Treatment of children with chronic viral hepatitis: what is available and what is in store

Abstract

The results of reported studies confirmed that at least some of the new drugs, with greater efficacy and/or minor side-effects, will be used clinically.

A Multicenter Study of the Antiviral Efficacy of Entecavir Monotherapy Compared to Lamivudine Monotherapy in Children with Nucleos(t)ide-naïve Chronic Hepatitis B

“…ETV is a recently approved drug to treat pediatric CHB and has shown potent antiviral effects, low drug resistance and tolerable side effects. 11 14 15 16 17 In an adult study, Chang et al 13 reported the superiority of ETV to LAM in HBeAg-positive CHB, with histologic and HBV DNA level improvement and ALT normalization at 48 weeks. Another adult study comparing ETV vs. LAM therapy for naïve patients with spontaneously reactivated CHB presenting as acute-on-chronic liver failure showed that ETV significantly reduced HBV DNA titers, improved Child-Turcotte-Pugh and model for end-stage liver disease scores and extended long-term survival rates.…”

“…The major limitation of LAM treatment is the need for prolonged treatment, which leads to higher resistance rates. 6 9 10 11 20 In a pediatric multicenter trial, 19% of children undergoing 52 weeks of LAM therapy developed codon changes in the YMDD (tyrosine-methionine-aspartate-aspartate) motif of the HBV polymerase gene. 21 In contrast, ETV exhibited lower resistance rates in a pediatric clinical trial (0.6% at 1 year of treatment and 2.6% at 2 years of treatment).…”

“… 13 In children, Jonas et al 14 reported superior antiviral outcomes of ETV treatment compared with placebo with a favorable safety profile. Several studies have shown similar results in pediatric CHB, 11 14 15 16 17 18 although no reports have compared ETV and LAM in children.…”

“… 2 9 LAM is an oral pyrimidine nucleoside analog that suppresses HBV replication by inhibiting viral reverse transcriptase; this drug improves liver histology and liver enzyme normalization but also carries a high risk of drug resistance. 6 9 10 11 Furthermore, adefovir is no more effective than placebo in children aged 2–11 years and is associated with a high rate of resistance. 9 12 Tenofovir shows few side effects but is not approved for children under 12 years of age.…”

Chronic Hepatitis C Infection in Children: Current Treatment and New Therapies

“…The paucity of pharmacokinetic, efficacy, and safety data in children is one of three issues in treatment of CHC in children. 3 , 52 A second issue is the lack of consensus regarding which patients and when to treat, which is an issue that is likely to remain even after the first is resolved. 3 The lack of data and lack of consensus on whom to treat are inter-related problems because without a defined treatment population it is difficult to design a robust trial.…”