Drug Is Second Medicine for Liver Ailment to Get Nod From US Agency in a Month

The Food and Drug Administration approved a new treatment for hepatitis C in July (2002) the final tool in a battle kit doctors have been assembling for years to combat an ailment that threatens the lives of hundreds of thousands of Canadians and 2.7 million Americans.

The drug, an improved form of an antiviral medicine called interferon, will be sold under the brand name Pegasys by F. Hoffmann-La Roche Ltd. of Basel, Switzerland. It was initially approved for use by itself, but most doctors are likely to use it in combination with another drug, ribavirin, and formal FDA approval for that combination is expected soon. The combination appears to suppress the hepatitis C virus in more than half of the patients who receive it, a milestone that many doctors have compared with earlier breakthroughs in treating AIDS.

The action was the second FDA approval for a hepatitis drug in a month. The agency approved a drug last month to treat hepatitis B, an ailment that afflicts more than 1 million Americans. Coupled with other approvals over the past five years, doctors have an ambitious set of treatments to battle liver ailments that threaten the lives of about 1.5 percent of the American population.

Mitchell L. Shiffman, a top liver expert at the Medical College of Virginia at Richmond's Virginia Commonwealth University, cited the "tremendous improvement" in hepatitis treatment in recent years, noting that in the case of hepatitis C, doctors have gone from telling patients they have a 7 or 8 percent chance of suppressing the virus to better than 50 percent. In some subgroups of patients the chances are now 80 percent.

Many people think of hepatitis as the ugly but brief liver ailment one can get from eating tainted food. That's hepatitis A. Hepatitis B and C are far nastier, more insidious viruses that can lie dormant for years before they cause liver failure, cancer or other catastrophic problems.

Pegasys will compete directly with a drug called Peg-Intron, developed by the Schering-Plough Corp. of Kenilworth, N.J. Several studies, though not definitive, have suggested that Pegasys is marginally more effective and less likely to cause side effects, particularly a flulike syndrome that hits many patients on hepatitis treatment. In addition, Schering has been plagued by shortages of Peg-Intron. For those reasons, many doctors -- and patients on Schering waiting lists -- have been eagerly awaiting the Roche drug.

Pegasys is likely to be the last hepatitis C drug to win approval for several years, since others are in the earliest stages of research. "There's nothing I can foresee being out there that will dramatically change the treatments" in the next few years, said David E. Bernstein, a liver expert at New York University.

Although doctors have new drugs in hand, they are still figuring out how to use them. In particular, even the best combination treatment fails to eradicate the hepatitis C virus in a sizable minority of patients, so the National Institutes of Health has mounted a massive, years-long test of whether the drugs can be used as suppressive treatment to slow liver damage in those patients.

Doctors are hesitant to say that patients in whom the virus seems to have been eradicated -- nowadays, a majority of those receiving optimal treatment -- have nothing more to worry about. But some of those patients have been followed for a decade and the virus has not recurred.

"I think we are moving toward the word 'cure,' " Bernstein said.

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