LOS ANGELES, May 23 /PRNewswire/ -- Roche announced today interim results from a study investigating the cost-effectiveness of treating U.S. patients who have mild chronic hepatitis C (CHC) using PEGASYS(R) (peginterferon alpha- 2a) plus COPEGUS(R) (ribavirin). Results from the study were presented at the Annual Digestive Disease Week (DDW) conference on May 23 in Los Angeles, CA.
“Roche continues to show a commitment to people living with hepatitis C in several ways,” said James A. Thommes, M.D., Senior Medical Director, Roche. “An analysis of cost effectiveness presented at DDW demonstrates favorable outcomes resulting from treatment with PEGASYS and ribavirin in patients with mild chronic hepatitis C.”
Data for the cost effectiveness study were obtained from two phase III multinational, randomized, controlled trials of hepatitis C patients with genotype 1 with mild CHC who were treated with PEGASYS 180mcg plus ribavirin 1000/1200 mg/day. The overall sustained virologic response (SVR) of this group was 56 percent. The life-time disease progression to cirrhosis, hepatocellular carcinoma, and liver transplant in patients who failed to achieve an SVR was based on published data. The impact of early virologic response (EVR) at week 12 (86 percent) on the cost of treatment was included in the model.
Compared with no treatment, in HCV genotype 1 patients with mild CHC, PEGASYS plus ribavirin is a cost-effective treatment strategy in the U.S. setting. PEGASYS plus ribavirin increased quality-adjusted life expectancy (QALY) by 1.46 years yielding an incremental cost per QALY gained of $3,513.
About the REPEAT Trial
In addition to the cost-effectiveness analysis, interim results were announced at DDW from the REPEAT (REtreatment with PEgasys in pATients Not Responding to Peg-Intron Therapy) study showing that treatment with PEGASYS plus COPEGUS successfully reduced viral levels after 12 weeks of therapy in many hepatitis C patients who had previously failed treatment with Peg-Intron(R) (peginterferon alpha-2b) plus ribavirin.
The REPEAT trial focuses on patients who failed to respond to previous therapy with Peg-Intron. The analysis presented 12-week interim efficacy and safety data from the use of either standard-dose (180mcg) or fixed-dose induction (360mcg) therapy, and further identified outcomes for patients with cirrhosis and/or advanced fibrosis. After this initial 12-week treatment period, all patients continue to be studied while completing their therapy with the standard dose of PEGASYS and COPEGUS for a total treatment duration of either 48 or 72 weeks.
Interim results showed: * Forty-five percent of patients treated with the standard dose of PEGASYS with COPEGUS had an early viralogic response (EVR), defined as having a greater than or equal to 2 log drop in viral load or having no detectable virus after 12 weeks of treatment (n = 469). * An EVR rate of 62 percent was achieved in the group of patients who were treated with the higher fixed-dose induction of PEGASYS with standard COPEGUS for the first 12 weeks of therapy (n = 473). * The adverse event profiles were similar for patients taking the higher fixed-dose induction of PEGASYS with COPEGUS for 12 weeks compared to those taking the standard dose. However, more patients in the higher fixed-dose induction group had their dose of PEGASYS and ribavirin modified or were discontinued.
“The interim results from this study suggest that previous non-responders to treatment can still be re-treated with some success, particularly in those treated with the higher dose of PEGASYS with ribavirin,” said Donald Jensen, M.D., professor of medicine and director of the Center for Liver Diseases at the University of Chicago. “In addition, the interim data show that the high dose of PEGASYS is generally well tolerated by patients.”
About Hepatitis C
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.
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 http://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 greater than or equal to 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).
Roche
CONTACT: Bob Madison of Roche, Work: +1-973-562-2231, Cell:+1-973-919-7085, bob.madison@roche.com; or Robyn Meyer of Manning Selvage &Lee, +1-212-468-3376, robyn.meyer@mslpr.com, for Roche
