4.7 Article

Long-term outcome of entecavir treatment of nucleos(t)ide analogue-naive chronic hepatitis B patients in Japan

期刊

JOURNAL OF GASTROENTEROLOGY
卷 54, 期 2, 页码 182-193

出版社

SPRINGER JAPAN KK
DOI: 10.1007/s00535-018-1502-y

关键词

Hepatitis B virus; Entecavir; HBsAg seroclearance; Resistance; Viral breakthrough

资金

  1. Okinaka Memorial Institute for Medical Research
  2. Ministry of Health, Labor and Welfare of Japan
  3. Japan Agency for Medical Research and Development

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BackgroundWe determined the antiviral potency and viral breakthrough rate after 10years of continuous entecavir treatment in patients with chronic hepatitis B (CHB) infection.MethodsThe cumulative rates of undetectable hepatitis B virus DNA (HBV-DNA, <2.1logcopies/mL), alanine aminotransferase (ALT) normalization, hepatitis B e antigen (HBeAg) seroclearance, hepatitis B surface antigen (HBsAg) seroclearance, and viral breakthrough of 1094 nucleos(t)ide analogue-naive CHB patients (HBeAg-positive: 47%) who were on continuous entecavir treatment for 10years were calculated.ResultsThe median age was 50years and follow-up period was 5.5years, with 999, 804, 591, 390, 182 and 87 patients followed up for at least 1, 3, 5, 7, 9 and 10years, respectively. Incremental increases were noted in the rates of undetectable HBV-DNA, ALT normalization, HBeAg seroclearance, and HBsAg seroclearance, reaching 96, 79, 38 and 3.7%, respectively, by the tenth year. The mean decline in HBsAg level from baseline was -0.08logIU/mL/year. Multivariate analysis identified HBsAg level and genotype (A) as independent predictors of HBsAg seroclearance. Sixteen patients experienced viral breakthrough. The cumulative percentages of patients with viral breakthrough analyzed by the Kaplan-Meier test were 1.5 and 2.5% at years 5 and 10, respectively. There were no serious adverse events during treatment.ConclusionsLong-term entecavir treatment of nucleos(t)ide analogue-naive CHB patients was associated with an excellent viral response and a low rate of entecavir-resistant mutations at 10years. Baseline HBsAg levels and genotype were predictors of HBsAg seroclearance during entecavir treatment.

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