BASEL, Switzerland, April 26 /PRNewswire/ --
- Roche Also Provides Comment on Results of "IDEAL" Trial
Roche today announced that compelling new data from three studies indicate that chronic hepatitis C patients who received PEGASYS(R) (peginterferon alfa-2a) plus COPEGUS(R) (ribavirin) had a greater chance of being cured of their disease than those who received combination therapy with another pegylated interferon and ribavirin. Results from the studies were presented this week at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL) in Milan, Italy.
Ascione, et al: A Prospective, Randomised, Investigator-Initiated Head-to-Head Trial
Results of this independently-conducted study(1) were presented by Professor Antonio Ascione, Director of the Department of Gastroenterology Liver Unit at Cardarelli Hospital in Naples, Italy, in the oral late-breaker session at EASL. It is a prospective, randomised, investigator-initiated head-to-head trial designed to directly compare Pegasys with peginterferon alfa-2b, each in combination with ribavirin. Enrolling 320 patients in Italy, the study randomised patients to receive either Pegasys 180 mcg/week or peginterferon alfa-2b 1.5 mcg/kg/week. Importantly, patients received equivalent starting doses of ribavirin (either 1,000 or 1,200 mg ribavirin per day based on body weight), and the process for ribavirin dose reduction was the same for all patients.
The results showed that 68.7% of patients on Pegasys achieved a cure, compared to only 54.4% of patients on peginterferon alfa-2b (p=0.008). Furthermore, in genotypes 1 and 4 - the most difficult-to-treat patient group - Pegasys achieved a cure in 54.8% of patients, compared to only 39.8% on peginterferon alfa-2b (p=0.04). Side effects were similar, although there were more withdrawals for side effects in the peginterferon alfa-2b group.
T. Witthoeft, et al: Hepatitis C Treatment in Real-Life PRACTICE in Germany
Another study presented at EASL, called PRACTICE, analysed the response of 3,470 patients to hepatitis C treatment between 2000 and 2007 in 23 German treatment centres with a high volume of patients(2). Patients were matched by key baseline characteristics, as well as by those who received a similar cumulative ribavirin dose. Among these matched pairs, significantly more patients treated with Pegasys plus Copegus achieved a cure compared to those treated with peginterferon alfa-2b and ribavirin (59.3% vs. 53.0% (p = 0.008)).
Craxi, et al: PROBE Compares the Pegylated Interferons
PROBE, an observational study, was designed to prospectively evaluate the efficacy of the pegylated interferons in real-life practice(3). The study enrolled 1,351 patients with genotype 1 virus at 167 treatment centres in Italy. Again, the trial found a greater chance of a cure in patients treated with Pegasys combination therapy compared to those treated with peginterferon alfa-2b combination therapy (41% versus 34%, respectively (p=0.004)).
"We are pleased that three separate studies presented at EASL all indicate that Pegasys provided patients with a better chance for a cure. These results will help physicians and patients make an informed choice of treatment for chronic hepatitis C. In fact, in all the major markets, an increasing proportion of physicians and patients have selected Pegasys for their therapy in the last several months," said Dr Ueli Fankhauser, global leader for Pegasys at Roche. "We are committed to further advancing the treatment of hepatitis C. Reflecting Roche's leadership in this area, our comprehensive clinical trials programme aims to optimise treatment with Pegasys and Copegus in the hope of bringing treatment success to even more patients."
Roche Comments on Schering-Plough "IDEAL" Study
Roche reiterated its position on the Schering-Plough sponsored trial called "IDEAL," results of which were also presented at EASL. Clear biases(4) in the design of this study prevent any direct comparison of the pegylated interferons. These biases include:
- different blinding for the Pegasys arm,
- different ribavirin starting doses,
- a different ribavirin dose reduction protocol, and
- unequal thresholds for the use of erythropoietin-stimulating agents.
Despite these biases, it is interesting to note that significantly more patients in the Pegasys arm had an undetectable viral load while on treatment ("end of treatment" response)(5). This is a promising finding, given that the likelihood for a cure in these patients is even higher when modern treatment principles, such as extending the treatment period beyond 48 weeks, are applied. In addition, the study failed to show a benefit for weight-based dosing of peginterferon alfa-2b (which requires dose adjustments based on a patient's body weight) vs. Pegasys, which is given as a fixed dose regardless of a patient's body weight.
About Hepatitis C
Hepatitis C (HCV), the most common chronic blood-borne infection, is transmitted primarily through blood or blood products. HCV chronically affects 180 million people worldwide, which makes it over four times more prevalent than HIV. It is a leading cause of cirrhosis, liver cancer and liver failure, despite the fact that many patients can be cured.
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at http://www.roche.com.
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1.Ascione A, Tartaqlione MT, Lampasi F, et al. Peginterferon Alpha-2a plus ribavirin versus peginterferon alpha-2b plus ribavirin in naïve patients ith chronic hepatitis C viris infection: results of a prospective randomised trial. In: 43rd Annual Meeting of the European Association for the Study of the Liver (EASL); 23-27 April 2008; ; 2008; Milan, Italy; 2008.
2.Witthoeft T, Hueppe D, John C, et al. Efficacy and safety of peginterferon alfa-2a or -2b plus ribavirin in the routine daily treatment of chronic hepatitis C patients in Germany: the practice study. In: 43rd Annual Meeting of the European Association for the Study of the Liver (EASL); 23-27 April 2008; 2008; Milan, Italy; 2008.
3.Craxi A, Piccinino F, Alberti A, et al. Predictors of SVR in naïve HCV G1 patients in real life practice: the probe. In: 43rd Annual Meeting of the European Association for the Study of the Liver (EASL); 23-27 April 2008; 2008; Milan, Italy; 2008.
4.McHutchinson J and Sulkowski M. Scientific Rationale and study design of the individualised dosing efficacy vs. flat dosing to assess optimal pegylated interferon therapy (IDEAL) trial: determining optimal dosing with genotype 1 chronic hepatitis C. Journal of Viral Hepatitis. doi:10.1111/j.1365-2893.2008.00973.x
5.Schering-Plough Reports Top-Line Results of the IDEAL Study. Schering-Plough News Release, 2008. (Accessed April 16, 2008, at http://www.schering-plough.com/schering_plough/news/release.jsp?releaseI....)
Contact: Mike Nelson, Roche, +41(79)572-5165, Michelle Marchione, Axon Communications, +44 (0) 208 439 9449