Safety and Antiviral Activity of Albinterferon Alfa-2b in Prior Interferon Nonresponders With Chronic Hepatitis C

David R. Nelson, Vinod Rustgi, Vijayan Balan, Mark S. Sulkowski, Gary L. Davis, Andrew J. Muir, Louis R. Lambiase, Rolland C. Dickson, Russell H. Weisner, Michele Fiscella, Patrick W. Cronin, Erik Pulkstenis, John G. McHutchison, G. Mani Subramanian

Research output: Contribution to journalArticle

37 Scopus citations

Abstract

Background & Aims: Pegylated interferon alfa-2a/2b is used in combination with ribavirin to treat patients with chronic hepatitis C (CHC), although many do not achieve a sustained virologic response (SVR). Albinterferon alfa-2b, a recombinant protein consisting of interferon alfa-2b fused to human albumin, may increase drug exposure. This phase 2 study evaluated the safety/efficacy of albinterferon in CHC patients who had not responded to interferon-based regimens. Methods: A total of 115 patients were assigned to 5 groups given 1200 μg albinterferon every 4 weeks or 900, 1200, 1500, or 1800 μg every 2 weeks, plus oral ribavirin, for 48 weeks. The primary efficacy end point was achievement of an SVR after 24 weeks. Treatment was extended to 72 weeks for 6 slow responders who were negative for hepatitis C virus RNA after 24 weeks. Results: The types of adverse events were similar across groups; the overall discontinuation rate as a result of adverse events was 10.4%. Reductions in absolute neutrophil counts were less frequent in the every 4 weeks group and comparable among the every 2 weeks groups. The overall SVR rate was 17% (11% for previous nonresponders to pegylated interferon-alfa/ribavirin with genotype 1 infection). An SVR occurred in 3 of 6 slow responders by 72 weeks. The greatest reductions in hepatitis C virus RNA in nonresponders to pegylated interferon-alfa/ribavirin with genotype 1 infection were observed in the 1800-μg group. Conclusions: In patients with CHC who did not respond to interferon-based regimens, higher doses of albinterferon had significant early antiviral activity and a low incidence of adverse events, with the types of adverse events similar to those observed with interferon.

Original languageEnglish (US)
Pages (from-to)212-218
Number of pages7
JournalClinical Gastroenterology and Hepatology
Volume7
Issue number2
DOIs
StatePublished - Feb 1 2009

    Fingerprint

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Nelson, D. R., Rustgi, V., Balan, V., Sulkowski, M. S., Davis, G. L., Muir, A. J., Lambiase, L. R., Dickson, R. C., Weisner, R. H., Fiscella, M., Cronin, P. W., Pulkstenis, E., McHutchison, J. G., & Subramanian, G. M. (2009). Safety and Antiviral Activity of Albinterferon Alfa-2b in Prior Interferon Nonresponders With Chronic Hepatitis C. Clinical Gastroenterology and Hepatology, 7(2), 212-218. https://doi.org/10.1016/j.cgh.2008.10.035