Roche agrees hep C trial design with FDA

Swiss drug major Roche has agreed with the US Food and Drug Administration on the final design for a Phase IIb trial with R7128, a  nucleoside inhibitor of hepatitis C, slated to initiate in the first  quarter of this year.

The trial will enroll about 400 treatment-naive, genotype-1 or genotype  4, HCV-infected patients and will evaluate the dose and duration of the  treatment in combination with Pegasys (peginterferon alfa-2a) and  Copegus (ribavirin). The primary efficacy endpoint will be the  proportion of patients that achieve a sustained virologic response,  defined as undetectable 24 weeks after completion of treatment.