BY OUR PHARMA CORRESPONDENT
13 September,2005: Following the findings of a study using peginterferon and ribavirin against hepatitis C, Japanese authorities awarded priority review status to the combination therapy.
Japanese Regulatory Agency (MHLV)'s priority status will bring forward the review time by approximately 6 months. The approval of the combination expected in Q3, 2006, Roche and Chugai announced in a press release.
The combination of peginterferon alfa-2a (Pegasys) plus ribavirin (Copegus) has been studied in a phase III Japanese clinical trial. Results showed that 61% of treatment naïve genotype 1b patients who received Pegasys plus Copegus achieved a sustained virological response (which is indicative of a cure) compared with 26% of patients who received Pegasys alone.
This is a breakthrough for combination treatment, providing the highest sustained virological response (SVR) rates reported in these patients. Patients with genotype 1b hepatitis C are considered to be a difficult group of patients treat.
The key results of the registration study are:
• 61% of patients who were treatment naïve, genotype 1b achieved an SVR when treated with Pegasys combination therapy. This is compared to an SVR of 26% for patients who received Pegasys as monotherapy (P<0.001).
• Difficult to treat patients with an initially high viral load also responded well to the combination therapy with an SVR of 56% in the combination therapy group compared with 16% in the monotherapy group – a 3-fold increase in SVR
In a separate arm of the trial, Pegasys combination therapy also made a significant difference to the most difficult to treat patients
• In patients who had previously been treated with conventional interferon but either did not respond or relapsed after an initial response (so called ‘nonresponders’ or ‘relapsers’) the overall response rate was 54% with Pegasys plus ribavirin
This is the largest phase III clinical trial to examine the efficacy and safety profile of the combination of Pegasys plus ribavirin in Japanese patients. The trial was conducted in 43 centers in Japan and enrolled 300 patients.
Pegasys is marketed in Japan by Chugai Pharmaceutical Co. Ltd.The drug was approved in October 2003 with the indication for monotherapy treatment of chronic hepatitis C and is marketed under the tradename of Pegasys. Pegasys is the market leader worldwide in hepatitis C therapy.
Ribavirin is currently being developed in Japan by Chugai Pharmaceutical Co Ltd. Outside Japan, this drug is used as an anti-virus therapy for treatment of various types of infectious diseases. The ribavirin used in this trial is a ribavirin tablet (overseas trade name: Copegus) developed by Roche for use in combination with Pegasys for the treatment of chronic hepatitis C.
Hepatitis C is a potentially life threatening viral infection that can lead to liver inflammation, liver disease, cirrhosis or liver cancer. Transmitted primarily through infected blood, more than 170 million people world wide are infected making it more common than HIV virus.
Genotype is the classification of the hepatitis C virus and reflects differences in the genetic sequence of the virus. Genotype 1 hepatitis C is considered to be difficult to treat. The dominant genotypes in Japanese patients are 1b, 2a, and 2b. 1b in particular accounts for 70% of the total chronic hepatitis C in Japan and is considered to be difficult to treat.
Chugai Pharmaceutical Co., Ltd. is one of Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products and in the therapeutic fields of oncology, renal diseases and bone/joint. With pharmaceutical sales of 295 billion yen in 2004, Chugai has invested in research and development capabilities in the US and Europe, and has established sales and marketing operations in France, Germany and the UK. Chugai employs 5,327 employees world-wide.
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in Diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004, sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.
BY OUR PHARMA CORRESPONDENT