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news.The European Commission has approved Schering-Plough's 48-week standard-dose Pegintron and Rebetol combination therapy for retreating adult patients with chronic hepatitis C who have failed a prior treatment.
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The approval is based on results from an ongoing non-comparative clinical study (EPIC3) in which 1,336 patients with moderate to severe fibrosis or cirrhosis who failed previous treatment with combination alpha interferon/ribavirin therapy were retreated with Pegintron combination therapy.
In this study, virological response at week 12 of treatment was shown to be an important predictor for achieving a sustained virological response (SVR), with 57% of patients who had undetectable virus (HCV- RNA) at week 12 going on to achieve SVR with a 48-week course of therapy. Within this subgroup, the SVR rates were 59% and 47% for patients who failed prior therapy with non-pegylated or pegylated interferon, respectively.
Overall, 23% of patients in the study achieved SVR, including 16% of patients who failed prior peginterferon and ribavirin combination therapy. Based on results from the EPIC3 study, the recommended duration of dosing with Pegintron combination therapy for retreating patients who failed previous therapy and who have undetectable virus at week 12 is 48 weeks, regardless of HCV genotype.
Pegintron and Rebetol is the first and only pegylated interferon combination therapy approved in the EU for retreating both hepatitis C (HCV)relapsers and nonresponders. The European Commission approval of this expanded indication for Pegintron and Rebetol results in marketing authorization with unified labeling that is valid in the current EU 27 member states as well as in Iceland and Norway.