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Chronic Hepatitis B Patients Still in Remission Two Years After Treatment With Pegasys (Peginterferon Alfa-2a)

Sustained Response Allows Patients to Live Treatment-Free

BASEL, SWITZERLAND -- April 28, 2006 -- In two hepatitis B studies, researchers have confirmed that patients treated for one year with Pegasys(R) (peginterferon alfa-2a (40KD)) have a durable response that lasts for years after stopping therapy.

This durable response means that patients can live without the burden of daily antiviral medications. Results from these studies were presented today at the 41^st Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria.

"Pegasys acts in two ways: by having direct antiviral activity, and boosting the body's immune system. These two actions help patients achieve lasting remission that continues for at least a year after treatment has stopped," said Professor Patrick Marcellin, Hepatologist at the Hôpital Beaujon, Clichy, France and an investigator of the studies. "This is encouraging news as patients in remission do not need daily, life-long, antiviral medication."

Study One: Power of Pegasys Durable After Two Years [i]
HBeAg-negative chronic hepatitis B is more common in the Mediterranean regions and has traditionally been plagued with higher rates of relapse following treatment. Now, important results from a large, long-term follow-up study indicate that 95 per cent of patients who responded to a single 48-week treatment course with Pegasys kept their response for at least two years after completing treatment. This means that these patients stayed in remission and were able to continue living without daily antiviral medications.

"These results are very encouraging for physicians treating chronic hepatitis B, as the current therapies have been associated with low rates of durable response, meaning patients have had to remain on therapy for many years. This can lead to the virus becoming resistant to the daily antiviral medications," said Professor Marcellin. "Patients who respond to Pegasys treatment may actually keep that response even though they have been off treatment for two years."

Study Two: Long Term Study in South East Asian Patients Also Confirms Durable Response to Pegasys [ii]
Results from a similar follow-up study in South East Asian patients were also presented at the conference. The results found that patients with HBeAg-positive chronic hepatitis B treated with Pegasys also kept their response after being off treatment for one year. Patients treated with Pegasys who have lasting remission (and low viral load) are unlikely to need further treatment. Research has shown that when viral levels are low, liver damage is reduced so the liver can start to repair itself, and the risk of liver cancer is lessened.[iii]

"This is exciting news in that the chance of a patient achieving sustained remission actually increases after Pegasys therapy is completed," said Dr George Lau, Gastroenterologist at the Queen Mary Hospital, Hong Kong and lead investigator of the study. "A durable response following treatment is what physicians look for in an effective hepatitis B treatment like Pegasys."

About Chronic Hepatitis B
Chronic hepatitis B is a serious global healthcare problem that affects more than 350 million people worldwide. It is one of the principal causes of chronic liver disease, cirrhosis, and primary liver cancer. Approximately one million people die from chronic hepatitis B annually, making it the tenth leading cause of death worldwide. For those chronically infected, the immediate aim of treatment is remission of liver disease to prevent progression to cirrhosis, liver failure, and primary liver cancer.

Treating Chronic Hepatitis B
Pegasys works to fight the disease in two ways: by boosting the immune system and at the same time, directly attacking the virus. Pegasys is the only pegylated interferon to be approved for the treatment of chronic hepatitis B in over 60 countries including the EU, the US and the People's Republic of China. Nucleoside/nucleotide analogues have a direct antiviral effect only and patients taking these medications tend to relapse (the disease comes back after being in remission) when treatment has stopped. In turn, the virus can start to multiply again, and as a result, the liver damage can come back.[iv],[v],[vi] Because of the risk of relapse, patients usually have to take these medications indefinitely.[iv],[vii],[viii]


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REFERENCES:
[i] Marcellin P, Lau GKK, Bonino F, et al. The majority of patients with HBeAg-negative chronic hepatitis B treated with peginterferon alfa-2a (40KD) [Pegasys(R)] sustain responses 2 years post-treatment. Presented at 41^st Annual Meeting of the European Association for the Study of the Liver, Vienna, Austria, 26-30 April, 2006.
[ii]Lau GKK, Piratvisuth T, Luo K-X et al. Durability of response and occurrence of late response to peginterferon alfa-2a (40KD) [Pegasys] one year post-treatment in patients with HBeAg-positive chronic hepatitis B. Presented at 41^st Annual Meeting of the European Association for the Study of the Liver, Vienna, Austria, April 26-30, 2006.
[iii] Liaw YF, Leung N, Guan R, et al. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2005 update. Liver Int 2005;25(3):472-89.
[iv] Song BC, Suh DJ, Lee HC, Chung YH, Lee YS. Hepatitis B e antigen seroconversion after lamivudine therapy is not durable in patients with chronic hepatitis B in Korea. Hepatology 2000;32(4 Pt 1):803-6.
[v] Chien RN, Yeh CT, Tsai SL, Chu CM, Liaw YF. Determinants for sustained HBeAg response to lamivudine therapy. Hepatology 2003;38(5 ):1267-73.
[vi] Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, et al. Long-term therapy with adefovir dipivoxil for HBeAg-negative chronic hepatitis B. N Engl J Med 2005;352(26):2673-81.
[vii] Leung NW, Lai CL, Chang TT, et al. Extended lamivudine treatment in patients with chronic hepatitis B enhances hepatitis B e antigen seroconversion rates: results after 3 years of therapy. Hepatology 2001;33(6):1527-32.
[viii] Marcellin P, Chang TT, Lim SG, et al. Long-term efficacy and safety of adefovir dipivoxil (ADV) 10 mg in HBeAg+ chronic hepatitis B (CHB) patients: increasing serologic, virologic and biochemical response over time. Hepatology 2004;40 (4 (Suppl 1)):655A.


SOURCE: Roche Pharmaceuticals

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