ZEPATIER® now covered in Quebec for the treatment of chronic hepatitis C

KIRKLAND, QC, March 21, 2017 /CNW Telbec/ - Merck Canada Inc. today announced that ZEPATIER® (elbasvir/grazoprevir) will be listed among the drugs covered by Quebec's health insurance board, the Régie de l'assurance maladie du Québec (RAMQ), as of March 22. Quebec joins other jurisdictions that have approved the product for reimbursement under their public healthcare plans for chronic hepatitis C patients presenting with recognized criteria. Zepatier is indicated for the treatment of chronic infection by genotypes 1, 3 or 4 of the hepatitis C virus in adults.1 The product monograph, including detailed product information and indication, is available online by clicking here.

"This announcement reflects the hepatitis C agreement between Merck and the pan-Canadian Pharmaceutical Alliance (pCPA). We are proud to contribute a solution in the fight against this disease, all the while helping reduce the cost pressure on the healthcare system," says Chirfi Guindo, President and Managing Director of Merck Canada Inc.

Hepatitis C patients without significant hepatic fibrosis who present with certain comorbidities or specific conditions will be eligible for the treatment, including those who have chronic kidney disease, who are co-infected with the human immunodeficiency virus (HIV) or the hepatitis B virus (HBV), who have undergone an organ transplant or who present with extrahepatic manifestations of the disease.

"Zepatier, which was approved in Canada in 2016 for cirrhotic and non-cirrhotic patients with a genotype 1a, 1b or 4 infection who were not previously treated or who experienced relapse after previous treatment meets the unmet needs of some groups, including renally impaired and dialysis patients," adds Dr. Marc Poliquin, a gastroenterologist with the Clinique médicale du Quartier Latin. "It also makes it possible to continue simple anti-reflux treatments, especially for patients who cannot change their acid reflux therapy without interfering with the effectiveness of hepatitis C treatment."

If not treated in time, hepatitis C can lead to serious complications, such as cirrhosis, liver cancer or the need for a liver transplant.2 In 2013, costs related to HCV complications were estimated at $161.4 million in Canada (estimates range from $85.4 million to $251.5 million).3

About Hepatitis C

Hepatitis C is a chronic liver disease caused by the hepatitis C virus (HCV). In Canada, an estimated 250,000 individuals are infected with HCV, but many don't know it. Hepatitis C is a leading cause of health-related problems including cirrhosis, liver cancer and liver transplants. New treatments can cure hepatitis C and prevent further liver damage.4

There are at least six distinct HCV genotypes (genotypes 1–6). In Canada, genotype 1 represents 65% of the infections, genotype 2 and 3 represent approximately 14% and 20% respectively of the cases while genotypes 4, 5 and 6 are considered rare.5 Knowing which genotype a person carries helps determine the best treatment option.6

Today, injection drug use accounts for an increasingly high proportion of cases of hepatitis C infection. In people who inject drugs, the frequency of infection is estimated to be between 57%–90%.7 

Merck's Commitment to HCV

For nearly 30 years, Merck, known has MSD outside Canada and the United States,  has been at the forefront of the response to the HCV epidemic. Merck employees are dedicated to applying their scientific expertise, resources and global reach to deliver innovative healthcare solutions that support people living with HCV worldwide.

About Merck

For over a century, Merck has been a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information about our Canadian operations, please visit www.merck.ca or follow us on YouTube and Twitter @MerckCanada.

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2016 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

ZEPATIER® is a trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

1 Merck Canada Inc. Zepatier Monograph. Latest update: July 22, 2016. p. 3. 

2 Ontario Ministry of Health and Long-Term Care, Hepatitis C, [on line], http://www.health.gov.on.ca/en/public/programs/hepatitis/hep_c.aspx/en/self.html, consulted in February 2017.

3 Myers et al. Burden of Disease and Cost of Chronic Hepatitis C Virus Infection in Canada. Canadian Journal of Gastroenterology & Hepatology. Vol 28 No 5 May 2014. http://pubmedcentralcanada.ca/pmcc/articles/PMC4049256/

4 CLF. Hepatitis C. Online: http://www.liver.ca/liver-disease/types/viral_hepatitis/Hepatitis_C.aspx (accessed February 2017)

5 Myers, Robert P. and all, 2015. Canadian journal of Hepatology. An update on the management of chronic hepatitis C:2015 consensus guidelines from the Canadian Association for the Study of the Liver. Online: http://www.liver.ca/files/Professional_Education___Partnerships/Information___Resources_for_HCP/CASL_Hep_C_Consensus_Guidelines_Update_-_Jan_2015.pdf (accessed February 2017)

6 CDC, 2016. Hepatitis C FAQs for Health Professionals. Online: http://www.cdc.gov/hepatitis/HCV/HCVfaq.htm (accessed June 2016)

7 Wedemeyer, H. Chapter 80 Hepatitis C. In: Feldman, M, Friedman, LS, et al., editors. Sleisenger and Fordtran's Gastrointestinal and Liver Disease. 10th ed. Philadelphia, PA: Saunders; 2015. p. 1332-52.p.1336


SOURCE Merck Canada Inc.

For further information: Media relations: Dominique Quirion, 514-428-3469


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