Data Sets Include Treatment-Naïve,
Treatment-Experienced and HIV Co-Infected Patients with Chronic
Hepatitis C Virus Genotypes 1, 4 or 6 Infection
Merck Remains on Track to Submit New Drug
Application (NDA) to U.S. Food and Drug Administration (FDA) in
First Half of 2015
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced the first presentations of data from the
company’s ongoing C-EDGE pivotal Phase 3 clinical trial program
evaluating the investigational once-daily tablet
grazoprevir/elbasvir (100mg/50mg) in patients with or without
cirrhosis who are infected with chronic hepatitis C virus (HCV)
genotypes 1, 4 or 6 (GT1, 4 or 6).1 Patients in both the HCV
infected, treatment-naïve (C-EDGE TN), and HIV/HCV co-infected,
treatment-naïve (C-EDGE CO-INFXN) trials treated for 12 weeks
achieved rates of sustained virologic response 12 weeks after the
completion of treatment (SVR12) of 95 percent (299/316 and 207/218,
respectively). In addition, HCV infected, treatment-experienced
patients (C-EDGE TE) treated with or without ribavirin (RBV) for 12
weeks achieved SVR12 rates of 94 percent (98/104) and 92 percent
(97/105), respectively, and those treated for 16 weeks achieved
SVR12 rates of 97 percent (103/106) and 92 percent (97/105),
respectively. These data were presented at The International Liver
CongressTM 2015 – the 50th annual congress of the European
Association for the Study of the Liver (Abstract #G07, E-Poster
P0886 and E-Poster P0887). A paper detailing the findings of C-EDGE
TN was published online in the Annals of Internal Medicine
today.
“Patients with co-morbidities and varying treatment experiences
represent important segments of the chronic hepatitis C population
in need of additional innovative treatment options,” said Dr. Eric
Lawitz, vice president, scientific and research development, The
Texas Liver Institute and clinical professor of medicine, The
University of Texas Health Science Center, San Antonio. “These
findings are important because they demonstrate that a single pill
of grazoprevir/elbasvir taken once-daily achieved consistently high
rates of SVR12 in the patient populations studied.”
Summary of SVR12 findings: C-EDGE TN, C-EDGE CO-INFXN,
C-EDGE TE C-EDGE TN
C-EDGECO-INFXN C-EDGE TE
WithoutRBV(n=316) Without
RBV(n=218) Without RBV
(n=105) WithRBV(n=104)
Without RBV (n=105)
WithRBV(n=106) Duration 12
weeks 12 weeks
12 weeks
12 weeks 16 weeks 16
weeks All Patients: 95% 95% 92% 94%
92% 97%
SVR12 (299/316)
(207/218) (97/105) (98/104) (97/105)
(103/106)
Cirrhotic 97% 100% 89% 89% 92% 100%
(68/70) (35/35) (33/37) (31/35) (35/38)
(37/37)
Non-cirrhotic 94% 94% 94% 97% 93% 96%
(231/246) (172/183) (64/68) (67/69)
(62/67) (66/69)
Genotype 1a 92% 94% 90% 93%
94% 95% (144/157) (136/144) (55/61)
(56/60) (45/48) (55/58)
Genotype 1b or
other Genotype 99% 96% 100% 97% 96% 100%
1
(129/131) (43/45) (35/35) (28/29)
(46/48) (38/38)
Genotype 4 100%
96%
78% 93% 60% 100% (18/18)
(27/28)
(7/9) (14/15) (3/5) (8/8)
Genotype
6 80% 100% 75% 100% (8/10) (1/1)
N/A N/A (3/4) (2/2)
“At Merck, we continue to build upon our clinical experience
using grazoprevir/elbasvir across diverse populations of patients
infected with chronic hepatitis C virus,” said Dr. Eliav Barr, vice
president, infectious diseases, Merck Research Laboratories. “We
remain on track to submit a New Drug Application with the U.S. Food
and Drug Administration in the first half of 2015.”
C-EDGE TN Overview and Additional
Findings
C-EDGE TN is a randomized, blinded, placebo-controlled trial
evaluating the efficacy and safety of grazoprevir/elbasvir in
treatment-naïve patients with or without cirrhosis infected with
chronic HCV GT1, 4 or 6 who received therapy for 12 weeks. Patients
were randomized to an immediate treatment group that received
grazoprevir/elbasvir for 12 weeks or to a deferred treatment group
that received placebo for 12 weeks, were followed for an additional
four weeks, and then received open label grazoprevir/elbasvir for
the next 12 weeks. The primary efficacy analysis included those
patients who received immediate treatment with grazoprevir/elbasvir
or placebo. Of the 316 patients who received immediate treatment
with grazoprevir/elbasvir, 50 percent were infected with GT1a, 42
percent with GT1b, six percent with GT4 and three percent with GT6.
Overall, 22 percent of patients had liver cirrhosis.
In this study, virologic failure occurred in 13 patients (4%) in
the immediate treatment group, including one virologic breakthrough
and 12 virologic relapses. Serious adverse events occurred in nine
(3%) and three (3%) patients in the immediate treatment and
corresponding placebo arms, respectively; none were considered
drug-related. The most common adverse events reported (greater than
5% incidence) in the immediate treatment and corresponding placebo
groups, were headache (17%, 18%), fatigue (16%, 17%), nausea (9%,
8%) and arthralgia (6%, 6%), respectively.
C-EDGE CO-INFXN Overview and Additional
Findings
C-EDGE CO-INFXN is an open label, single-arm study evaluating
the efficacy and safety of grazoprevir/elbasvir in treatment-naïve
patients with or without cirrhosis infected with chronic HCV GT1, 4
or 6 and HIV who received therapy for 12 weeks. Of the 218 patients
enrolled in the trial, 66 percent were infected with HCV GT1a, 21
percent with GT1b or other GT1, 13 percent with GT4, and one
percent with GT6. Overall, 16 percent of patients had liver
cirrhosis.
In this study, virologic failure occurred in seven patients
(3%), including six virologic relapses and one reinfection. There
were no reported drug-related serious adverse events. The most
common (greater than 5% incidence) adverse events reported were
fatigue (13%), headache (12%) and nausea (9%).
C-EDGE TE Overview and Additional
Findings
C-EDGE TE is a randomized study evaluating the efficacy and
safety of once-daily grazoprevir/elbasvir with or without
twice-daily RBV in treatment-experienced (prior null response,
partial response or relapse with peg-interferon/RBV) patients with
or without cirrhosis infected with chronic HCV GT1, 4 or 6 who
received therapy for 12 weeks or 16 weeks.
12 week arms
Of the 209 patients randomized to the 12 week arms, 105 patients
received grazoprevir/elbasvir only and 104 patients
received grazoprevir/elbasvir plus RBV. Patients in the
grazoprevir/elbasvir only arm comprised 58 percent GT1a, 33
percent GT1b or other GT1 and nine percent GT4. Overall, 35 percent
had liver cirrhosis. Among the 104 patients receiving
grazoprevir/elbasvir plus RBV, 58 percent were infected with
chronic HCV GT1a, 28 percent GT1b or other GT1, and 14 percent GT4.
Overall, 34 percent had liver cirrhosis.
In the grazoprevir/elbasvir only and grazoprevir/elbasvir plus
RBV arms, six patients in each arm (6%) were reported to have
virologic relapse. No patients were reported to have virologic
breakthrough or rebound. Serious adverse events were reported in
four patients in the grazoprevir/elbasvir only arm (4%) and three
patients in the grazoprevir/elbasvir plus RBV arm (3%). The most
common (greater than 10% incidence) adverse events reported in the
grazoprevir/elbasvir and grazoprevir/elbasvir plus RBV arms,
respectively, were fatigue (19%, 27%), headache (21%, 20%) and
nausea (9%, 14%).
16 week arms
Of the 211 patients enrolled in the 16 week arms, 105 patients
received grazoprevir/elbasvir only and 106 patients received
grazoprevir/elbasvir plus RBV. In the grazoprevir/elbasvir only
arm, 46 percent were infected with chronic HCV GT1a, 46
percent with GT1b or other GT1, five percent with GT4 and four
percent with GT6. Overall, 36 percent of patients had liver
cirrhosis. Among those in the grazoprevir/elbasvir plus RBV arm, 55
percent were infected with chronic HCV GT1a, 36 percent with GT1b
or other GT1, eight percent with GT4, and two percent with GT6.
Overall, 35 percent had liver cirrhosis.
Among the patients receiving grazoprevir/elbasvir only, three
patients (3%) were reported to have virologic breakthrough or
rebound and four patients (4%) were reported to have virologic
relapse. No virologic failures occurred in patients receiving
grazoprevir/elbasvir plus RBV. Serious adverse events were reported
in three patients in the grazoprevir/elbasvir only arm (3%) and
four patients in the grazoprevir/elbasvir plus RBV arm (4%). The
most common (greater than 10% incidence) adverse events reported in
the grazoprevir/elbasvir and grazoprevir/elbasvir plus RBV arms,
respectively, were fatigue (16%, 30%), headache (19%, 19%) and
nausea (4%,17%).
About the C-EDGE Program
C-EDGE is the Phase 3 clinical development program for Merck’s
investigational HCV treatment grazoprevir/elbasvir comprising five
studies with more than 1,700 patients across more than 25
countries. These studies are evaluating grazoprevir/elbasvir in
multiple genotypes (GT1, 4 and 6) and diverse patient populations,
including difficult-to-treat patients such as:
treatment-experienced, patients with cirrhosis, HIV/HCV
co-infection, advanced chronic kidney disease, inherited blood
disorders, and those receiving opiate substitution therapies.
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 Grazoprevir is an HCV NS3/4A protease inhibitor and elbasvir
is an HCV NS5A replication complex inhibitor
MerckMedia:Doris Li , 908-246-5701orSarra Herzog,
201-669-6570orInvestors:Joe Romanelli, 908-740-1986orJustin Holko,
908-740-1879
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