Data Presented at the American Association for the Study of Liver Diseases
2011 Annual Meeting
MONTREAL, Nov. 7, 2011 /CNW/ - Today Merck announced results of an
interim analysis from the PROVIDE study, an open-label study examining
the efficacy of VICTRELIS™ (boceprevir), the company's first-in-class, oral hepatitis C virus
(HCV) protease inhibitor, in combination with peginterferon alpha and
ribavirin (P/R) in adult patients with chronic HCV genotype 1 who had a
null response to prior P/R therapy. These patients are significantly
less likely to respond to subsequent treatments. In this interim
analysis, 38 per cent (16/42) of prior null responders achieved a
sustained virologic response (SVR), meaning they were able to clear the
virus from the body, when treated with boceprevir in combination with P/R. These results
were presented at the 62nd Annual Meeting of the American Association for the Study of Liver
Diseases (AASLD) in San Francisco.
"The null responders are the toughest patient group to treat and until
now, there was not much optimism that they could ever clear the
hepatitis C virus," says Eric Yoshida, M.D., study investigator and
Professor of Medicine at the University of British Columbia. "The
PROVIDE study definitely demonstrates that boceprevir with
peginterferon and ribavirin can provide these patients with hope for
About the PROVIDE Study
The PROVIDE study is an ongoing, open-label, single-arm, multicenter
rollover study for patients who participated in the P/R control arms of
the Phase II and Phase III studies for boceprevir and failed to achieve
SVR. Of these, 48 patients from the two pivotal Phase III trials for
boceprevir (HCV SPRINT-2 and HCV RESPOND-2) met the traditional
definition for null response (less than a 2 log HCV-RNA decline at
treatment week 12). These patients were retreated with a 4-week lead-in
of peginterferon alpha-2b (1.5 mcg/kg/week) and ribavirin (600-1,400
mg/day), followed by the addition of boceprevir (800 mg three times a
day) for 44 weeks. Three of these patients discontinued treatment
during the 4-week P/R lead-in phase prior to receiving boceprevir, two
patients are currently on treatment and one patient is currently in the
follow-up phase. Among patients completing treatment and follow-up, 38
per cent (16/42) achieved SVR and 16 per cent (3/19) relapsed.
Hepatitis C in Canada
An estimated 250,000 individuals in Canada are infected with HCV and
there are 3,200 to 5,000 newly infected individuals each year1. HCV damages the liver and may lead to serious complications, including
death, when left untreated2. It is the leading cause of liver transplants in Canada3.
There is a stigma linked with hepatitis C infection because of its
association with injection drug use4, which poses a major barrier to detection and treatment. As a result,
those who are undiagnosed may continue to unknowingly spread the virus
Boceprevir in Canada
Boceprevir (VICTRELIS™) was approved for use in Canada in July of this
year for the treatment of chronic hepatitis C genotype 1 infection, in
combination with peginterferon alpha and ribavirin, in adult patients
(18 years of age and older) with compensated liver disease, including
cirrhosis, who are previously untreated or who have failed previous
peginterferon and ribavirin therapy6.
Common side effects of combination treatment include fatigue, anemia,
nausea, headache and bad taste (dysgeusia)7.
Merck's global commitment to advancing hepatitis therapy
Merck is committed to building on its strong legacy in the field of
viral hepatitis by continuing to discover, develop and deliver vaccines
and medicines to help prevent and treat viral hepatitis. In hepatitis
C, company researchers developed the first approved therapy for chronic
HCV in 1991 and the first combination therapy in 1998. In addition to
ongoing studies with boceprevir extensive research efforts are underway
to develop additional innovative oral therapies for viral hepatitis C
Today's Merck is a global healthcare leader working to help the world be
well. Merck is known as MSD outside the United States and Canada.
Through our medicines, vaccines, biologic therapies, and consumer and
animal 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
operations in Canada, visit www.merck.ca.
This news release includes "forward-looking statements" within the
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but are not limited to, statements about the benefits of the merger
between Merck and Schering-Plough, including future financial and
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risks and uncertainties. Actual results may differ from those set forth
in the forward-looking statements.
The following factors, among others, could cause actual results to
differ from those set forth in the forward-looking statements: the
possibility that the expected synergies from the merger of Merck and
Schering-Plough will not be realized, or will not be realized within
the expected time period; the impact of pharmaceutical industry
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dependence on the effectiveness of Merck's patents and other
protections for innovative products; the risk of new and changing
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materially from those described in the forward-looking statements can
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1 Canadian Institutes of Health Research. About the Hep C Research
Initiative. http://www.cihr-irsc.gc.ca/e/38855.html. Accessed November 2, 2011.
2 Public Health Agency of Canada. http://www.phac-aspc.gc.ca/hepc/pubs/multiling-hepc/index-eng.php.
Accessed November 2, 2011.
3 Canadian Liver Foundation. http://www.liver.ca/Liver_Disease/. Accessed November 2, 2011.
4 HCV Advocate. Stigma and Hepatitis C. http://www.hcvadvocate.org/hepatitis/factsheets_pdf/Stigma_09.pdf. Accessed on November 2, 2011.
5 Health Canada. http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/diseases-maladies/hepc-eng.php.
Accessed on November 2, 2011.
6 VICTRELIS™, Product Monograph, July 27, 2011, p. 3.
7 VICTRELIS™, Product Monograph, July 27, 2011, p. 8.
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