Basel, Switzerland (ots/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
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
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
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
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;
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
ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.ch
Contact: Mike Nelson, Roche, +41(79)572-5165, Michelle Marchione,
Axon Communications, +44 (0) 208 439 9449