Merck to Present New Data on ZEPATIER™ (elbasvir and grazoprevir) and Chronic Hepatitis C Clinical Development Programs at The Liver Meeting® 2016


October 3, 2016 7:00 am ET

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside of the United States and Canada,
today announced that new data from the company’s chronic hepatitis C
virus (HCV) clinical development programs will be presented at The
Liver Meeting® 2016
. Fifteen scientific abstracts,
including seven oral and eight poster presentations, will highlight
findings from Merck’s HCV clinical development programs. The data
include evaluations of ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg
tablets and the company’s investigational MK-3682B (MK-36821/grazoprevir2/rusazvir)
in a broad range of patients with chronic HCV infection. The Liver
Meeting® 2016 will take place in Boston, MA, from November
11-15, 2016.

“Merck has been a part of the fight against chronic hepatitis C
infection for more than 30 years, and that fight continues. Chronic
hepatitis C is a complex infectious disease that affects tens of
millions of patients globally, each with their own personal
circumstances, co-morbidities and challenges,” said Dr. Eliav Barr,
senior vice president, global clinical development, infectious diseases
and vaccines, Merck Research Laboratories. “At AASLD this year,
researchers will share data from numerous studies that are underway to
better understand the potential of ZEPATIER and our investigational
medicines in diverse patient populations.”

Key presentations at The Liver Meeting® 2016 will include:

ZEPATIER (elbasvir and grazoprevir)

Saturday, November 12

  • HCV reinfection and injecting risk behavior following
    elbasvir/grazoprevir treatment in patients on opioid agonist therapy:

    Three Year Follow-up Study (Poster presentation, Abstract #871, 2:00
    p.m. – 7:30 p.m. EDT)
  • High Efficacy in Patients With Chronic Hepatitis C Virus (HCV)
    Genotype (GT)1b Infection Treatment With Elbasvir/Grazoprevir for 12
    Weeks: An Integrated Analysis (Poster presentation, Abstract #874,
    2:00 p.m. – 7:30 p.m. EDT)
  • Concomitant Proton Pump Inhibitor Use Does Not Reduce the Efficacy of
    Elbasvir/Grazoprevir (Poster presentation, Abstract #869, 2:00 p.m. –
    7:30 p.m. EDT)
  • Elbasvir/Grazoprevir (EBR/GZR) Does Not Worsen Renal Function in
    Patients With Hepatitis C Virus (HCV) Infection and Pre-existing Renal
    Disease (Poster presentation, Abstract #889, 2:00 p.m. – 7:30 p.m. EDT)
  • Final Results from Phase 3 Portion in Phase 2/3 Study of Elbasvir /
    Grazoprevir in Hepatitis C Genotype 1 Infected Japanese Patients
    (Poster presentation, Abstract #851, 2:00 p.m. – 7:30 p.m. EDT)

Sunday, November 13

  • Efficacy and Safety of Elbasvir/Grazoprevir in Treatment-Naïve
    Subjects with Chronic HCV GT1, GT4 and GT6 Infection (
    A Phase III Randomized Multinational Clinical Trial (Oral
    presentation, Abstract #76, 3:45 p.m. – 4:00 p.m. EDT)

  • C-ISLE
    Grazoprevir/Elbasvir plus Sofosbuvir in Treatment-naïve and
    Treatment-experienced HCV GT3 Cirrhotic Patients Treated for 8, 12 or
    16 weeks (Oral presentation, Abstract #74, 3:15 p.m. – 3:30 p.m. EDT)


Sunday, November 13

  • Safety and Efficacy of the Fixed-Dose Combination Regimen of
    MK-3682/Grazoprevir/MK-8408 With or Without Ribavirin in Non-cirrhotic
    or Cirrhotic Patients with Chronic HCV GT1, 2 or 3 Infection (Part B

    (Oral presentation, Abstract #110, 5:00 p.m. – 5:15 p.m. EDT)
  • High Sustained Virologic Response (SVR) Rates in Patients with Chronic
    HCV GT1, 2 or 3 Infection Following 16 Weeks of
    MK-3682/Grazoprevir/MK-8408 Plus Ribavirin After Failure of 8 Weeks of
    Therapy (Part C of

    (Oral presentation, Abstract #112, 5:30 p.m. – 5:45 p.m. EDT)

Monday, November 14

  • Safety and Efficacy of the Fixed-Dose Combination Regimen of
    MK-3682/Grazoprevir/MK-8408 in Cirrhotic or Non-cirrhotic Patients
    with Chronic HCV GT1 Infection who Previously Failed a Direct-acting
    Antiviral Regimen (
    (Oral presentation, Abstract #193, 3:00 p.m. – 3:15 p.m. EDT)

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

About ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg Tablets

ZEPATIER is a fixed-dose combination product containing elbasvir, a HCV
NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor. In
the United States, ZEPATIER is indicated with or without ribavirin (RBV)
for treatment of chronic HCV GT1 or 4 infection in adults. ZEPATIER is
not indicated to treat chronic HCV GT3 or GT6 infection. ZEPATIER was
approved in the United States on January 28, 2016 and is also approved
in the European Union, Canada, Japan, Australia, Saudi Arabia, Israel
and Switzerland, with additional regulatory approvals anticipated.

Selected Safety Information about ZEPATIER

ZEPATIER is not for use in patients with moderate or severe hepatic
impairment (Child Pugh B or C). ZEPATIER is also not for use with
organic anion transporting polypeptides 1B1/3 (OATP1B1/3) inhibitors
(e.g., atazanavir, darunavir, lopinavir, saquinavir, tipranavir,
cyclosporine), strong cytochrome P450 3A (CYP3A) inducers (e.g.,
carbamazepine, phenytoin, rifampin, St. John’s Wort), and efavirenz. If
ZEPATIER is administered with RBV, healthcare professionals should refer
to the prescribing information for RBV as the contraindications,
warnings and precautions, adverse reactions and dosing for RBV also
apply to this combination regimen.

Elevations of alanine transaminase (ALT) to greater than 5 times the
upper limit of normal (ULN) occurred in 1% of subjects, generally at or
after treatment week 8. These late ALT elevations were typically
asymptomatic and most resolved with ongoing or completion of therapy.
Healthcare professionals should perform hepatic lab testing on patients
prior to therapy, at treatment week 8, and as clinically indicated. For
patients receiving 16 weeks of therapy, additional hepatic lab testing
should be performed at treatment week 12.

Patients should be instructed to consult their healthcare professional
without delay if they have onset of fatigue, weakness, lack of appetite,
nausea and vomiting, jaundice or discolored feces. Healthcare providers
should consider discontinuing ZEPATIER if ALT levels remain persistently
greater than 10 times ULN. ZEPATIER should be discontinued if ALT
elevation is accompanied by signs or symptoms of liver inflammation or
increasing conjugated bilirubin, alkaline phosphatase, or international
normalized ratio.

The concomitant use of ZEPATIER with certain drugs may lead to adverse
reactions or reduced therapeutic effect due to drug interactions.
Certain strong CYP3A inhibitors may increase the plasma concentration of
ZEPATIER, leading to possibly clinically significant adverse reactions.
Moderate CYP3A inducers may decrease the plasma concentration of
ZEPATIER, leading to reduced therapeutic effect and possible development
of resistance. Coadministration of ZEPATIER with these drugs is not
recommended. Physicians should consult the Prescribing Information for
potential drug interactions.

In subjects receiving ZEPATIER for 12 weeks, the most commonly reported
adverse reactions of all intensity (greater than or equal to 5% in
placebo-controlled trials) were fatigue, headache and nausea. In
subjects receiving ZEPATIER with RBV for 16 weeks, the most commonly
reported adverse reactions of moderate or severe intensity (greater than
or equal to 5%) were anemia and headache.

Selected Dosage and Administration Information for ZEPATIER (elbasvir
and grazoprevir)

ZEPATIER is a single tablet taken once daily. The recommended dosing is
12 or 16 weeks with or without RBV, depending on HCV genotype, prior
treatment history and, for patients with genotype 1a infection, presence
of certain baseline NS5A resistance-associated polymorphisms. See
Prescribing Information for ZEPATIER for specific dosage regimens and
durations. Refer to RBV prescribing information for RBV dosing and
dosage modifications when ZEPATIER is given with RBV. To determine
dosage regimen and duration of ZEPATIER for genotype 1a patients,
testing for the presence of virus with one or more baseline NS5A
resistance-associated polymorphisms at positions 28, 30, 31, or 93 is
recommended prior to initiating treatment.

Merck’s Commitment to HCV

For more than 30 years, Merck has been at the forefront of the response
to the HCV epidemic. Merck’s chronic HCV clinical development programs
have included more than 135 clinical trials in approximately 40
countries and have enrolled nearly 10,000 participants. As part of our
longstanding leadership in infectious diseases, Merck collaborates with
the scientific and patient communities to develop and deliver innovative
solutions to support people living with chronic HCV worldwide.

About Merck

For 125 years, Merck has been 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
and connect with us on Twitter,
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 2015 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 (

Please see Prescribing Information for ZEPATIER (elbasvir and
grazoprevir) at

and the Patient Information for ZEPATIER at

1 MK-3682 is an HCV nucleotide analogue NS5B polymerase inhibitor
2 Rusazvir (MK-8408) is an HCV NS5A inhibitor

Doris Li, 908-740-1903
Ian McConnell, 908-740-1921
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898

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