Entecavir Treatment in Children and Adolescents with Chronic Hepatitis B Virus Infection

The aim of this study was to investigate the treatment response of entecavir (ETV) in children and adolescents with chronic hepatitis B (CHB) who acquired infection perinatally or during early childhood. Methods: A total of nine treatment-naïve patients [median aged 12.2 years (range: 2.6–18.0); fiv...

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Main Authors: Kai-Chi Chang, Jia-Feng Wu, Hong-Yuan Hsu, Huey-Ling Chen, Yen-Hsuan Ni, Mei-Hwei Chang
Format: Article
Language:English
Published: Elsevier 2016-10-01
Series:Pediatrics and Neonatology
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S1875957215001849
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author Kai-Chi Chang
Jia-Feng Wu
Hong-Yuan Hsu
Huey-Ling Chen
Yen-Hsuan Ni
Mei-Hwei Chang
author_facet Kai-Chi Chang
Jia-Feng Wu
Hong-Yuan Hsu
Huey-Ling Chen
Yen-Hsuan Ni
Mei-Hwei Chang
author_sort Kai-Chi Chang
collection DOAJ
description The aim of this study was to investigate the treatment response of entecavir (ETV) in children and adolescents with chronic hepatitis B (CHB) who acquired infection perinatally or during early childhood. Methods: A total of nine treatment-naïve patients [median aged 12.2 years (range: 2.6–18.0); five girls and four boys], with hepatitis B e antigen (HBeAg) seropositive > 6 months, alanine aminotransferase (ALT) > 2 times of upper limit of normal value (30 IU/L), were enrolled for ETV therapy. They received ETV therapy with a dose of 0.015 mg/kg/d, with a maximal dose of 0.5 mg daily for at least 52 weeks. Another 27 untreated CHB patients matched for age, sex, ALT levels, and HBeAg status were recruited as the control group. A complete response at 48–52 weeks was defined as follows: (1) normalization of ALT; (2) undetectable hepatitis B virus DNA; and (3) HBeAg/anti-HBe seroconversion. All 36 patients were retrospectively reviewed for their biochemical, serological, and virologic responses. Results: ETV-treated patients achieved rapid ALT normalization (all before 8 months of treatment) compared with the control group (p < 0.001) and they had a greater chance of achieving undetectable HBV DNA levels at Week 52 after treatment (55.6% vs. 11.1%, p = 0.013). The cumulative incidence rates of HBeAg seroconversion were similarly high in both groups (ETV group 44% at 1 year 78% at 2 years; control group 37% at 1 year 63% at 2 years, respectively). The ETV group also had a trend of better complete response than the control group (22.2% vs. 0%, p = 0.057). None of the ETV-treated patients reported significant adverse effects. Conclusion: Entecavir for pediatric CHB treatment is safe and shows clinical benefits in short-term biochemical and virologic responses. Further studies to determine long-term remission and drug resistance are required.
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spelling doaj.art-764ab866cb4a4392bb59b82a474fc8602022-12-21T21:58:51ZengElsevierPediatrics and Neonatology1875-95722016-10-0157539039510.1016/j.pedneo.2015.09.009Entecavir Treatment in Children and Adolescents with Chronic Hepatitis B Virus InfectionKai-Chi Chang0Jia-Feng Wu1Hong-Yuan Hsu2Huey-Ling Chen3Yen-Hsuan Ni4Mei-Hwei Chang5Department of Pediatrics, National Taiwan University Hospital, Taipei, TaiwanDepartment of Pediatrics, National Taiwan University Hospital, Taipei, TaiwanDepartment of Pediatrics, National Taiwan University Hospital, Taipei, TaiwanDepartment of Pediatrics, National Taiwan University Hospital, Taipei, TaiwanDepartment of Pediatrics, National Taiwan University Hospital, Taipei, TaiwanDepartment of Pediatrics, National Taiwan University Hospital, Taipei, TaiwanThe aim of this study was to investigate the treatment response of entecavir (ETV) in children and adolescents with chronic hepatitis B (CHB) who acquired infection perinatally or during early childhood. Methods: A total of nine treatment-naïve patients [median aged 12.2 years (range: 2.6–18.0); five girls and four boys], with hepatitis B e antigen (HBeAg) seropositive > 6 months, alanine aminotransferase (ALT) > 2 times of upper limit of normal value (30 IU/L), were enrolled for ETV therapy. They received ETV therapy with a dose of 0.015 mg/kg/d, with a maximal dose of 0.5 mg daily for at least 52 weeks. Another 27 untreated CHB patients matched for age, sex, ALT levels, and HBeAg status were recruited as the control group. A complete response at 48–52 weeks was defined as follows: (1) normalization of ALT; (2) undetectable hepatitis B virus DNA; and (3) HBeAg/anti-HBe seroconversion. All 36 patients were retrospectively reviewed for their biochemical, serological, and virologic responses. Results: ETV-treated patients achieved rapid ALT normalization (all before 8 months of treatment) compared with the control group (p < 0.001) and they had a greater chance of achieving undetectable HBV DNA levels at Week 52 after treatment (55.6% vs. 11.1%, p = 0.013). The cumulative incidence rates of HBeAg seroconversion were similarly high in both groups (ETV group 44% at 1 year 78% at 2 years; control group 37% at 1 year 63% at 2 years, respectively). The ETV group also had a trend of better complete response than the control group (22.2% vs. 0%, p = 0.057). None of the ETV-treated patients reported significant adverse effects. Conclusion: Entecavir for pediatric CHB treatment is safe and shows clinical benefits in short-term biochemical and virologic responses. Further studies to determine long-term remission and drug resistance are required.http://www.sciencedirect.com/science/article/pii/S1875957215001849chronic hepatitis Bentecavir
spellingShingle Kai-Chi Chang
Jia-Feng Wu
Hong-Yuan Hsu
Huey-Ling Chen
Yen-Hsuan Ni
Mei-Hwei Chang
Entecavir Treatment in Children and Adolescents with Chronic Hepatitis B Virus Infection
Pediatrics and Neonatology
chronic hepatitis B
entecavir
title Entecavir Treatment in Children and Adolescents with Chronic Hepatitis B Virus Infection
title_full Entecavir Treatment in Children and Adolescents with Chronic Hepatitis B Virus Infection
title_fullStr Entecavir Treatment in Children and Adolescents with Chronic Hepatitis B Virus Infection
title_full_unstemmed Entecavir Treatment in Children and Adolescents with Chronic Hepatitis B Virus Infection
title_short Entecavir Treatment in Children and Adolescents with Chronic Hepatitis B Virus Infection
title_sort entecavir treatment in children and adolescents with chronic hepatitis b virus infection
topic chronic hepatitis B
entecavir
url http://www.sciencedirect.com/science/article/pii/S1875957215001849
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