Hepatitis B Virus in Children: More Therapeutic Options—But Unknown and Known Unknowns Still Present

摘要

In the current issue, Jonas et al, present the results of their multicenter study on the use of entecavir for chronic hepatitis B virus (HBV) infection in 180 children between 2 and 18 years of age. This well-designed, industry-sponsored, placebo-controlled study reports that oral entecavir treatment is superior to placebo in nucleoside-naive patients (24.2% [29 of 120 entecavir-treated children] vs. 3.3% [2 of 60 placebo-treated children]; P = 0.0008) for inducing the primary endpoint hepatitis B envelope antigen/hepatitis B envelope antibody (HBeAg/anti-HBe) seroconversion and undetectable HBV DNA <50 IU/mL at week 48. The investigators have also observed a difference in the secondary endpoints, including the normalization of alanine aminotransferase (67.5% [81 of 120 patients] vs. 23.3% [14 of 60 patients]; P< 0.0001) and HBeAg antibody seroconversion with no HBV DNA loss (24.2% [29 of 120 patients] vs. 10.0% [6 of 60 patients]; P= 0.021). Regulatory agencies promptly responded by granting a licence for the use of entecavir in children ages 2-18 years several months ago, some 10 years after its approval for use in adult HBV patients.