Efficacy Data on PEG-INTRON(R) and REBETOL(R) in Wide Range of
Hepatitis Patient Populations to Be Presented at Digestive Disease WEEK (DDW)
Annual Meeting in New Orleans
Researchers Present 48 Abstracts on Schering-Plough Interferon Products
KENILWORTH, N.J., May 12 /PRNewswire-FirstCall/ -- Important new data on the
efficacy and safety of PEG-INTRON(R) (peginterferon alfa-2b) and REBETOL(R)
(ribavirin, USP) combination therapy will be presented by clinical
investigators at the 2004 Digestive Disease Week (DDW) annual meeting at the
Morial Convention Center in New Orleans, May 15-20. Researchers will report on
the use of PEG-INTRON in treating a wide range of special hepatitis patient
populations, including hepatitis C patients with normal ALT (alanine
aminotransferase) levels, non-responders to previous therapies and patients
infected with chronic hepatitis B. Strategies to improve patient adherence to
therapy and PEG-INTRON cost-effectiveness studies also will be presented.
Hepatitis C virus (HCV) is the most common blood-borne infection in America and
the most common form of liver disease, affecting nearly 4 million people -- or
one in 50 adults -- in the United States and 200 million people worldwide.
Hepatitis B affects more than 1 million people in the United States and 400
million people worldwide.
PEG-INTRON and REBETOL combination therapy is indicated for the treatment of
chronic hepatitis C in patients with compensated liver disease who have not
been previously treated with interferon alpha and are at least 18 years of age.
PEG-INTRON studies to be presented at DDW include: 1. Treatment of Patients with Chronic HCV Infection and Normal Liver
Enzymes with PEG IFN alfa 2b + Ribavirin: Results from a
Prospective, Randomized, Controlled, Multicenter Trial
S. Flamm et al. Poster session, Hall F, Sunday, May 16,
8:00 am - 5:00 pm This study examines individualized, weight-based PEG-INTRON and REBETOL
combination therapy in chronic hepatitis C patients with normal ALT (alanine
aminotransferase) levels. Approximately 30 percent of patients with chronic
HCV have persistently normal liver enzymes, including some who have progressive
liver disease.
2. Peginterferon Alfa-2b Plus Ribavirin for Retreatment of Chronic
Hepatitis C
D. Dalke et al. Oral presentation, Rooms 343-345, Sunday, May 16,
4:15 - 4:30 pm This study examines PEG-INTRON and REBETOL combination therapy in chronic
hepatitis C patients who failed prior therapy with conventional interferon and
ribavirin.
3. Pegylated Interferon (alfa-2b) and Ribavirin (REBETOL) for the
Treatment of HCV Infected Patients Who Failed Prior Therapy
P. Gaglio et al. Poster session, Hall F, Monday, May 17,
8:00 am - 5:00 pm This study examines PEG-INTRON and REBETOL combination therapy in patients who
failed prior treatment with conventional interferon, with or without ribavirin. This large, ongoing, prospective multicenter study has enrolled more than 400
patients to date.
4. Combination of Peginterferon Alfa-2b and Lamivudine versus Lamivudine
Alone in the Treatment of Chronic Hepatitis B Infection
J. Sung et al. Oral presentation, La Nouvelle Orleans Ballroom A/B,
Tuesday, May 18, 9:30 - 9:45 am This study evaluates the efficacy and safety of PEG-INTRON and lamivudine
versus lamivudine alone in patients with chronic hepatitis B. Treatment of
chronic hepatitis B infection is still considered to be unsatisfactory and
previous studies combining conventional interferon and lamivudine yielded
conflicting results. This prospective, randomized study involves 100 HbeAg-
positive treatment-naive patients.
5. The Risk of Acute Rejection in Patients Treated with Pegylated
Interferon and Ribavirin for Recurrent Hepatitis C Post Liver
Transplantation
N. Elhajj et al. Poster session, Hall F, Sunday, May 16,
8:00 am - 5:00 pm Treatment of hepatitis C with interferon after orthotopic liver transplantation
theoretically may precipitate acute cellular rejection, as is seen with kidney
transplantation. This study evaluates the use of PEG-INTRON and REBETOL
combination therapy in patients with histological evidence of HCV recurrence
following a liver transplant.
6. Medical Adherence and QOL with Cognitive Behavioral Therapy in
Patients Receiving PEG IFN alfa 2b (1.5 mcg/kg/wk) + Ribavirin (800-
1400 mg/day) Persists Through 48 Weeks of Therapy: Results of a
Prospective, Randomized, Controlled Multicenter Trial
S. Flamm et al. Poster session, Hall F, Sunday, May 16,
8:00 am - 5:00 pm This study seeks to determine if patients treated with PEG-INTRON and REBETOL
combination therapy, who received patient education, aggressive side- effect
management and expanded supportive nursing intervention with cognitive
behavioral treatment by telephone via Schering-Plough's Be In Charge patient
support program, improved medication adherence and quality of life (QOL) over a
48-week treatment period.
7. Cost-Effectiveness Implications of the Timing of Peginterferon Alfa-2b
plus Ribavirin for Chronic Hepatitis C in HIV-HCV Co-Infected Patients
J. Wong et al. Oral presentation, Rooms 353-355, Monday, May 17,
2:45 - 3:00 pm This study estimates the cost-effectiveness of hepatitis C treatment with
PEG-INTRON and REBETOL combination therapy in patients coinfected with chronic
hepatitis C and HIV by examining lifetime clinical and economic outcomes based
on Cox proportional hazard models.
8. Cost-Effectiveness of Peginterferon Alfa-2b plus Ribavirin Treatment
of Chronic Hepatitis C with F1 Fibrosis
J. Wong et al. Poster session, Hall F, Monday, May 17,
8:00 am - 5:00 pm This study estimates the cost-effectiveness of individualized, weight- based
PEG-INTRON and REBETOL combination therapy compared to no treatment in
hepatitis C patients with early-stage (F1) fibrosis.
Commitment to Hepatitis C Research To further illustrate the efficacy of individualized, weight-based PEG-INTRON
combination therapy, Schering-Plough Research Institute is conducting
comparative studies with the two approved forms of pegylated interferon.
Foremost among these is the IDEAL Study (Individualized Dosing Efficacy vs. flat dosing to Assess optimaL pegylated interferon therapy), a major randomized
clinical study involving 2,880 patients that directly compares the efficacy and
safety of individualized weight-based dosing with PEG-INTRON and REBETOL versus
PEGASYS (peginterferon alfa-2a), which is administered as a flat dose to all
patients regardless of individual body weight, and COPEGUS (ribavirin, USP)
dosed either at 1,000 mg or 1,200 mg, in U.S. patients with chronic hepatitis
C, genotype 1. PEGASYS and COPEGUS are trademarks of Hoffmann-La Roche Inc.
Additional Comparative Studies The PEG-INTRON and PEGASYS interferon molecules differ significantly, both in
the structure of their protein and in the size, shape, and site of their PEG
(polyethylene glycol) attachment. Alpha interferons exert their antiviral
effects through physical interaction with the alpha/beta interferon receptor on
the host cell. To understand the in vivo consequence of differing peg molecule
sizes and to explore the relationship between the pharmacokinetics (PK) and
pharmacodynamics (PD) of pegylated alfa interferons, Schering-Plough Research
Institute has conducted a randomized, third-party blind, parallel group study
in 36 previously untreated patients chronically infected with hepatitis C,
genotype 1. Results of this study are expected to be reported this year.
Commitment to Hepatitis C Patients In addition to its ongoing commitment to research and development,
Schering-Plough is committed to supporting hepatitis C patients with education
and service programs as well as to help locate reimbursement assistance for
patients in need. The company's programs for patients in the United States are
among the most comprehensive in the industry, providing support and guidance to
patients, and ensuring that all eligible patients have access to the company's
hepatitis C products.
Schering-Plough's Be In Charge hepatitis C patient-support program has helped
more than 100,000 people with hepatitis C in the United States since its
inception in 1997. This U.S. program is designed to support patients diagnosed
with hepatitis C as well as patients treated with Schering-Plough's
interferon-based hepatitis C therapies through the use of educational materials
and telephone contact with registered nurse counselors who are available 24/7
and skilled in the management of hepatitis C.
The company's Commitment to Care program is designed to ensure that eligible
U.S. patients have access to Schering-Plough's hepatitis products, either by
assisting patients in obtaining the reimbursement or assistance for which they
qualify, or by providing products free of charge to eligible patients. The
market value of assistance and treatment provided to hepatitis C patients
through this program in 2003 exceeded $150 million.
PEG-INTRON Combination Therapy PEG-INTRON is the only peginterferon approved for dosing according to patient
body weight. It is a longer-acting form of INTRON(R) A (interferon alfa-2b,
recombinant) Injection that uses proprietary PEG technology developed by Enzon,
Inc. (NASDAQ:ENZN) of Bridgewater, N.J. PEG-INTRON, recombinant interferon
alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a
once-weekly therapy that is designed to achieve an effective balance between
antiviral activity and elimination half-life. Schering-Plough holds an
exclusive worldwide license to PEG-INTRON.
REBETOL is an oral formulation of ribavirin, a synthetic nucleoside analog.
Schering-Plough has worldwide rights to market oral ribavirin for hepatitis C
through a licensing agreement with Valeant Pharmaceuticals International
(NYSE:VRX), formally ICN Pharmaceuticals, of Costa Mesa, Calif.
WARNING
-- REBETOL monotherapy is not effective for the treatment of chronic
hepatitis C virus infection and should not be used alone for this
indication. (See WARNINGS.) -- The primary toxicity of ribavirin is hemolytic anemia. The anemia
associated with REBETOL therapy may result in worsening of cardiac
disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease
should not be treated with REBETOL. (See WARNINGS, ADVERSE REACTIONS,
and DOSAGE AND ADMINISTRATION.) -- Significant teratogenic and/or embryocidal effects have been
demonstrated in all animal species exposed to ribavirin. In addition,
ribavirin has a multiple-dose half-life of 12 days, and so it may
persist in nonplasma compartments for as long as 6 months. Therefore,
REBETOL therapy is contraindicated in women who are pregnant and in the
male partners of women who are pregnant. Extreme care must be taken to
avoid pregnancy during therapy and for 6 months after completion of
treatment in both female patients and in female partners of male
patients who are taking REBETOL therapy. At least two reliable forms
of effective contraception must be utilized during treatment and during
the 6-month post-treatment follow-up period. (See CONTRAINDICATIONS,
WARNINGS, PRECAUTIONS-Information for Patients and Pregnancy Category
X.) -- Alpha interferons, including PEG-INTRON and INTRON A, may cause or
aggravate fatal or life-threatening neuropsychiatric, autoimmune,
ischemic and infectious disorders. Patients should be monitored
closely with periodic clinical and laboratory evaluations. Patients
with persistently severe or worsening signs or symptoms of these
conditions should be withdrawn from therapy. In many but not all cases
these disorders resolve after stopping therapy with PEG-INTRON or
INTRON A. (See WARNINGS, ADVERSE REACTIONS.) PEG-INTRON
There are no new adverse events specific to PEG-INTRON as compared to INTRON A,
however, the incidence of some (e.g., injection site reactions, fever, rigors,
nausea) were higher. The most common adverse events associated with PEG-INTRON
were "flu-like" symptoms, occurring in approximately 50% of patients, which may
decrease in severity as treatment continues. Application site disorders were
common (47%), but all were mild (44%) or moderate (4%) and no patient
discontinued, and included injection site inflammation and reaction (i.e.,
bruise, itchiness, irritation). Injection site pain was reported in 2% of
patients receiving PEG-INTRON. Alopecia (thinning of the hair) is also often
associated with alpha interferons including PEG-INTRON.
Psychiatric adverse events, which include insomnia, were common (57%) with
PEG-INTRON, but similar to INTRON A (58%). Depression was most common at 29%. Suicidal behavior including ideation, suicidal attempts, and completed suicides
occurred in 1% of patients during or shortly after completing treatment with
PEG-INTRON. PEG-INTRON is contraindicated in patients with autoimmune
hepatitis and decompensated liver disease.
The following serious or clinically significant adverse events have been
reported at a frequency <1% with PEG-INTRON or interferon alpha: Severe
decreases in neutrophil or platelet counts, hypothyroidism, hyperglycemia,
hypotension, arrhythmia, ulcerative and hemorrhagic colitis, development or
exacerbation of autoimmune disorders including thyroiditis, RA, systemic lupus
erythematosus, psoriasis, pulmonary disorders (dyspnea, pulmonary infiltrates,
pneumonitis and pneumonia, some resulting in patient deaths), urticaria,
angioedema, bronchoconstriction, anaphylaxis, retinal hemorrhages and cotton
wool spots.
Renal failure patients should be closely monitored for signs and symptoms of
interferon toxicity and PEG-INTRON should be used with caution in patients with
creatinine clearance <50 mL/min. Patients on PEG-INTRON therapy should have
hematology and blood chemistry testing before the start of treatment and then
periodically thereafter.
INTRON A All patients receiving INTRON A therapy experienced mild-to-moderate side
effects. Some patients experienced more severe side effects, including
neutropenia, fatigue, myalgia, headache, fever, chills and increased SGOT. Other frequently occurring side effects were nausea, vomiting, depression,
alopecia, diarrhea and thrombocytopenia. DEPRESSION AND SUICIDAL BEHAVIOR,
INCLUDING SUICIDAL IDEATION, SUICIDAL ATTEMPTS, AND COMPLETED SUICIDES, HAVE
BEEN REPORTED IN ASSOCIATION WITH TREATMENT WITH ALFA INTERFERONS, INCLUDING
INTRON A THERAPY.
DISCLOSURE NOTICE: The information in this press release includes certain
"forward-looking" statements concerning PEG-INTRON, the market for drugs to
treat hepatitis and Schering-Plough's products. Forward-looking statements are
subject to risks and uncertainties, which may cause actual results to differ
materially. These risks and uncertainties include product availability,
current and future branded, generic and OTC competition, the regulatory process
for new products and new indications, market acceptance of new products and new
indications, timing of trade buying, and patent positions. For further details
and a discussion of these and other risks and uncertainties, see the company's
past and future Securities and Exchange Commission filings, including the
company's 2003 10-K filed Feb. 26, 2004.
Schering-Plough is a global science-based health care company with leading
prescription, consumer and animal health products. Through internal research
and collaborations with partners, Schering-Plough discovers, develops,
manufactures and markets advanced drug therapies to meet important medical
needs. Schering-Plough's vision is to earn the trust of the physicians,
patients and customers served by its more than 30,000 people around the world.
For more information about Schering-Plough, visit the company's Web site at
http://www.schering-plough.com/.
For information about hepatitis and for full prescribing information regarding
PEG-INTRON and REBETOL, visit http://www.hepatitisinnovations.com/ .
See the PEGASYS and COPEGUS product inserts for information on these products. DATASOURCE: Schering-Plough Corporation CONTACT: Media - Robert J. Consalvo, +1-908-298-7409, Investors - Alex Kelly, +1-908-298-7450, Lisa W. DeBerardine, +1-908-298-7437, or Janet M.
Barth, +1-908-298-7417, all of Schering-Plough Corporation Web site: http://www.schering-plough.com/ http://www.hepatitisinnovations.com/ Company News On-Call: http://www.prnewswire.com/comp/777050.html
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