Patients with Compensated Liver Cirrhosis
Among Most Difficult-to-Treat
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced the presentation of results from an
integrated analysis of patients with compensated liver cirrhosis
(Child-Pugh class A) from six Phase 2 and 3 clinical trials
evaluating the efficacy and safety of the investigational
once-daily tablet elbasvir/grazoprevir1 (50mg/100mg) with or
without ribavirin (RBV) in patients with chronic hepatitis C virus
(HCV) genotypes (GT) 1, 4 or 6 infection. Results from the full
analysis set (FAS) (n=402) demonstrate that treatment-naïve
patients with compensated liver cirrhosis who received
elbasvir/grazoprevir with or without RBV for 12 weeks achieved
sustained virologic response 12 weeks after the completion of
treatment (SVR12, or virologic cure) at rates of 90 percent (28/31)
and 98 percent (135/138), respectively. Treatment-experienced
patients who received elbasvir/grazoprevir with or without RBV for
12 weeks achieved virologic cure rates of 91 percent (74/81) and 89
percent (48/54), respectively. Treatment-experienced patients who
received elbasvir/grazoprevir with or without RBV for 16 or 18
weeks achieved virologic cure rates of 100 percent (49/49) and 94
percent (46/49), respectively. These data will be presented during
an oral presentation at The Liver Meeting® (Abstract #42).
“Patients with chronic hepatitis C virus infection and
compensated cirrhosis have historically been difficult to treat
because their bodies’ ability to respond to antiviral therapy is
compromised,” said Dr. Ira Jacobson, site chair, department of
medicine, Mount Sinai Beth Israel, New York. “In this integrated
analysis of data from multiple trials, patients treated with
elbasvir/grazoprevir were able to achieve high virologic cure
rates, often without the addition of ribavirin.”
The integrated analysis included patients with compensated liver
cirrhosis (Child-Pugh class A) from six Phase 2 and 3 clinical
trials, the individual results of which have been previously
presented: C-WORTHy, C-SURFER, C-EDGE TN, C-EDGE CO-INXFN, C-EDGE
TE and C-SALVAGE. The analysis evaluated the efficacy and safety of
investigational once-daily elbasvir/grazoprevir with or without RBV
for 12 weeks in treatment-naïve patients (n=169) and 12 and 16 or
18 weeks in treatment-experienced patients (n=233). Of the
treatment-experienced patients, 64 percent (150/233) were prior
non-responders, 21 percent (49/233) were prior relapsers and 15
percent (34/233) were previously treated with HCV NS3/4A protease
inhibitors (simeprevir, telaprevir and boceprevir).
Two sets of patients were analyzed. In the FAS, the assessment
included all randomized patients who received at least one dose of
drug (n=402). The integrated analysis also assessed a modified full
analysis set (mFAS) (n=398) that excluded four patients who
discontinued treatment for reasons unrelated to the study drug: one
treatment-naïve patient on 12 weeks of elbasvir/grazoprevir without
RBV; two treatment-experienced patients on 12 weeks of
elbasvir/grazoprevir without RBV; and one treatment-experienced
patient on 12 weeks of elbasvir/grazoprevir with RBV. Compensated
cirrhosis was determined by one of the following methods: liver
biopsy, FibroScan, AST to platelet ratio or FibroTest.
Summary of SVR12 Findings: FAS
Table 1
Treatment-Naïve
Treatment-Experienced Without
RBV
(n=138)
With RBV
(n=31)
Without RBV
(n=54)
With RBV
(n=81)
Without RBV
(n=49)
With RBV
(n=49)
Duration
(Weeks)
12 12 12 12 16 or 18 16
or 18
All Patients
98%
(135/138)*
90%
(28/31)†
89%
(48/54)§
91%(74/81)‡
94%
(46/49)#
100%(49/49)
* Virologic failure occurred in one percent (2/138) of patients
including one breakthrough and one relapse.
† Virologic failure occurred in 10 percent (3/31) of patients
including one breakthrough and two relapses.
§ Virologic failure occurred in seven percent (4/54) of patients
including four relapses.
‡ Virologic failure occurred in seven percent (6/81) of patients
including six relapses.
# Virologic failure occurred in six percent (3/49) of patients
including two rebounds and one relapse.
Summary of SVR12 Findings: mFAS2
Table 2a
Treatment-Naïve Without RBV
(n=137)* Duration (Weeks) 12 All
Patients 99% (135/137)**
Genotype
GT1a GT1b GT4
GT6 97%
(73/75)
100%
(56/56)
100%
(6/6)
-
* In the additional population of treatment naïve patients
administered elbasvir/grazoprevir with RBV for 12 weeks, 90%
(28/31) achieved SVR12.
** Virologic failure occurred in one percent (2/137) of patients
including one breakthrough and one relapse.
Table 2b
Treatment-Experienced†
Without RBV (n=52)* With RBV (n=49)**
Duration (Weeks) 12 16 or 18
All Patients 92% (48/52)*** 100% (49/49)
Genotype GT1 GT4
GT6 GT1 GT4
GT6 94%
(44/47)
80%
(4/5)
- 100%
(44/44)
100%
(4/4)
100%
(1/1)
† Prior null response, partial response or relapse with
pegylated interferon/RBV
* In the additional population of treatment-experienced patients
administered elbasvir/grazoprevir with RBV for 12 weeks, 93%
(74/80) achieved SVR12.
** In the additional population of treatment-experienced
patients administered elbasvir/grazoprevir without RBV for 16 or 18
weeks, 94% (46/49) achieved SVR12.
*** Virologic failure occurred in eight percent (4/52) of
patients including four relapses.
The most common adverse events (AEs) reported in patients who
received elbasvir/grazoprevir, or elbasvir/grazoprevir with RBV,
and placebo were: fatigue (15%, 31% and 18%, respectively),
headache (17%, 21% and 14%, respectively) and nausea (4%, 14% and
14%, respectively). One serious drug-related AE occurred in a
patient taking elbasvir/grazoprevir due to severe abdominal pain
without associated symptoms. Seven patients discontinued due to
treatment-related AEs (two patients taking elbasvir/grazoprevir;
four patients taking elbasvir/grazoprevir with RBV; and one patient
taking placebo).
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). Merck’s broad clinical trials program includes
evaluations of elbasvir/grazoprevir with or without ribavirin for
multiple HCV genotypes, together with patients with
difficult-to-treat conditions, such as cirrhosis, advanced chronic
kidney disease, HIV/HCV co-infection, inherited blood disorders and
those on opioid agonist 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
for elbasvir/grazoprevir for the treatment of patients with chronic
HCV GT1 infection with end stage renal disease on hemodialysis, and
Breakthrough Therapy Designation 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 healthcare 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, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) 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 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 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; 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 Elbasvir is an HCV NS5A replication complex inhibitor and
grazoprevir is an HCV NS3/4A protease inhibitor.
2 Data presented in Tables 2a and 2b include regimens by
treatment population with the highest rates of SVR or comparable
SVR without the addition of RBV.
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MerckMedia:Doris Li, 908-246-5701orSarra Herzog,
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