Dual Sofosbuvir/Daclatasvir Therapy for Chronic Hepatitis C Infection: Lessons from Our Studies in Pediatric Age Groups

Background: Dual sofosbuvir/daclatasvir (SOF/DCV) therapy was extensively used in our busy hepatology centers though it has not been recommended in guidelines. We designed a series of clinical studies to answer 4 research questions: Is dual SOF/DCV therapy safe and effective in children as proved in adults? Can the treatment duration be shortened to 8 weeks based on an on-treatment early response qualifier? Does SOF/DCV treatment negatively affect growth in pediatric age as the case with Interferon-based therapy? Does SOF/DCV therapy affect complete remission in survivors of childhood malignancy?

Methods: Consecutive eligible patients presenting to our clinical centers from each target population were included in our clinical study program.

All included patients were treated with dual SOF/DCV therapy but doses, durations and endpoints were adapted according to each studied age group, body weight and the research question.

Results and Conclusions: The efficacy results were the same in pediatric patients as previously proved in adults. All studies on adolescents or adults showed sustained virologic response at week 12 after end of treatment (SVR12) of more than 96% intent-to-treat population (ITT) and approaching 100% in per-protocol population. No observed serious adverse effects or negative impact on linear growth or weight. The shortened duration of therapy of 8 weeks proved non-inferior to the recommended 12 weeks duration. No reported relapse/recurrence for the HCV virus infection or the malignant disease in survivors of childhood hematologic malignancy.