The European Commission (EC) has approved an expanded indication for peginterferon alfa-2b injection plus ribavirin tablets (PegIntron and Rebetol, Schering-Plough), allowing use of the drug combination for re-treating adult patients with chronic hepatitis C virus (HCV) infection who have not achieved a sustained response with prior interferon-alfa plus ribavirin therapy.
The approval was based on data from an ongoing non-comparative clinical study [Evaluation of PegIntron in Control of Hepatitis C Cirrhosis, or EPIC(3)] of 1336 patients with moderate to severe fibrosis or cirrhosis who received 1.5 µg/kg peginterferon alfa-2b once weekly along with 800 to 1200mg/day ribavirin for 48 weeks.
Results showed that the majority (57%) of patients with undetectable viral load at 12 weeks (37%) achieved sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks post treatment. Subgroup analysis revealed that SVR rates were higher in patients who had failed prior therapy with nonpegylated vs pegylated interferons (59% vs 47%).
Virologic response at 12 weeks was a major predictor of SVR outcome: patients who had achieved a significant decrease (>2 log10 copies/mL) but did not achieve undetectable levels of virus had little chance of achieving SVR (6%). Overall, 23% of patients in the study achieved SVR, including 16% of those who failed the treatment before.
“The predictability of response with PegIntron means patients with undetectable virus at week 12 have an even chance of success regardless of whether they failed previous therapy with pegylated or non-pegylated interferon and can be motivated to continue treatment, and those patients who fail to achieve an early response can have their therapy stopped with confidence,” said Thierry Poynard, MD, professor of medicine, University of
Paris VI, Hopital Pitie-Salpetriere, and a lead investigator of the EPIC(3) study.
Peginterferon alfa-2b/ribavirin therapy previously was approved by the EC to treat HCV infection in treatment-naive adults, including those with clinically stable HV infection.
In the US, peginterferon alfa-2b alone or with ribavirin is indicated for the treatment of HCV infection in adult patients with compensated liver disease who have not previously received interferon-alfa.