Roche starts global REPEAT trial of Pegasys and Copegus
Roche has launched in Europe the first global trial to study the efficacy of PEGASYS and Copegus in hepatitis C patients who failed to respond to the first pegylated interferon combination therapy (peginterferon alfa-2b and ribavirin). This trial will be known as REPEAT (REtreatment with PEGASYS in pATients not responding to prior Peginterferon alfa-2b/Ribavirin combination therapy).
Until the launch of this trial, all studies using pegylated interferon to retreat non-responders have measured themselves against conventional monotherapy and conventional interferon combination therapy. Today, however, the standard of care is pegylated interferon and ribavarin and most patients receive one of the two pegylated interferon combination therapies. Despite advances in the percentage of patients that can achieve a sustained virological response, a study published in The Lancet in 20011, demonstrates that 46% of patients who take peginterferon alfa-2b and ribavirin will not respond to it.
'The two pegylated interferons are different drugs, with different properties and we know that Pegasys with Copegus 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 72-week period, as well as examining the role of an induction regimen in this treatment-resistant population. Close to 1,000 patients will participate in this study from Europe, North America and Latin America.