Volume 44, Issue 4, Pages 671-678 (April 2006) A phase 2 study to evaluate the antiviral activity, safety, and pharmacokinetics of recombinant human albumin-interferon alfa fusion protein in genotype 1 chronic hepatitis C patients  Vincent G. Bain, Kelly D. Kaita, Eric M. Yoshida, Mark G. Swain, E. Jenny Heathcote, Avidan U. Neumann, Michele Fiscella, Ren Yu, Blaire L. Osborn, Patrick W. Cronin, William W. Freimuth, John G. McHutchison, G. Mani Subramanian  Journal of Hepatology  Volume 44, Issue 4, Pages 671-678 (April 2006) DOI: 10.1016/j.jhep.2005.12.011 Copyright © 2006 European Association for the Study of the Liver Terms and Conditions

Fig. 1 Mean HCV RNA reduction and proportion of patients with ≥2 log10 IU/mL reduction (in parenthesis) in HCV RNA at Day 28. Journal of Hepatology 2006 44, 671-678DOI: (10.1016/j.jhep.2005.12.011) Copyright © 2006 European Association for the Study of the Liver Terms and Conditions

Fig. 2 Mean HCV RNA (log10 IU/mL) change from baseline. The study duration of 42 days allowed assessment of antiviral response 28 days following the second injection of alb-IFN administered on Day 14 (vertical line). Journal of Hepatology 2006 44, 671-678DOI: (10.1016/j.jhep.2005.12.011) Copyright © 2006 European Association for the Study of the Liver Terms and Conditions

Fig. 3 Box plot of HCV RNA reduction (log10 IU/mL) at Week 4 by body mass index in kg/m2 (BMI) and treatment group. Journal of Hepatology 2006 44, 671-678DOI: (10.1016/j.jhep.2005.12.011) Copyright © 2006 European Association for the Study of the Liver Terms and Conditions

Fig. 4 Biphasic viral kinetics. Panel A: First phase HCV RNA reduction (log10 IU/mL) in the low dose (200–670μg) or high dose (900–1200μg) treatment groups is represented. The mean (±SD) HCV RNA reduction (horizontal bar) for the low dose and high dose groups is provided. The dashed line represents the clinically significant first-phase response (HCV RNA reduction of >0.5 log10 IU/mL). Panel B: Second-phase HCV RNA reduction slope (log10 IU/mL) in the low-dose (200–670μg) or high-dose (900–1200μg) treatment groups is represented. The mean (± SD) HCV RNA reduction (horizontal bar) for the low- and high-dose groups is provided. The dashed line represents the clinically significant second-phase slope of 0.3 log/wk. Journal of Hepatology 2006 44, 671-678DOI: (10.1016/j.jhep.2005.12.011) Copyright © 2006 European Association for the Study of the Liver Terms and Conditions

Fig. 5 Mean (± SD) serum albumin-interferon alfa concentrations. Journal of Hepatology 2006 44, 671-678DOI: (10.1016/j.jhep.2005.12.011) Copyright © 2006 European Association for the Study of the Liver Terms and Conditions

Fig. 6 Frequency (panel A) and median duration (panel B) of most common adverse events following the first and second injections of albumin-interferon alfa. Journal of Hepatology 2006 44, 671-678DOI: (10.1016/j.jhep.2005.12.011) Copyright © 2006 European Association for the Study of the Liver Terms and Conditions

Fig. 7 Percent change from baseline in absolute neutrophil counts (panel A) and platelet counts (panel B). Journal of Hepatology 2006 44, 671-678DOI: (10.1016/j.jhep.2005.12.011) Copyright © 2006 European Association for the Study of the Liver Terms and Conditions