Entecavir Is Highly Effective in Reducing

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HBV DNA Regardless of Baseline ALT Abstract Summary Chronic hepatitis B (CHB) patients with normal ALT typically demonstrate lower response rates to both interferon and lamivudine, possibly due to an interaction of the host immune system with antiviral or immunomodulator therapy. Entecavir (ETV), a potent nucleoside analog with activity against hepatitis B virus (HBV), is currently in Phase III development. In the current study, researchers in Malaysia, the Phillipines, Hong Kong, and Toronto, Canada evaluated the effect of baseline ALT on viral load reduction in a Phase II dose-ranging trial of nucleoside-naive patients with CHB comparing 3 doses of ETV (0.01, 0.1 and 0.5 mg QD) to Epivir-HBV (lamivudine/LAM) 100 mg QD for 24 weeks. Viral load reduction was measured by change in serum HBV DNA and analyzed by treatment group and baseline ALT status. 177 patients started drug and 169 were evaluable for efficacy after 24 weeks. 43 patients on ETV 0.5 mg were evaluable, compared to 40 evaluable patients on LAM. ETV 0.5 mg was highly effective in reducing HBV DNA -4.7 log10 by PCR regardless of baseline ALT level elevation. In contrast, there were large differences in response to LAM depending on baseline ALT: the mean difference in viral load reduction between high and low ALT groups was 1.64 log (p<0.0001). A similar pattern was observed with HBV DNA measured by Quantiplex bDNA assay. Conclusion: These Phase II data suggest that, in contrast to lamivudine, entecavir 0.5 mg is highly effective in reducing HBV DNA regardless of baseline ALT. 03/24/03 Reference M. Rosmawati and others. BASELINE ALT LEVEL DOES NOT PREDICT VIRAL LOAD REDUCTION IN RESPONSE TO ENTECAVIR THERAPY. Abstract 4429.00. Abstracts of the 38th Annual Meeting of the European Association of the Study of the Liver (EASL)