Multiple Provinces Align to Provide Public Funding for Harvoni™, The First Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C Virus Infection

-- Reimbursement of Harvoni Within Five Months of Health Canada Notice of Compliance
Brings Patients Earlier Opportunity for a Cure
--

MISSISSAUGA, ON, March 24, 2015 /CNW/ - Gilead Sciences Canada, Inc. (Gilead Canada) today announced that multiple provinces will provide public access to Harvoni (ledipasvir/sofosbuvir), the first once-daily, single tablet regimen for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adults.  In Canada, it is estimated that more than 250,000 Canadians are living with chronic HCV infection, with thousands of new cases diagnosed each year.1  Genotype 1 infection represents an estimated 65 per cent of patient cases.2 

Public reimbursement comes after a positive recommendation from the Common Drug Review, and as a result of a productive collaboration between Gilead Canada and the Pan-Canadian Pharmaceutical Alliance (pCPA) to ensure participating provinces are able to provide timely access to patients in need of curative treatment.  This review, co-led by the BC Ministry of Health and the Ontario Ministry of Health and Long-Term Care, resulted in an agreement with member provinces to fund the innovative therapy for patients.

"We have been waiting for an innovative therapy like Harvoni since interferon was first used to treat the disease," said Dr. Alnoor Ramji, Clinical Associate Professor of Medicine (Gastroenterology and Hepatology), University of British Columbia.  "This is a transformative, interferon-free therapy, with a combination of high cure rates, good tolerability and simplicity of treatment.  Harvoni provides patients with the confidence to commit to therapy and a very high probability to achieve a cure."

Current treatments include interferon and ribavirin that often exclude patients from treatment or lead to early discontinuation of treatment due to associated side effects.  Harvoni represents a significant advance in the treatment of genotype 1 HCV infection, the most prevalent genotype in Canada.  Harvoni is the only once-daily, single tablet regimen that offers cure rates between 94 and 99 per cent, eliminates the need for interferon and ribavirin, and shortens the duration of treatment to as little as eight weeks for many patients.  Eight weeks of treatment with Harvoni can be considered for treatment-naïve patients without cirrhosis who have baseline HCV viral load below 6 million IU/mL.  Recently, the Canadian Association for the Study of the Liver updated the Canadian consensus guidelines on the management of hepatitis C and recommended Harvoni as first-line therapy for all genotype 1 patients.

"Today's announcement recognizes the significant health-system and societal benefits associated with curing this disease and preventing its complications," said Dr. Paul Marotta, Associate Professor, University of Western Ontario and with London Health Sciences Centre.  "Access to Harvoni will help us confront this serious public health issue and start formulating longer-term solutions that may prove relevant to the hepatitis C disease elimination efforts across Canada."

In a recent article, "Burden of disease and cost of chronic hepatitis C virus infection in Canada," (Canadian Journal of Gastroenterology and Hepatology), leading Canadian hepatitis C specialists highlighted an expected 205 per cent increase in cases of liver cancer, a 160 per cent increase in liver-related deaths, and a 60 per cent increase in total healthcare costs over the next 20 years.2  Recently, the article was recognized with a scientific award for its groundbreaking research in Canada.     

In addition to Harvoni, Gilead Canada's Sovaldi® (sofosbuvir) has also been listed for public reimbursement for chronic HCV genotypes 1, 2 and 3 infection in multiple provinces. 

"We live in an era of rapid evolution in the treatment of chronic hepatitis C infection, and Gilead Canada is pleased that our collaboration with the pCPA has allowed multiple provinces to recognize the clinical value of Harvoni as a simple, well tolerated and curative therapy for patients living with genotype 1 HCV," said Edward Gudaitis, General Manager, Gilead Sciences Canada, Inc.  "Gilead Canada will continue to work closely with all provinces and territories to bring this cost-effective, once-daily treatment to patients across Canada."

Important Safety Information for Harvoni
Warnings and Precautions

General: The safety and efficacy of Harvoni in combination with other anti-HCV medicines has not been studied. The sustained virologic response of Harvoni is reduced in treatment-experienced patients with HCV containing certain NS5A baseline mutations.

Risk of Reduced Therapeutic Effect of Harvoni Due to P-gp Inducers: Rifampin and St. John's wort should not be used with Harvoni as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations leading to reduced therapeutic effect of Harvoni and potential loss of virologic response.

Patients with Other HCV Genotypes: The safety and efficacy of Harvoni have not been studied in patients infected with HCV genotype 2, 4, 5 or 6 and has not been fully established in patients infected with genotype 3.

Risk of Increase in Tenofovir Exposure: Harvoni has been shown to increase tenofovir exposure when used together with an HIV regimen containing tenofovir disoproxil fumarate and a pharmacokinetic enhancer (ritonavir or cobicistat).  The safety of tenofovir in the setting of Harvoni and a pharmacokinetic enhancer has not been established. Patients receiving Harvoni concomitantly with Stribild or tenofovir DF and a boosted HIV protease inhibitor should be monitored for tenofovir-associated adverse reactions.

Related Products Not Recommended: Harvoni should not be administered concurrently with other products containing sofosbuvir (Sovaldi).

Adverse Reactions
Most common (≥10%, all grades) adverse reactions were fatigue and headache.

Drug Interactions
Rifampin and St. John's wort should not be used with Harvoni.  Coadministration of Harvoni is also not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of ledipasvir and sofosbuvir, reducing the therapeutic effect of Harvoni.

The safety and efficacy of Harvoni in combination with simeprevir have not been established.

Consult the full Canadian Product Monograph for Harvoni for more information on potentially significant drug interactions, including clinical comments.

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. 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 the risk that physicians and patients may not see advantages of Harvoni over other therapies and physicians may therefore be reluctant to prescribe the product.  Further, additional studies of Harvoni may produce unfavorable results. 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 Annual Report on Form 10-K for the year ended December 31, 2014, 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.

Note to Editor:  The drug benefit formulary published by each province should be consulted for additional details and specific criteria for both Harvoni and Sovaldi.  

Canadian Product Monograph for HARVONI is available at www.Gilead.ca.

Harvoni and Sovaldi are trademarks or registered 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.

References:

  1. Government of Canada. Healthy Canadians - Hepatitis C. http://healthycanadians.gc.ca/health-sante/disease-maladie/hepc-eng.php (October 21, 2013).
  2. "Burden of disease and cost of chronic hepatitis C infection in Canada"; RP Myers, M Krajden, M Bilodeau, K Kaita, P Marotta, K Peltekian, A Ramji, C Estes, H Razavi, M Sherman; Canadian Journal of Gastroenterology and Hepatology (May 2014).

SOURCE Gilead Sciences, Inc.

Image with caption: "Multiple Provinces Align to Provide Public Funding for Harvoni™, The First Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C Virus Infection (CNW Group/Gilead Sciences, Inc.)". Image available at: http://photos.newswire.ca/images/download/20150324_C8919_PHOTO_EN_13495.jpg

For further information: CONTACTS: Patrick O'Brien, Investors, (650) 522-1936; Michele Rest, Media, (650) 577-6935


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