Welwyn Garden City – November 2, 2007 – Roche today announced final results from the REPEAT study which demonstrate that treatment with once-weekly PEGASYS® (peginterferon alfa-2a) and daily COPEGUS® (ribavirin) can achieve viral clearance in a number of patients who did not respond to initial treatment with ViraferonPeg (peginterferon alfa-2b) , another drug commonly used to treat hepatitis C1.
This outcome gives hepatitis C patients the opportunity to tackle their disease a second time after initial treatment failure. Furthermore, the results show that a patient’s response to treatment at 12 weeks is a powerful predictor of the eventual outcome: 57% of patients with undetectable virus levels at 12 weeks went on to achieve a sustained virological response (SVR), indicating treatment success. Few patients with detectable virus at 12 weeks achieved SVR. This demonstrates the value of response guided therapy as a way to optimise a patient’s chance of success. These data were presented in an oral session at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), being held in Boston, Nov. 2-61.
“One of the greatest areas of need in hepatitis C today is to find solutions for patients who have not had treatment success with an initial course of therapy. REPEAT is a landmark study that adds significantly to our knowledge about how to manage these patients, demonstrating that extending treatment with PEGASYS is a promising option”, said Donald Jensen, MD, Professor of Medicine and Director of the Center for Liver Diseases at the University of Chicago Hospital in Chicago, and lead investigator in REPEAT. “An important finding from REPEAT is confirmation of the reliability of using a patient’s response at 12 weeks as a predictor of treatment success, even in patients with cirrhosis. This means that patients who achieve undetectable virus at 12 weeks can continue treatment with a good likelihood of success. It also means that clinicians can confidently discontinue treatment in patients who do not achieve an early response.”
More About the REPEAT Study
Enrolling 950 patients from Europe, North America and Latin America, REPEAT was designed to explore whether intensified treatment with a higher fixed-dose induction of PEGASYS® (peginterferon alfa-2a) and/or longer treatment duration may increase treatment success rates. Patients received one of four regimens:
Arms A and B received peginterferon alfa-2a 360 mcg/week for 12 weeks, followed by 180 mcg/week for a further 60 or 36 weeks, respectively,
Arms C and D received peginterferon alfa-2a 180 mcg/week for 72 or 48 weeks, respectively.
All patients received ribavirin (1,000/1,200 mcg/day) in combination with peginterferon alfa-2a.
The primary endpoint was met: SVR, defined by undetectable hepatitis C virus RNA in the blood six months after the end of treatment, was significantly higher for arm A (16%) compared to arm D (9%)
A pooled analysis of the 72-week arms vs. the 48-week arms showed that 72 weeks of treatment had the biggest impact on success of treatment, with a doubling of SVR rates compared to 48 weeks (16% vs. 8%, respectively)
Response at 12 weeks was a strong predictor of successful treatment
Of patients whose virus was undetectable after 12 weeks of therapy, 57% in the 72-week arms went on to achieve treatment success (by comparison, among patients who still had detectable virus after 12 weeks, only 4% achieved treatment success). The proportion of patients with undetectable virus at 12 weeks was 17%
“REPEAT exclusively enrolled patients who had not previously responded to pegylated interferon therapy, in this case PegIntron and ribavirin”, continued Dr Jensen. “These patients are more a difficult-to-cure group than patients who relapsed and those who did not respond at all to treatment with non-pegylated interferons, either alone or with ribavirin. For this reason, results from REPEAT cannot be meaningfully compared to results from trials with a large proportion of patients who were relapsers or who did not respond to treatment with older interferons.”
The incidence and types of adverse events and serious adverse events were generally consistent across all the arms, and the frequency of moderate to severe hematologic effects were broadly similar. Discontinuations for adverse events and lab abnormalities were higher for extended treatment. Patients with cirrhosis had a somewhat higher incidence of adverse events, premature withdrawals and dose modifications.
Efficacy of PEGASYS (peginterferon alfa-2a) plus COPEGUS (ribavirin) Combination Therapy
PEGASYS (peginterferon alfa-2a) plus COPEGUS (ribavirin) is the only pegylated interferon combination therapy to have demonstrated significantly superior benefits over conventional interferon combination therapy across all HCV genotypes, irrespective of viral load.2,3,4 The combination consistently shows high cure rates – up to 66% overall sustained virological response – across a number of large, randomised clinical studies including in patients with difficult-to-cure disease such as genotype 1 HCV, cirrhosis, and HIV-HCV co-infection.2,3-7
About Hepatitis C in the UK
Hepatitis C, one of the most common chronic blood-borne infections, is transmitted primarily through blood or blood products. Estimates of prevalence for hepatitis C in England and Wales vary considerably from 200,000 to 500,000. It is a leading cause of cirrhosis, liver cancer and liver failure, despite being potentially curable.
About Roche in the UK
Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world’s leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Globally Roche is the leader in diagnostics, and a major supplier of medicines for the treatment of cancer, transplantation, virology, bone and rheumatology, obesity and renal anaemia. To see a copy of the SPC or to find out more please visit www.rocheuk.com
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1. Jensen DM et al. Pegylated interferon alfa-2a plus ribavirin in prior non-responders to peglyated interferon alfa-2b: final efficacy and safety outcomes of the REPEAT study. AASLD 2007
2. Hadziyannis SJ, Sette H, Jr., Morgan TR, et al. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med 2004;140(5):346-55.
3. Torriani FJ, Rodriguez-Torres M, Rockstroh JK, et al. Peginterferon Alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N Engl J Med 2004;351(5):438-50.
4. Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002;347(13):975-82.
5. Marcellin P, Brillanti S, Cheinquer H. Peginterferon alfa-2a (40KD) (PEGASYS) plus ribavirin (COPEGUS) is an efficacious and safe treatment for chronic hepatitis C (CHC) in patients with compensated cirrhosis. . In: 38th Annual Meeting of the European Association for the Study of the Liver (EASL) July 3-6, ; 2003; Geneva, Switzerland; 2003.
6. Heathcote EJ, Shiffman ML, Cooksley WG, et al. Peginterferon alfa-2a in patients with chronic hepatitis C and cirrhosis. N Engl J Med 2000;343(23):1673-80.
7. Zeuzem S, Pawlotsky JM, Lukasiewicz E, et al. International, multicenter, randomized, controlled study comparing dynamically individualized versus standard treatment in patients with chronic hepatitis C. J Hepatol 2005;43(2):250-57.