Schering-Plough hepatitis combo shows clinical benefit

Results from the first treatment phase of the EPIC(3) trial, a major ongoing study, have shown that a significant portion of patients chronically infected with hepatitis C virus (HCV) who failed previous therapies achieved a sustained viral response (SVR) when retreated with weight-based PegIntron (peginterferon alfa-2b) and Rebetol (ribavirin) combination therapy.

Of the first 978 patients enrolled in the trial, 21% achieved an SVR, defined as undetectable virus six months after the end of therapy. This is nearly double the SVR rate of 12% in patients retreated with peginterferon alfa-2a and ribavirin reported in a similar patient population in a trial named HALT-C.

In addition to examining the ability of PegIntron and Rebetol to achieve SVR in patients who failed previous therapy, researchers also evaluated the ability of early virologic response (EVR). Of those patients who attained EVR, 36% achieved SVR, 57% of those with undetectable HCV-RNA at week 12 achieved SVR, but only 4% of those with detectable viral load at week 12. Patients who were nonresponders or relapsers with undetectable HCV-RNA at week 12 were equally like to achieve SVR.

Results of EPIC(3) showed that in addition to patients with undetectable HCV-RNA at week 12, retreatment also may be a good option for patients with other key factors affecting response. For example, SVR was higher in patients with genotype 2 or 3 virus, in patients who had relapsed after previous therapy, and in patients with F2/3 (mild-to-moderate) fibrosis.