The pharmaceutical company Schering-Plough announced that it will initiate a broad, multi-national clinical trial to evaluate the use of low-dose PEG-INTRON® (peginterferon alfa-2b) maintenance therapy in patients co-infected with both the hepatitis C (HCV) and HIV/AIDS viruses. The aim of the study, which is named “Endure,” is to identify a treatment for co-infected patients that will slow or stop hepatitis C disease progression and the subsequent development of complications such as liver disease. Investigators expect to enroll 448 patients at approximately 80 sites worldwide for the Endure study.
Although a combination of pegylated interferon/ribavirin is commonly used to treat patients with HCV, many co-infected individuals do not respond to this therapy. PEG-INTRON® monotherapy and PEG-INTRON/REBETOL® (ribavirin, USP) combination therapy is approved by the U.S. Food and Drug Administration for use in patients with HCV but not for those who are co-infected. “Until more effective HCV agents such as protease and polymerase inhibitors are available, it is critically important to try to prevent or delay progression of liver disease in these patients," said Mark S. Sulkowski, MD, associate professor of medicine in the Division of Infectious Diseases at Johns Hopkins University School of Medicine and co-lead investigator of the study.
Source: Schering-Plough news release dated January 13, 2006 and Datamonitor News Wire, January 16, 2006