Pharmaceutical Business review

Roche initiates trial in post-transplant hepatitis

The new study will compare prophylactic combination therapy with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin, USP), with the same combination therapy administered once hepatitis C infection recurs histologically in the transplanted liver.

The study will enroll approximately 300 patients and include 28 trial sites throughout the US. All patients will be evaluated at 24 months to determine if they have experienced hepatitis C recurrence measured by fibrosis stage two or greater and/or inflammation grade three or greater.

“There are many questions to be answered such as how safe and effective is hepatitis C combination therapy for patients who have received a liver transplant, and when is treatment most effective,” said Dr Michael Charlton, associate professor of medicine and director of transplant research at Mayo Clinic College of Medicine.

“It is our hope that this study will help determine the best strategy for managing hepatitis C in patients who have received a liver transplant.”