VICTRELIS™ Approved in Canada: First in new class of drugs to significantly improve clearance of chronic hepatitis C virus from the body
MONTREAL, Aug. 3, 2011
MONTREAL, Aug. 3, 2011 /CNW/ - Merck announced today that VICTRELIS™
(boceprevir) has been approved in Canada for the treatment of chronic hepatitis C (CHC) genotype 1 infection in combination with the current standard therapy, peginterferon alpha and ribavirin (peg/riba), in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous therapy.1
"If patients receive hepatitis C treatment at an early stage, they may be able to avoid the most severe consequences of their disease - cirrhosis, liver cancer or liver failure requiring a liver transplant," says Dr. Morris Sherman, Chairman of the Canadian Liver Foundation. "Up until now, currently available therapies have only been effective for a small percentage of hepatitis C patients. Boceprevir is one of a new generation of drugs that mark a significant step forward in hepatitis C treatment. For patients who have not yet been treated or have not responded to previous treatment, this is an exciting development that offers them greater hope for a cure."
Merck is Committed to Hepatitis C Patient Support
"Merck has been developing innovative therapies for the treatment of CHC infection for nearly three decades, and we are very proud to add boceprevir to our treatment options against this infection," says Josee Brisebois, PhD, Director of Medical Affairs at Merck Canada. "Merck understands the treatment of CHC genotype 1 infection weighs heavily, not only on those infected, but also on their health care providers. We have a support program in place for patients on peginterferon alpha and ribavirin, the current standard treatment, and will be adding support for boceprevir to the program."
Elements of the current hepatitis C patient support program include: nurses to provide support and guidance to patients and financial assistance for those who qualify based on specific income and health-related criteria.
Adding VICTRELIS™ Can Help Clear Virus
Boceprevir is a first-in-class oral hepatitis C virus (HCV) protease inhibitor that when added to peg/riba, can significantly increase a patient's chance of clearing the virus from the body.2,3 Two studies, HCV RESPOND-2 and HCV SPRINT-2, published earlier this year in The New England Journal of Medicine, found that boceprevir tripled the treatment response in patients who have previously failed treatment4 and nearly doubled the treatment response in previously untreated patients.5
Adding VICTRELIS™ May Shorten Therapy
"The improved response rates when you add boceprevir to current standard therapy are really significant when you consider the challenges associated with treating patients who have chronic hepatitis C genotype 1 infection," says Dr. Stephen Shafran, Professor, Division of Infectious Diseases, Department of Medicine at the University of Alberta. "With this combination of drugs the majority of patients will be able to clear the virus. Many of them will also be able to finish therapy faster, which is important as treatment side effects can be devastating."
Response-guided therapy (RGT) - a new treatment paradigm described in the pivotal clinical studies HCV RESPOND-2 and HCV SPRINT-2 - may cut 126 or 20 weeks7 from the standard 48 weeks of treatment for previously treated patients or untreated patients, respectively.
"The drugs made me feel so sick that I had to stop my first treatment after several months. No one can understand how bad the side effects can be unless you've experienced them first-hand," says Tina Ferstman, a Montreal resident who contracted the hepatitis C virus from a former surgery. "I got through my therapy the second time around because I was better prepared. Unfortunately, even though I completed the treatment, I wasn't cured."
Common side effects of treatment include fatigue, headache, nausea, anemia and bad taste (dysgeusia).8
The Burden of CHC in Canada
Long-term complications of hepatitis C are costly. Three-quarters of those who acquire HCV become chronically infected and 14 to 19 per cent will develop cirrhosis within 20 years, which may lead to liver failure, liver cancer (hepatocellular carcinoma) and death.9 The incidence of serious complications from chronic hepatitis C (CHC) in Canada are predicted to continue to rise significantly up to the year of 2027,10 not taking into account the possible impact of the expanded use of currently available antiviral medications (e.g., pegylated interferon and ribavirin) nor the potential impact of new, more effective regimens.11
VICTRELIS™ is now available and the list price is $1,050.00 per week.
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1 VICTRELISTM, Product Monograph, July 27, 2011, p. 3.
2 Poordad, F., et al., for the SPRINT-2 Investigators. Boceprevir for Untreated Chronic HCV Genotype 1 Infection. N Engl J Med 2011; 364:1195-1206, page 1195.
3 Bacon, B.R., et al., for the HCV RESPOND-2 Investigators. Boceprevir for Previously Treated Chronic HCV Genotype 1 Infection. N Engl J Med 2011; 364:1207-1217, p. 1207.
5 Poordad, F., et al., for the SPRINT-2 Investigators. Boceprevir for Untreated Chronic HCV Genotype 1 Infection. N Engl J Med 2011; 364:1195-1206, p. 1200-1201.
6 Bacon, B.R., et al., for the HCV RESPOND-2 Investigators. Boceprevir for Previously Treated Chronic HCV Genotype 1 Infection. N Engl J Med 2011; 364:1207-1217, p. 1209.
7 Poordad, F., et al., for the SPRINT-2 Investigators. Boceprevir for Untreated Chronic HCV Genotype 1 Infection. N Engl J Med 2011; 364:1195-1206, p. 1197.
8 VICTRELISTM, Product Monograph, July 27, 2011, p. 8.
9 Krajden M, Kuo M, Zagorski B, Alvarez M, Yu A, Krahn M. "Health care cost associated with hepatitis C: Longitudinal cohort study. Can J Gastroenterol 2010;24(12):717-726, p. 717.
10 Remis RS. Modelling the incidence and prevalence of hepatitis c infection and its sequelae in Canada, 2007 . Public Health Agency of Canada website [updated 2007; cited 2011 Jan 4]. Available from: http://www.phac- aspc.gc.ca/sti-its-surv-epi/model/pdf/model07-eng.pdf, p. 5.
11 Remis RS. Modelling the incidence and prevalence of hepatitis c infection and its sequelae in Canada, 2007 . Public Health Agency of Canada website [updated 2007;cited 2011 Jan 4]. Available from: http://www.phac- aspc.gc.ca/sti-its-surv-epi/model/pdf/model07-eng.pdf, p. 46
Sheila Murphy Julia Alter