U.S. Government Panel Backs New Hepatitis Drug; Therapy, Created to Fight AIDS, Works Against Liver Infection

The Food and Drug Administration's Antiviral Drugs Advisory Panel 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 investment in AIDS research. It was originally developed for AIDS and then rejected because it damaged the kidneys, but it proved effective against hepatitis B in lower, and safer, doses.

FDA panel members said they remained 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 lower doses of the drug used in treating hepatitis tipped the balance of risks and benefits in favor of adefovir. The FDA is not required to follow the recommendations of its advisory panels, but it usually does. Gilead Sciences said it hoped to market the drug by the end of the year.

Hepatitis infects five times as many people as HIV and sometimes takes decades to produce symptoms. Many of the infected are baby boomers 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 awaiting donor livers.

Scientists, following the AIDS treatment model, are using antiretroviral drugs in various combinations over long periods to slow hepatitis' damage. Adefovir 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 may eventually become an element in a combination regimen.

Several hepatitis patients who spoke to the panel referred to adefovir as a "miracle." Larry Kramer, an AIDS activist who has spent years criticizing drug companies, told panel members that adefovir, which he received as an experimental drug, had kept him alive long enough to undergo a liver transplant. "Needless to say, I am not accustomed to appearing on behalf of any drug company," he said, making a point that he paid his own way to Tuesday's meeting.

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