AIDS war helps drug makers fight hepatitis

WOODLAWN, Ky. -- Barbara Haun went to her doctor to find out why she was suffering nausea and pain and learned she'd been infected with hepatitis B for at least 10 years -- maybe for her entire life.

That was three years ago, and Haun, now 45 and living with a severely damaged liver, says her life is "a nightmare, it's scary, it's living with death every day and then saying, well, I'm not going to die."

Haun, among the 30 to 40 percent of hepatitis B sufferers whose infections quietly develop with no obvious symptoms, was diagnosed too late to be helped by even the most powerful of treatments currently on the market.

Now, advances in therapy by companies such as Britain's Glaxo Welcome and Canada's BioChem Pharma could make it possible to stop even long-term hepatitis infections before they cause irreversible liver damage, cirrhosis or cancer. Some of these treatments draw on medical advances achieved as part of the war on AIDS.

Like AIDS, hepatitis B may be passed through sexual contact or shared needles. Hepatitis B can also strike indiscriminately, though. Haun, an interpreter for the deaf who lives in northern Kentucky, said she may never know how she got the liver-destroying virus. "I know I'm monogamous. I've had one partner for life. I've never shot drugs."

Hepatitis B is 100 times more infectious than HIV, and the virus can live for at least seven days outside of an infected person. Worldwide, 350 million people are infected with hepatitis B -- 10 times the number that have AIDS -- and the infection is the ninth leading cause of deaths, claiming a million lives annually.

Analysts say the market for effective drugs to treat hepatitis B could easily top $3 billion. "There are huge, huge spoils for the winner," said Richard van den Broek, an analyst with Hambrecht & Quist.

There are vaccines available to prevent hepatitis B made by companies including Merck and SmithKline Beecham. While more and more children in the United States are getting vaccinated every year, worldwide immunization rates are still relatively low.

And the vaccines can't do anything for those already infected.

Currently, immune-system boosting drugs known as alpha- interferons, sold by companies including Roche Holding and Schering- Plough, are the mainstay of hepatitis B therapy. Only a small portion of patients take the injected drugs, however, because they're expensive, have nasty side effects and are often ineffective.

"We're still at the point where there's nothing really great out there," said Kathleen Smith, associate director of the Hepatitis B Foundation in Doylestown, Pa. "We're very hopeful" about new drugs in development, she said.

The new treatments are the result of a greater understanding of how the virus acts and reproduces in liver cells. These treatments, some of which were designed as treatments for HIV, target the virus directly.

Gilead Sciences, for instance, is studying its experimental adefovir drug for both hepatitis and HIV.

And Glaxo and BioChem are in late stages of testing their lamivudine drug, sold as 3TC for the treatment of HIV, in hepatitis B patients. Glaxo has filed applications to sell the drug in at least 29 countries including the United States, China, South Korea and countries in Europe.

With strong effectiveness against the virus, few side effects and a dosage that can be taken by mouth, lamivudine should win easy approval and gain swift popularity, analysts said. Worldwide sales could top $400 million within a few years.

"We think this is going to be a huge drug," said David Stone, an analyst with SG Cowen & Co.

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