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| |  Albinterferon Alfa-2b Comparable to Pegylated Interferon Alfa-2b in Treating Chronic HCV: Presented at EASL By Cameron Johnston COPENHAGEN, Denmark -- April 30, 2009 -- Albinterferon alfa-2b plus ribavirin (alb-IFN/R) offers comparable efficacy to pegylated interferon alfa-2b plus ribavirin (PEG-IFN/R) in treatment-naïve patients with chronic hepatitis C virus (HCV) of the genotype 1 variation, researchers stated here at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL). The results of the multicentre, phase 3 study were released in a late-breaking session on April 26 by Stefan Zeuzem MD, Department of Internal Medicine, Gastroenterology, Hepatology, J.W. Goethe University Hospital, Frankfurt, Germany. The study was conducted at 140 sites in 12 countries. For the study, 1,323 patients were randomised to receive either PEG-IFN 180 mcg every week (control arm); alb-IFN 900 mcg every 2 weeks or alb-IFN 1,200 mcg every 2 weeks. All patients received weight-based ribavirin 800 to 1,200 mg/day. After 24 weeks of therapy, 2 patients developed interstitial lung disease, which led the data safety monitoring board to recommend reducing the dose of alb-IFN in the 1,200-mcg arm to 900 mcg every 2 weeks. Sustained viral response (SVR) was the primary endpoint. At 48 weeks follow-up, 51% of patients in the control arm, 48.2% of patients in the 900-mcg-dose arm, and 47.3% of patients in the arm originally randomised to 1,200 mcg had an SVR. In a multivariate regression model, having an HCV RNA viral load of <400,000 IU/mL versus >800,000 IU/mL was the strongest predictor of SVR. Patients who had normal gamma-glutamyl transferase, elevated alanine aminotransferase, and who were aged younger than 45 years were also most likely to have an SVR. The rates of serious adverse events were similar among the 3 arms, ranging from 23% to 28%. However, Dr. Zeuzem pointed that the rate of drug discontinuation was markedly higher among patients in the alb-IFN/R compared with the PEG-IFN/R arm (PEG-IFN/R = 4.1%; alb-IFN 900 mcg every 2 weeks = 10.4%, and alb-IFN 1,200 mcg every 2 weeks = 10.0%). There was a substantial difference between SVR rates for patients who discontinued the trial before the 48-week endpoint due to nonefficacy reasons: 8.0%, 20.4%, and 23.5% for the PEG-IFN/R, alb-IFN 900-mcg, and the alb-IFN 1,200-mcg (reduced to 900-mcg) arms, respectively. "This suggests that the discontinuation from the albinterferon likely occurred very late in the course of the study," he said. No significant differences in haematologic parameters were seen among the arms, although the rate of anaemia (<10 mg/dL) was high in all 3 groups ranging from 32% to 38.9%. One adverse event that stood out was that of a dry cough, seen among 37% to 39% of patients in the alb-IFN/R arms. Dr. Zeuzem said the majority of these coughs were mild to moderate in severity and resolved once the patient stopped alb-IFN/R therapy. The cough was not associated with changes on chest x-ray or spirometry measurements. Dr. Zeuzem concluded that alb-IFN/R met the primary efficacy and safety endpoints for the study, and it was found to be noninferior to PEG-IFN/R. While certain adverse events were higher in the alb-IFN/R arms, the rates of these events, the types of events, and the rate of discontinuations were comparable to what had been seen in other studies.
[Presentation tile: Efficacy and Safety of Albinterferon Alfa-2b in Combination With Ribavirin in Treatment-Naïve, Chronic Hepatitis C Genotype 1 (CHC G1) Patients. Oral Abstract 1041]
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