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Investor Update

Basel, 17 June 2005

Pegasys Plus Ribavirin Significantly More Effective than Monotherapy in Landmark Japanese Clinical Trial

61% Sustained Virologic Response In Japanese Patients with Difficult-to-Treat Hepatitis C

Japanese hepatitis C patients treated with a combination of PEGASYS (peginterferon alfa-2a (40KD)) plus ribavirin have double the rate of response compared to patients treated with PEGASYS as monotherapy, according to results presented at the 41st Annual Conference of the Japan Society of Hepatology in Osaka (June 16-17, 2005).  Results from a landmark phase III Japanese clinical trial show that 61% of treatment naïve genotype 1b patients in the combination therapy arm achieved a sustained virological response (SVR, which is indicative of a cure) compared with 26% of patients who received PEGASYS alone.

‘This trial provides compelling evidence that PEGASYS in combination with ribavirin provides significant benefits for Japanese patients with hepatitis C’ said Ciro Caravaggio, Life Cycle Leader for Hepatitis. ‘The SVR achieved in these difficult-to-treat naïve patients with genotype 1b hepatitis C are the highest we have seen in Japanese phase III clinical trials.’

The key results of the study are:

  • In patients who were treatment naïve, genotype 1b, a 61% SVR was achieved for those who received PEGASYS plus ribavirin. This is compared to an SVR of 26% for patients who received PEGASYS as monotherapy. The difference is statistically significant (P<0.001)
  • In patients who were pretreated with conventional interferon but did not respond or relapsed (so called ‘nonresponders’ or ‘relapsers’) the overall response rate was 54% with PEGASYS plus ribavirin
  • 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

No additional safety considerations with combination therapy
Overall, the side effect profile was similar in both of the treatment groups and there was no difference in withdrawal rates. The most common side effects were influenza-like symptoms. Also, abnormal laboratory values such as neutropenia and thrombocytopenia, were similar in all patient groups. As expected, the rate of anemia was higher in patients who received ribavirin.

About the study design
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.

The trial consisted of two main treatment groups:

  • Genotype 1b patients with no previous treatment
    In a randomized, placebo controlled, double blind trial design, a total of 201 naive patients with Genotype 1b were assigned to receive PEGASYS 180ug once weekly plus daily ribavirin (600-1000mg, depending on body weight) or PEGASYS 180ug once weekly plus placebo
  • Patients previously treated with conventional interferon therapy
    In an open trial design, 100 patients who were previously treated with conventional interferon but did not respond to treatment (so called “Nonresponder”) or patients who responded but then relapsed (so called “Relapser”) were re-treated with PEGASYS 180ug once a week plus daily ribavirin (600-1,000 mg depending on body weight).

All patients were treated for 48 weeks and followed for an additional 24 weeks after stopping the study medication. The primary end point was the sustained virologic response (defined as the absence of detectable HCV RNA 24 weeks after stopping treatment).

About PEGASYS
PEGASYS is marketed in Japan by Chugai Pharmaceutical Co.Ltd. In Japan, PEGASYS was approved in October 2003 with the indication for monotherapy treatment of chronic hepatitis C and is marketed under the tradename of PEGASYS. PEGASYS, the market leader worldwide in hepatitis C therapy, provides significant benefit over conventional combination interferon therapy in hepatitis C patients of all genotypes. The benefits of PEGASYS are derived from its large 40 kilodalton (KD) branched-chain polyethylene glycol (PEG) construction, which allows for sustained drug levels over the course of a full week. PEGASYS also distributes more readily to the liver (the primary site of infection) than conventional interferon. PEGASYS is the only pegylated interferon available as a ready-to-administer solution. Each weekly subcutaneous injection contains 180mcg of pegylated interferon alfa-2a (40KD), which is the approved starting dose for all patients, regardless of body weight.

About Ribavirin
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.

About 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.

About Genotype
Genotype is the classification of genes of the hepatitis C virus. The dominant genotypes in Japanese patients are 1b, 2a, and 2b. 1b in particular accounts for 70% of the total intractable chronic hepatitis C in Japan and is considered to be difficult to treat.

About Roche
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. Additional information about the Roche Group is available on the Internet (www.roche.com).

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