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UNLABELLED: This ongoing, randomized phase III study assesses the safety and efficacy of entecavir versus placebo in nucleos(t)ide-naïve children (2 to 12 to 6 to ≤12. Rates for the primary endpoint at week 48 were significantly higher with entecavir than placebo (24.2% 29 of 120 vs. 3.3% 2 of 60; P = 0.0008). Furthermore, higher response rates were observed with entecavir compared with placebo for the key week 48 secondary endpoints: HBV DNA <50 IU/mL (49.2% 59 of 120 vs. 3.3% 2 of 60; P < 0.0001); alanine aminotransferase normalization (67.5% 81 of 120 vs. 23.3% 14 of 60; P < 0.0001); and HBeAg seroconversion (24.2% 29 of 120 vs. 10.0% 6 of 60; P = 0.0210). Among entecavir-randomized patients, there was an increase in all efficacy endpoints between weeks 48 and 96, including an increase from 49% to 64% in virological suppression. The cumulative probability of emergent entecavir resistance through years 1 and 2 of entecavir was 0.6% and 2.6%, respectively. Entecavir was well tolerated with no observed differences in adverse events or changes in growth compared with placebo. CONCLUSION: In childhood CHB, entecavir demonstrated superior antiviral efficacy to placebo with a favorable safety profile. These results support the use of entecavir as a therapeutic option in children and adolescents with CHB.
Jonas et al. (Wed,) studied this question.