Abstract

12 and throughout the study. No safety issues were reported. HCC developed in 5 non cirrhotics (2.4%) between month 19 and 46 of treatment, with an yearly rate of 0.5%. The 155 compensated cirrhotics remained clinically stable, yet 17 developed a HCC to give a 5-year cumulative rate of 14% and an yearly rate of 2.8%, despite full suppression of viral replication in most cases. Five cirrhotics died for non-liver related causes, 2 for HCC and 4 were transplanted for HCC: the overall 5-year cumulative survival and liver-related survival were 91% and 95%, respectively. Conclusion: Entecavir monotherapy efficiently suppressed HBV in naive patients with CHB, fully preventing clinical decompensation but not HCC.

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