Entecavir Effectively Reduces

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HBV Viral Load and ALT in HBeAg-negative and -positive Patients Who Failed Epivir-HBV (lamivudine) Abstract Summary Entecavir (ETV) is a potent and selective antiviral in phase III clinical trials for chronic hepatitis B (CHB). CHB patients with HBeAg-negative disease generally experience good response to antivirals, but often relapse with treatment discontinuation. The objective of this multi-national, multicenter study was to analyze impact of HBeAg status on response, as measured by HBV DNA reduction and ALT normalization. 181 patients with serum HBV DNA > 10MEq/mL (Quantiplex assay) after at least 24 weeks of Epivir-HBV (lamivudine/LAM) therapy or YMDD mutation and serum ALT <10x ULN were randomized to ETV 0.1, 0.5, or 1.0 mg, or LAM 100 mg daily for up to 52 weeks. Treatment groups were comparable for baseline demographics, HBeAg status (67% positive), mean HBVDNA (8.1 log10 copies/ml PCR), and median ALT (71 u/L). Mean decrease from baseline in HBV DNA for all ETV doses was superior to LAM at 48 weeks. For HBeAg-negative patients in the ETV 0.1, 0.5, and 1.0 mg groups, mean log10 HBV DNA reductions were 2.9, 4.0 and 5.6, respectively, versus 0.7 for LAM; whereas ALT normalization occurred in 5/10, 10/12, and 9/10 ETV patients, respectively, versus 0/13 LAM. For HBeAg-positive patients, mean log10 HBV DNA reductions were 2.8, 4.6 and 4.7 respectively, versus 1.8 for LAM; whereas ALT normalization occurred in 6/11, 7/12, and 9/15 ETV patients, respectively, versus 2/10 LAM. Preliminary analysis demonstrates durable virologic suppression and ALT normalization through 6 months off treatment follow-up in a substantial proportion of ETV patients. Conclusion: In patients previously failing LAM therapy, HBV DNA reduction and ALT normalization after 48 weeks of ETV therapy were comparable in HBeAg-positive and negative patients. HBeAg-negative patients who responded to ETV treatment frequently demonstrated a durable post-treatment response. 03/24/03 Reference R Gish and others. SUSTAINED VIRAL LOAD AND ALT REDUCTION FOLLOWING 48 WEEKS OF ENTECAVIR TREATMENT IN HBEAG-NEGATIVE AND -POSITIVE PATIENTS WITH CHRONIC HEPATITIS B WHO HAVE FAILED PRIOR LAMIVUDINE THERAPY. Abstract Number: 4296.00. Abstracts of the 38th Annual Meeting of the European Association of the Study of the Liver (EASL).