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Abstract

Objective: We aimed to estimate Entecavir's long-term on-treatment safety and efficacy in young children with HBeAg-positive chronic hepatitis, who acquired perinatally Methods: This is an observational study of 14 nucleoside/nucleotide-naïve children with HBeAg-positive chronic hepatitis who were candidates for Entecavir. Treatment eligibility included persistent elevation of alanine aminotransferase (ALT) for at least 6 months, high HBV viremia, and moderate to severe hepatic inflammation and/or fibrosis. Results: Participants received Entecavir for up to 5 years (2-5). Their ages at baseline were 5.1 ± 1.6 years (range, 3-8), and they had an equal gender distribution. None had coinfection with hepatitis C or D. ALT elevation, and high HBV viremia persisted for a median of 17 months (12-24) before undergoing liver biopsy. Only one girl had mild inflammation and fibrosis and was included because of a family history of liver cirrhosis. Entecavir responses were as follows: 71.4% showed HBeAg seroconversion, 85.7% had undetectable HBV viremia, and all children normalized ALT. Approximately 71% of cases experienced combined biochemical, serologic, and virologic responses and were considered good responders, while the remaining cases were classified as partial responders. Good-responders had significantly more frequent HBeAg seroconversion and lower HBV viremia at 12-month treatment than partial responders. Rates of good treatment responses increased with the duration of Entecavir Treatment. Entecavir was well-tolerated, with mild, transient side effects observed in the first months. No negative impact on growth parameters, kidney function, or blood counts was noted in our study group. Conclusion: Entecavir yields considerable on-treatment responses with a wide safe margin in young nucleoside/nucleotide-naïve perinatally-infected children with HBeAg-positive chronic hepatitis and severe necro-inflammation or fibrosis. The duration of Entecavir Treatment and HBeAg seroconversion at 12 months were significantly associated with an excellent long-term response to Entecavir.

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