Schering-Plough begins phase 3 study of Peg-Intron in patients coinfected with hepatitis C, HIV

By Lisa Kerner

Erie, Pa., Jan. 13 - Schering-Plough is initiating a phase 3 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 reducing the occurrence of liver transplantation, liver cancer and death in cirrhotic patients with hepatitis C who are coinfected with HIV.

Known as Endure, the large randomized, open-label, multinational study is targeted to enroll 448 patients at approximately 80 sites including centers in the United States, Europe and Canada, according to a company news release.

All patients will be enrolled within the first 12 months of the 36-month study. Patients will be treated until the end of the study or until a clinical event occurs.

The parallel-group study will evaluate the efficacy and safety of maintenance therapy with low-dose Peg-Intron (0.5 mcg/kg once weekly) versus standard supportive care.

The primary objective of the study is to compare efficacy for the two treatment groups at the end of the study. Primary endpoints of the study will be the time to any of the following clinical events: death, liver decompensation, liver transplant or liver cancer.

"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, Mark S. Sulkowski, co-lead investigator of the study, said in the release.

"However, many coinfected 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."

Approximately one third of HIV patients, or about 10 million people worldwide, are coinfected with the hepatitis C virus and HIV.

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. It is not approved for treatment of patients who are coinfected with hepatitis C and HIV, said the release.

Schering-Plough, based in Kenilworth, N.J., is a science-based healthcare company with leading prescription, consumer and animal health products.

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