1.Department of HepatologyToranomon HospitalTokyoJapan
2.Okinaka Memorial Institute for Medical ResearchTokyoJapan
3.Research Institute for HepatologyToranomon Branch HospitalKawasakiJapan
Original Article—Liver, Pancreas, and Biliary Tract
First Online: 22 August 2018
8 Downloads
Abstract
Background
We determined the antiviral potency and viral breakthrough rate after 10 years of continuous entecavir treatment in patients with chronic hepatitis B (CHB) infection.
Methods
The cumulative rates of undetectable hepatitis B virus DNA (HBV-DNA, < 2.1 log copies/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-naïve CHB patients (HBeAg-positive: 47%) who were on continuous entecavir treatment for 10 years were calculated.
Results
The median age was 50 years and follow-up period was 5.5 years, with 999, 804, 591, 390, 182 and 87 patients followed up for at least 1, 3, 5, 7, 9 and 10 years, 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 − 0.08 log IU/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.
Conclusions
Long-term entecavir treatment of nucleos(t)ide analogue-naïve CHB patients was associated with an excellent viral response and a low rate of entecavir-resistant mutations at 10 years. Baseline HBsAg levels and genotype were predictors of HBsAg seroclearance during entecavir treatment.
Keywords
Hepatitis B virus Entecavir HBsAg seroclearance Resistance Viral breakthrough作者: StephenW 时间: 2018-8-25 15:54
中位年龄为50岁，随访期为5。5年，999,804,591,390,182和87例患者分别随访至少1年，3年，5年，7年，9年和10年。 HBV-DNA检测率，ALT正常化，HBeAg血清清除率和HBsAg血清清除率均显着增加，到第10年分别达到96％，79％，38％和3.7％。 HBsAg水平相对于基线的平均下降为-0.08 log IU / mL /年。多变量分析确定HBsAg水平和基因型（A）是HBsAg血清清除的独立预测因子。 16名患者经历了病毒突破。通过Kaplan-Meier检验分析的病毒突破患者的累积百分比分别在第5年和第10年分别为1.5％和2.5％。治疗期间没有严重的不良事件。
结论