AEGiS-Reuters: FDA panel recommends HIV drug for hepatitis

Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

FDA panel recommends HIV drug for hepatitis

Reuters NewMedia - Tuesday October 6, 1998

SILVER SPRING, Md., Oct 6 (Reuters) - Doctors who advise the U.S. Food and Drug Administration (FDA) recommended on Tuesday that the agency approve a drug used against the AIDS virus to fight hepatitis B as well.

The drug, Epivir, would be the first pill that people could take for hepatitis B, which infects an estimated 350 million people around the world. Epivir, sold by Glaxo Wellcome Plc (quote from Yahoo! UK & Ireland: GLXO.L), fights the HIV virus that causes AIDS by blocking its replication. Known generically as lamivudine or 3TC, it works the same way against the hepatitis B virus.

"I think lamivudine offers definitive hope for patients when where was nothing to be done in the past," said FDA panelist Maria Sjogren of the Walter Reed Army Medical Center.

The FDA is not bound by the advice of its panels but generally follows it. About a third of people infected with hepatitis B go on to develop serious progressive liver disease, which can cause liver failure or liver cancer. They can die of either.

Repeated injections of interferon, a genetically engineered version of a natural immune system molecule, is currently the only approved treatment for hepatitis B, which kills about a million people a year. Interferon only helps about 40 percent of patients.

There is a vaccine, and also a combined hepatitis A/hepatitis B vaccine. Several other companies are racing to test antiviral drugs against hepatitis B. SmithKline Beecham (quote from Yahoo! UK & Ireland: SB.L) is developing its herpes drug Famvir, also known as famciclovir, for use against hepatitis B. Bristol Myers Squibb (NYSE:BMY - news) has started tests of lobucavir, an experimental reverse transcriptase inhibitor developed for HIV, against hepatitis B and reports promising results.
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