الفهرس 
Aim of the workOnly 14 pages are availabe for public view
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Abstract
The present work was done on fifty Treatment-Naïve patients with chronic HCV genotype 4 infection presented at Hepatology outpatient clinic, Mansoura University Children’s Hospital. Our aim of the work was to evaluate the safety and efficacy of combined Sofosbuvir/ Ledipasvir (400/90 mg) regimen given for 12 weeks in children aged 12-18 years or weighing at least 35 kg with HCV genotype 4 infection. In this prospective therapeutic trial study, patients received Ledipasvir–Sofosbuvir fixed dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir) taken orally once daily at fixed time with or without food for 12 weeks. During the period of treatment, visits were arranged at 4,8 and 12 weeks. Patients had easy access to pediatric hepatology unit and the treating physician if any urgent problem happened in between the visits. One of the strength points of the present study over other studies including children with HCV is the assessment of the response rate and side effects of DAAs in a significant proportion of children with comorbid conditions (52%) who achieved comparable response rate with negligible adverse events. The study showed 100% efficacy of Ledipasvir–Sofosbuvir fixed dose combination given for 12 weeks in children aged 12-18 years or weighing at least 35 kg with HCV genotype 4 infection. Also, in all patients there was a significant decrease in the liver enzymes after end of treatment. Minimal side effects were reported during treatment course, but no patient had stopped the drug because of serious adverse event. Most frequent SE was headache followed by drowsiness.While sleepiness and abdominal pain were the least documented SE. No reported SE in 11 patients without comorbidity and in 12 patients with comorbidity.