EC clears short-course Pegasys/Copegus

Swiss drug major Roche says that the European Commission has approved a new short-course therapy for hepatitis C patients that combines its two antiviral products Pegasys (pegylated interferon alfa-2a) and Copegus (ribavirin). The new regimen is specifically designed to treat patients infected by HCV genotypes 1 and 4, traditionally regarded as a difficult-to-treat group.

The firm explained the approval is based on data from two pivotal clinical trials, which demonstrated that among patients who experienced a rapid clinical response, defined as an undetectable level of virus at week four, 93% of those infected with genotype 1 HCV and 83% of those with genotpe 4, were cured after 24 weeks of therapy, a similar cure rate to that which is achieved after 48 weeks of treatment.

Identifies patients most likely to benefit