Researchers seeking to enhance transplant patient care with less toxic drug regimens presented early findings of a steroid-free treatment regimen in liver transplant recipients with hepatitis C. One-year data from an open label study reported Sunday at the American Transplant Congress (ATC) suggests that a steroid-free treatment regimen including CellCept (mycophenolate mofetil) provided comparable efficacy and safety to a standard steroid-containing protocol. CellCept is approved for the prevention of organ rejection in combination with cyclosporine and corticosteroids in patients receiving kidney, heart and liver transplants.

Steroids have been a cornerstone of transplant therapy for the past 50 years. However, long-term steroid use has shown significant side effects, which can include bone and muscle problems, eye disease, delayed wound healing and decreased ability to fight infection. For patients with hepatitis C, steroids are widely recognized to have an adverse effect on virus replication, putting them at an increased risk for hepatitis C recurrence following liver transplantation.

"The question has always been: how do we achieve the right balance of immunosuppression to prevent acute rejection without over-suppressing the immune system, which would allow hepatitis C virus to rapidly replicate?" said Goran Klintmalm, M.D., principal investigator, who is Chief and Chairman of the Baylor Regional Transplant Institute, Baylor University Medical Center, Dallas. "In our study, the steroid-free CellCept regimen demonstrated comparable efficacy, without increasing the risk of hepatitis C recurrence. We are encouraged by these trends at one year."

Study Background and Results¹
A total of 312 adult hepatitis C liver transplant patients participated in the open-label, prospective multicenter study. Patients were randomized to one of three treatment regimens: tacrolimus and prednisone (arm one); CellCept, tacrolimu
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Contact: Adam Pawluk
adam.pawluk@ketchum.com
917-847-8488
Ketchum
23-May-2005

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