VCU news

By Lorraine Cichowski and Mitchell Shiffman

RICHMOND, Va. – The oral antiviral medicine adefovir dipivoxil, which is sold under the trade name Hepsera, appears to be an effective treatment for chronic Hepatitis B and avoids the most serious side effects common with previous drugs, according to a study to be published in the Feb. 27 issue of the New England Journal of Medicine.

The study, based on two years of worldwide clinical trials that included Virginia Commonwealth University, concluded that patients suffering from chronic Hepatitis B improved significantly after 48 weeks of treatment with either 10 mg or 30 mg of adefovir dipivoxil. More than half of the patients showed improvement in their liver tissue, and the drug suppressed the virus completely in 13 percent of patients.

Adefovir dipivoxil also worked effectively during the trials in Hepatitis B patients who had developed resistance to other drugs and did not show evidence of causing its own drug resistance.  

"This drug is a tremendous improvement in treatment options for patients suffering from Hepatitis B," said liver expert Mitchell L. Shiffman, M.D., professor of medicine, chief of the Hepatology Section of the VCU Health System and co-author of the NEJM article.

"Not only does this drug appear to suppress the virus in greater numbers of patients during the first year of treatment, allowing those patients to stop taking medicine for their illness, it does not appear to build up resistance as older medicines did, allowing Hepatitis B to recur."

Hepatitis B is a serious disease that attacks the liver and can cause cirrhosis, liver cancer and death. It is estimated that 1.25 million people in the United States have chronic Hepatitis B, and approximately 100,000 new infections occur annually.

Previous treatments included interferon, which was effective in only about 43 percent of patients and caused serious side effects including influenza-like symptoms, anorexia and depression, and lamivudine, sold under the trade name Epivir, which caused drug resistance in almost one third of patients after one year of therapy.

Hepsera, made by Gilead Sciences of Foster City, CA, was approved by the Federal Drug Administration for sale in the United States in September 2002 for treatment of Hepatitis B.  The FDA approval was based partially on clinical trial data reported in today's NEJM article.