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  Clinical Gastroenterology and Hepatology  Volume 7, Issue 2, Pages 212-218 (February 2009) DOI: 10.1016/j.cgh.2008.10.035 Copyright © 2009 AGA Institute Terms and Conditions

Figure 1 Study disposition. aPatients were randomized to either the 1200 μg every 4 weeks or every 2 weeks, or 900 μg every 2 weeks groups, whereas the 1500- and 1800-μg groups were enrolled sequentially, and were not randomized. bMore than 1 reason may be recorded. cCompleting the 48-week treatment period (72 weeks for late responders) or discontinuation owing to lack of efficacy and completion of the required posttreatment follow-up period. Clinical Gastroenterology and Hepatology 2009 7, 212-218DOI: (10.1016/j.cgh.2008.10.035) Copyright © 2009 AGA Institute Terms and Conditions

Figure 2 Serum concentration of albinterferon alfa-2b at steady-state levels for (A) all treatment groups (week 12) and (B) during treatment with 1500 μg every 2 weeks (weeks 2–24). Dotted lines represent mean concentrations. Clinical Gastroenterology and Hepatology 2009 7, 212-218DOI: (10.1016/j.cgh.2008.10.035) Copyright © 2009 AGA Institute Terms and Conditions

Figure 3 Virologic response rates (A) overall and in (B) patients with Gt 1 CHC with a nonresponse to prior treatment with PEG-IFN alfa plus RBV. aP = .84; bP = .71; cP = .17; dP = .86; eP = .21; fP = .35; gP = .12; hP = .62; iP = .64; jP = .81. evr12, early virologic response at week 12; LOD, limit of detection. Clinical Gastroenterology and Hepatology 2009 7, 212-218DOI: (10.1016/j.cgh.2008.10.035) Copyright © 2009 AGA Institute Terms and Conditions

Figure 4 Antiviral activity of albinterferon alfa-2b in patients with Gt 1 CHC with a nonresponse to prior treatment with PEG-IFN alfa plus RBV. (A) Mean change in HCV RNA level over 24 weeks of treatment; (B) reduction in viral load at week 12 of treatment. Clinical Gastroenterology and Hepatology 2009 7, 212-218DOI: (10.1016/j.cgh.2008.10.035) Copyright © 2009 AGA Institute Terms and Conditions