Three Studies Presented at 43rd EASL Strongly Indicate Better Efficacy for PEGASYS in Curing Hepatitis C
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.
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 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.
All trademarks used or mentioned in this release are protected by law.
Film footage is available for broadcast journalists from The NewsMarket
at http://www.thenewsmarket.com. Video is compressed in MPEG2 and is
available for download to your FTP server.
References
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?releaseID=1096126.)
Source: Roche
Contact: Mike Nelson, Roche, +41(79)572-5165, Michelle Marchione, Axon Communications, +44 (0) 208 439 9449
-------
Profile: Transplant News
posted by Transplant News #
9:25 AM
