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
C-EDGE CO-STAR 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 HBV.
Key presentations at The Liver Meeting® 2017 will include:
ZEPATIER® (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)
ADDITIONAL STUDIES OF NOTE
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:
http://www.aasld.org/events-professional-development/liver-meeting.
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,
visit www.merck.com and connect with us
on Twitter, Facebook, Instagram, 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), including the Boxed Warning about the risk of HBV
reactivation in patients coinfected with HCV and HBV, at
http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf
and Patient Information for ZEPATIER at
http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_ppi.pdf
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MerckMedia:Pam Eisele, 267-305-3558Michael Close,
267-305-1211orInvestors:Teri Loxam, 908-740-1986Amy Klug,
908-740-1898
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