Merck to Present New Data for VICTRELIS® (boceprevir) and MK-5172 at The American Association for the Study of Liver Diseases 2012 Annual Meeting
October 1, 2012 10:12 am ET
Merck (NYSE: MRK), known as MSD outside of the United States and Canada,
announced today that new data from Phase III studies of VICTRELIS® (boceprevir)
200 mg Capsules, the company’s oral hepatitis C virus (HCV) NS3/4A
protease inhibitor will be presented at the 63rd Annual
Meeting of the American Association for the Study of Liver Diseases
(AASLD). The meeting will take place November 9-13 in Boston.
More than 20 abstracts highlighting Merck medicines and investigational
therapies for chronic HCV will be presented at AASLD, including two oral
presentations and six posters on VICTRELIS. New data will also be
presented on the efficacy and safety of MK-5172, Merck’s
investigational, once-daily, second generation oral HCV NS3/4A protease
inhibitor, in patients chronically infected with HCV genotype 1.
“We are pleased to present new data on VICTRELIS that provides
healthcare professionals with information that may better inform them as
they consider VICTRELIS combination therapy for appropriate patients,”
said Eliav Barr, M.D., vice president, Infectious Diseases, Project
Leadership and Management, Merck Research Laboratories. “We also look
forward to continued discussions with the global scientific and patient
communities about Merck’s investigational medicines for chronic
hepatitis C, as we remain committed to reducing the burden of this
serious disease worldwide.”
The abstracts were published today and can be accessed on the AASLD
website. For program information, please visit https://www.aasld.org.
Key presentations for VICTRELIS (boceprevir)
Boceprevir (BOC) Combined with Peginterferon alfa-2b/Ribavirin (P/RBV)
in Treatment-Naïve Chronic HCV Genotype 1 Patients with Compensated
Cirrhosis: Sustained Virologic Response (SVR) and Safety Subanalyses
From the Anemia Management Study. Lawitz, F. et al. Oral Presentation:
Sunday, Nov. 11, 3:15 p.m.-3:30 p.m., Hynes Convention Center, Ballroom
Timing and Magnitude of Ribavirin Dose Reduction (RBV DR) Do Not Impact
Sustained Virologic Response Rates with Boceprevir (BOC) + Peginterferon
alfa-2b / Ribavirin (P/RBV) in the Anemia Management Study in Chronic
HCV Genotype 1 Patients. Poordad, F. et al. Oral Presentation: Monday,
Nov. 12, 3:45 p.m.-4:00 p.m., Hynes Convention Center, Ballroom B/C.
Other key Merck presentations
Safety and Sustained Viral Response of MK-5172 for 12 Weeks in
Combination with Pegylated Interferon Alfa-2b and Ribavirin for 24 Weeks
in HCV Genotype 1 Treatment-Naïve Noncirrhotic Patients. Marcellin, P.
et al. Poster 766. Sunday, Nov. 11, 8:00 a.m.-5:30 p.m., Hynes
Convention Center Poster Hall.
MK-5172, A Potent Second-Generation HCV NS3/4a Protease Inhibitor,
Retains Potent in vitro Activity Against a Panel of Boceprevir Resistant
HCV G1a and G1b Patient Isolates. Ogert, R.A. et al. Poster 1724.
Tuesday, Nov. 13, 8:00 a.m.-12:00 p.m., Hynes Convention Center Poster
Hall. Selected as a Presidential Poster of Distinction.
Indications and usage for VICTRELIS
VICTRELIS 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.
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.
VICTRELIS efficacy 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.
VICTRELIS in combination with PR has not been studied in patients
documented to be historical null responders (less than a 2 log HCV-RNA
decline by treatment week 12) during prior therapy with PR. The
clinical studies included patients who were poorly interferon
responsive. Patients with less than 0.5 log HCV-RNA decline in viral
load at treatment week 4 with PR alone are predicted to have a null
response (less than a 2 log viral load decline by treatment week 12)
to PR therapy.
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 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 two or more forms of effective
contraception, including intrauterine devices and barrier methods,
during treatment and for at least 6 months after treatment has
concluded. Systemic hormonal contraceptives may not be as effective in
women while taking 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 also is 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,
drosperinone, 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 to 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. Dose reduction of
VICTRELIS is not recommended. VICTRELIS must not be administered in the
absence of PR.
Complete blood counts (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 4, 8 and 12, and should be monitored closely at other time points,
as clinically appropriate.
The most commonly reported adverse reactions (greater than 35 percent)
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 greater than or equal to 5 percent above
the rates for PR alone in either clinical study. The incidence of these
adverse reactions in previously untreated patients who were treated with
combination therapy with VICTRELIS compared with peginterferon and
ribavirin alone were: fatigue (58 vs. 59 percent), anemia (50 vs. 30
percent), nausea (46 vs. 42 percent) and dysgeusia (35 vs. 16 percent),
respectively. The incidence of these adverse reactions in previous
treatment-failure patients who were treated with combination therapy
with VICTRELIS compared with PR alone were: fatigue (55 vs. 50 percent),
anemia (45 vs. 20 percent), nausea (43 vs. 38 percent) and dysgeusia (44
vs. 11 percent), 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 with VICTRELIS, 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
healthcare through far-reaching policies, programs and partnerships. For
more information, visit www.merck.com
and connect with us on Twitter, Facebook and YouTube.
This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. Such statements may include,
but are not limited to, statements about the benefits of the merger
between Merck and Schering-Plough, including future financial and
operating results, the combined company’s plans, objectives,
expectations and intentions and other statements that are not historical
facts. Such statements are based upon the current beliefs and
expectations of Merck’s management and are subject to significant risks
and uncertainties. Actual results may differ from those set forth in the
The following factors, among others, could cause actual results to
differ from those set forth in the forward-looking statements: the
possibility that all of the expected synergies from the merger of Merck
and Schering-Plough will not be realized, or will not be realized within
the expected time period; the impact of pharmaceutical industry
regulation and health care legislation in the United States and
internationally; Merck’s ability to accurately predict future market
conditions; dependence on the effectiveness of Merck’s patents and other
protections for innovative products; and the exposure to litigation
and/or regulatory actions.
Merck 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 Merck’s 2011 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.
VICTRELIS® is a trademark of Schering Corp.,
a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA.
Revatio® and Adcirca®
are trademarks of their respective owners and are not trademarks of
Merck & Co., Inc., Whitehouse Station, N.J., USA.
Pamela Eisele, 908-423-5042
Lainie Keller, 908-423-4187
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088