Should they wait? Two children under 3 years old infected by HCV 1b successfully treated by ledipasvir/sofosbuvir: A report of two cases

Abstract

Although direct-acting antivirals (DAAs) have notably increased the sustained virological response (SVR) rates in hepatitis C virus (HCV)-infected adolescent patients, the efficacy and safety for young children under 3 years old remain unclear. Currently, no guidelines recommend DAA therapy for this situation worldwide. Furthermore, the China National Medical Products Administration has not approved any DAA for treating children below 12 years old. Here, we described the characteristics of two children approximately 2 years old, who were infected by HCV genotype 1b and had significant clinical symptoms. Both received 12 weeks of ledipasvir/sofosbuvir (case 1: 45.00 mg/200 mg per day, weight 17 kg; case 2: 33.75 mg/150 mg per day, weight 12 kg). They achieved SVR at 12 weeks after treatment completion without obvious treatment-related adverse effects. Therefore, the safety and benefits of ledipasvir/sofosbuvir treatment in children under 3 years old seem to be confirmed. Our findings require further evaluation.