EASL Clinical Practice Guidelines

Efficacy of currently available therapies

The U.S. Food and Drug Administration (FDA) approved five medications for treatment of children with CHB: IFN-α, lamivudine, adefovir, entecavir and, recently, tenofovir. IFN-α can be used in children older than 12 months of age, lamivudine starting at 3 years of age, adefovir and tenofovir in children aged 12 years and older, and entecavir starting from 16 years of age. Each of these treatments has advantages and disadvantages (Table 2). Response rates and side effects are summarized in Fig. 2 and Table 3. So far, none of these medications have been approved by the European Medical Agency for the treatment of children.

Table 2
Available treatments for chronic hepatitis B in pediatric age.


Fig. 2
Response to antiviral treatments currently licensed for children: rates of virological (white bars), serological (HBeAg loss: light blue bars; HBeAg seroconversion: blue bars; HBsAg loss: dark blue bars) and biochemical (black bars) response in pediatric clinical trials.
Entecavir has not been included as no pediatric trials have been conducted so far.

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Table 2
WHC and clinical description.




Table 3 reports studies on HBeAg-positive chronic hepatitis as, in children and adolescents, it is much more common than HBeAg-negative hepatitis. P, pediatric study; A, adults study; VR, virological response; SC, seroconversion; DB, double-blind; PDB, partially double-blind; OL, open-label; RCT, randomized controlled trial; HR, histologic response [reduction of 2 or more points in the Knodell necroinflammatory score (K), with no worsening in the fibrosis score, or in the Ishak fibrosis score (I) at the end of the study protocol, as compared to baseline], n.s., not significant. aOn-treatment analysis. bIntention-to-treat analysis.