Treatment of Chronic Hepatitis C Infection by Ledipasvir/Sofosbuvir in Naïve Children

The calculated sample size of the study was ....participants at 5% level of significance and 80 % power, using the following formula: N= (Z1-α/2+Z1-β) 2 σ1\* σ2 / δ 2 This study aims to evaluate the safety and efficacy of the combined Sofosbuvir/ Ledipasvir regimen given for 12 weeks in children aged 12-18 years or weighing at least 35 kg with HCV genotype 4 infections. Patients will receive Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir) taken orally once daily at a fixed time with or without food for 12 weeks. Visits will be arranged at 4, 8, and 12 weeks. Patients will have easy access to the pediatric hepatology unit and the treating physician if any urgent problem happens in between the visits. The SPSS software version 24, SPSS was used for data processing