"A head-to-head study of two comparable regimens is still uncommon in the pharmaceutical industry because these studies generally are large, lengthy and expensive in order to get truly meaningful results," says Steven Flamm, M.D., a hepatologist at Northwestern Memorial Hospital, associate professor of medicine at Northwestern University's Feinberg School of Medicine and the principal investigator of the study at Northwestern. "This trial is a milestone in the treatment of hepatitis C. It should provide doctors with a blueprint that will make it much easier to decide which treatment to recommend based upon a patient's individual profile."
Currently, the most effective treatment for the hepatitis C virus is the combination of pegylated interferon alpha and ribavirin. Pegylated interferon alpha is an antiviral drug used to boost the immune system and combat the virus. Ribavirin, also an antiviral medication, enhances the effectiveness of pegylated interferon alpha. "We've learned from earlier studies that this combination is effective in about 55 percent of patients," says Dr. Flamm. "However, since the two commercially available regimens of combination therapy have never been directly compared, we do not know if one is more effective than the other."
The trial, which is being funded by one of the regimen's manufacturers – Schering-Plough Research Institute – will compare two different dosages of PEG-intron + Rebetol (manufactured by Schering-Plough Corporation) to its competitor PEGASYS + Copegus (manufactured by Hoffman-LaRoche, Inc). Researchers will compare safety, side effects and rates of "sustained viral response" – an undetectable level of virus in a participants' blood 24 weeks after the end of the study.
Approximately 3.9 million Americans are infected with hepatitis C. The virus is primarily spread through contact with human blood. It eventually leads to cirrhosis (scarring of the liver) in many patients. Liver failure and/or liver cancer may result. Hepatitis C is currently the leading indication for liver transplantation in the United States.
"Just a few years ago, we didn't have curative drug therapies to offer our hepatitis C patients," says Dr. Flamm. "So it is exciting that we are now looking at two therapeutic options that are proving to be effective in about 55 percent of hepatitis C patients. By eradicating the virus, we are able to prevent further damage to the liver. We hope that wiping out the virus in those patients on whom the therapies are successful will translate into prolonged survival, a lower incidence of liver cancer and less need for liver transplantation."
The trial, named IDEAL (Individualized Dosing Efficacy vs. flat dosing to Assess optimaL pegylated interferon therapy), will enroll 2,880 participants from approximately 100 sites throughout the United States. "It is an excellent study for participants because eligible participants will receive study-related office visits, blood-testing and study medications free of charge," says Dr. Flamm. Dosing is one of the primary differences between the two treatments in the study.
PEGASYS is administered in the same dose to all participants regardless of weight, while the dose of PEG-INTRON is calculated based upon each individual participant's weight. "Currently, most physicians base their decision about which treatment to use on their own familiarity with one of the two products," says Dr. Flamm.
Northwestern's Division of Hepatology is one of the largest and most comprehensive programs in the country. Seven specialists solely dedicated to the treatment of liver disease care for patients needing adult liver disease management, end-stage disease treatment and liver transplantation. In its research study, Northwestern Memorial is enrolling only people with the most common strain of the hepatitis C virus (genotype 1), which accounts for nearly three-quarters of those infected in the United States. People who have never been treated with any interferon or ribavirin, either alone or in combination, may be eligible to enroll. For more information on the research study, please call Northwestern Memorial Hospital's physician referral department at 312-926-8400 or 1-877-926-4664.
About Northwestern Memorial Hospital
Northwestern Memorial Hospital (NMH) is one of the country's premier academic medical centers and is the primary teaching hospital of Northwestern University's Feinberg School of Medicine. Northwestern Memorial and its Prentice Women's Hospital and Stone Institute of Psychiatry have 744 beds and more than 1,200 affiliated physicians and 5,000 employees. Providing state-of-the-art care, NMH is recognized for its outstanding clinical and surgical advancements in such areas as cardiothoracic and vascular care, gastroenterology, neurology and neurosurgery, oncology, organ and bone marrow transplantation, and women's health.
Northwestern Memorial was ranked as the nation's 5th best hospital by the 2002 Consumer Checkbook survey of the nation's physicians and is listed in the majority of specialties in this year's US News & World Report's issue of "America's Best Hospitals." NMH is also cited as one of the "100 Best Companies for Working Mothers" by Working Mother magazine and has been chosen by Chicagoans year after year as their "most preferred hospital" in National Research Corporation's annual survey.