C-SURFER Trial is First to Investigate an
All-Oral Ribavirin-Free Hepatitis C Treatment Regimen in
Treatment-Naïve and Treatment-Experienced Patients with Advanced
Chronic Kidney Disease Infected with Hepatitis C Virus Genotype
1
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced the first presentation of data from
C-SURFER, the company’s Phase 2/3 clinical trial evaluating the
investigational once-daily treatment regimen of grazoprevir (100mg)
and elbasvir (50mg) in patients with advanced chronic kidney
disease (CKD) infected with chronic hepatitis C virus (HCV)
genotype 1 (GT1).1 Treatment-naïve patients and patients who failed
prior pegylated interferon HCV therapy, with or without cirrhosis,
all of whom had CKD stages 4 or 5, were enrolled.2 Following 12
weeks of treatment with grazoprevir and elbasvir, 99 percent
(115/116) of patients in the pre-specified primary population for
analysis of efficacy data achieved a sustained virologic response
12 weeks after the completion of treatment (SVR12).3 These data
will be presented today at The International Liver CongressTM 2015
– the 50th annual congress of the European Association for the
Study of the Liver (late breaking E-Poster #LP02).
“There is an unmet medical need to treat chronic hepatitis C
virus infection in patients with advanced chronic kidney disease,”
said Dr. Howard Monsour, Jr., chief of hepatology, Houston
Methodist Hospital, Houston, Texas. “In this trial, the first to
investigate an all-oral ribavirin-free treatment regimen in
treatment-naïve and treatment-experienced CKD patients, treatment
with grazoprevir and elbasvir for 12 weeks was effective in this
study population with HCV genotype 1 infection.”
The ongoing C-SURFER Phase 2/3 clinical trial is a randomized,
parallel-group, placebo-controlled study evaluating patients
infected with chronic HCV GT1 with advanced CKD with or without
liver cirrhosis. Patients were randomized to one of two study
arms:
- Immediate treatment group (ITG),
grazoprevir plus elbasvir (blinded) once-daily for 12 weeks
(n=111);
- Deferred treatment group (DTG),
initially placebo (control arm) for 12 weeks followed by a four
week follow-up period and then treatment with grazoprevir plus
elbasvir (open label) once-daily for 12 weeks (n=113).
In addition, 11 patients received grazoprevir plus elbasvir
(open label) once-daily for 12 weeks with intensive pharmacokinetic
sampling.
Of the 122 patients who received grazoprevir plus elbasvir, 83
percent were treatment-naïve, 36 percent had diabetes, 18 percent
had stage 4 CKD, 82 percent had stage 5 CKD, 75 percent were
receiving hemodialysis and 45 percent were African-American. Among
those patients who received at least one dose of grazoprevir plus
elbasvir, five percent (6/122) were excluded from the pre-specified
primary efficacy analysis population, or modified full analysis
set, due to missing data caused by death or early discontinuation
for reasons unrelated to study drug. In the modified full analysis
set, 99 percent (115/116) of patients receiving grazoprevir plus
elbasvir achieved SVR12. One GT1b infected, non-cirrhotic,
interferon-intolerant patient showed a viral relapse at follow-up
week 12. Within the modified full analysis set, efficacy was
consistent across the patient sub-populations assessed. In a
supportive analysis of all 122 patients who received at least one
dose of grazoprevir plus elbasvir in the ITG arms, including
patients who did not complete the study for reasons not related to
study drug, 94 percent (115/122) of patients achieved SVR12.
“Merck’s broad clinical development program includes studies
dedicated to bringing a once-daily regimen to diverse populations
of patients infected with chronic HCV, including certain types of
patients with co-morbidities, such as advanced chronic kidney
disease,” said Dr. Eliav Barr, vice president, infectious diseases,
Merck Research Laboratories. “These data highlight how emerging
innovations in chronic hepatitis C treatment may lead to new
options for patient populations in which it historically has been
difficult to achieve high rates of sustained viral clearance.”
No patients in the ITG arms discontinued treatment due to
adverse events (AEs), while four percent (5/113) of patients in the
comparator placebo phase of the DTG arm discontinued treatment due
to AEs. The rates of serious AEs reported were 14 percent (16/111)
in the ITG arms and 17 percent (19/113) in the placebo control DTG
arm. The most common treatment-related AEs in the ITG arms and DTG
arm (placebo) were headache (17%, 17%), nausea (15%, 16%) and
fatigue (10%, 15%), respectively. There were four deaths reported
during the initial treatment phase and the first 14 days of study
follow-up. One patient (1%) in the open label arm died from cardiac
arrest (not considered related to study medicine) and three
patients (2%) in the placebo group died from aortic aneurysm,
pneumonia and an unknown cause.
On April 8, 2015, the company announced that the U.S. Food and
Drug Administration (FDA) had granted Breakthrough Therapy
designation to grazoprevir/elbasvir for the treatment of patients
infected with chronic HCV GT1 with end-stage renal disease on
hemodialysis and patients infected with chronic HCV GT4.
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.
About C-SURFER
C-SURFER is a Phase 2/3 clinical trial evaluating Merck’s
investigational grazoprevir plus elbasvir in patients infected with
chronic HCV GT1 and with advanced chronic kidney disease (stages 4
and 5, including patients on hemodialysis) with or without liver
cirrhosis, which are among those with HCV infection who are most
difficult to treat, over 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 Grazoprevir/Elbasvir
Grazoprevir/elbasvir is an investigational, once-daily single
tablet regimen consisting of grazoprevir (NS3/4A protease
inhibitor) and elbasvir (NS5A replication complex inhibitor). As
part of Merck’s broad clinical trials program, grazoprevir/elbasvir
is being studied in multiple HCV genotypes and in patients with
difficult-to-treat conditions such as HIV/HCV co-infection,
advanced chronic kidney disease, inherited blood disorders, liver
cirrhosis and those on opiate substitution therapy.
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
This news release includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of Merck’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 health care
legislation in the United States and internationally; global trends
toward health care cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; Merck’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 Merck patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
Merck undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise except as required by applicable law.
Additional factors that could cause results to differ materially
from those described in the forward-looking statements can be found
in Merck’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 In Phase 2 studies, grazoprevir/elbasvir are administered as
two separate tablets
2 Stages 4 and 5 chronic kidney disease are defined as severely
or very severely reduced kidney function, based on estimated
glomerular filtration rate <30 mL/min/1.73m2
3 Includes patients who received ≥1 dose of study drug and
excluded those with missing data because of death or early
discontinuation for reasons unrelated to study drug
Media:Doris Li, 908-246-5701orSarra Herzog,
201-669-6570orInvestors:Joe Romanelli, 908-740-1986orJustin Holko,
908-740-1879
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