Study Evaluating Anemia Management Strategies Used with VICTRELIS(TM) (boceprevir) Presented at International Liver Conference
BARCELONA, April 19, 2012 /PRNewswire/ – Today Merck announced results
demonstrating no difference in the rates of viral clearance between two
anemia management strategies for patients with chronic hepatitis C
virus (HVC) genotype 1 infection treated with VICTRELIS(TM) (boceprevir)
in combination with peginterferon alfa-2b and ribavirin (P/R). Anemia
is a common development of P/R therapy for chronic hepatitis C
patients. For the patients studied, the anemia was either managed by
ribavirin dose reduction or with the addition of erythropoietin (EPO),
a drug that stimulates the bone marrow to produce red blood cells.
“The results are good news for treating physicians and patients as they
show that reducing the dose of ribavirin is just as effective for the
treatment of anemia as adding EPO, meaning there is no need for
patients to take an additional drug,” said Dr. Samuel Lee,
hepatologist, Professor of Medicine at the University of Calgary and
Canadian study investigator and author. “The new boceprevir combination
therapy is a major advance in our ability to cure hepatitis C. We’re
pleased to note that our study confirmed that the rates of viral
clearance were just above seventy percent.”
The rates of sustained virologic response (SVR*) were 71 percent for
both those patients whose anemia was managed by ribavirin dose
reduction (178/249) and those patients whose anemia was managed by the
addition of erythropoietin (EPO) (178/251). The rates of relapse were
identical at 10 percent in both groups. These results from a Phase III,
open-label study are being presented at The International Liver
Congress(TM)/47th European Association for the Study of the Liver (EASL)
annual meeting in Barcelona, Spain.
Boceprevir in Canada
Boceprevir was approved for use in Canada in July 2011 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 therapy.
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 year.(1) HCV damages the liver and may lead to serious complications, including
death, when left untreated.(2) It is the leading cause of liver transplants in Canada.(3)
About the Study
In this study, 687 treatment-naïve adult patients with chronic HCV
genotype 1 who had baseline hemoglobin levels of less than or equal to
15 g/dL were enrolled in a multinational, open-label trial and
monitored for the development of anemia. Patients were treated with a
4-week lead-in of peginterferon alfa-2b (1.5 mcg/kg/week) and an
investigational dose of ribavirin (600-1,400 mg/day), followed by the
addition of boceprevir (800 mg three times a day) after week 4 for 24
or 44 weeks based on HCV-RNA levels at treatment week 8. Sixteen (16)
percent (111/687) of patients were enrolled in Cohort 1 and assigned a
fixed-dose regimen that included the 4-week lead-in of P/R followed by
the addition of boceprevir for 44 weeks. A protocol amendment was then
added to allow the use of the response-guided therapy (RGT) paradigm,
consistent with findings in the pivotal clinical studies for
boceprevir, and the rest of the patients were enrolled in Cohort 2.
The results for patients receiving the fixed-dose regimen (Cohort 1)
versus the RGT paradigm (Cohort 2) did not differ and have been
combined in the presentation of these data. Patients with a less than
2-log10 decline in HCV-RNA at week 12, or a greater than or equal to
lower limit of quantification of HCV-RNA at week 24 were considered
treatment failures and were discontinued from the studies.
A total of 500 patients developed anemia, defined by having hemoglobin
of less than or equal to 10 g/dL (or less than 11 g/dL and were
expected to reach less than or equal to 10 g/dL before the next visit).
These patients were randomized to receive either ribavirin dose
reduction (by 200 to 400 mg/d) or the addition of EPO (40,000 IU/week).
A secondary method of anemia management, such as the addition of EPO,
ribavirin dose reduction or transfusion, was later permitted if a
patient’s hemoglobin reached less than or equal to 8.5 g/dL. Treatment
was discontinued if hemoglobin levels reached less than or equal to 7.5
g/dL. If the initial hemoglobin measurement qualifying a patient as
anemic was less than or equal to 8.5 g/dL, that patient was not
randomized to one of the anemia management strategies.
The primary endpoint of the study was the comparison of SVR in patients
who were randomized to receive ribavirin dose reduction or the addition
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 VICTRELIS, extensive research efforts are underway
to develop additional innovative oral therapies for viral hepatitis
Today’s Merck is a global health care 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 health care through far-reaching
policies, programs and partnerships. For more information about our
operations in Canada, visit www.merck.ca.
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(TM) Trademark of Schering Corporation, a subsidiary of Merck & Co., Inc. Used under license.
(*)SVR, the protocol specified primary efficacy endpoint of the study, is
defined as achievement of undetectable HCV-RNA at 24 weeks after the
end of treatment in all randomized patients treated with any study
medication. Per protocol, if a patient did not have a 24-week
post-treatment assessment, the patient’s 12-week post-treatment
assessment was utilized.
(1) Canadian Institutes of Health Research. About the Hep C Research
Initiative. http://www.cihr-irsc.gc.ca/e/38855.html. Accessed April 13, 2012.
(2) Public Health Agency of Canada. http://www.phac-aspc.gc.ca/hepc/pubs/multiling-hepc/index-eng.php. Accessed April 13, 2012.
(3) Canadian Liver Foundation. http://www.liver.ca/Liver_Disease/. Accessed April 13, 2012.