Health‐related Quality of Life in Adolescent Patients With Hepatitis C Genotype 1 Treated With Sofosbuvir and Ledipasvir

ABSTRACT Objective: The aim of the study was to assess the effect of treatment with ledipasvir/sofosbuvir (LDV/SOF) on the health‐related quality of life (HRQL) of pediatric patients with chronic hepatitis C virus (HCV) infection. Methods: Adolescents (12–17 years) with HCV were treated with LDV/SOF (90/400 mg daily) for 12 weeks. HRQL was assessed using the PedsQLv4.0‐SF15 completed by the children and caregivers before, during, and after treatment. Results: We included 100 adolescents with HCV genotype 1 infection (14.7 ± 2.0 years, 1% known cirrhosis, 80% treatment‐naïve, 97% sustained virologic response‐12). At baseline, HRQL the caregiver‐ perceived HRQL scores were lower than adolescents’ self‐reported scores (by 6.7–7.9 points, all P < 0.01). At the end of 12 weeks of treatment, however, the caregiver‐reported HRQL scores showed a significant improvement (+all P < 0.04), whereas the adolescents’ self‐reported scores did not change from the baseline. HRQL scores reported by caregivers remained higher than baseline (by +4.7–+7.5, P < 0.01) through 12 weeks after treatment, as did the adolescents’ self‐reported Emotional Functioning scores (+4.3 from baseline, P = 0.0009); observed improvements were sustained after 24 weeks of follow‐up (all P < 0.04). Multivariate analysis showed that, after adjustment for location, age, and sex, having a history of anxiety and panic disorders were consistent predictors of impaired HRQL in adolescents with HCV infection (P < 0.05). Conclusions: Treatment of HCV in adolescents with LDV/SOF is associated with some improvement in HRQL. Caregivers’ reports of HRQL in adolescents with HCV significantly increased with treatment and were similar to the adolescent self‐reported HRQL after sustained virologic response‐12.