Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, today announced the publication of results from C-EDGE
CO-STAR. C-EDGE CO-STAR is a Phase 3 trial evaluating the use of
ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg tablets in patients
with chronic hepatitis C (HCV) genotype (GT) 1, GT4 and GT6
infection receiving opioid agonist therapy (OAT) (methadone and
buprenorphine), commonly used to treat opioid addiction. The
results, recently published online in the Annals of Internal
Medicine, showed treatment with 12 weeks of ZEPATIER resulted in
high rates of sustained virologic response 12 weeks after the
completion of therapy (SVR12, considered virologic cure based on
undetectable HCV RNA levels). These results and full study design
were previously presented at The Liver Meeting® in November
2015.
“C-EDGE CO-STAR is the first phase 3 clinical trial dedicated to
evaluating direct-acting antiviral therapy for chronic hepatitis C
infection in patients on opioid agonist therapy without excluding
patients actively using drugs with high abuse potential,” said Dr.
Alain Litwin, professor of medicine and psychiatry and behavioral
sciences at Albert Einstein College of Medicine, New York. “This
study demonstrates that people who inject drugs can be effectively
treated with direct-acting antiviral therapy.”
The published efficacy results from the randomized,
double-blind, placebo-controlled C-EDGE CO-STAR trial showed 92
percent (184/201) of patients receiving ZEPATIER for 12 weeks in
the study’s immediate treatment group achieved SVR12, with
comparable rates across GT1a (94%, 144/154), GT1b (93%, 28/30) and
GT4 (92%, 11/12) patients; in the limited number of GT6 patients,
SVR12 was 20 percent (1/5). These results classify patients who
cleared their baseline infection but subsequently acquired a new
infection as treatment failures; previously presented results from
this trial considered these patients as treatment successes,
according to the study protocol. A supportive analysis showed that
the vast majority of patients were adherent to therapy, despite
ongoing use of drugs of potential abuse (e.g., cocaine, heroin,
amphetamines) by the majority of patients throughout the trial. The
rates of adverse events were generally comparable between active
treatment and placebo groups, with the most common adverse events
(greater than 10%) in both groups including fatigue (16%, 20%),
headache (12%, 13%) and nausea (11%, 9%), respectively. Secondary
efficacy endpoint (SVR24) and reinfection analyses were presented
at The International Liver Congress™ in April 2016.
“Merck continues to take a leadership role in exploring the
potential to treat chronic hepatitis C infection in underserved and
undertreated patient populations, including those who continue to
use illicit drugs,” said Dr. Eliav Barr, vice president, infectious
diseases, Merck Research Laboratories. “These findings contribute
to the robust body of evidence supporting the efficacy and safety
profile of ZEPATIER in a broad range of patients with chronic
hepatitis C genotype 1 or genotype 4 infection.”
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, and is indicated with or without ribavirin
(RBV) for treatment of chronic HCV GT 1 or 4 infection in adults.
ZEPATIER is not indicated to treat chronic HCV GT6 infection.
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.
About Chronic HCV Infection and Injection Drug Use
Injection drug use is responsible for the majority of new and
existing HCV infections in high-income countries. It is estimated
that 60 to 80 percent of people who inject drugs are tested
positive with chronic HCV infection.
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
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MerckMedia:Pamela Eisele, 267-305-3558orSarra Herzog,
201-669-6570orInvestor:Teri Loxam, 908-740-1986orAmy Klug,
908-740-1898
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