of relevant clinical and in vitro data.
• Safety and efficacy has not been established in patients with severe hepatic impairment (Child-Pugh Class C).
• Should not be administered concurrently with other medicinal products containing sofosbuvir.
• Should not be used with potent P-glycoprotein (P-gp) inducers and/or moderate to potent inducers of CYP2B6, CYP2C8, or CYP3A4.
• Co-administration with amiodarone is not recommended due to risk of symptomatic bradycardia.
• If administered with amiodarone, cardiac monitoring is recommended.
• Co-administration with an efavirenz-containing regimen is not recommended.

For additional important safety information for EPCLUSA, including the complete warnings and precautions, adverse reactions and drug-drug interactions, please see the Canadian Product Monograph for EPCLUSA.

About Gilead Sciences

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. 

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 risks that physicians and patients may not see advantages of EPCLUSA over other therapies and may therefore be reluctant to prescribe the product, and the risk that payers may be reluctant to approve or provide reimbursement for the product.  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 March 31, 2016, 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 EPCLUSA will be available at www.Gilead.ca.

EPCLUSA™ and Gilead Momentum Support Program^® 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.

Image with caption: "EPCLUS(TM) (sofosbuvir 400 mg/velpatasvir 100 mg), is the first once-daily, pan-genotypic single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection approved by Health Canada. (CNW Group/Gilead Sciences, Inc.)". Image available at: http://photos.newswire.ca/images/download/20160714_C8890_PHOTO_EN_734305.jpg

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