Results from Merck’s Phase 3 Study of Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir in Patients with Advanced Chronic Kidney Disease Published in The Lancet


October 5, 2015 6:01 pm ET

KENILWORTH, N.J.–(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
. Data from this study were initially presented at The
International Liver CongressTM 2015
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

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,
and connect with us on Twitter,
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
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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
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by competitors; challenges inherent in new product development,
including obtaining regulatory approval; the company’s ability to
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or delays; financial instability of international economies and
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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 (

1 Included small Phase 2 pharmacokinetic assessment 
Elbasvir is an HCV NS5A replication complex inhibitor 
Grazoprevir is an HCV NS3/4A protease inhibitor

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