FDA Approves Treatment for Hepatitis C

The Food and Drug Administration last night approved a new treatment for hepatitis C. The drug, an improved form of interferon, will be sold under the brand name Pegasys by F. Hoffman-La Roche Ltd. of Basel, Switzerland. While it was approved for use by itself, most doctors are expected to use it with ribavirin, and FDA approval of that combination is expected soon. The combination appears to suppress hepatitis C virus in more than half the patients who receive it -- a milestone that many doctors have compared with earlier breakthroughs in treating AIDS.

The action was the FDA's second hepatitis drug approval in a month. In September, the agency approved a drug to treat hepatitis B, which afflicts more than 1 million Americans. Taken together with other approvals over the past five years, the new developments give doctors an ambitious set of treatments to battle liver ailments that threaten the lives of about 1.5 percent of the US population.

Pegasys will compete directly with Peg-Intron, developed by Schering-Plough Corp. Several studies, though not definitive, suggest that Pegasys is marginally more effective and less likely to cause side effects, especially a flu-like syndrome that affects many people on hepatitis treatment. Also, Schering has been plagued by shortages of Peg-Intron, so many doctors and patients have eagerly awaited the Roche drug. Pegasys is likely to be the last hepatitis C drug to win approval for several years, because other candidates are in the earliest stages of research.

Even the best combination treatment fails to eradicate 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 -- now the majority of those receiving optimal treatment -- have nothing to worry about. But some patients have been followed for a decade, and their virus has not recurred. "I think we are moving toward the word 'cure,'" said David E. Bernstein, a New York University liver expert.

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