Pegasys (Peginterferon alfa-2a) More Tolerable Treatment for Hepatitis C Patients
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Pegasys (Peginterferon alfa-2a) More Tolerable Treatment for Hepatitis C Patients

BASEL, SWITZERLAND -- March 14, 2003 -- Two weeks after initiating treatment with Pegasys®, a new study has found that hepatitis C patients experienced significantly less fatigue, pain, physical and emotional limitations, and had improved vitality compared to patients treated with conventional interferon. Notably, maintaining health-related quality of life during treatment may reduce the risk of early treatment discontinuation. The study is published in the current issue of Pharmacoeconomics.

"We know that many patients do not adhere to their hepatitis C treatment because the side effects are often considered by patients to be more objectionable than the symptoms of the disease," said Dr. Jens Rasenack, the study author and Professor of Medicine in the department of Gastroenterology and Hepatology at the Albert-Ludwigs-University of Freiburg Germany. "The positive impact that Pegasys has on health-related quality of life makes it more likely that they will complete their treatment and ultimately improve their chances of being cured."

Previous studies have demonstrated that interferon therapy has a negative effect on health-related quality of life (HRQL) during the initial three to six months of therapy. Patients typically experience side effects such as flu-like symptoms, fatigue, lack of energy, body pain and alterations in mood, making it difficult for them to participate in every day activities.

Patients treated with Pegasys demonstrated significantly better scores in all health areas surveyed compared to those treated with conventional interferon and reported less disabling fatigue. The less disabling fatigue that Pegasys-treated patient experienced is thought by the study authors "to be attributed to the near-constant and sustained serum levels produced by the weekly dosing regimen of peginterferon alfa-2a (40KD) compared with the peaks and troughs associated with thrice weekly administration of unmodified interferon alfa-2a."

The patients treated with Pegasys also reported fewer problems with work due to physical or emotional problems and were less likely to report lacking pep or energy, being tired or feeling worn out. These patients were also less likely to report moderate or severe pain that interfered substantially with their work. These benefits continued for at least the first 12 weeks of treatment and in some cases right up to the 48th week of treatment.

The authors note that this analysis further extends the understanding of the documented benefits of Pegasys' better tolerability. Given that worsening health-related quality of life while on treatment negatively influences compliance, the study authors conclude that "the impact of quality of life should be considered when selecting a treatment against chronic hepatitis C to ensure adherence to treatment."

About the study
The health-related quality of life analysis was based on an international multicentre, open-label, randomized dose efficacy and safety study comparing Pegasys with unmodified interferon alfa-2a. Patients received either the standard dose of Pegasys (180mcg once weekly) for 48 weeks or conventional interferon (6MIU thrice weekly for 12 weeks followed by 3 MIU thrice weekly for a further 36 weeks). Patients were followed until 72 weeks after the start of treatment. The study was conducted in 36 centres in Australia, Canada, Germany, Mexico, New Zealand, Spain, Switzerland, Taiwan and the United Kingdom and included 531 patients. The results of the study "Peginterferon alfa-2a (40KD) (Pegasys) improves health-related quality of life outcomes compared with unmodified interferon alfa 2-a in patients with chronic hepatitis C" are published in this month's issue of Pharmacoeconomics.

How quality of life and fatigue were measured
Patients' quality of life and levels of fatigue were assessed at 2, 12, 24, 48 and 72 weeks after the start of treatment. Quality of life and fatigue were measured using the internationally recognised Short Form 36 health survey and the Fatigue Severity Scale.

About hepatitis C
Chronic hepatitis C is a serious viral infection of the liver and the leading cause of liver damage throughout the world. As many as 3% of the world's population are infected with the hepatitis C virus. Those who develop chronic hepatitis C risk cirrhosis, liver cancer, liver failure and liver transplantation.

About Pegasys
Pegasys, a new generation hepatitis C therapy that is different by design, provides significant benefit over conventional interferon therapy in patients infected with HCV of all genotypes. The benefits of Pegasys are derived from its new generation large 40 kilodalton branched-chain polyethylene glycol (PEG) construction, which allows for constant viral suppression. Pegasys also distributes more readily to the liver (the primary site of infection) than conventional interferon. Pegasys is the only pegylated interferon available as a ready-to-administer solution. Each weekly subcutaneous injection contains 180mcg of pegylated interferon alfa-2a which is the recommended dose for all patients, regardless of body weight.

About Roche
Roche is committed to the viral hepatitis disease area, having first introduced Roferon-A for hepatitis B and then C, followed by Pegasys in hepatitis C. Pegasys is also in phase III clinical development for patients infected with the HBV virus. Roche has also launched its own brand of ribavirin, Copegus, to be used in conjunction with Roferon A or Pegasys. Roche manufactures and sells the Amplicor HCV Test (v2.0) and the Amplicor HCV Monitor Test (v2.0) - two tests used to detect the presence of HCV RNA in a person's blood.

The company's commitment to hepatitis is further reinforced by the in-licensing of Levovirin, an alternative antiviral. Levovirin will be studied with the objective of demonstrating superior tolerability over the current standard, ribavirin.

All trademarks used or mentioned in this release are legally protected.

The journal Pharmacoeconomics is available online at www.ingenta.com. Film footage is available for broadcast journalists from The NewsMarket at www.thenewsmarket.com. Video is compressed in MPEG2 and is available for download to your FTP server.

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