Copegus/Pegasys gets MHLW OK for Hep C

Switzerland's Roche and its Japanese subsidiary Chugai say that the Japanese Ministry of Health Labor and Welfare has approved Copegus (ribavirin) plus Pegasys (peginterferon alfa-2a) as a treatment for patients infected with hepatitis C. The firms added that the decision is based on the results of a Phase III clinical trial of the combined regimen, which demonstrated that the majority of patients with the genotype 1b version of the virus achieved a sustained virological response during treatment.

The Japanese trial enrolled 300 HCV sufferers, 200 of whom were infected with the difficult-to-treat viral 1b genotype and had not received prior therapy, while the remaining 100 had not achieved sufficient progress, despite previous interferon-based treatment. The results showed that 59.4% of the treatment-naive group achieved an SVR, compared with 24% of those who received Pegasys alone. In the treatment-experienced cohort, an SVR was achieved by 51.4% who received combination therapy.

In addition, the companies reported that the side effect profiles were similar across all of the treatment groups, and added that, as expected, the rate of anemia was higher in all patients who received ribavirin.