Longer-Acting Drug Approved for Hepatitis C

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Jan. 31, 2001 -- "If you heard about the cure being worse than the disease, that's the way it feels," says Barb, a 50-year-old nurse in Cleveland, who is struggling with the simple act of bringing a cup of herbal tea to her lips.

Barb is in the fourth week of treatment for hepatitis C, and she has a long way to go -- 48 weeks in all to complete treatment.

Hepatitis C is often called the silent menace, a ticking time bomb that can sit within cells for decades and then suddenly flare up. Worldwide, an estimated 10 million people are infected. The virus is transmitted either by contaminated blood products -- our nation's blood supply was not protected from hepatitis C until about a decade ago -- or by IV drug abuse or needlesticks. Left untreated, it attacks the liver and can eventually cause irreversible damage, known as cirrhosis, or even cancer. At that point, the only solution is a liver transplant.

Barb's eyes are red-rimmed and watery. She is 10 pounds lighter than she was at Christmas, and even then she was carrying a spare 119 pounds on her 5-foot-8-inch frame. She says she is "tired, nauseous, and my head is pounding."

These are all fairly typical symptoms of treatment with the drug called interferon alpha-2b, long the standard treatment for hepatitis C.

Three times a week, usually about 9 p.m. when she knows she will soon be heading for bed, Barb injects herself with interferon.

"I have to keep doing this, but it's hard, because I know how I'm going to feel by morning," she says. In addition to the thrice-weekly shots, every day she takes a pill containing the antiviral drug ribavirin.

Still, Barb is hopeful. A couple of days ago, she spent the morning at the Cleveland Clinic Foundation's hepatitis C clinic. Her fellow patients and her doctor, an internist with an interest in liver diseases, were all talking about "PEG-Intron," she says. "Everyone wants to find out if they can get the new drug -- imagine, one injection a week! Like a walk in the park," she says.

Continued

Last week, the FDA approved PEG-Intron, which is basically a longer-acting version of the interferon alpha Barb currently takes.

Part of what has her hopes up -- and the hopes of her fellow patients at the hepatitis clinic -- is that they've heard that the drug's manufacturer, Schering-Plough, is claiming that a combination of ribavirin and the new long-acting PEG-Intron is more likely to knock out the hepatitis C virus than the standard interferon regimen.

Studies have shown that only about 40% of patients taking the standard treatment will have a successful response, while the response rate seen in clinical trials of PEG-Intron and ribavirin range from 42-82%.

"The talk around the waiting room," Barb says, is that side effects may be about the same. But even if that's so, she says, the simplicity of once-a-week dosing should make life easier.

She may not get the chance to find out. The FDA has approved PEG-Intron only for use by itself, not in combination with other drugs -- and it hasn't even reached U.S. pharmacy shelves at this point.

In Munich, Josef says he hopes Barb gets a shot at the new drug. Josef is one of more than 1,500 patients who participated in a European trial of the long-acting drug in combination with ribavirin.

"When the study started, I had 2.5 million copies of the [hepatitis C] virus in my cells. That is hard to imagine, so much disease in one cell," Josef recalls.

Upon completing the trial, his viral load was down to 500 copies per cell, he says. "I think that is a response," Josef says.

Meanwhile, Barb continues to plan her life around the needle.

Today, it's late Sunday afternoon, and she's making preparations for a small group of friends and family who are coming over for a Super Bowl party. It's a good day to do it, she says, "because it's Sunday. I haven't had a shot since Friday. I guess you could say this is the very best day of the week for me. A good day for a party."

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