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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update
Hepatitis C Virus: Duke, Johns Hopkins to Lead First

October 22, 2003
Hepatitis Weekly (10.13.03) - Wednesday, October 22, 2003

In hopes of refining treatment practices for hepatitis C, researchers at Duke University Medical Center and the Johns Hopkins University School of Medicine will lead the first ever direct comparison of two leading treatments for the infection. Hepatitis C infects nearly 3.9 million Americans, according to CDC. Approximately 70 percent of patients have chronic hepatitis C, which can cause cirrhosis and liver cancer and is the leading indication for liver transplantation in the United States.

A combination of interferon and ribavirin is the most common hepatitis C treatment. A recent advance has been pegylated interferon, which improves pharmacokinetic characteristics compared to standard interferon, allowing more convenient weekly dosing instead of three times a week.

The study - led by John McHutchinson, MD, director of gastroenterology and hepatology research at the Duke Clinical Research Institute, and Mark Sulkowski, MD, assistant professor of medicine at Johns Hopkins - will compare three treatment regimens in 2,880 hepatitis C patients. The trial, IDEAL (Individualized Dosing Efficacy vs. flat dosing to Assess optimaL pegylated interferon therapy) is sponsored by the Schering-Plough Research Institute. Patients will be given one of two available pegylated interferon treatments - pegylated interferon alfa-2b (PEG-INTRON, by Schering-Plough Corp.) and pegylated interferon alfa-2a (PEGASYS, by Hoffman- LaRoche Inc.) - combined with ribavirin.

"The beginning of this trial is truly a milestone in research for treatments of hepatitis C virus," said McHutchinson. "This is the first time we have directly compared these two treatments in a head-to-head manner. We hope to learn important information that will directly impact the treatment of our hepatitis C patients." The trial will enroll patients from 100 different sites nationwide. Dosing is one of the primary differences between the two treatments, scientists said. Alfa-2a is given in the same dosage to all patients, while Alfa-2b is given based on the individual patient's weight. The trial's goal is to determine which treatment results in a sustained viral response (an undetectable level of virus in the patient's blood 24 weeks after the end of therapy) in the largest proportion of patients.

"By eradicating the virus during and after therapy, we are able to forestall, and in many cases, prevent further damage to the liver. This has a huge impact on patient health and quality of life and translates into prolonged survival, a lower incidence of liver cancer and may prevent the need for liver transplantation," said McHutchinson, who has served as a paid consultant to Schering and has received research support and lectured on behalf of both Schering-Plough and Hoffman- LaRoche.