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.
Original language | English (US) |
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Pages (from-to) | 354-362 |
Number of pages | 9 |
Journal | Journal of viral hepatitis |
Volume | 25 |
Issue number | 4 |
DOIs | |
State | Published - Apr 2018 |
Keywords
- direct-acting antiviral
- emotional well-being
- paediatric
- physical well-being
- social functioning
ASJC Scopus subject areas
- Hepatology
- Infectious Diseases
- Virology