Swiss drugmaker Roche says that combination therapy with its anti-hepatitis C drugs Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) was significantly more effective than Pegasys alone in a landmark Japanese clinical trial.
61% of patients with difficult-to-treat cases sustained a virologic response, over double the rate of response compared to those on a monotherapy. The study population consisted of treatment-naive genotype 1b patients and only 26% of patients who received Pegasys alone saw a SVR.
According to the Basel-headquartered firm, this is the largest Phase III clinical trial to examine the efficacy and safety profile of the combination therapy in Japanese subjects. It was conducted in 43 centers across the country and enrolled 300 patients. The pegylated drug was approved in Japan as a monotherapy two years ago (Marketletter October 27, 2003).
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