HBV (13.1) _ Interferon Therapy _ Pegasys

Pegasys offers greater benefits than existing standard drugs

The results, published today by the prestigious New England Journal of Medicine, have led the authors of the study to suggest that Pegasys be used as a first-line drug for the treatment of chronic hepatitis B. These results show that patients with the most common chronic hepatitis B are more likely to have a lasting remission if they are treated with Pegasys [Peginterferon alfa-2a (40KD)] compared to the existing standard drug lamivudine.

These findings and conclusions confirm the results of another three-stage trial of hepatitis B treated with Pegasys in 2004, also published in the New England Journal of Medicine (NEJM). The trial showed that patients with a more intractable form of pegasys treatment for the disease could achieve lasting relief more effectively than lamivudine. (ii) The authors also concluded that Pegasys could be seen as a first-line drug for the treatment of chronic hepatitis B.

Dr. George Lau, principal author of the NEJM, a professor of gastroenterology at Mary Hospital in Hong Kong, said: "This week's report shows that the HBeAg serum conversion is achieved in patients treated with pegasys (HBeAg Seroconversion) This important treatment target has more people than those who have achieved this goal in patients treated with lamivudine. Patients with Pegasys after treatment with hepatitis B are less likely to need further treatment, and their risk of cirrhosis, liver failure and liver cancer is reduced. These benefits are all a compelling reason to use Pegasys as the drug of choice for the treatment of hepatitis B. ”

Important results of this experiment

The trial, published this week in NEJM, was attended by 814 Hbeag-positive patients with chronic hepatitis B from 15 countries. In this trial, patients received 48 weeks of Pegasys (once a week, 180 mg each time) plus a placebo, lamivudine (once a day, 100 mg each time) or Pegasys plus lamivudine treatment. The therapeutic effect was evaluated after 24 weeks of non-treatment and after the last renewal period.

6 months after the end of treatment:

--32% of patients treated with Pegasys achieved HBEAG serum conversion (1), while 19% of patients treated with lamivudine achieved this goal. The use of Pegasys and the addition of lamivudine did not improve the therapeutic effect (27% of the people achieved HBEAG serum conversion).

It is important that 16 of the patients treated with pegasys (whether or not with lamivudine) have achieved HBsAg serum conversion (HBsAg seroconversion), while none of the patients who use lamivudine alone have achieved this serum conversion. HBSAG serum conversion can significantly reduce the risk of liver cancer or cirrhosis, and is rarely seen during clinical trials. The findings in this experiment were seen as the closest cure to hepatitis B.

The two trials published by NEJM are one of the largest clinical development plans for chronic hepatitis B, including three global trials in more than 1,500 patients from 19 countries. The results of these trials show that Pegasys is more effective than lamivudine and conventional interferon in achieving lasting remission.

"Chronic hepatitis B is a highly damaging disease that affects many people around the world," said Charles Gore, president of the European Association of Liver Disease patients. We welcome the efforts of pharmaceutical companies to develop increasingly effective drugs to combat the disease. Pegasys approval is a step in providing treatment options for hepatitis B. ”

Pegasys is currently in the process of regulatory approvals around the world and has been approved for treatment of chronic hepatitis B in more than 40 countries, including recent approvals from China, the United States and the European Union. Pegasys was the first and only pegylated interferon to be approved for the treatment of chronic hepatitis B.

Pegasys is treating the disease in two ways: it strengthens the immune system, and it can attack the virus directly. Lamivudine and other similar drugs only have the effect of directly attacking the virus and often need to be taken indefinitely, since hepatitis B will recur once the patient stops taking the drug. However, in the case of long-term use of the drug, the virus is resistant to lamivudine, which limits the effectiveness of the drug.

NEJM published a paper on Pegasys, bringing the journal to 7 articles on the drug, a pegylated interferon with the largest number of papers published in NEJM.

Introduction to chronic hepatitis B

Chronic hepatitis B is a serious global health problem, with more than 350 million people worldwide affected by it. It is one of the main causes of chronic liver disease, cirrhosis and primary liver cancer. Each year, about 1 million people die from chronic hepatitis B, making it the 10th leading cause of death worldwide. For patients with chronic hepatitis, the immediate goal is to alleviate liver disease and prevent it from developing into cirrhosis, liver failure and primary liver cancer.

HBV (13.1) _ Interferon Therapy _ Pegasys