Roche and Chugai announced that the combination of Copegus (ribavirin) plus Pegasys (peginterferon alfa-2a (40KD)) has been approved in Japan following fast track review by the Japanese regulatory agency (MHLW). This is good news for Japanese hepatitis C patients, who now have access to the world's gold standard treatment for the disease.

The approval in Japan is based on results from a landmark phase III Japanese clinical trial1, showing that nearly 60 per cent of genotype 1b patients with a high viral load achieved a cure with the Pegasys plus Copegus combination treatment. This is a breakthrough as genotype 1 patients are a difficult-to-cure patient group and this result is the highest response rate reported in these patients.

"This approval is another example of our ongoing commitment to give every hepatitis C patient the best chance for a cure" said William M. Burns, CEO of Roche's Pharmaceutical Division, "Together with Chugai, Roche is investigating how we can use current therapies to cure more patients today, while developing new treatment options for the future."

The study was conducted in 300 Japanese hepatitis C patients (200 treatment naïve patients who had genotype 1b and 100 patients who had previously been treated with conventional interferon but did not achieve an SVR). These patients are considered difficult to cure.

59.4 per cent of the treatment naïve patients who had genotype 1b and high viral load (>=100 KIU/mL) achieved an SVR. This is a significantly higher response rate compared to the group treated with Pegasys alone which was 24 per cent.

In patients who were pretreated with conventional interferon but did not respond (called 'nonresponders') the response rate in patients who had genotype 1b and high viral load was 51.4 per cent with Pegasys plus Copegus.

No unexpected safety considerations with combination therapy.

Overall, the side effect profile was similar in the treatment groups and there was no difference in withdrawal rates. As expected, the rate of anaemia was higher in patients who received ribavirin.

"Approximately 2 million people in Japan are infected with chronic hepatitis C, many of whom are progressing towards severe liver disease at an alarming rate," said Alexander Zehnder, Business Leader for Pegasys at Chugai. "Now with this approval of Copegus, patients and doctors have access to a powerful new ally in the fight against this terrible disease."

Copegus is now approved in Japan and will be marketed by Chugai Pharmaceutical Co Ltd. In Japan, Copegus is approved for use in combination with Pegasys for the treatment of chronic hepatitis C in

Pegasys, the market leader worldwide in hepatitis C therapy, provides significant benefit over conventional combination interferon therapy in hepatitis C patients of all genotypes. Pegasys is marketed in Japan by Chugai Pharmaceutical Co. Ltd. In Japan, Pegasys was the first pegylated interferon to be approved and has been reimbursed by the health insurance since December 2003. Pegasys is now also approved in Japan as combination therapy for chronic hepatitis C.