Trade News
Basel, 21 April 2009
Newly published study shows that re-treatment with Pegasys provides hepatitis C patients with a second chance for a cure
REPEAT study in Annals of Internal Medicine highlights a new solution for previously-treated hepatitis C patients
New data published today in a major peer-reviewed journal, Annals of Internal Medicine, show that re-treatment with PEGASYS® (peginterferon alfa-2a) plus COPEGUS® (ribavirin) provides previously-treated hepatitis C patients with a second chance for a cure. The study results demonstrated that patients most likely to respond to re-treatment could be identified after only 12 weeks, allowing patients and their doctors to be confident early on about the likelihood of success. 1
“While tremendous advances in hepatitis C treatment have cured many hepatitis C patients, a significant proportion of patients do not achieve success with their first treatment course. This is leading to a large and growing population of patients who are in urgent need of alternative treatment options,” said Donald Jensen, US principal investigator for REPEAT, and Professor of Medicine and Director of the Center for Liver Diseases at the University of Chicago Hospital in Illinois. “With 72 weeks of Pegasys and ribavirin combination treatment as a new solution for those with the most difficult-to-treat virus, patients can now feel more hopeful that they have the possibility to achieve a cure when previous therapy has failed.”
Pegasys received European Commission approval for the re-treatment of hepatitis C in December 2008, based in part on results of the newly-published REPEAT study. For patients with genotype 1 virus who were initially treated with pegylated interferon and ribavirin, it is recommended that they be retreated with Pegasys for an extended period of 72 weeks. Pegasys is now the first and only pegylated interferon to be approved anywhere for treatment of up to 72 weeks. For all other previously-treated patients, the recommended treatment period is 48 weeks.
The Need for Re-treatment Options
The standard of care for patients with chronic hepatitis C is the combination of a pegylated interferon plus ribavirin. In hepatitis C, sustained virologic response (SVR) to interferon-based treatment is widely equated to cure2 as it is associated with eradication of HCV infection and improvement in liver disease. Approximately 50% of patients with genotype 1, the most difficult to treat form of the disease, and 20-30% of patients with genotypes 2 or 3 do not achieve a cure after a first course of therapy.1
The REPEAT Study
Enrolling 950 patients from Europe, North America and Latin America, the REPEAT (REtreatment with PEgasys in pATients Not Responding to Peg-Intron Therapy) study was designed to explore whether intensified treatment with a higher initial dose of Pegasys in combination with Copegus, and/or longer treatment duration, may increase treatment success rates in patients who did not respond to at least 12 weeks of PegIntron™ (peginterferon alfa-2b) plus ribavirin and who didn’t discontinue treatment due to haematological adverse events.
The results demonstrated that while a fixed-dose induction did not contribute to treatment success, patients receiving 72 weeks of re-treatment with Pegasys doubled the chance of achieving a cure compared with the previous standard of 48 weeks (16% vs. 8%). Furthermore, the study showed that for the 17% of patients who responded by week 12 (defined as HCV RNA levels of less than 50 IU/mL), 57% went on to achieve a cure after a 72-week treatment course, compared to only 35% of patients who were re-treated for 48 weeks.
“It is a significant step forward that we now know that patients who have undetectable levels of hepatitis C at week 12 have a good likelihood of achieving a cure with Pegasys and ribavirin. This ability to predict success after just three months will give both doctors and hepatitis C patients additional confidence when considering whether to re-treat,” said Professor Jensen.
Treatment with Pegasys plus Copegus was well tolerated in the study. The adverse event profile was similar to that seen in patients treated for the first time. Further analyses of the 72-week treatment duration in REPEAT showed that it was associated with a more favourable benefit:risk ratio than 48 weeks of treatment. The most common side effects of treatment are flu-like symptoms, fatigue, depression and haematological abnormalities.
About hepatitis C
The hepatitis C virus (HCV) 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.3,4 It is a leading cause of cirrhosis, liver cancer and liver failure, despite the fact that many patients can be cured. In Europe alone, HCV is estimated to cause more than 86,000 deaths every year.5
A recent study examining the HCV-related burden of disease in 22 European countries estimated that 7.3-8.8 million people are infected with HCV, representing 1.1-1.3% of the population. The report also found that no uniform HCV surveillance exists at the European level, and that authorities need to work on an EU-wide, consistent surveillance system for HCV.6
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 2008 sales by the Pharmaceuticals Division totaled 36.0 billion Swiss francs, and the Diagnostics Division posted sales of 9.7 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interest in Chugai, and invested nearly 9 billion Swiss francs in R&D in 2008. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at www.roche.com.
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References
1) Jenson DM, Marcellin P, Bradley F et al. Re-treatment of chronic hepatitis C non-responders to peginterferon alfa-2b: a randomized trial. Annals of Internal Medicine 2009;150(8):528-540
2) Swain M, Lai M, Shiffman M, Cooksley W et al. Sustained virologic response (SVR) resulting from treatment with peginterferon alfa-2a (40KD) (PEGASYS®) alone or in combination with ribavirin (COPEGUS®) is durable and constitutes a cure: an ongoing 5-year follow-up. Abstract presented at Digestive Disease Week; 21 May 2007; Los Angeles, California, USA.
3) AIDS Epidemic Update. 2006. (Accessed April 15, 2009, at http://www.who.int/hiv/mediacentre/2006_EpiUpdate_en.pdf)
4) World Health Organization. Initiative for Vaccine Research, Viral Cancers, Hepatitis C. 2006. (Accessed April 15, 2009, at http://www.who.int/vaccine_research/diseases/viral_cancers/en/index2.html)
5) Siebert U, Muhlberger N and Zeuzem S. Pan European Perspectives on Hepatitis C. Volume 1: Burden of Disease. Pg. 10.
6) Siebert U, Muhlberger N and Zeuzem S. Pan European Perspectives on Hepatitis C. Volume 1: Burden of Disease. Pgs. 6 and 8.