Hepatitis B drug approved in Canada

Dr. Lorne Tyrell and hepatitis B patient Kit Li

At a news conference Nov. 30, Edmonton businessman Kit Li described the end stages of his liver disease caused by the hepatitis B virus. "I was like a 10-month pregnant woman all the time," he said. "My liver made me very short tempered. It affected my brain also." But among the worst symptoms was the internal hemorrhaging that meant blood unexpectedly pouring from his mouth.

Before he slipped into a coma, he recalls collapsing on the stairs of his home and his wife saying, "Let's pray to God."

The answer to that prayer came more than three months later. Dr. Lorne Tyrrell, dean of medicine and dentistry, asked the manufacturers of Heptovir, a drug developed from his research, to let Li's doctor try it on him.

That was in May of 1994. The drug held the virus at bay, allowing doctors to carry out a liver transplant without risk of the virus infecting the new liver.

And at that news conference announcing the drug was approved for use on the estimated 250,000 people infected with hepatitis B across Canada, a healthy Li said simply, "It definitely saved my life."

About 300 million people are infected worldwide, says Tyrrell, and as approval for the drug moves around the world, it could save roughly 4,500 lives each day.

"This work really began here at the University of Alberta," he said. "Today, we're announcing what is really the culmination of 12 years work."

That work started with a conversation in the Faculty Club between Tyrrell and Dr. Morris Robins, then a U of A chemistry professor who continues to collaborate in the research from Brigham Young University.

Tyrrell's lab adapted a cell-culture system to test compounds for anti-viral activity and began testing on ducks-supplied by Tyrrell's farm family-and woodchucks. "It was very basic work in the beginning and basic work that resulted in a very important clinical application," said Tyrrell.

After the animal tests, Tyrrell led the way to a different kind of new ground for the U of A by bringing industry into research. Glaxo Canada, now Glaxo Wellcome, supported the development of the Glaxo Heritage Research Institute and has expended $11 million over the last 10 years to support its research. That money and support from the Medical Research Council of Canada, the Alberta Heritage Foundation for Medical Research and the University of Alberta Hospitals Foundation saw the project through clinical trials.

The resulting drug, Heptovir, was synthesized by Dr. Bernard Billieu of BioChem Pharma, an international biopharma-ceutical company. BioChem will receive a royalty based on sales, while Glaxo Wellcome has the right to develop, manufacture and sell Heptovir worldwide. An equally owned joint venture between the two companies will commercialize Heptovir in Canada.

Heptovir is taken orally and will cost roughly $4.40 a day, "which compares with some of our modern therapies for hypertension," said Tyrrell. But while the pill will revolutionize treatment, "the best treatment in the world is prevention," he says. An effective vaccine is available and administered to Alberta children in Grade 5.

But while researchers are one step ahead of the virus, Tyrrell says Dr. Karl Fischer on the U of A research team discovered early on that over a period of time the virus can mutate. "We don't know if we can predict who might develop resistance," says Tyrrell. "It is a problem.we and other labs are working on other compounds." The ultimate weapon will probably be a "cocktail" of drugs likes those currently being used to treat AIDS.

While that work is going on, Tyrrell's team is moving down the alphabet and conducting parallel research on compounds to fight hepatitis C.

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