Merck to Present New Data on ZEPATIER® (elbasvir and grazoprevir) and Investigational Combination Therapy MK-3682B for the Treatment of Chronic Hepatitis C Infection at The International Liver Congress™ 2017


April 5, 2017 5:50 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 as well as real-world studies
on ZEPATIER® (elbasvir and grazoprevir) 50mg/100mg tablets
will be presented at the upcoming International
Liver Congress™ 2017
. Seventeen scientific abstracts will be
presented, including oral sessions featuring real-world data on chronic
HCV-infected patients treated with ZEPATIER from the U.S. Department of
Veterans Affairs Healthcare System and new results from the

trial evaluating MK-3682B [uprifosbuvir (MK-3682)1/grazoprevir2/rusazvir3]
in patients with chronic HCV infection who have previously failed a HCV
direct-acting antiviral regimen. The International Liver Congress™ 2017
will take place in Amsterdam, Netherlands from April 19 – 23, 2017.

“We continue to generate new data on ZEPATIER while advancing our
ongoing investigational program evaluating uprifosbuvir in combination
with other assets, underscoring our continued commitment to chronic HCV
research,” said Dr. Eliav Barr, senior vice president, global clinical
development, infectious diseases and vaccines, Merck Research
Laboratories. “Findings from both randomized clinical trials and
real-world data analyses help us better understand the treatment of
diverse patient types, including those who have been historically
underserved or for whom unmet needs remain.”

In the United States, ZEPATIER is indicated for the treatment of chronic
HCV genotype (GT) 1 or GT4 infection in adults. ZEPATIER is indicated
for use with ribavirin (RBV) in certain patient populations. The U.S.
Prescribing Information for ZEPATIER contains a Boxed Warning about the
risk of hepatitis B virus (HBV) reactivation in patients co-infected
with HCV and HBV.

Key presentations at The International Liver Congress™ 2017 will include:

ZEPATIER (elbasvir and grazoprevir)

Thursday, April 20

  • Real-World Use of Elbasvir/Grazoprevir and Outcomes in Patients With
    Chronic Hepatitis C: Retrospective Data Analyses From the TRIO Network
    (Poster presentation, Abstract THU-239, 8:00 a.m. – 6:00 p.m. CEST)
  • Prevention of Liver-Related Complications With Elbasvir/Grazoprevir in
    Hepatitis C Infected Patients who are Receiving Opioid Agonist Therapy
    (OAT) (Poster presentation, Abstract THU-246, 8:00 a.m. – 6:00 p.m.
  • Real-World Utilization of the New Fixed-Dose Combination
    Elbasvir/Grazoprevir in Adult Patients With Chronic Hepatitis C in
    Canada: Z-PROFILE Study (Poster presentation, Abstract THU-266, 8:00
    a.m. – 6:00 p.m. CEST)
  • Clinically Meaningful Differences in Health-Related Quality of Life
    and Fatigue in Patients With Hepatitis C Virus (HCV) Infection Treated
    With Elbasvir/Grazoprevir (EBR/GZR) Compared to Sofosbuvir (SOF) With
    Pegylated Interferon and Ribavirin (PR) (Poster presentation, Abstract
    THU-245, 8:00 a.m. – 6:00 p.m. CEST)
  • Projected Long Term Impact of Elbasvir/Grazoprevir (EBR/GZR) Compared
    to Sofosbuvir Plus Pegylated Interferon/Ribavirin (SOF+PR) in Chronic
    Hepatitis C Virus Genotype 1 and 4 Patients in Italy: Translation of

    Head-2-Head Study Findings (Poster presentation, Abstract THU-247,
    8:00 a.m. – 6:00 p.m. CEST)
  • Safety and Efficacy of Elbasvir and Grazoprevir With or Without
    Ribavirin for the Treatment of Hepatitis C Virus Genotype 1: Results
    of the Hepatitis C Virus-TARGET Study (Poster presentation, Abstract
    THU-237, 8:00 a.m. – 6:00 p.m. CEST)

Friday, April 21

  • Real World Experience With Elbasvir/Grazoprevir in the Veterans
    Affairs Healthcare System (Oral presentation, Abstract PS-095, 4:00 –
    4:15 p.m. CEST)
  • Efficacy and Safety of Elbasvir/Grazoprevir in Treatment-Naïve
    Patients With Chronic HCV GT 1, GT 4 and GT 6 Infection (
    A Phase III Randomized Multinational Clinical Trial (Poster
    presentation, Abstract FRI-266, 8:00 a.m. – 6:00 p.m. CEST)
  • Elbasvir/Grazoprevir Plus Sofosbuvir in Treatment-Naive and
    Treatment-Experienced Cirrhotic Patients With Hepatitis C Virus
    Genotype 3 Infection Treated for 8, 12, or 16 weeks: Final Results of

    Study (Poster presentation, Abstract FRI-213, 8:00 a.m. – 6:00 p.m.
  • Successful Treatment of Patients With HCV GT3 Infection and Cirrhosis
    with Elbasvir/Grazoprevir Plus Sofosbuvir Does Not Correct Insulin
    Resistance by 12 weeks Post-Treatment (Poster presentation, Abstract
    FRI-215, 8:00 a.m. – 6:00 p.m. CEST)
  • Impact of Elbasvir/Grazoprevir (EBR/GZR) on Health-Related Quality of
    Life (HRQOL) and Fatigue in Patients With Chronic Hepatitis C Virus
    (HCV) Infection and Inherited Blood Disorders (IBLD): Data From the

    Study (Poster presentation, Abstract FRI-251, 8:00 a.m. –
    6:00 p.m. CEST)

Saturday, April 22

  • Elbasvir/Grazoprevir Effectiveness in Patients With Chronic Hepatitis
    C and Chronic Kidney Disease: Real-World Experience From the TRIO
    Network (Poster presentation, Abstract SAT-297, 8:00 a.m. – 6:00 p.m.


Thursday, April 20

  • Efficacy and Safety of the Fixed-Dose Combination Regimen of MK3
    [MK-3682/Grazoprevir/Ruzasvir] With or Without Ribavirin in
    Non-Cirrhotic or Cirrhotic Patients With Chronic HCV GT1, 2, 3, 4 or 6
    Infection (Parts A & B of


    (Poster presentation, Abstract THU-285, 8:00 a.m. – 6:00 p.m. CEST)
  • High Sustained Virologic Response Rates in Patients With Chronic HCV
    GT1, 2 or 3 Infection Following 16 Weeks of
    MK-3682/Grazoprevir/Ruzasvir Plus Ribavirin After Having Failed 8
    Weeks of a Triplet Drug Regimen (Part C of


    (Poster presentation, Abstract THU-264, 8:00 a.m. – 6:00 p.m. CEST)

Saturday, April 22

  • Safety and Efficacy of the Fixed-Dose Combination Regimen of
    MK-3682/Grazoprevir/Ruzasvir in Cirrhotic or Non-Cirrhotic Patients
    With Chronic HCV GT1 Infection who Previously Failed a Direct-Acting
    Antiviral Regimen (
    (Oral presentation, Abstract PS-159, 9:30 a.m. – 9:45 a.m. CEST)

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



(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 for the treatment of chronic
HCV GT1 or 4 infection in adults. ZEPATIER is indicated for use with
ribavirin (RBV) in certain patient populations. ZEPATIER is not
indicated to treat chronic HCV GT3 or GT6 infection. ZEPATIER has been
approved in over 17 countries worldwide, including the United States,
Canada, the European Union, Switzerland, Israel, Saudi Arabia,
Australia, Japan, Vietnam, Georgia, Korea, New Zealand, Mexico, Taiwan,
Egypt, Bahrain, and Argentina, with additional regulatory approvals

Selected Safety Information about ZEPATIER

The U.S. Prescribing Information for ZEPATIER contains a Boxed Warning
about the risk of hepatitis B virus (HBV) reactivation in patients
coinfected with HCV and HBV. Healthcare professionals should test all
patients for evidence of current or prior HBV infection by measuring
hepatitis B surface antigen (HBsAg) and hepatitis B core antibody
(anti-HBc) before initiating treatment with ZEPATIER. HBV reactivation
has been reported in HCV/HBV coinfected patients who were undergoing or
had completed treatment with HCV direct-acting antivirals and were not
receiving HBV antiviral therapy. Some cases have resulted in fulminant
hepatitis, hepatic failure, and death. Healthcare professionals should
monitor HCV/HBV coinfected patients for clinical and laboratory signs of
hepatitis flare or HBV reactivation during HCV treatment and
post-treatment follow-up. Healthcare professionals should initiate
appropriate patient management for HBV infection as clinically indicated.

HBV reactivation has been reported in HBsAg positive patients and also
in patients with serologic evidence of resolved HBV infection (i.e.,
HBsAg negative and anti-HBc positive). The risk of HBV reactivation may
be increased in patients receiving some immunosuppressant or
chemotherapeutic agents. HBV reactivation is characterized as an abrupt
increase in HBV replication manifesting as a rapid increase in serum HBV
DNA level. In patients with resolved HBV infection, reappearance of
HBsAg can occur. Reactivation of HBV replication may be accompanied by
hepatitis, i.e., increases in aminotransferase levels and, in severe
cases, increases in bilirubin levels, liver failure, and death can occur.

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
inhibitors of organic anion transporting polypeptides 1B1/3 (OATP1B1/3)
that are known or expected to significantly increase grazoprevir plasma
concentrations (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 (elbasvir and grazoprevir) 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

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
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rate and currency exchange rate fluctuations; the impact of
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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
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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 2016 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

2 Grazoprevir is an HCV NS3/4A protease inhibitor (100mg).

3 Rusazvir (MK-8408) is an HCV NS5A inhibitor.

Doris Li, 908-740-1903
Michael Close, 267-305-1211
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898

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