Schering-Plough is initiating a large multinational clinical trial to evaluate the use of low-dose Peg-Intron (peginterferon alfa-2b) maintenance monotherapy in preventing or delaying hepatitis C disease progression and thus potentially reducing the occurrence of clinical events such as liver transplantation, liver cancer and death in cirrhotic patients with hepatitis C who are co-infected with HIV.
Known as the ENDURE study, the trial is targeted to enrol 448 patients at approximately 80 sites worldwide, including centres in the United States, Europe and Canada, states the company release
"The principal goal for treating patients infected with hepatitis C is viral eradication, with pegylated interferon and ribavirin combination therapy being the current standard of care. However, many co-infected patients fail to respond to this combination therapy and there currently is no approved treatment for such patients. 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, associate professor of medicine in the Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, US, and co-lead investigator of the study.
"Another patient group that may benefit from low-dose Peg-Intron maintenance monotherapy is cirrhotic patients with coinfection who are ineligible for combination therapy due to contraindications to ribavirin or who simply cannot tolerate full-dose combination therapy. The purpose of the ENDURE study is to address this question with a large, randomised, controlled clinical study," added co-lead investigator Massimo Puoti, associate professor in the Department of Infectious Diseases, University of Brescia, Italy, directed by professor G. Carosi.
ENDURE is a randomised, open-label, multi-center, phase III, parallel-group clinical study evaluating the efficacy and safety of maintenance therapy with low-dose Peg-Intron (0.5 mcg/kg once weekly) versus standard supportive care in patients with cirrhotic hepatitis C who are coinfected with HIV. The primary objective of the study is to compare efficacy for the two treatment groups at the end of the study, using the time to any of the following clinical events as primary endpoints: death, liver decompensation, liver transplant or liver cancer (hepatocellular carcinoma).
All patients will be enrolled within the first 12 months of this 36-month study and treated until the end of the study or until a clinical event occurs. Written informed consent will be obtained and all other regulatory requirements adhered to for all patients participating in the study.
The ENDURE study is consistent with Schering-Plough's research strategy to conduct and support clinical studies with weight-based Peg-Intron therapy, particularly in hepatitis patients with difficult-to-treat forms of the disease.
"Although we have made great advances over the past decade in the effective treatment of chronic hepatitis C, one of the most common blood-borne infections in the world, improved treatment options are still needed," said Robert J. Spiegel, chief medical officer and senior vice president of medical affairs, Schering-Plough Research Institute.
"Schering-Plough is undertaking studies with our existing hepatitis C products to explore new approaches to treatment, including maintenance therapy with our ongoing EPIC3 study in HCV patients and the new ENDURE study in co-infected patients, while at the same time developing new antiviral agents such as our investigational hepatitis C protease inhibitor. These research efforts underscore our long-term commitment to this therapeutic area and the hepatitis community," added Spielgel.
Peg-Intron is approved in the United States as monotherapy and for use in combination therapy with Rebetol (ribavirin, USP) for the treatment of chronic hepatitis C in patients with compensated liver disease who are at least 18 years of age, and is not approved for treatment of patients who are co-infected with HCV and HIV.
Approximately one third of HIV patients, or about 10 million people worldwide, are coinfected with the hepatitis C virus (HCV) and HIV. Liver disease caused by chronic hepatitis C is now a leading cause of morbidity and mortality among HIV-infected patients in the developed world.