Roche Pharmaceuticals

Renewed Hope for a Cure: Extending Pegasys Treatment to 72 Weeks Provides New Treatment Option for Difficult-to-Treat Hepatitis C Patients

Basel, Switzerland, November 1 (ots/PRNewswire) - - Three New Studies Presented at AASLD Demonstrate Efficacy and Safety of Extended Treatment in Non-Responders, Relapsers and Slow-Responders

Cure rates for certain groups of difficult-to-treat hepatitis C patients can be improved significantly by extending the treatment period with PEGASYS(R) (peginterferon alfa-2a (40KD)) and COPEGUS(R) (ribavirin) to 72 weeks, according to new studies being presented at AASLD this week in San Francisco.

"Seeking solutions for difficult-to-treat hepatitis C with the currently-available agents is a priority," said Dr Peter Ferenci, Professor of Medicine, Medical University of Vienna, Wein, Austria. "That's why it is so encouraging to see these new data showing that extending treatment with Pegasys and Copegus offers a greater chance of a cure to patients where the standard duration of treatment provides unsatisfactory results. Furthermore, all the studies show that it is possible to predict a patients' response early on in treatment - this provides encouragement and reassurance to continue treatment for patients who have an early response."

"Slow Responders"

"Response-guided therapy" is a new treatment concept in hepatitis C which seeks to tailor treatment for patients based on how well they respond. Patients who eliminate the virus from the blood within 4 weeks (rapid virologic response; RVR) can benefit from shortened treatment while preserving their chances to be cured. Patients who respond slowly can benefit from extending treatment duration, resulting in improved chances for a cure.

A new study(1) has found that treatment-naive genotype 1 or 4 patients without RVR but with an early virological response (EVR) by week 12 have a better chance for a cure, and less chance of relapse, by extending the treatment duration to 72 weeks.

This prospective, multicentre, randomised study enrolled 552 patients at several centers in Austria. Patients who did not achieve an RVR but had an EVR were randomised at week 12 to complete either 48 or 72 weeks of treatment. The primary outcome parameter was the relapse rate after end of follow-up. Relapse rates were shown to decrease by half in the patients who received 72 weeks of treatment (relapse rate of 33.6% in the 48 week arm vs. 19% in the 72-week arm).

Relapsers and Non-Responders

Although dramatic advances in the treatment of hepatitis C have been made in recent years, a significant number of patients do not achieve a cure with their first course of treatment. For this reason, seeking solutions for re-treating these patients is of particularly vital importance.

"Relapsers" are patients who responded to an initial course of hepatitis C treatment but whose virus returned within six months after stopping therapy. Now, a new study(2) conducted in Germany has found that half of these patients (54 out of 107) can achieve a cure with Pegasys and Copegus re-treatment for 72 weeks. Furthermore, an RVR after the first 4 weeks was highly predictive of a cure: almost all patients (97%) with an RVR went on to achieve a cure at the end of follow-up.

Generally considered the most difficult-to-treat patient group, "non-responders" are patients who did not respond to an initial treatment course of at least 12 weeks. REPEAT is a large, Roche-sponsored study which examined re-treatment with Pegasys and Copegus in 942 patients who had not responded to PegIntron(TM) (peginterferon alfa-2b) and Rebetol(R) (ribavirin). The primary analysis of the study showed that a 72-week course of Pegasys/Copegus in these patients had the biggest impact on success of treatment, with a doubling of the SVR rate compared to 48 weeks (16 % vs. 8 %). Response at treatment week 12 was a strong predictor of successful treatment: 57% of patients whose virus was undetectable after 12 weeks went on to achieve treatment success with 72 weeks of treatment.

A new safety analysis(3) of the study presented this year at AASLD confirms that the longer treatment duration does not pose a large additional safety burden on patients and is well tolerated by patients. The authors examined the incidence of adverse events (AE) per treatment year, and found a lower incidence in patients treated for 72 weeks vs. those treated for 48 weeks (8.1 vs. 10.1 AEs). Furthermore, for every cured patient, the number of adverse events during treatment was lower in the 72-week arm compared to the 48 week arm (55 vs. 100). The authors conclude that from an efficacy as well as a safety perspective, the 72-week regimen of Pegasys and Copegus is the preferred treatment duration for non-responders to previous peginterferon alfa-2b/ribavirin therapy.

Notes for Editors

About Chronic 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, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and 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 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 80,000 people. Additional information is available on the Internet at http://www.roche.com.

References:

    1) Ferenci P, Laferl H, Scherzer T, Gschwantler M, Maieron A.
    Response-guided therapy with peginterferon alfa-2a (40KD) plus ribavirin
    in patients with chronic hepatitis C genotype 1 or 4: Prospective
    randomized study of extended therapy in patients without a rapid
    virological response. Abstract presented at the American Association for
    the Study of Liver Disease; 31 October; San Francisco, California, USA.
    2) Kaiser S, Lutze B, Hass H, Werner, C. High sustained virologic
    response rates In HCV genotype 1 relapser patients retreated with
    peginterferon alfa-2a (40KD) plus ribavirin for 72 weeks. Abstract
    presented at the American Association for the Study of Liver Disease; 31
    October; San Francisco, California, USA.
    3) Marcellin P, Craxi A, Brandão-Mello C, Di Bisceglie A. A 72-week
    treatment duration with peginterferon alfa-2a (40KD) (PEGASYS(R)) plus
    ribavirin (COPEGUS(R)) has a favorable risk:benefit ratio in
    non-responders to pegylated interferon alfa-2b (12KD) plus ribavirin:
    findings of the multinational REPEAT study. Abstract presented at the
    American Association for the Study of Liver Disease; 31 October; San
    Francisco, California, USA. 

Contact:

Contact: Mike Nelson, Roche, +41(79)572-5165

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