Adding Boceprevir to HCV Combination Therapy Doubles Success Rate

Adding Boceprevir to HCV Combination Therapy Doubles Success Rate
May 28, 2009
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After four months of adding boceprevir to peginterferon alfa-2b and ribavirin, a whopping 75 percent of treatment-naïve individuals with Hepatitis C genotype 1 had undetectable viral levels.

Boceprevir eliminated Hep C virus in unprecedented number of patients

Patients that received a 48-week boceprevir regimen achieved a 75 per
cent SVR rate, nearly twice the efficacy rate provided by current
standard therapies

KIRKLAND, QC, May 26 /CNW/ - Schering-Plough Canada announced today that
final results of the HCV SPRINT-1 (HCV Serine Protease Inhibitor Therapy-1)
study showed boceprevir - its investigational oral hepatitis C protease
inhibitor - in combination with PEGETRON(R) (peginterferon alfa-2b and
ribavirin), significantly increased sustained virologic response (SVR)(1)
rates with either 28- or 48-week therapy regimens in treatment-naive genotype
1 patients, compared to current standard of care, peginterferon and ribavirin
(P/R) for 48 weeks.
When boceprevir was added to PEGETRON(R), 75 per cent (77/103) of
hepatitis C patients assigned to a 48-week regimen had undetectable levels of
virus after treatment completion. That was nearly double the 38 per cent
(39/104) response rate of patients who only received current standard of care
treatment (p(less than)0.0001)(2).
"I am very excited about the response. The response rates from this study
are extremely encouraging, especially when you consider the challenges
associated with hepatitis C management and the difficult nature of the
hepatitis C virus genotype 1 infection in this study's patient population,"
said Dr. Frank Anderson MD FRCP(C), one of the SPRINT-1 Investigators and
presentation co-author. "I believe that the findings of this study will help
further develop and improve hepatitis C treatment. The Phase III boceprevir
studies are currently underway in naive and treatment failure patients, both
are fully enrolled."
The results from this Phase II study - involving 595 patients who were
infected with the virus but had not previously been treated - were presented
at the 44th European Association for the Study of the Liver 2009 Annual
Meeting in Copenhagen, Denmark(3).
"Each HCV-infected patient responds differently to treatment. The results
of the SPRINT-1 study shed important light on response-guided therapy with
boceprevir," said Dr. Jenny Heathcote MD FRCP(C), Professor of Medicine at
University of Toronto and Toronto Western Hospital and a SPRINT-1 study
investigator. "Importantly, the results of SPRINT-1 show how one may best
individualize treatment duration based on the patients' week 4 and week 12
responses to boceprevir therapy. Based on the rate of response observed in
SPRINT-1, the majority of G1-infected treatment naive patients may have the
potential to be treated for a total of 28 weeks."
The HCV SPRINT-1 study was a randomized, controlled, multinational study
conducted at sites across the United States, Canada and Europe. The study
enrolled trial participants infected with HCV genotype 1, the most common and
hardest to treat form of hepatitis C, as well as patients with severe liver
disease, including cirrhosis.
Boceprevir works through a novel mechanism, by inhibiting the function of
a viral protein called 'protease' that the virus needs to replicate. Hepatitis
C is a serious and potentially life-threatening chronic liver disease caused
by the hepatitis C virus (HCV). An estimated 250,000 individuals are infected
with HCV in Canada(4) and there are 3,200 to 5,000 newly infected individuals
each year(5). It is the leading cause of liver transplants in Canada(6).

ABOUT THE HCV SPRINT-1 STUDY

During the first month of the study, all patients received PEGETRON(R),
which is a combination therapy of the two standard hepatitis C treatments: a
long-acting form of interferon called peginterferon alfa-2b and the anti-viral
pill ribavirin. Some patients also received PEGETRON(R) in combination with
boceprevir from the beginning of the study.
After four weeks, one group of PEGETRON(R)-only patients then added
boceprevir for 44 weeks and another group added boceprevir for 24 weeks.
Patients who received a 48-week boceprevir regimen achieved a 75 per cent
SVR rate (n=77/103) in patients who received four weeks of (P/R) followed by
the addition of boceprevir for 44 weeks (boceprevir P/R lead-in regimen). This
represents a near doubling of the 38 per cent SVR rate (n=39/104) for patients
in the control group (p(less than)0.0001). In a 28-week boceprevir P/R lead-in
regimen 56 per cent of patients (n=58/103) achieved SVR (p=0.005)(2).
In the HCV SPRINT-1 study, anemia occurred in approximately half of the
patients in the boceprevir arm and over a third of patients in the control
arm. A key finding of the HCV SPRINT-1 study is that treatment-emergent anemia
appeared to be associated with higher SVR, with anemic patients (hemoglobin
decreasing to less than 10 g/dL) having higher SVR rates than those without
anemia (hemoglobin did not decrease to less than 10 g/dL). Anemia is a known
adverse event with combination therapy for hepatitis C and this association
with higher SVR has been seen in other clinical studies with peginterferon and
ribavirin, including the IDEAL study(7). Boceprevir is associated with about a
1 g/dL incremental decrease in hemoglobin. Erythropoietin (EPO)
supplementation was allowed in the study at the discretion of the investigator
and was used by 26 per cent of patients in the control arm and 39 to 51 per
cent of patients in the boceprevir arms with standard-dose ribavirin.

ABOUT SCHERING-PLOUGH

Schering-Plough Canada Inc. is a country operation of Schering-Plough
Corporation that employs more than 950 people across Canada. Schering-Plough
Canada Inc.'s web site is WWW.SCHERING-PLOUGH.CA.
Schering-Plough is an innovation-driven, science-centered global health
care company. Through its own biopharmaceutical research and collaborations
with partners, Schering-Plough creates therapies that help save and improve
lives around the world. The company applies its research-and-development
platform to human prescription, animal health and consumer health care
products. Schering-Plough's vision is to "Earn Trust, Every Day" with the
doctors, patients, customers and other stakeholders served by its colleagues
around the world. The company is based in Kenilworth, N.J., and its Web site
is WWW.SCHERING-PLOUGH.COM.

References:
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1. SVR, the protocol specified primary efficacy endpoint, is defined as
achievement of undetectable HCV-RNA at 24 weeks after the end of
treatment. Per protocol, if a patient does not have a 24-week post-
treatment assessment, the patient's 12-week post-treatment assessment
will be utilized.

2. Intention-To-Treat (ITT) analysis - includes any patient who has
taken at least one dose of any study drug.

3. Kwo P, Lawitz E, McCone J, et al. HCV SPRINT-1 Final Results: SVR 24
from a Phase 2 study of Boceprevir Plus PegIntron (Peginterferon
alfa-2b)/Ribavirin in Treatment-Naive Subjects with Genotype.

4. Health Canada. http://www.phac-aspc.gc.ca/hepc/index-eng.php Accessed
April 27, 2009.

5. Health Canada.
http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/diseases-maladies/hepc-eng.php.
Accessed April 29, 2009.

6. Canadian Liver Foundation. http://www.liver.ca/Liver_Disease/
Accessed April 27, 2009.

7. Sulkowski M, Shiffman M, Afdhal N, et al. Hemoglobin decline is
associated with SVR among HCV genotype 1 infected persons treated
with peginterferon (PEG)/ribavirin (RBV): Analysis from the IDEAL
Study. 44th European Association for the Study of the Liver (EASL)
2009 Annual Meeting; April 22-26, Copenhagen, Denmark; oral
presentation, Abstract No. 126.


For further information: Media Contact: Mona Aubin, Schering-Plough
Canada, mona.aubin@spcorp.com, (514) 428-8833; Julia Alter, Edelman, (416)
979-1120 ext. 340, julia.alter@edelman.com; Schering-Plough Canada Inc., 16
750, route Transcanadienne, Kirkland, QC, H9H 4M7, www.schering-plough.ca

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Posted by Editors at May 28, 2009 4:47 PM