TY - JOUR
T1 - Safety and Antiviral Activity of Albinterferon Alfa-2b in Prior Interferon Nonresponders With Chronic Hepatitis C
AU - Nelson, David R.
AU - Rustgi, Vinod
AU - Balan, Vijayan
AU - Sulkowski, Mark S.
AU - Davis, Gary L.
AU - Muir, Andrew J.
AU - Lambiase, Louis R.
AU - Dickson, Rolland C.
AU - Weisner, Russell H.
AU - Fiscella, Michele
AU - Cronin, Patrick W.
AU - Pulkstenis, Erik
AU - McHutchison, John G.
AU - Subramanian, G. Mani
N1 - Funding Information:
The authors disclose the following: Supported by Human Genome Sciences, Inc., Rockville, MD, and Novartis Pharma AG, Basel, Switzerland. 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, and John G. McHutchison have received research support from Human Genome Sciences. Michele Fiscella, Patrick W. Cronin, Erik Pulkstenis, and G. Mani Subramanian are employees of Human Genome Sciences.
Copyright:
Copyright 2009 Elsevier B.V., All rights reserved.
PY - 2009/2
Y1 - 2009/2
N2 - 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.
AB - 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.
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U2 - 10.1016/j.cgh.2008.10.035
DO - 10.1016/j.cgh.2008.10.035
M3 - Article
C2 - 19061971
AN - SCOPUS:58849122392
VL - 7
SP - 212
EP - 218
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
SN - 1542-3565
IS - 2
ER -