To treat or not to treat young children with hepatitis C?--real-life experience

The aim of this study was to analyze the safety and efficacy of direct-acting antivirals (DAAs) in young children with hepatitis C in a real-life setting. All participants who had received DAAs since August 2019 were included. Young (preschool) children (aged 3-6 years) were compared with those in an older age group (7-17 years). Liver disease progression was determined on the basis of transient elastography evaluation. Fixed doses of DAAs (sofosbuvir/ledipasvir, sofosbuvir/velpatasvir, and glecaprevir/pibrentasvir) were used, adjusted to the patients' age and weight. The primary endpoints included evaluation of treatment efficacy (defined as a sustained virologic response (SVR12), with undetectable HCV RNA at 12 weeks posttreatment) and adverse event (AE) analysis. A total of 165 patients, including 35 (21%) 3-6-year-olds, were eligible for the study. Children in this group presented with elevated aminotransferase levels more often, but their median liver stiffness value was lower than that of the older age group (3.7 kPa vs. 4.6 kPa, p < 0.0001). Compared with 10/130 (8%) of the older children, no young children had significant fibrosis. In each age group, one child was lost to follow-up after the end of treatment, but all the remaining participants achieved SVR12. Thus, the intention-to-treat SVR12 was 97% in young children and 99% in the older group. There was no difference in the incidence of AEs between the groups (46% and 45%). Younger children reported headaches less often than older participants did (0 vs. 11%, p = 0.04).

This study confirms both the efficacy and tolerability of DAAs for the treatment of hepatitis C in children aged 3-6 years in a clinical setting. Qualification for treatment in this age group should be made individually on the basis of the child's ability and willingness to swallow medications.

•Young children are underrepresented in studies documenting treatment with direct-acting antivirals (DAAs), which leads to significant gaps in our knowledge concerning the effects of novel antiviral treatment options on HCV treatment in this age group.

• This is one of the few studies that analyzed the safety and efficacy of DAAs in young children with hepatitis C in a real-life setting, which confirmed both the efficacy and tolerability of DAAs for the treatment of hepatitis C in children aged 3-6 years. • We present a new algorithm for therapeutic management in young children with hepatitis C based on individual qualification for treatment according to the child's ability and willingness to swallow medications.