SAN FRANCISCO, Nov. 11 /PRNewswire/ -- A series of studies related to the treatment of hepatitis C with Pegasys(R) (peginterferon alpha-2a) plus Copegus(R) (ribavirin, USP) will be presented at the 56th American Association for the Study of Liver Disease (AASLD) annual meeting, which begins here today. The following study highlights will be presented. Roche continues to support Pegasys with the most extensive development program ever undertaken in hepatitis C, including major studies initiated to advance treatment for hepatitis C patients whose infections are considered challenging to treat.
Roche will also present interim results from its study showing that re-treatment with Pegasys plus Copegus reduced viral levels in hepatitis C patients for whom treatment with Peg-Intron(R) (peginterferon alpha-2b) plus Rebetol(R) (ribavirin, USP) had failed. Interim study results from the REPEAT (REtreatment with PEgasys in pATients Not Responding to Peg-Intron Therapy) study will be presented here on Nov. 14, 2005.
In addition to the initial REPEAT study information released today, presented at the AASLD annual meeting are studies that:
* Evaluated accelerated response rates in treatment of a sub-group of individuals with the most common form of hepatitis C in the U.S. * Assessed the rate of persistence in patients taking Pegasys versus those taking Peg-Intron. * Compared the economic and handling aspects of the Pegasys prefilled syringe versus the Peg-Intron Redipen in patients who started hepatitis C therapy in Germany. * Evaluated the effectiveness of Pegasys in individuals who had not tolerated treatment with Peg-Intron. Among the studies being presented at the meeting include the following:
Two Studies Examining Genotype 1 Patients Who Experienced a Rapid Virologic Response:
* Two studies examined the treatment of genotype 1 "super-responders," defined as patients in whom treatment with Pegasys and Copegus led to a rapid virologic response (RVR). RVR refers to patients with HCV RNA levels less than 50 IU/mL after 4 weeks. -- The first study, "Rapid Virological Response at Week 4 (RVR) of Peginterferon alfa-2a (PEGASYS(R)) plus Ribavirin (COPEGUS(R)) Treatment Predicts Sustained Virological Response (SVR) after 24 Weeks in Genotype 1 Patients," analyzed data from 729 patients in the United States. The study identified 146 patients (20 percent) who had a rapid virologic response. The objective was to see if patients with an RVR were more likely to experience a sustained virologic response after 24 weeks of treatment than those without an RVR, because of lower relapse rates.(1) Dr. Donald Jensen will present this poster on Tuesday, Nov. 15, from 8:00 a.m. - 12:30 p.m. -- The second study, "Is Shorter Treatment with Peginterferon alfa-2a (40KD) (PEGASYS(R)) Plus Ribavirin (COPEGUS(R)) Possible in HCV Genotype 1 'Super-Responders'? Preliminary Results of a Prospective Randomized Clinical Trial," based in Austria, comprised 366 patients. Seventy-nine of these were classified as "super-responders" and assigned to receive 24 weeks of therapy. Preliminary results will be presented on the 48 patients who have completed the study to date. Dr. Peter Ferenci will present this study on Sunday, Nov. 13, from 4:45 - 6:15 p.m.
"Persistence with Hepatitis C Therapy in the Department of Veterans Affairs (VA)"
* This study analyzed persistence in 5,611 patients in the VA who received Pegasys with Copegus or Peg-Intron with Rebetol. Persistence is defined as the period from the date of the first peginterferon prescription filled to the date of the last prescription filled. Dr. Sheikh Usman will present this poster on Tuesday, Nov. 15, from 8:00 a.m. - 12:30 p.m.
"Economic evaluation of standard-therapy (ST) for chronic hepatitis C (CHC) with Peginterferon alfa-2a (40KD) (PegIFN 2a) plus Ribavirin versus Peginterferon alfa-2b (12KD) (PegIFN 2b) plus Ribavirin: Ready-to-use syringe (SYR) versus Injector (INJ) (SPRINT)"
* The SPRINT study compared the economic and handling aspects of the Pegasys prefilled syringe versus the Peg-Intron Redipen among 75 patients who started hepatitis C therapy in Germany. In this study, 37 patients used the Pegasys prefilled syringe, and 38 used the Peg-Intron Redipen. Dr. Hans-Deiter Janisch will present this poster on Tuesday, Nov. 15, from 8:00 a.m. - 12:30 p.m.
"Interim Analysis of the Safety and Efficacy of Peginterferon Alfa-2a plus Ribavirin in Chronic Hepatitis C Patients Unable to Tolerate or Nonresponsive to Treatment with Peginterferon Alfa-2b plus Ribavirin"
* The Rescue study evaluated the efficacy and safety of Pegasys with Copegus in patients with genotype-1, the most difficult to treat form of hepatitis C, who had previously taken Peg-Intron with Rebetol without success. Patients were either intolerant to Peg-Intron due to depression, fatigue, flu-like symptoms or injection site reactions, or did not have an early virologic response (EVR). EVR is defined as undetectable RNA levels after twelve weeks. Dr. Vinod Rustgi will present this poster on Tuesday, Nov. 15, from 8:00 a.m. - 12:30 p.m. 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 U.S.
About Pegasys for Hepatitis C
Pegasys, a pegylated alpha interferon, and Copegus are indicated 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 include 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 administered orally at doses of 800-1200 mg daily.
Please see attached additional information about Pegasys indication and safety.
About Roche - More Than a Century in the U.S. and the World
Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is one of the world's leaders in diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on many fronts to improve people's health and quality of life. Roche employs roughly 65,000 people in 150 countries, including approximately 15,000 in the United States.
Roche's U.S. operations celebrate their American Centennial in 2005. In another milestone this year, Roche was named in January to Fortune magazine's list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado, Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation, dermatology and influenza. Roche's Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our worldwide and U.S. websites (Global: http://www.roche.com and U.S.: 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 (e.g., 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).
(1) "Rapid Virological Response at Week 4 of Peginterferon alfa-2a (40KD) (Pegasys) plus Ribavrin (RBV, Copegus) Treatment Predicts Sustained Virological Response (SVR) after 24 Weeks in Genotype 1 Patients, 2005, D. Jensen, et al.
RocheCONTACT: Bob Madison of Roche, +1-973-919-7085 (mobile), +1-973-562-2231(office); or David Freundel of MS&L for Roche, +1-917-806-6625 (mobile)
