Albinterferon alfa-2b was not inferior to pegylated interferon-α in a randomized trial of patients with chronic hepatitis C virus genotype 1

Stefan Zeuzem, Mark S. Sulkowski, Eric J. Lawitz, Vinod K. Rustgi, Maribel Rodrigueztorres, Bruce R. Bacon, Mircea Grigorescu, Alan D. Tice, Yoav Lurie, Janusz Cianciara, Andrew J. Muir, Patrick W. Cronin, Erik Pulkstenis, G. Mani Subramanian, John G. McHutchison

Research output: Contribution to journalArticlepeer-review

68 Scopus citations

Abstract

Background & Aims The current standard of care for patients with chronic hepatitis C virus (HCV) genotype 1 is once-weekly pegylated interferon-α (Peg-IFNα) plus daily ribavirin for 48 weeks. We evaluated the efficacy/safety of albinterferon alfa-2b (albIFN), a novel, long-acting, genetic fusion polypeptide of albumin and IFNα-2b. Methods In the phase 3 ACHIEVE-1 trial, 1331 patients were assigned equally to 3 open-label, 48-week treatment groups: Peg-IFNα-2a 180 μg every week, or albIFN 900 or 1200 μg every 2 weeks administered subcutaneously, with weight-based oral ribavirin 10001200 mg/day. During the study, the data monitoring committee recommended dose modification for all patients receiving albIFN 1200 μg to 900 μg because of increased pulmonary adverse events (AEs) in the 1200-μg arms of both ACHIEVE studies. Main outcome measure was sustained virologic response (SVR; undetectable serum HCV RNA at week 72). Results Intention-to-treat SVR rates were 51.0% (225/441), 48.2% (213/442), and 47.3% (208/440) with Peg-IFNα-2a, and albIFN 900 and 1200 μg, respectively. The primary objective of showing noninferiority of albIFN 900 μg (P < .001) and 1200 μg (P = .003) vs Peg-IFNα-2a for SVR was achieved. Multivariate modeling indicated consistency of treatment effect across subgroups. Serious/severe AE rates were 23.1%, 24.0%, 28.2%; treatment discontinuation rates because of AEs were 4.1%, 10.4%, 10.0%; discontinuation rates because of respiratory AEs were 0%, 0.9%, 1.6%; with Peg-IFNα-2a, and albIFN 900 and 1200 μg, respectively. Hematologic abnormality rates were comparable across the Peg-IFNα-2a and albIFN 900-μg groups. Conclusions albIFN 900 μg every 2 weeks showed comparable efficacy, with similar serious/severe AE rates, although with a higher discontinuation rate, vs Peg-IFNα-2a in patients with chronic HCV genotype 1.

Original languageEnglish (US)
Pages (from-to)1257-1266
Number of pages10
JournalGastroenterology
Volume139
Issue number4
DOIs
StatePublished - Oct 2010
Externally publishedYes

Keywords

  • ACHIEVE
  • AlbIFN
  • Pegylated Interferon-α
  • Sustained Virologic Response

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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