Safety of Sofosbuvir/Daclatasvir and Sofosbuvir/ Ribavirin in Children and Adolescents with Chronic Hepatitis C
Adil Hassan Chang *
FCPS, Department of Gastroenterology, Asian Institute of Medical Sciences, Hyderabad, Pakistan.
Ubedullah Bughio
FCPS, Department of Gastroenterology, Asian Institute of Medical Sciences, Hyderabad, Pakistan.
Rehmatullah Bhatti
FCPS, Department of Gastroenterology, Asian Institute of Medical Sciences, Hyderabad, Pakistan.
Laraib Jamali
Department of Medicine, Liaquat University of Medical & Health Sciences, Hyderabad, Pakistan.
Bushra Kadir
FCPS, Department of Gastroenterology, Asian Institute of Medical Sciences, Hyderabad, Pakistan.
Muhammad Sadik Memon
FCPS, Department of Gastroenterology, Asian Institute of Medical Sciences, Hyderabad, Pakistan.
*Author to whom correspondence should be addressed.
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.
Keywords: Adolescents, chronic hepatitis C, children, daclatasvir, sofosbuvir, ribavirin