A new, longer-lasting version of the standard drug for hepatitis C is much more effective in treating the liver disease, two studies show.

About 4 million Americans are infected with hepatitis C, which causes liver inflammation and can lead to cirrhosis and cancer. The drugs available to treat it are not very effective and can have serious side effects, including depression.

Standard treatment for the blood-borne virus is injections of interferon alpha or a combination of interferon and another anti-viral drug, ribavirin.

Two studies, sponsored by drug maker Hoffmann-La Roche Inc., tested its modified form of interferon, called Pegasys, against its standard interferon, Roferon-A. The findings in Thursday's New England Journal of Medicine show the new version to be significantly better at eliminating the virus.

"This is a major advance in the treatment of patients with hepatitis C from the prospective of a better response rate," said Dr. Raymond S. Koff of the University of Massachusetts Medical School, who was not involved in the research.

In the larger study, Pegasys was tested at 36 centers outside the United States between 1997 and 1999.

. Five hundred thirty-one patients received either regular interferon or Pegasys for 48 weeks. Pegasys was twice as effective, the researchers said. A signs of the virus disappeared in 39 percent of the Pegasys group versus 19 percent for the regular interferon group.

"We hoped to have some achievement but that you can double the response rate was really a good surprise," said one of the researchers, Dr. Stefan Zeuzem of the University of Frankfurt. Zeuzem has worked as a consultant for Hoffmann-La Roche and other drug companies, as have some of the other researchers.

Zeuzem said Pegasys was also tolerated better and had fewer side effects — typically flu-like symptoms. Because it is longer-lasting, it requires only one injection a week instead of three.

The second, smaller study tested two different doses of Pegasys against Roferon-A on 271 harder-to-treat hepatitis C patients with cirrhosis at 30 centers in the United States and elsewhere. The response rate was 30 percent in the high-dose Pegasys group; 15 percent for lower-dose Pegasys and 8 percent for Roferon-A.

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Zeuzem said the next step is combining Pegasys with ribavirin, which boosts the effectiveness of interferon. Tests are under way on the combination.

Hoffmann-La Roche has applied for Food and Drug Administration approval to sell Pegasys. Schering-Plough Corp. is also seeking FDA approval of a similar modified interferon, Peg-Intron. Tests of Peg-Intron in combination with ribavirin have shown it to be effective in 54 percent of patients.


On the Net: New England Journal of Medicine: www.nejm.org

Hepatitis Foundation International: www.hepfi.org

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