Merck (NYSE:MRK), known as MSD outside of the United States and
Canada, today announced results from multiple analyses at The Liver
Meeting® 2016, which provide additional evidence supporting the use
of ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg tablets in
chronic hepatitis C virus (HCV) genotype (GT) 1- or GT4-infected
patient populations, including those who receive opioid agonist
therapy (OAT), are infected with chronic HCV GT1b, use proton pump
inhibitors (PPIs) or have moderate kidney disease.
“Work remains to be done in the community’s efforts to reduce
the global burden of chronic hepatitis C, and Merck is committed to
pursuing this goal,” said Dr. Eliav Barr, senior vice president,
global clinical development, infectious diseases and vaccines,
Merck Research Laboratories. “Our clinical development program
continues to yield meaningful evidence for ZEPATIER in specific
patient populations.”
C-EDGE CO-STAR: Interim Results from the Three Year
Follow-Up (3YFU) Trial (Abstract #871)
The CO-STAR Three Year Follow-Up (3YFU) Trial is an
observational cohort study to evaluate chronic HCV reinfection and
injecting risk behaviors in patients who were treated with ZEPATIER
during the C-EDGE CO-STAR study. C-EDGE CO-STAR is a Phase 3
clinical trial including patients with chronic HCV GT1, GT4 and/or
GT6 infection who are on OAT (methadone and buprenorphine). The
study does not exclude patients who are actively using drugs with
high abuse potential. Primary efficacy and safety results from
C-EDGE CO-STAR were previously presented at The Liver Meeting® in
November 2015. Interim results presented today are from the ongoing
3YFU study.
The median time from the end-of-treatment (EOT) in the C-EDGE
CO-STAR study to the first visit as part of the 3YFU study was 330
days (range: 206-485). Of the 199 patients in the 3YFU study, 108
(54%) reported any drug use (non-injecting or injecting) in the
past six months, 40 of whom (37%) reported injection drug use in
the past month. At the first visit in the 3YFU study, two
individuals (1%) tested positive for evidence of HCV, suggesting
that chronic HCV reinfection was uncommon among patients on OAT in
the first year following treatment with ZEPATIER, despite ongoing
drug use.
GT1b Integrated Analysis (Abstract #874)
A retrospective integrated analysis of data from 11 Phase 2 and
Phase 3 trials in the clinical development program for ZEPATIER was
conducted to evaluate its efficacy in patients infected with GT1b,
the most common chronic HCV genotype globally and the second-most
common in the United States. The analysis included 1,070 patients
with chronic HCV GT1b infection who received ZEPATIER for 12 weeks,
including: patients who were treatment naïve or had prior
experience with peginterferon alfa/interferon and ribavirin (RBV),
with or without an NS3/4A protease inhibitor; those who were
compensated cirrhotic or non-cirrhotic; and those with or without
HIV-1 co-infection.
The analysis showed 97 percent of patients (1040/1070) achieved
sustained virologic response 12 weeks after the completion of
therapy (SVR12, considered virologic cure). Of the patients who did
not achieve SVR12, 15 were virologic failures (1%) and 15 patients
were lost to follow-up (1%). Rates of SVR12 were consistently high
regardless of patient characteristics, including prior treatment
experience (97%, 212/219), presence of compensated cirrhosis (99%,
188/189) and HIV-1 co-infection (94%, 51/54).
Serious adverse events occurred in 3 percent of patients
(35/1070) who received active treatment, and 2.9 percent (3/105) of
those who received placebo in studies that included a placebo
arm.
Pooled Analysis in Patients with Self-Reported PPI Use
(Abstract #869)
This post-hoc analysis of patients with chronic HCV GT1 and GT4
infection in six studies in the Phase 3 clinical program for
ZEPATIER assessed SVR12 among patients who self-reported
concomitant use of proton pump inhibitors (PPIs). Pharmacokinetic
interactions leading to reduced drug concentrations have previously
been reported for some HCV NS5A inhibitors when given concomitantly
with PPIs.
Overall, 12 percent (162/1322) of patients in the post-hoc
analysis who received ZEPATIER reported baseline use of PPIs. Of
those patients, 96 percent (155/162) achieved SVR12, compared to 97
percent (1129/1160) of patients without PPI use, suggesting that
PPI use was not a predictive factor in achieving SVR12.
This abstract received Presidential Poster of Distinction
recognition at The Liver Meeting® 2016.
Pooled Dataset Analysis in Patients with Moderate Kidney
Disease (Abstract #889)
This integrated analysis of data from the Phase 2 and Phase 3
clinical development program for ZEPATIER was conducted to evaluate
its impact on renal function, including in patients with chronic
kidney disease (CKD) stage 3 (estimated glomerular filtration rate
[eGFR] less than 60 and greater than or equal to 30
mL/min/1.73m2).1 The safety and efficacy profile of ZEPATIER in
patients with more severe renal disease was described in the
C-SURFER study, presented at the International Liver Congress™ in
April 2015 and subsequently published in The Lancet by Roth et
al.
The analysis included 32 patients with stage 3 CKD and 1,657
patients with eGFR greater than or equal to 60 mL/min/1.73m2 who
were treated with ZEPATIER with or without RBV for 8 (n=91, 5%), 12
(n=1238, 73%), 16 (n=211, 12%), or 18 (n=149, 9%) weeks. Among the
32 patients with stage 3 CKD, kidney function improved or remained
stable in 38 percent (12/32) and 63 percent (20/32), respectively,
at the end of treatment.
About ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg
Tablets
ZEPATIER is a fixed-dose combination product containing
elbasvir, an 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 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 Estimated glomerular filtration rate (eGFR) is a measure of
kidney function.
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