PRNewswire - November 7, 2001

One retrospective study analysis of PEGASYS in combination with the antiviral, ribavirin, explores the relationship between a patient's early response to treatment and long-term sustained virologic response (SVR). SVR refers to no detectable virus (negative HCV RNA) six months after treatment discontinuation.

The trial analysis results, to be presented by lead author, Dr. Peter Ferenci includes patients infected with genotype 1, one of the most difficult-to-treat forms of the disease and most prevalent genotype found in the U.S. This is the first and only time information of a predictive nature has been analyzed with PEGASYS in the treatment of hepatitis C. Efficacy and safety data from this study was presented earlier this year at the Digestive Diseases Week (DDW).

Other PEGASYS studies being presented address a number of hepatitis C treatment issues, such as the more difficult-to-treat populations; African Americans, HIV/HCV co-infected patients, patients with genotype 1, and additional combination therapies in patients who either relapsed or did not respond to Rebetron(TM). The studies, conducted in the U.S. and internationally, involved over 3,200 patients and represent the work of over 70 clinicians and scientists.

"The extensive body of research being presented helps further our knowledge of PEGASYS and, most importantly, allows physicians to determine possible treatment regimens for their patients," said Dr. Mitchell Shiffman, Chief of Hepatology at the Medical College of Virginia.

"We are committed to our rich clinical trial program, and furthering our understanding of how to manage the spectrum of hepatitis C patients, including the most difficult-to-treat," said Dr. Brian Murphy, PEGASYS Medical Director, Roche.

The most common serious adverse events reported for PEGASYS, observed in clinical studies to date, were infections, psychiatric disorders and gastrointestinal disorders. The most common adverse events included flu-like symptoms, such as fever, chills, fatigue, headache, myalgia/arthralgia, nausea/vomiting, anorexia, diarrhea and abdominal pain, injection site reactions, partial alopecia, depression, irritability, insomnia and dizziness.

Severe psychiatric adverse events have occurred during combination interferon/ribavirin or interferon alone therapy both in patients with and without a previous psychiatric disorder. In addition ribavirin has its own adverse events, the most serious of which are birth defects. For this reason ribavirin and interferon with ribavirin must not be used by women or male partners of women who intend to become pregnant during therapy or within six months of therapy. Ribavirin has been shown to cause anemia in some patients, which may exacerbate previous coronary heart disease, or deteriorate heart function.

Abstracts To Be Presented at AASLD

-- Long-Lasting Sustained Virological Response In Chronic Hepatitis C Patients Previously Treated With 40 KDA Peginterferon Alfa-2a (Pegasys(R))

-- Safety And Efficacy Of 40 KDA Peginterferon Alfa-2a (Pegasys(R)) In The Treatment Of Patients Co-Infected With HIV And HCV: Preliminary Results From A Randomized Multicenter Trial

-- Tolerability Of 40 KDA Peginterferon Alfa-2a (Pegasys(R)) Versus Standard Interferon Alfa-2b/Ribavirin Combination Therapy (IFN/RBV) In Patients With Chronic Hepatitis C (CHC)

-- 40 KDA Peginterferon Alfa-2a (Pegasys(R)) In Combination With Ribavirin In African American And Caucasian Patients With HCV Genotype 1: A Preliminary Report Of A Comparative, Multicenter,

Efficacy And Safety Study

-- Prospective Evaluation Of Early Virological Response Associated With 40 KDA Peginterferon Alfa-2a (Pegasys(R)) Plus Ribavirin Therapy From A Phase III, Randomized, Double-Blind Study Examining The Effects Of Treatment Duration And Ribavirin Dosing

-- Enhanced Virological Response To Treatment With 40 KDA Peginterferon Alfa-2a (Pegasys(R)) In Patients Previously Unresponsive To Treatment With Interferon Alfa-2a

-- 40 KDA Peginterferon Alfa-2a (Pegasys(R)) Can Be Administered Safely In Patients With End-Stage Renal Disease

-- Analyses Of 40 KDA Peginterferon Alfa-2a (Pegasys(R)) In Combination With Ribavirin, Mycophenolate Mofetil, Amantadine, Or Amantadine Plus Ribavirin In Patients That Relapsed Or Did Not Respond To Rebetron(TM) Therapy: A Report Of Two Randomized, Multicenter, Efficacy And Safety Studies

-- Treatment With 40 KDA Peginterferon Alfa-2a (Pegasys(R)) In Combination With Ribavirin Significantly Enhances Quality Of Life Compared With Interferon Alfa-2b Plus Ribavirin

-- 40 KDA Peginterferon Alfa-2a (Pegasys(R)) As A Prophylaxis Against Hepatis C Infection Recurrence After Liver Transplantation (LT): Preliminary Results Of A Randomized Multicenter Trial

-- 40 KDA Peginterferon Alfa-2a (Pegasys(R)) In Post-Liver Transplant Recipients With Established Recurrent Hepatitis C: Preliminary Results Of A Randomized Multicenter Trial

-- Early Prediction Of Response To 40 KDA Peginterferon Alfa-2a (Pegasys(R)) Plus Ribavirin (RBV) In Patients With Chronic Hepatitis C (CHC)

-- 40 KDA Peginterferon Alfa-2a (Pegasys(R)): Efficacy And Safety Results From A Phase II, Randomized, Actively Controlled, Multicenter Study In The Treatment Of HBEAG Positive Chronic Hepatitis B

More About Pegylation

Pegylation is the attachment of one or more chains of polyethelene glycol (also known as PEG) to another molecule. In peginterferon alfa-2a, a 40 kilodalton branched, mobile PEG is covalently bound to the interferon alfa-2a molecule and provides a selectively protective barrier, without significantly reducing binding site receptivity. Pharmacokinetic behavior of a pegylated molecule depends on the size of the PEG and the nature of the link between the PEG moiety and the protein.

Researchers believe the PEG creates a barrier that shields the interferon alfa-2a molecule from being rapidly degraded by proteases in the body and maintains its ability to consistently suppress the hepatitis C virus over the one-week dosing period. Specifically, clinical trials have demonstrated that drug levels following a single dose of peginterferon alfa-2a last more than one full week (168 hours).

Preliminary pre-clinical and human volunteer data suggest that the high molecular weight (40 kilodalton) branched PEG in peginterferon alfa-2a helps provide sustained pegylated interferon alfa-2a exposure at clinically significant levels over the one-week dosing period. In contrast, according to earlier Roche studies using smaller PEGs developed by the company, interferons with smaller PEGs are degraded more quickly, requiring more frequent dosing.

About Hepatitis C

Hepatitis C, a blood-borne infectious disease of the liver, is a leading cause of cirrhosis and liver cancer and the number-one reason for liver transplants in the U.S. An estimated 2.7 million Americans are chronically infected with the virus, with approximately 35,000 new infections each year. In the United States, the Centers for Disease Control and Prevention estimate that hepatitis C is responsible for eight to ten thousand deaths per year and could increase to 38,000 by the year 2010.

Hepatitis C is a blood-borne virus transmitted through body fluids, primarily blood or blood products, and sharing needles. In many patients, the mode of transmission is unknown. Unfortunately, most people who are infected with hepatitis C are unaware of it because it may take years for symptoms to develop.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world's leaders in pharmaceuticals, diagnostics and vitamins. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company's areas of therapeutic interest are: dermatology; genitourinary disease; infectious diseases, including influenza; inflammation, including arthritis and osteoporosis; metabolic diseases, including obesity and diabetes; neurology; oncology; transplantation; vascular diseases; and virology, including HIV/AIDS and hepatitis C.

For more information on the Roche pharmaceuticals business in the United States, visit the company's website at: http://www.rocheusa.com.

**Rebetron(TM) is a trademark of the Schering-Plough Corporation

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