Merck Announces Presentation of Phase 3 Results of Investigational Elbasvir/Grazoprevir in People with Chronic Hepatitis C Genotypes 1, 4 or 6 Infection Who Inject Drugs and Are on Opioid Agonist Therapy

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November 15, 2015 12:00 am EDT

Results from C-EDGE CO-STAR Presented at The Liver Meeting® Show High Sustained Virologic Response After 12 Weeks of Treatment

KENILWORTH, N.J.–(BUSINESS WIRE)–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
Sunday, November 15 (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.

Merck
Media Contacts:
Doris Li, 908-246-5701
Sarra Herzog, 201-669-6570
or
Investor Contacts:
Teri Loxam, 908-740-1986
Justin Holko, 908-740-1879

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