KENILWORTH, N.J., Oct. 24 /PRNewswire-FirstCall/ -- More than 50 data presentations involving Schering-Plough’s hepatitis products, including PEG- INTRON(R) (peginterferon alfa-2b) and REBETOL(R) (ribavirin, USP) combination therapy, will be presented by leading researchers at the 57th American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston, Oct. 27-31.
Among the key presentations will be data from the EPIC3 (Evaluation of PEG-INTRON in Control of Hepatitis C Cirrhosis) study, a large, prospective, controlled clinical trial designed to assess the safety and efficacy of PEG- INTRON and REBETOL in retreating patients who failed previous alpha interferon and ribavirin combination therapies, including peginterferon-based combination therapies.
Investigators for WIN-R (Weight-Based Dosing of PEG-INTRON and REBETOL), the largest community-based clinical study in hepatitis C ever conducted in the United States, will present results in patient populations traditionally considered hard to treat, including elderly patients and Hispanic patients.
Hepatitis C is the most common blood-borne infection in America and the most common form of liver disease, affecting nearly 5 million people in the United States and 200 million people worldwide. For program information, please visit the American Association of Liver Disease Web site at http://www.aasld.org.
Key Schering-Plough Clinical Study Data Presentations:
HCV RNA Negativity After 12 Weeks of Therapy is the Best Predictor of Sustained Viral Response (SVR) in the Re-Treatment of Previous Interferon- alpha/Ribavirin Non-Responders (NR): Results from the EPIC3 Program; T. Poynard et al., Poster Presentation, Tuesday, Oct. 31, 8:00 am-12:30 pm, Exhibit Hall C
Peginterferon Alfa-2b and Ribavirin are Equally Efficacious and Well Tolerated in Patients greater than 65 Years Old in Comparison to Other Age Groups: Subanalysis of a Randomized, Controlled Study (WIN-R Trial); S. Flamm et al., Poster Presentation, Saturday, Oct. 28, 2:00-8:00 pm, Exhibit Hall C
Prospective Analysis of Sustained Virologic Response (SVR) to Peginterferon Alfa-2b and Ribavirin Treatment in Asian and Hispanic Patients with Chronic Hepatitis C: Results from the WIN-R Trial; B. Freilich et al., Poster Presentation, Saturday, Oct. 28, 2:00-8:00 pm, Exhibit Hall C
Response to Peginterferon Alfa-2b and Ribavirin for Chronic Hepatitis C in Patients with Body Weight greater than 125 kg: Results from the WIN-R Trial; I. Jacobson et al., Poster Presentation, Saturday, Oct. 28, 2:00-8:00 pm, Exhibit Hall C
Risk Factors for Relapse in Genotype 3 High Viral Load Patients with Hepatitis C in the WIN-R Trial; R. Brown et al., Poster Presentation, Tuesday, Oct. 31, 8:00 am-12:30 pm, Exhibit Hall C
Peginterferon Alfa-2b plus Ribavirin in Patients with Genotype 1 Chronic Hepatitis C with a Slow Virologic Response: An Early Enrollers Analysis of the SUCCESS (Study to Assess Treatment with PEG-INTRON and REBETOL in Naive Patients with Genotype 1 Chronic Hepatitis C and Slow Virological Response) Study; M. Buti et al., Poster Presentation, Saturday, Oct. 28, 2:00-8:00 pm, Exhibit Hall C
An Interim Analysis of the Canadian POWeR Program (Peginterferon Alfa-2b Prospective Optimal Weight-Based Dosing Response): Consistent SVR Rates Across All Weight Categories; P. Marotta et al., Poster Presentation, Saturday, Oct. 28, 2:00-8:00 pm, Exhibit Hall C
Schering-Plough Sponsored CME Symposium
“HCV Management Today and Tomorrow”
Monday, Oct. 30, beginning at 6:30 p.m., Sheraton Boston Hotel, Back Bay Ballroom, 39 Dalton Street, Boston
FACULTY: Willis C. Maddrey, M.D. (Chair) Professor of Internal Medicine and Executive Vice President for Clinical Affairs The University of Texas Southwestern Medical Center at Dallas Dallas, Texas Ira M. Jacobson, M.D. Vincent Astor Professor of Clinical Medicine Medical Director of the Center for the Study of Hepatitis C Weill Medical College of Cornell University New York, New York Nezam H. Afdhal, M.D. Chief of Hepatology Director of Liver Center Beth Israel Deaconess Medical Center Harvard Medical School Boston, Mass. Mark S. Sulkowski, M.D. Associate Professor of Medicine John Hopkins University John Hopkins University School of Medicine Baltimore, Md. About PEG-INTRON
PEG-INTRON is approved in the United States as monotherapy and for use in combination therapy with REBETOL for the treatment of chronic hepatitis C in patients with compensated liver disease who are at least 18 years of age.
Important Safety Information Regarding U.S. Labeling for PEG-INTRON and REBETOL
WARNING
Alpha interferons, including PEG-INTRON, 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 PEG-INTRON therapy.
Ribavirin causes hemolytic anemia. Anemia associated with REBETOL therapy may exacerbate 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. It is advised that complete blood counts (CBC) be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically indicated.
REBETOL and combination REBETOL/PEG-INTRON therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and during the 6 months after stopping therapy. REBETOL and combination REBETOL/PEG-INTRON therapy should not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use effective contraception (at least two reliable forms) during treatment and during the 6- month post-treatment follow-up period. Significant teratogenic and/or embryocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of REBETOL. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064.
PEG-INTRON
There are no new adverse events specific to PEG-INTRON as compared to INTRON(R) A (interferon alfa-2b, recombinant) for Injection, 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/REBETOL is contraindicated in patients with autoimmune hepatitis, decompensated liver disease, and in patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia). The following serious or clinically significant adverse events have been reported at a frequency less than or equal to 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.
In the PEG-INTRON/REBETOL combination trial the incidence of serious adverse events was 17% in the PEG-INTRON/REBETOL groups compared to 14% in the INTRON A/REBETOL group. The incidence of severe adverse events in the PEG- INTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL group and 31-34% in the PEG-INTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEG-INTRON (1.5 mcg/kg)/ REBETOL and in 34% of those receiving INTRON A/REBETOL.
REBETOL should not be used in patients with creatinine clearance less than 50 mL/min.
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 32,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.
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