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news.Schering-Plough has initiated a large phase IV trial to evaluate the safety and efficacy of Peg-intron and Rebetol combination therapy in liver transplant recipients with recurrent hepatitis C virus infection.
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Named PROTECT, the Peg-intron (peginterferon alfa-2b) plus Rebetol (ribavirin, USP) trial is targeted to enroll 125 hepatitis C virus (HCV) patients at approximately 28 liver transplant centers across the US.
To date, only a few small studies have been conducted in this patient population using pegylated interferon and ribavirin, the current standard of care in treating HCV, and results of these small studies have varied widely. It is unclear what virologic response rates can be expected in the post-liver transplant setting.
“A large multicenter study in liver transplant recipients with recurrent HCV is needed to better understand how to maximize treatment outcomes for these patients,” said Dr Fred Gordon, of the division of gastroenterology and hepatology at Lahey Clinic, Massachusetts and lead investigator for the PROTECT study.
“Given the potential for diminished long-term survival and the shortage of available resources for liver transplant patients with HCV recurrence, viral eradication is an important goal of treatment and would benefit both patients and society,” he continued.