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New Drugs Provide Hope for Millions with Hepatitis C

By Michael Lasalandra
Beth Israel Deaconess Medical Center Correspondent

Five years ago, Jacqueline Kurkowski learned as a result of a routine blood test that she was infected with hepatitis C, a potentially deadly bloodborne virus that can destroy the liver. She apparently became infected at birth.

"I couldn't believe it," said Kurkowski, now 25, who was in college when she learned she was infected. "I had never done drugs, didn't have any tattoos. And I had no symptoms other than being tired. But tests showed I was one step short of having cirrhosis of the liver. I decided to get treated right away."

Kurkowski, who lives in Stoneham and works at a drug and alcohol treatment center, received the standard treatment regimen -- 48 weeks of injections of two drugs, interferon and ribavirin. The combination of non-specific antiviral agents and immune boosters only work for up to 40 percent of patients. They didn't work for her.

"It did nothing except to make me sick every weekend for nearly a year," she said.

After the first year of treatment, she tried again, this time using a double dose. The amount of virus in her liver decreased for a while, but jumped again once she went off the double dose. When she was done, her doctors told her there was nothing else they could give her.

But Kurkowski learned of a trial of a new drug, teleprevir, being run at Beth Israel Deaconess Medical Center. She enrolled in April of last year. The drug, made by Vertex Pharmaceuticals, is one of two new hepatitis C treatments now in advanced clinical trials at BIDMC. The other is bocepravir, made by Schering Plough. Both drugs are known as protease inhibitors. Like the drugs used to combat the AIDS virus, they are so-called "designer" drugs that attack hepatitis C specifically. They are taken orally.

Kurkowski was skeptical, having failed two rounds of earlier treatments. "I really didn't want another negative result," she said. "I had so much hope with the other two."

But she got into the study and got her hopes up again. In the study, teleprevir was given along with interferon and ribavirin. A control group got interferon, ribavirin and a placebo. Kurkowski didn't know which group she was in. But when the study was over she learned it had worked -- she had cleared the virus from her body. A checkup six months after the study had ended confirmed the virus was gone.

"It's a great feeling," she said. "It's a huge relief. I thought I was going to have to live with this for the rest of my life, maybe get a liver transplant. I only wish the drug had been available sooner."

Dr. Nezam Afdhal, Chief of Hepatology at Beth Israel Deaconess Medical Center and Associate Professor of Medicine at Harvard Medical School, was the principal investigator for the Phase II study. He said the drug cocktail containing teleprevir cured between 62 and 65 percent of those taking it for the first time. Another study using the Schering Plough drug, bocepravir, in combination with interferon and ribavirin, cured up to 74% of treatment naïve patients. Responses in patients like Jacqueline who had failed prior treatments are not as good but still improvements compared to standard interferon ad ribavirin.

"These are two hot new treatments," he said. "There is new hope for patients with genotype 1 hepatitis C."

According to the U.S. Centers for Disease Control, about 4 million Americans are infected with the virus.

Not only do the new three-drug drug cocktails appear to be more effective than the two-drug regimen, but the addition of the protease inhibitor doesn't seem to increase the side effects to any great degree, Afdhal said. The only new significant side effect reported is a skin rash (associated with teleprevir) in up to 8% of patients, he said.

In addition, the new cocktail appears to be able to be used for a shorter duration than the standard treatment -- 24 rather than 48 weeks, he said. Another plus is the fact that the two new protease inhibitors are designed specifically to treat hepatitis C genotype 1, which is the form of the virus most commonly found in the U.S.

Phase III trials are currently underway at BIDMC and elsewhere.

"I hope these drugs come to market soon," said Kurkowski. "There are a lot of people out there for whom the standard treatments aren't working."

Above content provided by Beth Israel Deaconess Medical Center. For advice about your medical care, consult your doctor.

Posted December 2009