Albinterferon alfa-2b dosed every two or four weeks in interferon-naïve patients with genotype 1 chronic hepatitis C

Authors


  • This study is registered on ClinicalTrials.gov (identifier NCT00115908; http://clinicaltrials.gov/ct2/show/NCT00115908?term=human+genome+sciences&rank=2)

  • Potential conflict of interest: Dr. McHutchison is a consultant for and received grants from Anadys, Colsy Pharmaceutical Group, First Circle Medical, GlaxoSmithKline, Human Genome Sciences, Idenix Pharmaceuticals, Intarcia, Novartis, Pharmasset, Pfizer, Roche, Schering-Plough, Valeant Pharmaceuticals, Vertex Pharmaceuticals, and Wyeth. He received grants from Globe Immune, Medtronics, Salix Pharmaceuticals, and Sanofi-Aventis. He is also a consultant for Biolex, Epiphany Biosciences, InterMune Pharmaceuticals, National Genetics Institute, Peregrine, and United Therapeutics. Drs. Subramanian, Cronin and Pulkstenis own stock in Human Genome Sciences, Inc. Dr. Kaita is a consultant for, is on the speakers' bureau of, and received grants from Schering-Plough, Roche, and Gilead. Dr. Zeuzem is a consultant for, is on the speakers' bureau of, and received grants from Human Genome Sciences, Novartis, Roche, and Schering-Plough. Dr. Yoshida received grants from and advises Hoffmann-La Roche. He also received grants from Schering-Plough, GlaxoSmithKline, Ortho Janssen, Pfizer, Gilead Sciences, and Cangene. He advises Novartis. Dr. Benhamou is a consultant for and is on the speakers' bureau of Human Genome Science and Roche. Dr. Pianko is a consultant for, advises, and is on the speakers' bureau of Human Genome Sciences, Novartis, and Roche. Dr. Bain is a consultant for Human Genome Sciences. Dr. Shouval received grants from Human Genome Sciences. Dr. Flisiak received grants from Debiopharm. He advises and received grants from Human Genome Sciences and Roche.

Abstract

The efficacy and safety of albinterferon alfa-2b (alb-IFN), a novel recombinant protein consisting of interferon alfa-2b genetically fused to human albumin, was evaluated in a phase 2b, open-label study of patients with genotype 1, chronic hepatitis C. In all, 458 IFN-alfa treatment-naïve patients were randomized to 48-week treatment with peginterferon alfa (PEG-IFNα)-2a 180 μg one time per week (qwk), or alb-IFN 900 or 1,200 μg once every two weeks (q2wk), or 1,200 μg once every four weeks (q4wk), administered subcutaneously, plus weight-based oral ribavirin 1,000 or 1,200 mg/day. Hepatitis C virus RNA was measured by real-time polymerase chain reaction (limit of detection: 10 IU/mL). The primary efficacy endpoint was sustained virologic response (hepatitis C virus RNA <10 IU/mL 24 weeks after the end of treatment). By intention-to-treat analysis, sustained virologic response rates were 58.5% (69/118) with alb-IFN 900 μg q2wk, 55.5% (61/110) with 1,200 μg q2wk, and 50.9% (59/116) with 1,200 μg q4wk, and 57.9% (66/114) with PEG-IFNα-2a (P = 0.64 for overall test). Discontinuation rates due to adverse events were 9.3% with alb-IFN 900 μg q2wk, 18.2% with 1,200 μg q2wk and 12.1% with 1,200 μg q4wk, and 6.1% with PEG-IFNα-2a (P = 0.04). Hematologic reductions were lowest in the q4wk group and comparable across other groups. At week 12, mean treatment-associated missed workdays were significantly lower with alb-IFN 900 μg q2wk versus PEG-IFNα-2a (1.1 versus 4.3 days; P = 0.006). Conclusion: Alb-IFN administered q2wk or q4wk may offer comparable efficacy, with an improved dosing schedule, compared with PEG-IFNα-2a. (HEPATOLOGY 2008;48:407–417.)

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