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Consensus IFN vs Pegasys for 72 Wks in Peg/RBV Relapsers
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"Comparison of Daily Consensus Interferon versus Peginterferon alfa 2a Extended Therapy of 72 Weeks for Peginterferon / Ribavirin Relapse Patients with Chronic Hepatitis C"
S. Kaiser, H.G. Hass, B. Lutze, L. Bissinger and M. Gregor
Dept of Medicine, University Hospital of Tuebingen, Germany
Reported by Jules Levin
DDW, May 2006, Los Angeles
Kaiser's study rationale:
Treatment with pegylated interferon and RBV for 48 weeks in naive chronic Hepatitis C patients results in relapse rates of about 20 -30 %. Recently improved response rates have been observed in retreatment trials using an extended treatment duration of 72 weeks. The efficacy of CIFN daily dosing + RBV versus PEG IFN a2a + RBV for 72 weeks in patients with a prior relapse to 48 weeks of treatment with PEG IFN + RBV was evaluated.
Study design
The efficacy of CIFN together with ribavirin (RBV) was evaluated and compared to pegylated interferon alpha 2a in patients with chronic hepatitis C and a prior relapse to pegylated interferon alpha 2a or 2b combination therapy for 48 weeks. All patients had histologically proven hepatitis and were viremic at starting of treatment, with 83% having genotype 1. 81 patients have been included so far. Average weight of patients was 78 kg.
Patients were either treated with CIFN at 9 ug QD for 72 weeks or with PEG IFN a2a at 180 ug QW for 72 weeks, both in combination with weight-based RBV.
Demographic data
RESULTS
Adverse Events
Kaiser reports a higher rate of IFN & RBV dose reductions and more low WBCs & low platelet counts for Pegasys than for Consensus IFN, is this believable?
and No growth factors were used in this study. Three patients experienced grade III thrombocytopenias, while no grade IV neutropenias or thrombocytopenias were observed. The overall tolerability of the CIFN QD regimen was comparable to PEG IFN a2a therapy, while the CIFN QD regimen lead to a higher rate of injection site reactions and a slightly higher drop out rate of 18% versus 12% for the PEG IFN a2a group. In contrast, hematologic grade III alterations were higher in the PEG IFN a2a group.
End Of Treatment and SVR Rates
After the initial 12 weeks a primary response with undetectable serum HCV-RNA was observed in 83 % of patients in the CIFN QD group and in 78 % in the PEG IFN 180 ug group. At the end of treatment at week 72, a negative PCR was observed in 89 % in the CIFN group, and in 76% of the PEG IFN 180 ug group (diff. not significant). The sustained viral response rates (SVR) were 69 and 44 %, respectively (p<0.05), indicating a significantly higher relapse rate in patients treated with PEG IFN a2a.
The authors concluded:
Data show that after the initial 12 weeks a primary response with undetectable serum HCV-RNA was observed in 83 % of patients in the CIFN QD group and in 78 % in the PEG IFN 180 ug group. At the end of treatment at week 72, a negative PCR was observed in 89 % in the CIFN group, and in 76% of the PEG IFN 180 ug group (diff. not significant). The sustained viral response rates (SVR) were 69 and 44 %, respectively (p<0.05), indicating a significantly higher relapse rate in patients treated with PEG IFN a2a.
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