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 C-SURGE 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. CEST)
- 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 the C-EDGE
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 (C-CORAL): 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 the C-ISLE Study (Poster presentation,
Abstract FRI-213, 8:00 a.m. – 6:00 p.m. CEST)
- 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 C-EDGE IBLD 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. CEST)
MK-3682B, INVESTIGATIONAL TRIPLE THERAPY
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
C-CREST-1 & 2) (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 C-CREST-1 &
2) (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 (C-SURGE) (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: http://ilc-congress.eu/.
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 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 anticipated.
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
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
www.merck.com and connect with us on Twitter, Facebook, YouTube 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 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 (www.sec.gov).
Please see Prescribing Information for ZEPATIER (elbasvir and
grazoprevir) at
http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf
and the Patient Information for ZEPATIER at
http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_ppi.pdf.
1 MK-3682 is an HCV nucleotide analogue NS5B polymerase
inhibitor.
2 Grazoprevir is an HCV NS3/4A protease inhibitor (100mg).
3 Rusazvir (MK-8408) is an HCV NS5A inhibitor.
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