Volume 130, Issue 7, Pages 2039-2049 (June 2006) Entecavir for Treatment of Lamivudine-Refractory, HBeAg-Positive Chronic Hepatitis B  Morris Sherman, Cihan Yurdaydin, Jose Sollano, Marcelo Silva, Yun–Fan Liaw, Janusz Cianciara, Anna Boron–Kaczmarska, Paul Martin, Zachary Goodman, Richard Colonno, Anne Cross, Gail Denisky, Bruce Kreter, Robert Hindes  Gastroenterology  Volume 130, Issue 7, Pages 2039-2049 (June 2006) DOI: 10.1053/j.gastro.2006.04.007 Copyright © 2006 American Gastroenterological Association Institute Terms and Conditions

Figure 1 Study design. Response at week 48 was defined as undetectable HBV DNA by bDNA assay (<0.7 MEq/mL) and loss of HBeAg. Virologic-only response at week 48 was defined as undetectable HBV DNA by bDNA assay, with persistent HBeAg positivity. Nonresponse was defined as HBV DNA ≥0.7 MEq/mL by bDNA assay at week 48. Patients achieving the protocol-defined response were to discontinue therapy and be followed for 24 weeks off treatment. Patients achieving a virologic-only response were to continue blinded study medication until week 96 or until a response was achieved, whichever occurred first. Patients with nonresponse were to discontinue blinded therapy and begin marketed anti-HBV therapy as recommended by their physician or enroll in an entecavir rollover protocol. Gastroenterology 2006 130, 2039-2049DOI: (10.1053/j.gastro.2006.04.007) Copyright © 2006 American Gastroenterological Association Institute Terms and Conditions

Figure 2 Mean change from baseline in log10 HBV DNA by PCR assay through 48 weeks (on blinded treatment) in patients treated with entecavir 1 mg/day or lamivudine 100 mg/day. The mean change from baseline in HBV DNA was −5.11 log10 copies/mL for entecavir-treated patients and −0.48 log10 copies/mL for lamivudine-treated patients. Error bars represent the standard error of the mean. Gastroenterology 2006 130, 2039-2049DOI: (10.1053/j.gastro.2006.04.007) Copyright © 2006 American Gastroenterological Association Institute Terms and Conditions

Figure 3 Proportion of patients who achieved ALT normalization (ALT ≤1 × ULN) through week 48. At week 48, 61% of entecavir-treated patients and 15% of lamivudine-treated patients had normal ALT levels. Error bars represent standard error of the mean. Gastroenterology 2006 130, 2039-2049DOI: (10.1053/j.gastro.2006.04.007) Copyright © 2006 American Gastroenterological Association Institute Terms and Conditions