Quality of life in adolescents with hepatitis C treated with sofosbuvir and ribavirin

Abstract

Chronic HCV infection has been associated with impairment of HRQL in both adults and paediatric patients. Our aim was to assess the HRQL of HCV-positive children treated with SOF + RBV. The data for this post hoc analysis were collected in a phase 2 open-label multinational study that evaluated safety and efficacy of SOF (400 mg/day) plus RBV (weight-based up to 1400 mg/day) for 12 or 24 weeks in adolescents with chronic HCV (GS-US-334-1112). Patients and their parents/guardians completed the PedsQL-4.0-SF-15 questionnaire at baseline, at the end of treatment and in post-treatment follow-up. We included 50 adolescents with HCV genotype 2 and 3 without cirrhosis (14.8 ± 1.9 years; male: 58%; treatment-naïve: 82%; vertically transmitted HCV: 70%). After treatment, 100% of patients with HCV genotype 2 and 95% with genotype 3 achieved SVR-12. During treatment with SOF + RBV, there were no significant decrements in any of patients' self-reported or parent-proxy-reported PRO scores regardless of treatment duration (all P > .05). After treatment cessation, we recorded a statistically significant improvement in patients' self-reported Social Functioning score by post-treatment week 12: on average, +4.8 points on a 0-100 scale (P = .02). By post-treatment week 24, parent-proxy-reported School Functioning score increased by, on average, +13.0 points (P = .0065). In multivariate analysis, history of abdominal pain and psychiatric disorders were predictive of impaired HRQL in adolescents with HCV (P < .05). Adolescents with HCV do not seem to experience any HRQL decrement during treatment with SOF + RBV and experience some improvement of their HRQL scores after achieving SVR.

Systematic review with meta‐analysis: the efficacy and safety of direct‐acting antivirals in children and adolescents with chronic hepatitis C virus infection

“…Indications for treatment of children and adolescents with chronic HCV infection are still uncertain 44‐47 . Some of the beneficial effects of DAAs such as the prevention of liver disease progression and the impact on the quality of life, are important for children and adolescents 48,49 . So far, as compared to adults, clinical trials on DAAs have included a limited proportion of patients younger than 18 years.…”

Direct-acting Antiviral Regimens for Patients with Chronic Infection of Hepatitis C Virus Genotype 3 in China

“…Early treatment also reduces the onset of cirrhosis and HCC (81)(82)(83), potentially reducing downstream costs of care (84,85). Cure following DAA treatment may improve impaired cognitive functioning, educational attainment and well-being (79,80). Cure enables adolescents to live free of a socially stigmatizing infection.…”

Hepatitis C virus infection in children in the era of direct-acting antiviral

“…Sofosbuvir and ribavirin were safe and highly effective in adolescents with chronic HCV genotype 2 or 3 infections[ 48 ]. To assess the HRQL of 50 HCV-positive adolescents treated with SOF + RBV, the patients and their parents completed the PedsQL-4.0-SF-15 questionnaire at baseline, at the end of treatment and during post-treatment follow-up[ 49 ]. During treatment with SOF + RBV, there were no significant decrements in any of the patients’ self-reported or parent-reported scores, regardless of treatment duration.…”