This protocol applies to children and adolescents aged 3 years or older with chronic hepatitis C — without cirrhosis or with compensated cirrhosis — who did not achieve the required virological response on an initial direct-acting antiviral (DAA) regimen and are candidates for retreatment.
Paediatric patients aged 3 years or older with chronic hepatitis C, either without cirrhosis or with compensated cirrhosis of the liver, requiring retreatment after failure of a first-line oral DAA-based combination.
The first-line regimen was an oral fixed-dose combination direct-acting antiviral treatment dosed by body weight. The goal of that course was sustained virological response at week 12 post-treatment (SVR12): undetectable HCV RNA in blood by a sensitive assay with a lower limit of detection of 15 IU/mL. This retreatment protocol is indicated when that SVR12 endpoint was not achieved.
Retreatment involves an oral triple direct-acting antiviral combination, sofosbuvir/velpatasvir/voxilaprevir, recommended once daily. It is reserved as a second-line option specifically for the few children who fail a first-line DAA combination. Full eligibility criteria, weight and age thresholds, and treatment duration are detailed in the structured protocol.
The endpoint of retreatment is SVR12: undetectable HCV RNA in blood by a sensitive assay with a lower limit of detection of 15 IU/mL, measured 12 weeks after the end of treatment.
DOI: 10.1002/jpn3.12160
We recommend treatment using DAA regimens for all treatment‑naïve and treatment‑experienced children (≥3 years of age) with chronic hepatitis C.
The opinion of the panel is that the combination of sofosbuvir/velpatasvir/voxilaprevir should not be used as a first line treatment but should be reserved as the second line for the few children who fail a DAA combination.
The endpoint of therapy with DAA in children is undetectable HCV RNA in blood by a sensitive assay with a lower limit of detection of 15 IU/mL 12 weeks after the end of treatment (SVR12).
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