A Multicenter Study of the Antiviral Efficacy of Entecavir Monotherapy Compared to Lamivudine Monotherapy in Children with Nucleos(t)ide-naïve Chronic Hepatitis B

Kyung Jae Lee, Byung Ho Choe, Jae Young Choe, Ju Young Kim, In Sook Jeong, Ju Whi Kim, Hye Ran Yang, Ju Yuong Chang, Kyung Mo Kim, Jin Soo Moon, Jae Sung Ko, Kyung Jae Lee, Byung Ho Choe, Jae Young Choe, Ju Young Kim, In Sook Jeong, Ju Whi Kim, Hye Ran Yang, Ju Yuong Chang, Kyung Mo Kim, Jin Soo Moon, Jae Sung Ko

Abstract

Background: The aim of this study was to compare the long-term efficacy of entecavir (ETV) and lamivudine (LAM) therapy in children with chronic hepatitis B (CHB) who had not received nucleoside analogue treatment.

Methods: In this multicenter, retrospective study, we included pediatric CHB patients younger than 20 years who received ETV or LAM treatment for at least 12 months and had no concomitant diseases. All of the patients were followed up every 1 to 3 months. At each visit, the patients underwent clinical evaluation and biochemical testing.

Results: Eight (53.3%), 14 (93.3%), and 2 (15.4%) of the ETV-treated patients achieved virologic suppression, alanine aminotransferase (ALT) normalization and hepatitis B e antigen (HBeAg) seroconversion, respectively, at 1 year. In the ETV group, the cumulative rate of virologic suppression at 3 years was 91.7%, which was significantly higher than that in the LAM group (P < 0.001). The mean duration of treatment before virologic suppression was shorter in the ETV group than in the LAM group (P = 0.040). The cumulative rate of seroconversion in the ETV group at 3 years was 39.4%, which was not significantly different from that in the LAM group (P = 0.439). The ETV group showed lower cumulate rates of virologic breakthrough (33.3% at 6 years) and genotypic mutation than the LAM group (P = 0.033 and P = 0.011, respectively).

Conclusion: ETV is superior to LAM in pediatric CHB treatment because of its higher virologic suppression rate and lower cumulative rates of virologic breakthrough and genotypic mutation.

Keywords: Children; Chronic Hepatitis B; Entecavir; Lamivudine.

Conflict of interest statement

The authors have no potential conflicts of interest to disclose.

© 2018 The Korean Academy of Medical Sciences.

Figures

Fig. 1
Fig. 1
Longitudinal changes in log10 HBV DNA titers. Mean HBV DNA levels through 24 months of treatment in the ETV and LAM groups. HBV = hepatitis B virus, ETV = entecavir, LAM = lamivudine.
Fig. 2
Fig. 2
Cumulative rates of virologic suppression, HBeAg seroconversion, virologic breakthrough, and genotypic mutation. (A) The cumulative virologic suppression rate is statistically higher in the ETV group compared to the LAM group (P < 0.001). (B) The cumulative HBeAg seroconversion rates are not significantly different between the ETV group and the LAM group (P = 0.439). (C) The cumulative virologic breakthrough rate is significantly higher in the LAM group than that in the ETV group (P = 0.033). HBeAg = hepatitis B e antigen, ETV = entecavir, LAM = lamivudine.

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