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

✍ Scribed by Stefan Zeuzem; Eric M. Yoshida; Yves Benhamou; Stephen Pianko; Vincent G. Bain; Daniel Shouval; Robert Flisiak; Vratislav Rehak; Mircea Grigorescu; Kelly Kaita; Patrick W. Cronin; Erik Pulkstenis; G. Mani Subramanian; John G. McHutchison

• Publisher: John Wiley and Sons
• Year: 2008
• Tongue: English
• Weight: 528 KB
• Volume: 48
• Category: Article
• ISSN: 0270-9139
• DOI: 10.1002/hep.22403

✦ Synopsis

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-naı ¨ve patients were randomized to 48-week treatment with peginterferon alfa (PEG-IFN␣)-2a 180 g one time per week (qwk), or alb-IFN 900 or 1,200 g once every two weeks (q2wk), or 1,200 g 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 intentionto-treat analysis, sustained virologic response rates were 58.5% (69/118) with alb-IFN 900 g q2wk, 55.5% (61/110) with 1,200 g q2wk, and 50.9% (59/116) with 1,200 g q4wk, and 57.9% (66/114) with PEG-IFN␣-2a (P ‫؍‬ 0.64 for overall test). Discontinuation rates due to adverse events were 9.3% with alb-IFN 900 g q2wk, 18.2% with 1,200 g q2wk and 12.1% with 1,200 g q4wk, and 6.1% with PEG-IFN␣-2a (P ‫؍‬ 0.04). Hematologic reductions were lowest in the q4wk group and comparable across other groups. At week 12, mean treatmentassociated missed workdays were significantly lower with alb-IFN 900 g q2wk versus PEG-IFN␣-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-IFN␣-2a.