Results from C-EDGE CO-STAR Presented at The
Liver Meeting® Show High Sustained Virologic Response
After 12 Weeks of Treatment
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced the presentation of results from the
company’s Phase 3 C-EDGE CO-STAR clinical trial evaluating the
efficacy and safety of the investigational once-daily tablet
elbasvir/grazoprevir1 (50mg/100mg) in patients with chronic
hepatitis C virus (HCV) genotypes (GT) 1, 4 or 6 infection who
inject drugs and are receiving opioid agonist therapy (OAT).
Ninety-five percent (189/198) of patients treated with
elbasvir/grazoprevir for 12 weeks in the pre-specified primary
efficacy analysis population achieved sustained virologic response
12 weeks after the completion of treatment (SVR12, considered
virologic cure). Adherence to treatment was high, with 97 percent
of patients taking at least 95 percent of their study medication
over the 12 weeks of therapy. These findings will be featured today
at the American Association for the Study of Liver Diseases’
President’s Press Conference at The Liver Meeting® and presented in
an oral session on Monday, November 16 (Abstract #40).
“Injection drug use is a major factor fueling the global
hepatitis C crisis, yet people with chronic hepatitis C virus
infection who inject drugs often remain overlooked and
underserved,” said Dr. Ronald Nahass, president, ID CARE, New
Jersey. “Patients in this study with chronic hepatitis C virus
infection on opioid agonist therapy, including many who continued
to use drugs during the trial, were able to complete treatment with
elbasvir/grazoprevir and achieve high virologic cure rates.”
C-EDGE CO-STAR is a Phase 3 randomized, double-blind,
placebo-controlled study evaluating treatment with
elbasvir/grazoprevir in patients with chronic HCV GT1, 4 or 6
infection who are on OAT (e.g., methadone, buprenorphine). The
study randomized 301 patients to one of two study arms: an
immediate treatment group (ITG) that received elbasvir/grazoprevir
(blinded) for 12 weeks (n=201), and a deferred treatment group
(DTG) that received 12 weeks of placebo (control arm) followed by a
four-week follow-up period and then elbasvir/grazoprevir
(open-label) for 12 weeks (n=100).
The primary efficacy analysis – or modified full analysis set
(mFAS) – excluded patients who discontinued treatment for reasons
unrelated to study drug (n=3) and classified patients who had
cleared their baseline infection but subsequently acquired a new
infection as treatment successes (n=5). In the mFAS, 96 percent of
GT1a patients (147/153), 97 percent of GT1b patients (28/29), 100
percent of GT4 patients (11/11) and 60 percent of GT6 patients
(3/5) achieved virologic cure when treated with
elbasvir/grazoprevir for 12 weeks. Results for patients with GT6
infection were limited by the small number of GT6 patients
enrolled. In a supportive efficacy analysis based on the full
analysis set (FAS), which included all subjects with HCV GT1, 4 or
6 infection who received at least one dose of study drug, the
overall SVR12 rate in the ITG was 92 percent (184/201).
Of the 301 patients evaluated across both treatment groups, 76
percent had GT1a infection, 21 percent had cirrhosis and 7 percent
had HIV/HCV co-infection. All patients were on OAT at baseline. The
use of non-prescribed drugs, such as cocaine and/or amphetamines,
was observed in 59 percent of patients at baseline and remained
steady throughout the trial; however, adherence to treatment with
elbasvir/grazoprevir was high.
In the mFAS, virologic failures occurred in nine patients in the
ITG, including seven relapses and two discontinuations for reasons
deemed related to study drug; in the FAS, an additional five
reinfections and three discontinuations for non-treatment related
reasons were counted as treatment failures. Across the ITG on
active study medication and DTG on placebo, four patients (1%)
discontinued treatment due to adverse events (AE), including two
patients (1%) in the ITG and two (2%) in the DTG. Two patients (1%
across both groups) reported a serious drug-related AE (0.5% in the
ITG, 1% in the DTG). The most common AEs in the ITG versus the DTG,
respectively, were fatigue (16% versus 20%), headache (13% versus
14%), nausea (11% versus 9%) and diarrhea (10% versus 9%). One
patient receiving placebo died for reasons unrelated to the study
drug.
“Limited research has been conducted in people with chronic
hepatitis C virus infection undergoing treatment for injection drug
use because of the perceived challenges and complexities involved
in treating this population,” said Dr. Eliav Barr, vice president,
infectious diseases, Merck Research Laboratories. “This is one of
the largest clinical trials to date evaluating an all-oral,
once-daily, ribavirin-free investigational treatment regimen for
patients with chronic hepatitis C virus infection on opioid agonist
therapy and reflects Merck’s ongoing commitment to study the
diverse real-world population of people living with this
disease.”
About Chronic HCV Infection and Opioid Agonist
Therapy
Injection drug use is the most common risk factor for chronic
HCV in the United States, and rates of transmission and reinfection
are higher among injection drug users than in other people with
HCV.i,ii In the United States, 67 percent to 84 percent of this
population on OAT has been infected with HCV.iii
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, 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 Elbasvir is an HCV NS5A replication
complex inhibitor and grazoprevir is an HCV NS3/4A protease
inhibitor.
i CDC (2015). Hepatitis C FAQs for Health
Professionals.
<http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm>.
ii Grady BP et al. Hepatitis C virus
reinfection following treatment among people who use drugs. Clin
Infect Dis. 2013 Aug;57 Suppl 2:S105-10.
iii CDC (2002). Methadone Maintenance
Treatment.
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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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