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Panel Recommends Approval Of New Hepatitis B Treatment

By Justin Gillis

An advisory panel of the Food and Drug Administration voted unanimously Tuesday to recommend approval of a new drug for hepatitis B, a potentially life-threatening liver ailment that afflicts more than 1 million Americans.

The drug, adefovir dipivoxil, is the latest payoff from the nation’s enormous investment in AIDS research. It was originally developed for that disease and then rejected because it damaged the kidneys, but it proved effective against hepatitis B in lower, and safer, doses.

The FDA is not required to follow the recommendations of its advisory panels, but it usually does so. Gilead Sciences Inc. of Foster City, Calif., said it hoped to win formal approval and put the drug on the market by the end of the year.

Approval of the drug would give liver doctors a new tool against viral hepatitis. About 1.5 percent of the American population is infected with hepatitis B or hepatitis C, two chronic illnesses with similar symptoms.

That is five times as many people as have the human immunodeficiency virus, which causes AIDS. But hepatitis is slower to produce symptoms, sometimes taking decades. Many of the afflicted are members of the baby boom generation who are moving gradually, but relentlessly, toward serious liver illness, potentially including cancer. Already, viral hepatitis is the nation’s leading cause of liver transplants, and many people die while awaiting donor livers.

Against this backdrop, scientists are laboring to copy the model they developed for AIDS treatment, using antiviral drugs in various combinations over long periods to slow the damage from hepatitis. The Gilead drug would be the second such drug approved for hepatitis B. It is expected to be used first in people for whom other drugs have stopped working, but it may eventually become an element of the same kind of combination regimens used in AIDS. “I think it’s a real winner,” said Eugeney Schiff, chief of hepatology at the University of Miami School of Medicine and a consultant for Gilead.

The same 15-member FDA Antiviral Drugs Advisory Committee voted to reject the drug when it was considered for AIDS treatment.

Panel members said they remain concerned about the potential for kidney damage from the drug, and they called for careful monitoring in patients who use it, especially for long periods. But they said with the lower doses of the drug used in treating hepatitis, the balance of risks and benefits had tipped in favor of adefovir.

Several hepatitis patients who spoke Tuesday referred to adefovir as a “miracle,” and they described dancing and shedding tears of joy when they learned how well the drug was working for them. “I beg you, please give this opportunity to many other people,” Elias said.