Roche Pegasys better at hep B?
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Roche plans to file its pegylated interferon Pegasys for hepatitis B next year, based on the results of a head-to-head Phase III study showing Pegasys to be more effective than lamivudine in difficult-to-treat variant hepatitis B. The highly statistically significant results showed that 42.9% of patients on Pegasys monotherapy met the primary endpoint of reduction in viral load below 20,000 copies/mL compared to 29.3% of lamivudine patients. Additionally, combination use of Pegasys and lamivudine reduced hepatitis B viral DNA in 44.1% of patients, "demonstrating that the addition of lamivudine to Pegasys does not improve the treatment outcome," Roche reports. Data were presented at the American Association for the Study of Liver Diseases annual meetin