Results from Merck’s Phase 3 Study of Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir in Patients with Adv...
October 05 2015 - 7:01PM
Business Wire
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced the publication of results from C-SURFER,
the first Phase 31 clinical trial to investigate an all-oral,
ribavirin-free chronic hepatitis C virus (HCV) treatment regimen in
treatment-naïve and treatment-experienced patients with advanced
chronic kidney disease (CKD) stages 4 or 5 and chronic HCV genotype
1 (GT1) infection. Data from the Phase 3 clinical trial evaluating
the investigational, once-daily treatment regimen of elbasvir
(50mg)2 and grazoprevir (100mg)3 in patients with advanced CKD were
published online in the medical journal The Lancet. Data from this
study were initially presented at The International Liver
CongressTM 2015 in April 2015; additional information about that
presentation and the design of the study can be found on the Merck
newsroom.
“People with advanced chronic kidney disease represent an
important segment of the chronic hepatitis C patient population,”
said Dr. Howard Monsour, Jr., chief of hepatology, Houston
Methodist Hospital. “The publication of this study details the
evidence supporting a potential future treatment option for these
patients who are currently underserved.”
The peer-reviewed, published results show that 12 weeks of
therapy with elbasvir plus grazoprevir in patients with chronic HCV
GT1 infection and advanced CKD resulted in high rates of sustained
virologic response 12 weeks after the completion of treatment
(SVR12). High rates of SVR were achieved regardless of patient
characteristics in this study, including African-American patients,
patients receiving hemodialysis and patients with the IL28B non-CC
genotype. Among those receiving elbasvir plus grazoprevir in the
primary analysis population, 99 percent (115/116) achieved SVR12,
with one relapse 12 weeks after the end of treatment. In a
secondary analysis that included six additional patients excluded
from the primary efficacy analysis for non-virologic reasons (study
discontinuation unrelated to study drug, loss to follow-up,
noncompliance, etc.), 94 percent (115/122) achieved SVR12. Adverse
events reported at or above 10 percent frequency in the active and
placebo treatment groups included headache, nausea and fatigue;
rates in the active treatment group were comparable to those in the
group that received placebo for the first 12 weeks.
About Chronic HCV Infection and Chronic Kidney
Disease
Chronic HCV infection is both a cause and complication of the
treatment of CKD. In patients with CKD, chronic HCV infection is
associated with an increased risk of accelerated loss of remaining
kidney function, kidney transplant failure and death. Furthermore,
patients with chronic HCV infection and advanced CKD represent an
unmet need due to a lack of demonstrated HCV treatment options for
this group.
About Elbasvir/Grazoprevir
Elbasvir/grazoprevir is Merck’s investigational, once-daily,
fixed-dose combination therapy containing elbasvir (HCV NS5A
replication complex inhibitor) and grazoprevir (HCV NS3/4A protease
inhibitor). Evaluations of elbasvir/grazoprevir for multiple HCV
genotypes as part of Merck’s broad clinical trials program include
patients with difficult-to-treat conditions such as cirrhosis,
advanced chronic kidney disease, HIV/HCV co-infection, inherited
blood disorders and those on opiate substitution therapy. In July
2015, the U.S. Food and Drug Administration (FDA) granted Priority
Review for the New Drug Application for elbasvir/grazoprevir, with
a Prescription Drug User Fee Act (PDUFA) action date of Jan. 28,
2016.
In April 2015, the FDA granted Breakthrough Therapy designation
status for elbasvir/grazoprevir for the treatment of patients with
chronic HCV GT1 infection with end stage renal disease on
hemodialysis, and Breakthrough Therapy designation status for
elbasvir/grazoprevir for the treatment of patients with chronic HCV
GT4 infection. Breakthrough Therapy designation is intended to
expedite the development and review of a candidate that is planned
for use, alone or in combination, to treat a serious or
life-threatening disease or condition when preliminary clinical
evidence indicates that the drug may demonstrate substantial
improvement over existing therapies on one or more clinically
significant endpoints.
Merck’s Commitment to HCV
For nearly 30 years, Merck 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 health care solutions that support people living
with HCV worldwide.
About Merck
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 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 health care through far-reaching policies, programs and
partnerships. For more information, visit www.merck.com and connect
with us on Twitter, Facebook and YouTube.
Forward-Looking Statement of Merck & Co. Inc.,
Kenilworth, NJ, USA
This news release of Merck & Co., Inc., Kenilworth, NJ, USA
(the “company”) includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States 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 healthcare
legislation in the United States and internationally; global trends
toward healthcare 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 2014
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).
1 Included small Phase 2 pharmacokinetic assessment 2
Elbasvir is an HCV NS5A replication complex inhibitor 3
Grazoprevir is an HCV NS3/4A protease inhibitor
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version on businesswire.com: http://www.businesswire.com/news/home/20151005006479/en/
MerckMedia Contacts:Doris Li, 908-246-5701Sarra Herzog,
201-669-6570orInvestor Contacts:Teri Loxam, 908-740-1986Justin
Holko, 908-740-1879
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