Safety of Sofosbuvir/Daclatasvir and Sofosbuvir/ Ribavirin in Children and Adolescents with Chronic Hepatitis C

Abstract

Introduction: Sofosbuvir/ribavirin and sofosbuvir/ledipasvir regimes are approved by European Association for Study of Liver (EASL) for Chronic Hepatitis C (CHC) infection in adolescents although none of the combinations is approved for age below twelve years. Objective: The aim of the study is to investigate the use of sofosbuvir/daclatasvir with or without ribavirin and sofosbuvir/ribavirin in children and adolescents with CHC infection. Methods: A single-centre, observational (off-label) study was performed. Patients with CHC and detectable HCVRNA, of either gender with age between three to seventeen years were included. Patients were given one of the two combinations; sofosbuvir/daclatasvir with or without ribavirin for 12 weeks and sofosbuvir/ribavirin for 24 weeks, according to the body weight. The patients were followed precisely for side effects of treatment and sustained virological response after twelve week (SVR12). Results: Fourteen patients were enrolled with mean age of 12.36 ± 5.43 years. Six (42.9%) were less than twelve years and eight (57.1%) were more than twelve years. Nine (64.28%) patients were given sofosbuvir/daclatasvir with or without ribavirin and five (35.71%) patients were given sofosbuvir/ribavirin. All fourteen (100%) patients achieved SVR12. No side effect was observed and normal growth was evaluated. Conclusion: The combination of sofosbuvir/daclatasvir with or without ribavirin showed high safety and efficacy in children and adolescents. Moreover, sofosbuvir/ribavirin combination also showed comparable safety and efficacy in age less than twelve years.