Schering-Plough Highlights PEGINTRON Clinical Data Presentations atthe American Association for the Study of Liver Diseases (AASLD)2007 Annual Meeting
KENILWORTH, N.J., October 30, 2007 /PRNewswire-FirstCall/ -- Leading researchers will present 68 data presentations involving Schering-Plough's hepatitis products, including Pegintron(TM) (peginterferon alfa-2b) and Rebetol(R) (ribavirin, USP) combination therapy, a current standard of care in the treatment of chronic hepatitis C, at the 59th American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston, Nov. 2-6.
Among these are several studies discussing the predictability of response with PEGINTRON and REBETOL and assessing how results at important treatment milestones early in the course of therapy can help physicians and patients make informed treatment decisions.
Researchers will present the final results from the POWeR (Peginterferon alfa-2b Prospective Optimal Weight-based Dosing Response) program, a large observational study involving nearly 2,000 patients conducted at academic and community clinics in Canada between 2002 and 2006. In the study, PEGINTRON and REBETOL combination therapy achieved consistent sustained virologic response (SVR) rates across patient weights and consistently low relapse rates in a "real-life" treatment setting.
Investigators also will present new data on the investigational use of low-dose PEGINTRON as maintenance therapy in chronic hepatitis C nonresponder patients with fibrosis or cirrhosis. The goal of maintenance therapy in this very hard-to-treat patient population is to prevent or delay the progression of liver disease.
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.
Key PEGINTRON Presentations:
Predictability of Response
Predictability of Response: Positive and Negative Predictive Values of Rapid and Early Virologic Responses to Peginterferon Alfa-2b and Ribavirin in the Treatment of Chronic Hepatitis C; F. Poordad et al., Abstract 305, Saturday, Nov. 3, 2:00 pm, Exhibit Hall C
Ultra Rapid Virologic Response Predicts Sustained Virologic Response in HCV Infected Patients with Genotype 3 and High Viral Load: The Get-C Study; S. Pianko et al., Abstract 349, Saturday, Nov. 3, 2:00 pm, Exhibit Hall C
Rapid Virological Response at Week 4 Is the Best Predictor of Treatment Outcome in Patients with Chronic Hepatitis C: A Multivariate Analysis; M. Martinot-Peignoux et al., Abstract 303, Saturday, Nov. 3, 2:00 pm, Exhibit Hall C
Assessment of Both Virological Response at Week 4 and At Week 12 Optimizes Prediction of Treatment Outcome In Patients with Chronic Hepatitis C Treated with Peginterferon Alfa-2b Plus Ribavirin; M. Martinot-Peignoux et al., Abstract 304, Saturday, Nov. 3, 2:00 pm, Exhibit Hall C
Viral Kinetics Can Quickly Predict Sustained Virological Response in HCV Patients with Normal ALT Treated with Pegylated Interferon Alfa-2b and Ribavirin: A Prospective Study; P. Deltenre et al., Abstract 312, Saturday, Nov. 3, 2:00 pm, Exhibit Hall C
PEGINTRON POWeR Study
Final Results of the Canadian POWeR (Peginterferon Alfa-2b Prospective Optimal Weight-Based Dosing Response) Program: Sustained Virologic Response (SVR) To Weight-Based Peginterferon Alfa-2b plus Ribavirin in a Large, Mixed Community and Academic Observational Study; Paul Marotta et al., Abstract 254, Saturday, Nov. 3, 2:00 pm, Exhibit Hall C
Consistency of Sustained Virologic Response (SVR) Across Weight Categories: Results from the Canadian POWeR (Peginterferon Alfa-2b Prospective Optimal Weight-Based Dosing Response) Program; S. Feinman et al., Abstract 302, Saturday, Nov. 3, 2:00 pm, Exhibit Hall C
Response to Peginterferon Alfa-2b plus Ribavirin Combination Therapy in Genotype 2 and 3 Patients with Poor Baseline Prognostic Factors: Results of The Canadian POWeR Program; R. Bailey et al., Abstract 246, Saturday, Nov. 3, 2:00 pm, Exhibit Hall C
Low-Dose PEGINTRON Maintenance Therapy
Tolerability of Low-Dose Peginterferon Alfa-2b in Hepatitis C Patients with Cirrhosis: Results from the COPILOT Trial; M. Shah et al., Abstract 1322, Tuesday, Nov. 6, 8:00 am, Exhibit Hall C
Long-Term Low- Dose Treatment with Pegylated Interferon Alfa-2b Leads to a Significant Reduction in Fibrosis and Inflammatory Score in Chronic Hepatitis C Nonresponder Patients with Fibrosis or Cirrhosis; S. Kaiser, et al., Abstract 1311, Tuesday, Nov. 6, 8:00 am, Exhibit Hall C
Schering-Plough Sponsored CME Symposium
"Clinical Approaches to HCV Management: Community Cases, Expert Analysis" Monday, Nov. 5, 6:30-8:30 p.m., Sheraton Boston Hotel - Grand Ballroom and Liberty 39 Dalton Street, Boston
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
Steven L. Flamm, M.D.
Associate Professor of Medicine and Medical Director, Liver Transplantation, Feinberg School of Medicine, Northwestern University, Chicago
John B. Gross, M.D.
Associate Professor of Medicine, Mayo Clinic College of Medicine Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minn.
Stephen Harrison, M.D.
Chief of Hepatology and Associate Program Director, GI Fellowship Brooke Army Medical Center, Fort Sam Houston, Texas
In the United States, PEGINTRON is indicated for use alone or with ribavirin for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and who are at least 18 years of age.
Important Safety Information Regarding U.S. Labeling for PEGINTRON and REBETOL
Alpha interferons, including PEGINTRON and INTRON(R) 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 PEGINTRON and/or INTRON A therapy.
Use with Ribavirin: Ribavirin may cause birth defects and/or death of the unborn child. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with REBETOL therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen.
PEGINTRON is contraindicated in patients with hypersensitivity to PEGINTRON or any other component of the product, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6 [class B and C]) in cirrhotic CHC patients before or during treatment. INTRON A (Interferon alfa- 2b, recombinant) for Injection is contraindicated in patients with hypersensitivity to INTRON A or any component of the product, autoimmune hepatitis, and decompensated liver disease. PEGINTRON or INTRON A in combination with REBETOL therapy is additionally contraindicated in patients with hypersensitivity to ribavirin or any other component of the product, women who are pregnant, men whose female partners are pregnant, patients with hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia), and patients with creatinine clearance less than 50 mL/min.
REBETOL therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of therapy. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients during therapy and 6 months post- treatment. Patients should use at least two effective forms of contraception and have monthly pregnancy tests during therapy and for 6 months after completion of therapy. A Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment, and for 6 months following cessation of treatment. Physicians and patients are encouraged to report such cases by calling 1-800-593-2214.
Incidence of Adverse Events
There are no new adverse events specific to PEGINTRON 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 PEGINTRON 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 PEGINTRON. Alopecia (thinning of the hair) is also often associated with alpha interferons including PEGINTRON.
Psychiatric adverse events, which include insomnia, were common (57%) with PEGINTRON 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 PEGINTRON.
The following serious or clinically significant adverse events have been reported at a frequency less than 1% with PEGINTRON 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 PEGINTRON/REBETOL combination trial, the incidence of serious adverse events was 17% in the PEGINTRON/REBETOL groups compared to 14% in the INTRON A/ REBETOL group. The incidence of severe adverse events in the PEGINTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL group and 31-34% in the PEGINTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEGINTRON (1.5 mcg/kg)/REBETOL and in 34% of those receiving INTRON A/REBETOL.
Additional Safety Information
Relapse of drug addiction/overdose has occurred in patients on PEGINTRON therapy. Aggressive behavior sometimes directed towards others has occurred in patients with and without a previous psychiatric disorder during PEGINTRON and/or INTRON A treatment and follow-up. If patients develop psychiatric problems, including clinical depression, it is recommended that patients be carefully monitored during treatment and in the 6-month follow-up period. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with PEGINTRON and/or INTRON A be discontinued, and the patient be carefully followed with psychiatric intervention, as appropriate. Cases of encephalopathy have been observed in some patients, usually elderly, treated with higher doses of PEGINTRON and/or INTRON A. Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alpha therapies, including PEGINTRON and INTRON A. Dental and periodontal disorders have been reported in patients receiving PEGINTRON or INTRON A in combination with REBETOL therapy.
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 approximately 33,500 people around the world.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential market for PEGINTRON and REBETOL. Forward-looking statements relate to expectations or forecasts of future events. Schering- Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering- Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details and a discussion of risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part II, Item 1A, "Risk Factors" in the company's third quarter 2007 10-Q.
CONTACT: Media, Robert J. Consalvo, +1-908-298-7409, or Investors, AlexKelly, +1-908-298-7436, Robyn Brown, +1-908-298-7436, all forSchering-Plough
Posted: October 2007