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: CO-STAR 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 (C-CORAL): 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)
INVESTIGATIONAL TRIPLE-THERAPY REGIMEN
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 of C-CREST 1 & 2) (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 C-CREST 1 & 2) (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 (C-SURGE) (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:
http://www.aasld.org/events-professional-development/liver-meeting.
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
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 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 (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 Rusazvir (MK-8408) is an HCV NS5A inhibitor
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MerckMedia:Doris Li, 908-740-1903Ian McConnell,
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