Erratum to: Hepatol Int (2010) 4:414–422 DOI 10.1007/s12072-009-9162-x

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Abstract

Results

After 96 weeks in ETV-060 (148 weeks total entecavir treatment time), 55% (36/65) of patients had hepatitis B virus (HBV) DNA of <400 copies/mL, 85% (52/61) had alanine aminotransferase (ALT) of ≤1 × upper limit of normal (ULN), and 14.6% (7/48) achieved HBe seroconversion.

A subset of 42 patients received entecavir 1 mg from phase II baseline through 148 weeks: 54% (19/35) had HBV DNA of <400 copies/mL, 84% (27/32) had ALT of ≤1 × ULN, and 15% (4/27) achieved HBe seroconversion.

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Fig. 2 Distribution of HBV DNA over time in the lamivudine refractory, long-term treatment cohort. The proportion of patients with HBV DNA of <400 copies/mL increased through ETV-060 week 96 (148 weeks of total entecavir treatment time).

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HBV DNA was further suppressed during 96 weeks of treatment in ETV-060. At baseline of study ETV-060, 33% (27/82) of patients had HBV DNA of <400 copies/mL (Fig. 2).

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In this subset, among patients with available samples, 54% (19/35) had HBV DNA of <400 copies/mL, 84% (27/32) had ALT of ≤1 × ULN, and 15% (4/27) achieved HBe seroconversion after 3 years of continuous treatment with entecavir 1 mg daily.

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In that trial, after 48 weeks of treatment with entecavir 1 mg daily, the mean change from baseline in HBV DNA was −5.11 log10 copies/mL, and 19% of patients achieved HBV DNA of <300 copies/mL. Among patients who continued to a second year of entecavir therapy, the mean change from baseline in HBV DNA increased to −5.9 log10 copies/mL, and 40% of patients achieved HBV DNA of <300 copies/mL. In the current study in Japanese patients, 54% achieved HBV DNA of <400 copies/mL.