News from Hepatitis Week of July 6, 2003 / Vol. 3 No. 27

New Pegasys Trial to Enroll Hepatitis C Patients Not Helped by PEG-Intron

Hepatitis C patients who failed to respond to the first pegylated interferon combination therapy (peginterferon alfa-2b and ribavirin) are being recruited for a new global trial of peginterferon alfa-2a and ribavirin, it was announced at the 38th Annual Meeting of the European Association for the Study of the Liver.

Roche, which markets peginterferon alfa-2a as Pegasys, said the trial, which ultimately expects to enroll 1,000 patients in this study from Europe, North America and Latin America, will be known as REPEAT (REtreatment with Pegasys in pATients not responding to prior Peginterferon alfa-2b/Ribavirin combination therapy).

"Non-responders," as these hepatitis C patients are called, are those who failed to achieve a sustained virological response (increasingly regarded as a "cure") as a result of their treatment, and who continued to have virus present throughout their course of therapy.

The trial will be the first to compare repeat treatment of "non-responders" who previously were treated with peginterferon alfa-2b, which is marketed by Roche competitor Schering. Previous studies using pegylated interferon to retreat "non responders" have measured themselves against earlier therapies.

Today, the standard of care is pegylated interferon and ribavirin, and most hepatitis C patients receive one of the two pegylated interferon combination therapies.

"The two pegylated interferons are different drugs, with different properties and we know that Pegasys with Copegus (ribavirin) has yielded impressive results in hepatitis C patients," said William M. Burns, head of the pharmaceutical division at Roche. "We feel it is important for this pivotal trial to show how Pegasys with Copegus can help that sizeable group of patients who have not responded to the first pegylated interferon combination therapy."

The REPEAT study will evaluate the efficacy and safety of the combination of Pegasys and Copegus given for a longer, 72-week period, as well as examining the role of an induction regimen in this treatment- resistant population, Roche said.

"We've already seen that Pegasys in combination with Copegus is a highly effective treatment in [first-time] patients with some of the most difficult-to-treat strains of the virus,"said the European lead researcher Dr. Patrick Marcellin from Hospital Beaujon in France. "Given this performance, Pegasys may prove to give these particular patients another chance to respond and be cured."

Other sources: Roche