"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"
Contact: Amanda Widtfeldt
Northwestern Memorial Hospital