Merck to Present New Data on Investigational Chronic Hepatitis C Treatment Elbasvir/Grazoprevir at The Liver Meeting® 2015, Including Phase 3 Results in Selected Difficult-to-Treat Populations


October 20, 2015 9:35 am ET

New Data Will Also be Presented from Phase 2a C-CREST Trials of Merck’s Investigational Triple-Combination Chronic Hepatitis C Therapies

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that new data from clinical trials of its
investigational treatment portfolio for chronic hepatitis C virus (HCV)
are scheduled to be presented at The
Liver Meeting® 2015
(the 66th
annual scientific congress of the American Association for the Study of
Liver Diseases) in San Francisco, from Nov. 13-17, 2015. Merck’s
late-stage investigational portfolio includes elbasvir/grazoprevir1,
MK-36822 and MK-84083.

A range of data will be presented from more than 20 accepted abstracts.
Among these are two late-breaking abstracts from the C-CREST and C-SWIFT
clinical trial programs.

“Recent innovations in the treatment of chronic hepatitis C are enabling
health systems and physicians to address the burden of this disease.
Continued innovation is essential, particularly for patients for whom
current therapies may not be suitable,” said Dr. Eliav Barr, vice
president, infectious diseases, Merck Research Laboratories. “Merck is
committed to evaluating our chronic hepatitis C investigational
medicines in a broad range of patients and treatment durations to help
address the global unmet needs that still exist.”

Elbasvir/grazoprevir is currently under Priority Review with the U.S.
Food and Drug Administration, with a Prescription Drug User Fee Act
(PDUFA) action date of Jan. 28, 2016.

Key Presentations of Interest

Oral Presentations for Elbasvir/Grazoprevir

Sunday, Nov. 15:

  • C-EDGE CO-STAR: Efficacy of Grazoprevir and Elbasvir in Persons
    Who Inject Drugs (PWID) Receiving Opioid Agonist Therapy (Abstract
    #40, 3:45 – 4:00 p.m. PST)
  • An Integrated Analysis of 402 Compensated Cirrhotic Patients With HCV
    Genotype (GT) 1, 4 or 6 Infection Treated With Grazoprevir/Elbasvir
    (Abstract #42, 4:15 – 4:30 p.m. PST)

Tuesday, Nov. 17:

  • High Efficacy of Grazoprevir/Elbasvir (GZR/EBR) in HCV Genotype 1, 4,
    and 6-Infected Patients With HIV Coinfection: SVR24 Data From the
    Phase 3 C-EDGE Coinfection Study (Abstract #210, 9:15 –
    9:30 a.m. PST)
  • High Efficacy of Grazoprevir and Elbasvir With or Without Ribavirin in
    103 Treatment-Naive and Experienced Patients With HCV Genotype 4
    Infection: A Pooled Analysis (Abstract #251, 12:15 – 12:30 p.m. PST)

Late-Breaking Presentations

Monday, Nov. 16:

  • Poster: Prevalence and Impact of Baseline NSA Resistance
    Associated Variants (RAVs) on the Efficacy of Elbasvir/Grazoprevir
    (EBR/GZR) against GT1a Infection (Abstract #LB-22)
  • Poster: Phase 2, Randomized, Open-Label Clinical Trials of the
    Efficacy and Safety of Grazoprevir and MK-3682 (NS5B Polymerase
    Inhibitor) with Either Elbasvir or MK-8408 (NS5A Inhibitor) in
    Patients with Chronic HCV GT1, 2 or 3 Infection (Part A of C-CREST-1
    & 2)
    (Abstract #LB-15)
  • Poster: C-SWIFT Retreatment (Part B): 12 weeks of
    Elbasvir/Grazoprevir with Sofosbuvir and Ribavirin Successfully
    Treated GT1-infected Subjects who Failed Short-Duration All-Oral
    Therapy (Abstract #LB-12)

Select Poster Presentations for Elbasvir/Grazoprevir

Saturday, Nov. 14:

  • Projected Long-Term Impact of Grazoprevir (GZR, MK-5172)/Elbasvir
    (EBR, MK-8742) in Treatment-Naive and Treatment-Experienced Patients
    with Hepatitis C Virus Genotype 1 Infection and Chronic Kidney Disease
    (Abstract #727)
  • C-EDGE Co-Infection: Impact of 12-Week Oral Regimen of
    Grazoprevir (GZR, MK-5172)/Elbasvir (EBR, MK-8742) on Patient-Reported
    Outcomes (PROs) in Treatment-Naïve Patients with HCV/HIV Co-infection
    (Abstract #729)
  • C-EDGE TN: Impact of 12-Week Oral Regimen of Grazoprevir (GZR,
    MK-5172)/Elbasvir (EBR, MK-8742) on Patient-Reported Outcomes (PROs)
    in Treatment-Naïve Patients with Chronic Hepatitis C Virus (HCV)
    Genotype (GT) 1, 4, or 6 Infection (Abstract #717)
  • High Efficacy of the Combination HCV Regimen Grazoprevir and Elbasvir
    for 8 or 12 Weeks With or Without Ribavirin in Treatment-Naive,
    Noncirrhotic HCV GT1b–Infected Patients: An Integrated Analysis
    (Abstract #701)
  • Predictors of Response to Grazoprevir/Elbasvir Among HCV Genotype 1
    (GT1)–Infected Patients: Integrated Analysis of Phase 2-3 Trials
    (Abstract #700)
  • Safety and Tolerability of Grazoprevir/Elbasvir in Patients With
    Chronic Hepatitis C (HCV) Infection: Integrated Analysis of Phase 2-3
    Trials (Abstract #712)
  • The Combination of Grazoprevir and Elbasvir ± RBV is Highly Effective
    for the Treatment of GT1a-Infected Patients (Abstract #703)
  • Efficacy, Safety And Pharmacokinetics Of Grazoprevir (MK-5172) And
    Elbasvir (MK-8742) In Hepatitis C Genotype 1 Infected Non-Cirrhotic
    Japanese Patients (Phase 2 Portion In Phase 2/3 Combined Study)
    (Abstract #707)

For more information, including a complete list of abstract titles,
please visit:

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 opiate substitution
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,
and connect with us on Twitter,
and YouTube.

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
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receive the necessary regulatory approvals or that they will prove to be
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including obtaining regulatory approval; the company’s ability to
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and other protections for innovative products; and the exposure to
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The company undertakes no obligation to publicly update any
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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 (

1 Elbasvir is an HCV NS5A replication complex inhibitor and
grazoprevir is an HCV NS3/4A protease inhibitor
MK-3682 is an oral prodrug HCV nucleotide analogue NS5B polymerase
3 MK-8408 is an HCV NS5A replication complex

Doris Li, 908-246-5701
Sarra Herzog, 908-740-1871
Teri Loxam, 908-740-1986
Justin Holko, 908-740-1879

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