Giuseppe Indolfi

Background & Aims The aim of this study was to assess the effect of treatment with sofosbuvir/velpatasvir (SOF/VEL) on the health‐related quality of life (HRQL) of children with chronic hepatitis C. Methods In the non‐commercial, non‐randomized, open‐label PANDAA‐PED study, 50 children aged 6–18 years with chronic hepatitis C were treated with a fixed dose of SOF/VEL. All patients achieved sustained virologic response 12 weeks after the end of treatment (SVR12). Evaluation of HRQL was performed twice: at baseline (before the treatment) and during the SVR12 analysis using the KIDSCREEN‐27 questionnaires, which included 5 dimensions of HRQL, for child self‐reporting and parent proxy reporting. The normal range for the population was set to T values of 50 ± 10 points. Child–parent agreement was analysed using the intra‐class correlation coefficient (ICC) and Bland–Altman test. Results Mean T values were within the normal range for all dimensions, both before and after treatment. There was a significant improvement in physical well‐being based on the children's self‐assessment (from 48.53 to 51.21, p = .03). In addition, a trend towards better scores in the ‘social support & peers’ part of the parent proxy evaluation (from 45.98 to 48.66, p = .06) was noticed. After the treatment, the proportion of children self‐assessing their physical well‐being as below normal significantly decreased from 17% to 5% ( p = .007). HRQL scores were not associated with patients' sex, but in most cases, younger age correlated with better HRQL. Evaluation of the ICC for child self‐reports versus parent proxy reports revealed poor to moderate agreement for most single measures. Bland–Altman analysis showed that in all dimensions, both before and after treatment, the limits of agreement (LoAs) exceeded ±5 points (half of the SD and considered a maximum allowed difference). Conclusions A significant proportion of children with chronic hepatitis C have decreased HRQL in all dimensions, but effective treatment with SOF/VEL leads to an improvement in some areas of well‐being. As the effect of HCV on HRQL is more pronounced in older patients, treatment of younger children should be indicated to prevent them from experiencing decreased HRQL due to ongoing HCV infection in the future.