Merck to Present New Data on VICTRELIS® (boceprevir) and Investigational Compounds MK-5172 and Vaniprevir for Chronic Hepatitis C Virus at The International Liver CongressTM / 2013 EASL Annual Meeting
April 8, 2013 9:37 am ET
Merck (NYSE: MRK), known as MSD outside of the United States and Canada,
announced today that two analyses of VICTRELIS (boceprevir) and data
from Phase II studies of two of Merck’s investigational medicines for
chronic hepatitis C virus (HCV) genotype 1, MK-5172 and vaniprevir
(MK-7009), will be presented at the 2013 International Liver Congress
(EASL) Annual Meeting. The meeting will take place in Amsterdam from
April 24-28, 2013.
Key Presentations About VICTRELIS 200 mg Capsules
Safety And Efficacy Of Boceprevir/Peginterferon/Ribavirin (Boc/P/R)
Combination Therapy For Chronic HCV G1 Patients With Compensated
Cirrhosis: A Meta-Analysis Of Five Phase III Clinical Trials, J.M.
Vierling et al. Late Breaker. Thursday, April 25, 9:00- 18:00. RAI
Virologic Response Rates Are Similar In Previously Untreated And
Previously Treated And Relapsed Patients Receiving Boceprevir Triple
Therapy: A Retrospective Analysis. Bacon, B. et al. Poster 791.
Friday, April 26, 12:30-14:00. RAI Convention Centre.
Key Investigational Compound Presentations
High Sustained Viral Response at 12- and 24-week follow-up of MK-5172
with Pegylated Interferon alfa-2b and Ribavirin (PR) in HCV Genotype 1
Treatment-naïve Non-cirrhotic Patients. Manns, M. et al. Oral
Presentation: Friday, April 26, 16:00-18:00, RAI Convention Centre.
MK-5172 In Combination With Peg-Interferon And Ribavirin Elicits
Limited Resistance While Demonstrating Robust Efficacy In Treatment
Naïve Genotype 1 Chronic HCV-Infected Patients. Howe, A. et al. Poster
1197. Saturday, April 27, 12:30-13:30. RAI Convention Centre.
Sustained Viral Response And Safety Of MK-7009 In Cirrhotic
Treatment-Experienced Patients With Genotype 1 HCV Infection Who Have
Failed Previous Pegylated Interferon And Ribavirin Treatment.
Rodriguez-Torres, M. et al. Oral Presentation. Saturday, April 27,
8:30-10:30. RAI Convention Centre.
“We are pleased to present new data on VICTRELIS that will help inform
health care professionals as they consider the use of VICTRELIS in
appropriate patients,” said Eliav Barr, M.D., vice president, Infectious
Diseases, Project Leadership and Management, Merck Research
Laboratories. “Merck is committed to helping reduce the burden of this
serious disease worldwide. We look forward to sharing our new data about
VICTRELIS and Merck’s investigational medicines for chronic hepatitis C
with the global scientific community.”
MK-5172 is an investigational, once-daily, oral HCV NS3/4A protease
inhibitor currently in Phase II development. Vaniprevir is an oral,
twice-daily HCV NS3/4A protease inhibitor in Phase III development in
Japan for the treatment of genotype 1 patients.
The abstracts were published today and can be accessed on the EASL
website. For program information, please visit http://www2.kenes.com/liver-congress/pages/home.aspx.
Indications and usage for VICTRELIS
VICTRELIS® (boceprevir) is indicated for the treatment
of chronic hepatitis C virus (HCV) genotype 1 (G1) infection, in
combination with peginterferon alfa and ribavirin (PR), in adult
patients (18 years and older) with compensated liver disease, including
cirrhosis, who are previously untreated or who have failed previous
interferon and ribavirin therapy, including prior null responders,
partial responders, and relapsers.
The following points should be considered when initiating VICTRELIS for
treatment of chronic HCV infection:
VICTRELIS must not be used as monotherapy
and should only be used in combination with PR.
The efficacy of VICTRELIS has not been studied in patients who have
previously failed therapy with a treatment regimen that includes
VICTRELIS or other HCV NS3/4A protease inhibitors.
Poorly interferon responsive patients who were treated with VICTRELIS
in combination with PR have a lower likelihood of achieving a
sustained virologic response (SVR), and a higher rate of detection of
resistance-associated substitutions upon treatment failure, compared
to patients with a greater response to PR.
Important safety information about VICTRELIS
All contraindications to PR also apply since VICTRELIS must be
administered with PR. Because ribavirin may cause birth defects and
fetal death, VICTRELIS in combination with PR is contraindicated in
pregnant women and in men whose female partners are pregnant. Avoid
pregnancy in female patients and female partners of male patients.
Patients must have a negative pregnancy test prior to therapy; have
monthly pregnancy tests; and use 2 or more forms of effective
contraception during treatment and for at least 6 months after treatment
has concluded. One of these forms of contraception can be a combined
oral contraceptive product containing at least 1 mg of norethindrone.
Oral contraceptives containing lower doses of norethindrone and other
forms of hormonal contraception have not been studied or are
VICTRELIS is contraindicated in patients with a history of a
hypersensitivity reaction to VICTRELIS. VICTRELIS is contraindicated in
coadministration with drugs that are highly dependent on CYP3A4/5 for
clearance, and for which elevated plasma concentrations are associated
with serious and/or life-threatening events. VICTRELIS is also
contraindicated in coadministration with potent CYP3A4/5 inducers, where
significantly reduced VICTRELIS plasma concentrations may be associated
with reduced efficacy. Drugs that are contraindicated with VICTRELIS
include: alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin,
dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride,
St. John’s Wort (hypericum perforatum), lovastatin, simvastatin,
drospirenone, Revatio® (sildenafil) or Adcirca®
(tadalafil) (when used for the treatment of pulmonary arterial
hypertension), pimozide, triazolam, and orally administered midazolam.
Anemia and/or Neutropenia – The addition of VICTRELIS to PR is
associated with an additional decrease in hemoglobin concentrations
compared with PR alone and/or may result in worsening of neutropenia
associated with PR therapy alone. Dose reduction or discontinuation of
peginterferon alfa and/or ribavirin may be required. If peginterferon
alfa or ribavirin is permanently discontinued, VICTRELIS must also be
discontinued. Dose reduction of VICTRELIS is not recommended. VICTRELIS
must not be administered in the absence of PR.
Complete blood count (with white blood cell differential counts) must be
conducted in all patients prior to initiating combination therapy with
VICTRELIS. Complete blood counts should be obtained at Treatment Weeks
2, 4, 8, and 12, and should be monitored closely at other time points,
as clinically appropriate. Serious acute hypersensitivity reactions (eg,
urticaria, angioedema) have been observed during combination therapy
with VICTRELIS and PR. If such an acute reaction occurs, combination
therapy should be discontinued and appropriate medical therapy
The most commonly reported adverse reactions (>35%) in clinical trials
in adult patients receiving the combination of VICTRELIS with PR were:
fatigue, anemia, nausea, headache, and dysgeusia. Of these commonly
reported adverse reactions, fatigue, anemia, nausea, and dysgeusia
occurred at rates ≥5% above the rates for PR alone in either clinical
study. The incidence of these adverse reactions in previously untreated
subjects that were treated with combination therapy with VICTRELIS
compared with PR alone were: fatigue (58% vs 59%), anemia (50% vs 30%),
nausea (46% vs 42%), and dysgeusia (35% vs 16%), respectively. The
incidence of these adverse reactions in previous treatment failure
patients that were treated with combination therapy with VICTRELIS
compared with PR alone were: fatigue (55% vs 50%), anemia (45% vs 20%),
nausea (43% vs 38%), and dysgeusia (44% vs 11%), respectively.
VICTRELIS is a strong inhibitor of CYP3A4/5 and is partly metabolized by
CYP3A4/5. The potential for drug-drug interactions must be considered
prior to and during therapy.
Please see U.S. prescribing information at: http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf
Merck’s Global Commitment to Advancing Hepatitis Therapy
Merck is committed to building on its strong legacy in the field of
viral hepatitis by continuing to discover, develop and deliver vaccines
and medicines to help prevent and treat viral hepatitis. In hepatitis C,
company researchers developed the first approved therapy for chronic HCV
in 1991 and the first combination therapy in 1998. In addition to
ongoing studies for our marketed and investigational medicines for the
treatment of chronic HCV, extensive research efforts are underway to
develop additional innovative oral therapies for viral hepatitis
Today’s Merck is a global healthcare 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
consumer care 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
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more information, visit www.merck.com
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This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
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subject to significant risks and uncertainties. There can be no
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found in Merck’s 2012 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 VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_pi.pdf
and Medication Guide for VICTRELIS at http://www.merck.com/product/usa/pi_circulars/v/victrelis/victrelis_mg.pdf.
Revatio® and Adcirca®
are trademarks of their respective owners and are not trademarks of
Merck & Co., Inc., Whitehouse Station, N.J., USA.
is a trademark of Schering Corp., a subsidiary of Merck & Co., Inc.,
Whitehouse Station, N.J., USA.
Caroline Lappetito, 267-305-7369
Sarra Herzog, 908-423-6154
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088