Entigin Adverse Reactions

Assessment of adverse reactions is based on four studies (AI463014, AI463022, AI463026, AI463027) in which 1720 subjects with chronic hepatitis B infection received double-blind treatment with entecavir 0.5mg/day (n=679), entecavir 1mg/day (n=183), or lamivudine (n=858) for up to 2 years. Median duration of therapy was 69 weeks for entecavir-treated subjects and 63 weeks for lamivudine-treated subjects in Studies AI463022 and AI463027 and 73 weeks for entecavir-treated subjects and 51 weeks for lamivudine-treated subjects in Studies AI463026 and AI463014. The safety profiles of entecavir and lamivudine were comparable in these studies. The most common adverse events of any severity with at least a possible relation to study drug for entecavir-treated subjects were headache, fatigue, dizziness, and nausea. The most common adverse events among lamivudine-treated subjects were headache, fatigue, and dizziness. 1% of entecavir-treated in these four studies compared with 4% of lamivudine-treated subjects discontinued for adverse events or abnormal laboratory test results.
Clinical Adverse Events: Selected clinical adverse events of moderate-severe intensity and considered at least possibly related to treatment occurring during therapy in four clinical studies in which entecavir was compared with lamivudine are presented in Table 2. (See Table 2.)

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Exacerbations of Hepatitis after Discontinuation of Treatment: An exacerbation of hepatitis or ALT flare was defined as ALT>10 x ULN and >2 x the subject's reference level (minimum of the baseline or last measurement at end of dosing). For all subjects who discontinued treatment (regardless of reason), Table 3 presents the proportion of subjects in each study who experienced post-treatment ALT flares. In these studies, a subset of subjects was allowed to discontinue treatment at or after 52 weeks if they achieved a protocol-defined response to therapy. If entecavir is discontinued without regard to treatment response, the rate of post-treatment flares could be higher. (See Table 3.)

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