Merck to Present New Data on ZEPATIER® (elbasvir and grazoprevir) for the Treatment of Chronic Hepatitis C Virus Infection at The Liver Meeting® 2017


October 3, 2017 5:55 am ET

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside of the United States and Canada,
today announced that data from the company’s chronic hepatitis C
clinical development programs and real-world studies are scheduled to be
presented at The
Liver Meeting® 2017
. These data presentations include new
analyses of ZEPATIER
(elbasvir and grazoprevir) in
real-world settings and follow-up analyses from Phase 3 clinical trials,
including findings from the

three-year observational follow-up study evaluating
chronic hepatitis C virus (HCV) reinfection incidence and risk behaviors
in patients who were treated with ZEPATIER while on opioid agonist
therapy (OAT). The Liver Meeting® 2017 will take place in
Washington, D.C., from Oct. 20-24, 2017.

“Merck has been a leader in chronic hepatitis C for more than 30 years.
Now, with the availability of treatments such as ZEPATIER, we believe
our focus needs to be on understanding its application in the real
world,” said Dr. Michael Robertson, executive director of clinical
research, Merck Research Laboratories. “Analysis of data from patients
treated with ZEPATIER around the world provides important insights that
may help inform elimination efforts, particularly among
difficult-to-treat populations.”

In the United States, ZEPATIER is indicated for the treatment of chronic
HCV genotype (GT) 1 or 4 infection in adults. ZEPATIER is indicated for
use with ribavirin 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 coinfected with HCV and

Key presentations at The Liver Meeting® 2017 will include:



(elbasvir and grazoprevir)
50mg/100mg tablets

Saturday, October 21

  • Effectiveness of Elbasvir/Grazoprevir in Patients With Chronic
    Hepatitis C and Chronic Kidney Disease: Results From the Veterans
    Affairs System (Poster presentation, Abstract 1113, 2:00 p.m. – 7:30
    p.m. EDT)
  • A Pragmatic Approach to Optimizing the Efficacy of
    Elbasvir/Grazoprevir Using Baseline Viral Load in Participants With
    Hepatitis C Virus (HCV) Genotype (GT)1a Infection: A Post Hoc Analysis
    of 11 Clinical Trials (Poster presentation, Abstract 1124, 2:00 p.m. –
    7:30 p.m. EDT)
  • Impact of Treatment Duration and Ribavirin (RBV) Addition on
    Real-World Effectiveness of Elbasvir/Grazoprevir (EBR/GZR) in Select
    Patient Subgroups With Genotype 1 (GT1) Chronic Hepatitis C (HCV):
    Retrospective Data Analyses From the Trio Network. (Poster
    presentation, Abstract 1128, 2:00 p.m. – 7:30 p.m. EDT)
  • Real-World Cost-Effectiveness of Elbasvir/Grazoprevir (EBR/GZR) in
    Treatment-Naive (TN) Patients With Chronic Hepatitis C (CHC) Virus
    Genotype 1 (GT1) in the United States (US) (Poster presentation,
    Abstract 1155, 2:00 p.m. – 7:30 p.m. EDT)

Sunday, October 22

  • Safety and Efficacy of Elbasvir/Grazoprevir in Asian Participants With
    Hepatitis C Virus Genotypes 1 and 4 Infection: An Integrated Analysis
    of Data From 11 Phase 2/3 Trials (Poster presentation Abstract 1522,
    8:00 a.m. – 5:30 p.m. EDT)
  • Co-Morbidities and Clinically Relevant Drug-Drug Interactions (DDIs)
    in Patients Undergoing Treatment of Chronic HCV Genotype 1 (GT1)
    Infection With Elbasvir (EBR)/Grazoprevir (GZR): Results From the
    German Hepatitis C Registry (DHC-R) (Poster presentation, Abstract
    1546, 8:00 a.m. – 5:30 p.m. EDT)
  • Utilization and Effectiveness of Elbasvir/Grazoprevir (EBR/GZR) in
    Treatment Naïve (TN) Genotype 1a (G1a) Chronic Hepatitis C Virus (HCV)
    Patients With/Without Baseline NS5A Resistance-Associated
    Substitutions (RASs) (Poster presentation, Abstract 1568, 8:00 a.m. –
    5:30 p.m. EDT)
  • Safety and Efficacy of Elbasvir (EBR)/Grazoprevir (GZR) in Hepatitis C
    Virus (HCV) GT1- and GT4-infected Participants 65 Years and Older: An
    Integrated Analysis of Twelve Clinical Trials (Poster presentation,
    Abstract 1589, 8:00 a.m. – 5:30 p.m. EDT)

Monday, October 23

  • Hepatitis C Virus (HCV) Reinfection and Injecting Risk Behavior
    Following Elbasvir (EBR)/Grazoprevir (GZR) Treatment in Participants
    on Opiate Agonist Therapy: Co-STAR Part B (Oral presentation, Abstract
    195, 3:30 p.m. – 3:45 p.m. EDT)


Saturday, October 21

  • Epidemiologic Impact of Expanding Chronic Hepatitis C (CHC) Treatment
    in People who Inject Drug (PWID) in the United States (US): A
    Mathematical Model Using Data From the C-EDGE CO-STAR Study (Poster
    presentation, Abstract 976, 2:00 p.m. – 7:30 p.m. EDT)
  • Economic Burden of Chronic Hepatitis C (CHC) in Medicaid and
    Commercially Insured Patients in the United States (Poster
    presentation, Abstract 1008, 2:00 p.m. – 7:30 p.m. EDT)
  • Perceived Barriers Related to the Management of HCV Infection Among
    Physicians Prescribing Opioid Agonist Therapy: The C-SCOPE Study
    (Poster presentation, Abstract 1064, 2:00 p.m. – 7:30 p.m. EDT)

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

Selected Safety Information about ZEPATIER

The US 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 (ie, 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, ie, increases in aminotransferase levels and, in severe
cases, increases in bilirubin levels, liver failure, and death can occur.

ZEPATIER (elbasvir and grazoprevir) 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 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 (elbasvir and grazoprevir) 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 more than a century, Merck, a leading global biopharmaceutical
company known as MSD outside of the United States and Canada, has been
inventing for life, bringing forward medicines and vaccines for many of
the world’s most challenging diseases. 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. Today, Merck continues to be at the forefront of
research to advance the prevention and treatment of diseases that
threaten people and communities around the world – including cancer,
cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease
and infectious diseases including HIV and Ebola. For more information,
and connect with us on TwitterFacebookInstagram,
and LinkedIn.

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“company”) includes “forward-looking statements” within the meaning of
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The company undertakes no obligation to publicly update any
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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), including the Boxed Warning about the risk of HBV
reactivation in patients coinfected with HCV and HBV, at

and Patient Information for ZEPATIER at

Pam Eisele, 267-305-3558
Michael Close, 267-305-1211
Teri Loxam, 908-740-1986
Amy Klug, 908-740-1898

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