LOS ANGELES, May 19 /PRNewswire/ -- Six new studies evaluating the hepatitis C treatment Pegasys(R) (peginterferon alfa-2a) and Copegus(R) (ribavirin, USP) will be presented at the Digestive Disease Week (DDW) meeting taking place here May 20-25. The meeting will bring together leading physicians, researchers and academics in the fields of gastroenterology and hepatology, among other areas.
Data from several Pegasys studies will be presented and discussed at the DDW meeting, including:
1. Cost-Effectiveness of First-Line Peginterferon Alfa-2a plus Ribavirin in Patients with Mild Chronic Hepatitis C in the United States H.B. El-Serag; K.K. Patel; N. Wintfeld; J. Green; S. D. Sullivan This retrospective study takes into account the years of quality life in evaluating the cost-effectiveness of treating genotype 1 patients who have mild chronic hepatitis C (CHC) with Pegasys (40KD) plus ribavirin (1000/1200 mg/day). 2. Pegasys (40KD) Plus Ribavirin in Pegylated Interferon Alfa-2b (12KD)/Ribavirin Non-Responders with Cirrhosis/Advanced Fibrosis: Interim Analysis of the REPEAT Study N. Gitlin; A. Di Bisceglie, P. Marcellin, H. Bonkovsky; R, Rai; M. Rizzetto; G. Teuber; D. Jensen This study assesses the safety and efficacy of Pegasys (40KD) plus ribavirin in patients for whom previous treatment with Peg-Intron (12KD)/ribavirin failed to achieve a sustained virologic response. 3. High Response Rates with Pegasys (40KD) plus Ribavirin in Japanese Non- Responders or Relapsers to Conventional Interferon N. Izumi; S. Iino; T. Okuno; M. Omata; K. Kiyosawa; H. Kumada; N. Hayashi; G. Yamada; T. Sakai This is the first study to evaluate the efficacy and safety of Pegasys plus Copegus in Japanese patients who had not responded to conventional interferon monotherapy. 4. High Response Rates with Peginterferon Alfa-2a (40KD) (Pegasys(R)) plus Ribavirin (Copegus(R)) in Treatment-Naive Japanese Chronic Hepatitis C Patients: A Randomized, Double-Blind, Multicenter, Phase III Trial T. Sakai; S. Iino; T. Okuno; M. Omata; K. Kiyosawa; H. Kumada; G. Yamada; N. Hayashi This randomized multinational trial evaluates the safety and efficacy of Pegasys (40KD) alone or in combination with ribavirin in 200 Japanese patients with HCV genotype 1b infection. 5. Efficacy and tolerability of peginterferon alfa-2a (40kd) and ribavirin in GT-1 patients with chronic hepatitis C in Germany - a contribution to health care research E. Zehnter; S. Mauss; C. John; R. Heyne; B. Moeller; T. Lutz; B. Bokemeyer; R. Kihn; G. Moog; H. Vornkahl; U. Alshuth; D. Hueppe This ongoing observational German study evaluates the efficacy of treatment in chronic genotype 1 hepatitis C in routine clinical practice, including screening and treatment phases with the goal of achieving optimal care for these patients. 6. Initial HCV Response in Patients with End Stage Renal Disease treated with Combination Pegylated Interferon alfa-2a and Ribavarin W. Hakim; S. Sheikh; I. Inayat; M. Bia; C. Caldwell; D. Jain; D. Smith; F. Lakkis; A. Friedman; M. Lorber; R. Formica; W. Mehal This observational pilot study aims to determine the initial and sustained viral response of combination treatment in 20 hepatitis C patients with end-stage renal disease.
Pegasys and Copegus are approved by the U.S. Food and Drug Administration for the treatment of chronic hepatitis C and are the only combination regimen FDA-approved for the treatment of chronic hepatitis C in patients coinfected with hepatitis C and HIV.
Hepatitis C, a blood-borne infectious disease of the liver, is transmitted through body fluids, primarily blood or blood products and by sharing needles. Hepatitis C chronically infects an estimated 2.7 million Americans and 170 million people worldwide and is the leading cause of cirrhosis and liver cancer and the number one reason for liver transplants in the United States.
Roche has backed Pegasys with the most extensive development program ever undertaken in hepatitis C, including major studies initiated to advance treatment for hepatitis C patients with unmet needs, such as African Americans, patients coinfected with HIV and hepatitis C, patients with cirrhosis and patients who have failed to respond to previous therapy.
About Pegasys
Pegasys, a pegylated alpha interferon, and Copegus were approved by the FDA in December 2002 for use in combination for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis.
Pegasys is dosed at 180mcg as a subcutaneous injection taken once a week. Copegus is available as a 200mg tablet, and is administered orally two times a day as a split dose. Roche has backed Pegasys with the most extensive clinical research program ever undertaken in hepatitis C, with major studies initiated to advance treatment for hepatitis C patients with unmet needs, including patients co-infected with HIV and HCV, African Americans, patients with cirrhosis, and patients who have failed to respond to previous therapy. Please see attached additional information about Pegasys indication and safety.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or www.roche.us.
IMPORTANT SAFETY INFORMATION
PEGASYS, alone or in combination with COPEGUS, is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that is clinically stable (eg, antiretroviral therapy not required or receiving stable antiretroviral therapy).
Alpha interferons, including PEGASYS(R) (Peginterferon alfa-2a), 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. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping PEGASYS therapy (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in complete product information).
Use with Ribavirin. Ribavirin, including COPEGUS(R), may cause birth defects and/or death of the fetus. 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 ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen (see CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS in complete product information).
PEGASYS is contraindicated in patients with hypersensitivity to PEGASYS or any of its components, autoimmune hepatitis, and hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment. Pegasys is also contraindicated in hepatic decompensation with Child-Pugh score greater than or equal to 6 in cirrhotic CHC patients coinfected with HIV before or during treatment. PEGASYS is also contraindicated in neonates and infants because it contains benzyl alcohol. Benzyl alcohol is associated with an increased incidence of neurological and other complications in neonates and infants, which are sometimes fatal. PEGASYS and COPEGUS therapy is additionally contraindicated in patients with a hypersensitivity to COPEGUS or any of its components, in women who are pregnant, men whose female partners are pregnant, and patients with hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).
COPEGUS THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO INITIATION OF THERAPY. Women of childbearing potential and men must use two forms of effective contraception during treatment and during the 6 months after treatment has concluded. Routine monthly pregnancy tests must be performed during this time. If pregnancy should occur during treatment or during 6 months post-therapy, the patient must be advised of the significant teratogenic risk of COPEGUS therapy to the fetus. Healthcare providers and patients are strongly encouraged to immediately report any pregnancy in a patient or partner of a patient during treatment or during 6 months after treatment cessation to the Ribavirin Pregnancy Registry at 1-800-593-2214.
Chronic hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including PEGASYS. Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART. During treatment, patients' clinical status and hepatic function should be closely monitored, and PEGASYS treatment should be immediately discontinued if decompensation (Child-Pugh score >/= 6) is observed.
The most common adverse events reported for PEGASYS and COPEGUS combination therapy observed in clinical trials were fatigue/asthenia (65%), headache (43%), pyrexia (41%), myalgia (40%), irritability/anxiety/nervousness (33%), insomnia (30%), alopecia (28%), neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia (24%), injection-site reaction (23%), arthralgia (22%), depression (20%), pruritus (19%) and dermatitis (16%). The adverse event profile of coinfected patients treated with PEGASYS and COPEGUS was generally similar to that shown for monoinfected patients. Events occurring more frequently in coinfected patients were neutropenia (40%), anemia (14%), thrombocytopenia (8%), weight decrease (16%) and mood alteration (9%).
Serious adverse events included neuropsychiatric disorders (homicidal ideation, suicidal ideation, suicide attempt and suicide), serious and severe bacterial infections (sepsis), bone marrow toxicity (cytopenia and rarely, aplastic anemia), cardiovascular disorders (hypertension, supraventricular arrhythmias and myocardial infarction), hypersensitivity (including anaphylaxis), endocrine disorders (including thyroid disorders and diabetes mellitus), autoimmune disorders (including idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, psoriasis, lupus, rheumatoid arthritis and interstitial nephritis), pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis), colitis (ulcerative and hemorrhagic/ischemic colitis), pancreatitis and ophthalmologic disorders (decrease or loss of vision, retinopathy including macular edema and retinal thrombosis/hemorrhages, optic neuritis and papilledema).
RocheCONTACT: Bob Madison, Roche, W: +1-973-562-2231, C: +1-973-919-7085,Bob.Madison@roche.com; Sarah Spielvogel, Manning Selvage & Lee, +1-212-468-4312, Sarah.Spielvogel@mslpr.com
