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  38th Annual Meeting of the European Association for the Study of the Liver
Istanbul, Turkey. March 28-April 1, 2003
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Pegasys News: 4 year follow-up; study of treating cirrhotics; study of Peg-Intron non-responders
  Two Pegasys studies of interest were reported at the EASL Conference held in Geneva July 3-6, 2003. In the first study researchers examined patients with a sustained viral response from several studies of Pegasys and found that greater than 99% remained HCV negative up to 4 years after stopping therapy.
A second study (abstract below) found cirrhotic patients achieved 49% sustained viral response with Pegasys plus ribavirin 1000/1200mg compared to 33% for patients receiving interferon plus ribavirin 1000/1200mg/day. 38% of cirrhotic patients with genotype 1 receiving Pegasys/RBV achieved sustained response vs 25% for patients receiving interferon/RBV 1000/1200mg/day. Non-1 genotype patients had 71% rate of sustained response with Pegasys/RBV 1000/1200mg/day vs 45% for patients receiving interferon/RBV 1000/1200mg/day. This study examined the viral response and safety for patients in 2 phase III studies with compensated cirrhosis who received Pegasys plus ribavirin 1000/1200 mg/day or standard interferon a-2b plus ribavirin 1000/1200 mg/day. Overall safety profile was similar for patients receiving Pegasys plus RBV or interferon a-2b plus RBV. There was a lower incidence of depression reported with Pegasys compared to interferon treatment (41% vs 19%).
Also, Roche announced they are planning a study to evaluate the efficacy of Pegasys and Copegus (Roche brand of ribavirin) in patients who are non-responders to Peg-Intron plus Rebetol (Schering Plough brand of ribavirin. The trial is called REPEAT, which stands for "REtreatment with PEGASYS in patients not responding to prior peginterferon alfa-2b/ribavirin combination therapy." Nearly 1000 patients will enroll in the 72-week trial. The REPEAT study will evaluate the efficacy and safety of the combination of Pegasys and Copegus given for a longer (72-week) period, as well as examine the role of an induction regimen in this treatment- resistant population. Patients in Europe, North America and Latin America will participate in the study.
".....99% of patients with sustained virological response remained HCV RNA negative up to 4 years after the end of therapy including patients HCV genotype 1 or cirrhosis..."
M. Swain*,1 M. -Y. Lai,2 M. L. Shiffman,3 W. G. Cooksley,4 A. Abergel,5 M. Diago,6 M. Brunda,7 1Division Of Hepatology, University Of Calgary, Calgary, Alberta, Canada 2National Taiwan Hospital, Taipei, Taiwan 3Medical College Of Virginia, Richmond, Virginia, USA 4Royal Brisbane Hospital, Herston, Australia 5Hopital Hotel Dieu, Clermont-Ferrand, France 6General Universitario, Valencia, Spain 7Hoffmann-La Roche Inc, Nutley, New Jersey, USA
Background: Treatment of patients with CHC with peginterferon alfa-2a (40KD) alone or with ribavirin results in sustained virological response of up to 61%. To date, there has been no long-term follow-up of these patients.
Objective: To investigate the long-term virological effects of treatment with peginterferon alfa-2a (40KD) alone or with ribavirin in patients with CHC.
Methods: Patients with CHC who previously (1 to 4 years previously) completed 1 of 5 phase III trials (peginterferon alfa-2a (40KD) alone or with ribavirin) and had sustained virological response were eligible for this longitudinal study.
Patients could not have been on any anti-HCV therapy subsequent to their original treatment. To test the durability of response (defined as <50 IU/mL of hepatitis C virus [HCV] RNA after 24 weeks of a treatment-free follow-up), HCV RNA levels were assayed.
Results: To date, over 400 patients have been enrolled in the long term follow-up study. Approximately 60% and 40% of patients were treated with peginterferon alfa-2a (40KD) and ribavirin or peginterferon alfa-2a (40KD) monotherapy, respectively. Greater than 99% of patients with sustained virological response remained HCV RNA negative up to 4 years after the end of their original therapy; 3 patients (<1%) experienced relapse. All patients who were originally infected with HCV genotype 1 or had a histological diagnosis of cirrhosis remained HCV RNA negative.
Conclusion: Virological response was durable up to 4 years after the end of therapy in patients treated with peginterferon alfa-2a (40KD) alone or with ribavirin.
P. Marcellin*,1 S. Brillanti,2 H. Cheinquer,3 W. G. E. Cooksley,4 M. L. Shiffman,5 W. E. Schmidt,6 M. Brunda,7 1Hopital Beaujon, Clichy, France 2University Of Bologna, 3Universidade Federal Do Rio Grande Do Sul, 4Royal Brisbane Hospital, 5Medical College Of Virginia Commonwealth University, 6Ruhr-University Bochum Medical School, 7Hoffman-La Roche Inc
Objective: To investigate efficacy and safety of peginterferon alfa-2a(40KD) (180 mcg/week) in combination with RBV in CHC patients with compensated cirrhosis treated in two phase III studies.
Methods: Patients with CHC and compensated cirrhosis received:
- Peginterferon alfa-2a(40KD) +RBV 800/mg/day for 24 weeks (A; n=44);
- Peginterferon alfa-2a(40KD) +RBV 1000-1200/mg/day for 24 weeks (B; n=71);
- Peginterferon alfa-2a(40KD) +RBV 800/mg/day for 48 weeks (C; n=91);
- Peginterferon alfa-2a(40KD) +RBV 1000-1200/mg/day for 48 weeks (D; n=171);
- Interferon alfa-2b (3 MIU tiw) +RBV 1000/1200 mg/day for 48 weeks (E; n=54).
Cirrhosis was evaluated on liver biopsy obtained within 15 months prior to initiation of therapy. Sustained virological response (SVR) was defined as undetectable HCV RNA at the end of the 24 weeks untreated follow-up period.
Results: Treatment regimen D resulted in a greater SVR than regimen E (49% vs 33%, p=0. 042). The rates of SVR in patients with HCV genotype 1 were 38%, 28%, 26%, 26% and 25% for regimens D, C, B, A and E, respectively. In patients with genotype non-1 rates of SVR were 71%, 75%, 67%, 72% and 45% for regimens AB, C, D and E, respectively.
Overall safety profile in patients treated with peginterferon alfa-2a(40KD) and ribavirin was similar to that in patients receiving interferon alfa-2b and ribavirin.
A lower incidence of depression was reported with peginterferon alfa-2a(40KD) treatment than with interferon alfa-2b (19% vs 41%).
Conclusion: Peginterferon alfa-2a(40KD) and ribavirin is efficacious and safe in patients with CHC and compensated cirrhosis.