Twelve Weeks Sofosbuvir/Daclatasvir in HCV Infected Children Aged 6-18 Years
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Trial details
- Who runs it
- National Liver Institute, Egypt
- Trial code
- NCT07905989
- Record updated
- 30 October 2026
- Original description
Recently the era of direct-acting antiviral drugs for hepatitis C treatment has changed the world map of HCV. Results in adults are promising. FDA approved only two drugs in the pediatric age group 12 to 17 years. Younger children are still on the wait list for treatment. The current study aimed to study the efficacy and safety of combined sofosbuvir (SOF)/daclatasvir (DCV) in children with hepatitis C virus infection aged 6-18 years.Read full original descriptionShow less
Safety and Efficacy of Sofosbuvir / Daclatasvir in Children With HCV Aged 6-18 Years
Recently the era of direct-acting antiviral drugs for hepatitis C treatment has changed the world map of HCV. Results in adults are promising. FDA approved only two drugs in the pediatric age group 12 to 17 years. Younger children are still on the wait list for treatment. The current study aimed to study the efficacy and safety of combined sofosbuvir (SOF)/daclatasvir (DCV) in children with hepatitis C virus infection aged 6-18 years.
Inclusion: Children with chronic HCV; Age 6-18 y old; Must be able to swallow tablets; Basal HCV viremia less than 6.8 log IU/ml; Treatment -naive; No cirrhosis.
Exclusion: Patients with dual HBV and HCV infection or associated with chronic hepatitis other than chronic HCV Age below 6 years or above 18 years HCV/HIV coinfection. Patients with HCV infection and HCC Patients with HCV infection and underlying cardiac comorbidities Decompensated patients with HCV Hypoalbuminemia of <3.5 g/dl International normalized ratio (INR)>2. Advanced fibrosis scoring by transient elastography (F4 fibroscan) Any concomitant malignancy. Parents' refusal for participation of their children in the study.