BASEL, Switzerland, April 20 /PRNewswire/ -- New data published today in a major peer-reviewed journal, Annals of Internal Medicine, show that re-treatment with Pegasys(R) (peginterferon alfa-2a) plus Copegus(R) (ribavirin) provides previously-treated hepatitis C patients 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 Chicago. "With 72 weeks of Pegasys and ribavirin combination treatment as a new solution for those with the most difficult-to-treat form of the virus, patients can now feel more hopeful that they have the possibility to achieve a cure when previous therapy has failed."
Pegasys (peginterferon alfa-2a) received European Commission approval for the re-treatment of hepatitis C in December 2008, based in part on results of the newly-published study. For patients with genotype 1 virus who were initially treated with pegylated interferon and ribavirin, it is recommended that they be retreated with peginterferon alfa-2a for an extended period of 72 weeks. Peginterferon alfa-2a 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 cure(2) 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 (peginterferon alfa-2a) in combination with ribavirin, and/or longer treatment duration, may increase treatment success rates in patients who didn't respond to at least twelve weeks of PegIntron(TM) (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 peginterferon alfa-2a 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 with only 35% of patients who were re-treated for 48 weeks.
"It is a significant step forward that we now know 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 peginterferon alfa-2a plus ribavirin 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.(3) The most common side effects of treatment were 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.(4),(5) 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.(6)
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.(6) 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)
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients.
In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan.
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A copy of the Summary of Products Characteristics for peginterferon alfa-2a can be accessed at http://www.emc.medicines.org.uk
(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(R)) alone or in combination with ribavirin (Copegus(R)) 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) Marcellin P. et al. 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. Poster (PO1873) presented at Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 31 October - 4 November 2008; San Francisco, California, USA.
(4) AIDS Epidemic Update. 2006. (Accessed April 15, 2009, at http://www.who.int/hiv/mediacentre/2006_EpiUpdate_en.pdf).
(5) 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/e...).