Safety and Tolerability of Peginterferon Alfa-2a (Pegasys)/Ribavirin in HCV Patients Non-Tolerant or Nonresponsive to Peginterferon Alfa-2b (PegIntron)/Ribavirin

HCV-infected patients treated with peginterferon alfa-2a [Pegasys]/ribavirin have a lower incidence of depression and flu-like symptoms than patients treated with standard interferon/ribavirin. In contrast, patients treated with peginterferon alfa-2b [PegIntron]/ribavirin had a similar incidence of these adverse events as patients treated with standard interferon/ribavirin.

An open-label, multicenter trial assessed the efficacy and safety of peginterferon alfa-2a/ribavirin in HCV genotype 1-infected patients who were treated with peginterferon alfa-2b/ribavirin for a maximum of 12 weeks but did not achieve early virologic response (EVR) or were intolerant due to depression, fatigue, flu-like symptoms, or injection site reactions.

Patients non-responsive or non-tolerant to 12 weeks of peginterferon alfa-2b/ribavirin were treated with peginterferon alfa-2a/ribavirin for 60 and 36 weeks, respectively, and assessed 24 weeks after end of therapy. Patients with detectable HCV RNA after 12 weeks of peginterferon alfa-2a/ribavirin were discontinued from treatment.

Results

• Of the 25 non-tolerators and 32 non-responders to peginterferon alfa-2b/ribavirin, 24 (96%) and 26 (81%) completed the protocol-defined 12 weeks of treatment with peginterferon alfa-2a/ribavirin, making the overall completion rate 88% (50/57).

• One non-tolerator (4%) and 24 non-responders (75%) were terminated after 12 weeks due to lack of response (HCV RNA >60 IU/mL).

• Twenty-three non-tolerators (92%) completed 36 weeks, and 2 non-responders (6.3%) completed 60 weeks, of peginterferon alfa-2a/ribavirin.

• Four non-responders (12.5%) and 0 non-tolerators were withdrawn due to adverse events or intercurrent illness.

• Peginterferon alfa-2a and ribavirin doses were adjusted for adverse events or laboratory abnormalities in 3 and 9 non-responders and in 3 and 4 non-tolerators, respectively.

• Measurements of depression, fatigue, flu-like symptoms and local injection site reaction all declined during treatment. Fourteen non-tolerators (56%) and 1 non-responder (3.1%) achieved sustained virologic response (SVR).

Conclusion

The majority of patients who were non-tolerant or did not respond to peginterferon alfa-2b/ribavirin were able to tolerate peginterferon alfa-2a/ribavirin.

As expected, non-tolerators of peginterferon alfa-2b/ribavirin had a higher SVR rate than non-responders when retreated with peginterferon alfa-2a/ribavirin.

05/25/07

Reference
V K Rustgi, S Esposito, F M Hamzeh, and others. Safety and Tolerability of Peginterferon -2a/Ribavirin in HCV Patients Non-Tolerant or Nonresponsive to Peginterferon -2b/Ribavirin. DDW 2007. May 19-25, 2007. Washington, D.C. Abstract # M 1872.

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