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| |  Low-Dose Pegylated Interferon Regimen Shows Sustained Viral Response in Patients With Hepatitis C Genotype 1: Presented at EASL By Emma Hitt, PhD MILAN, Italy -- April 30, 2008 -- Sustained virological response and safety appear to be similar for 3 treatment regimens containing pegylated interferon (PEG-IFN) used for treating hepatitis C virus (HCV), including a low-dose regimen, according to final results of a major phase 3b randomised study, presented here at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL). Mark Sulkowski, MD, Associate Professor of Medicine, Division of Infectious Disease, Department of Medicine, Johns Hopkins University, Baltimore, Maryland, reported the late-breaking findings of The Individualized Dosing Efficacy Versus Flat Dosing to Assess Optimal Pegylated Interferon Therapy (IDEAL) trial. A total of 3,070 previously untreated patients with HCV genotype 1 were randomised to receive 1 of 3 treatment regimens: (1) PEG-IFN alfa 2b at a dose of 1.5 mcg/kg/week plus ribavirin (RBV) 800 to 1,400 mg/day (n = 1,019); (2) a lower dose of PEG-IFN alfa 2b (1.0 mcg/kg/week) plus RBV 800 to 1400 mg/day (n = 1,016); and (3) PEG-IFN alfa 2a 180 mcg/week plus RBV 1,000 to 1,200 mg/day (n = 1,035). Patients were treated for up to 48 weeks with 24 weeks of follow-up. Sustained viral response, the primary endpoint of the study, was similar for the 3 treatment regimens, with 40% versus 38% versus 41%, respectively, achieving this endpoint overall. The study also found that more of the patients in the PEG-IFN alfa 2b combination arms with undetectable HCV ribonucleic acid (RNA) in plasma after 4 and 12 weeks of treatment went on to achieve sustained viral response than did those in the PEG-IFN-alfa-2a combination arm (92% vs 87% vs 80% at 4 weeks; and 81% vs 83% vs 74% at 12 weeks in the 3 arms, respectively). End-of-treatment response at week 48 was higher in the PEG-IFN alfa 2a combination arm (53% vs 49% vs 64%, respectively), although relapse rates after the end of treatment were lower for patients in the PEG-IFN alfa 2b combination therapy arms compared with the PEG-IFN-alfa-2a arm (24% vs 20% vs 32%, respectively). Factors affecting relapse included baseline viral load, age, fibrosis, PEG-IFN regimen, fasting glucose, and alanine aminotransferase level. Safety and tolerability were similar among the 3 treatment groups, with no unexpected adverse events. Overall, serious adverse events were reported in 9% versus 9% versus 12% of the 3 arms, respectively. Discontinuation rates due to adverse events were similar across the 3 treatment arms (13% vs 10% vs 13%, respectively), as were discontinuation rates due to psychiatric adverse events (3% vs 2% vs 2%, respectively). One of the concerns with the trial design of IDEAL is that an unfair comparison might have been possible due to a lower RBV dosage assigned to patients in the PEG-IFN alfa 2a arm. The current findings, however, indicated that, irrespective of outcome, patients in the PEG-IFN alfa 2a arm actually received a significantly higher average RBV dosage (approximately 13 mg/kg/day) compared with those used in either of the PEG-IFN alfa 2b arms (approximately 12 kg/mg/day). "PEG-IFN alfa 2b at a lower, 1.0 mcg/kg/week dosage appears to be safe and effective, and is appropriate for patients requiring dose reductions," said Dr. Sulkowski, "although the higher dosage may be preferable in some important patient groups, such as women and African Americans." Funding for this study was supported by Schering-Plough Corporation.
[Presentation title: Final Results of the IDEAL (Individualized Dosing Efficacy Versus Flat Dosing to Assess Optimal Pegylated Interferon Therapy) Phase IIIb Study. Abstract 991]
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