Dual Sofosbuvir/Daclatasvir Therapy in Management of Chronic HCV in Pediatric Age Groups. Lessons from Analysis of Clinical Studies on Genotype-4

Objectives: Although dual sofosbuvir/daclatasvir (SOF/DCV) therapy is recommended by WHO as a safe and effective pan-genotypic option for the treatment of chronic HCV (all genotypes) in adults; it is still not considered for the treatment of patients younger than 18 years old.

The availability of cost-effective generic products in Egypt which proved highly successful in clinical studies and in the real-world nation-wide mass-treatment campaign, urged our team to investigate its effects in pediatric age groups in several studies.

Methods: We conducted 6 prospective, multicenter clinical studies to answer the following 4 research questions:

(1) Is the generic SOF/DCV therapy, safe & effective in adolescents as in adults?

(2) Does DAAs treatment negatively affect linear growth and development in pediatric age as the case with IFN-based therapy?

(3) Can the treatment duration be shortened to 8 weeks instead of 12 weeks, based on an early virologic response kinetics based qualifier?

(4) Does DAAs therapy affect the state of complete remission in survivors of childhood malignancy?

In this lecture we are going to present summary for the methods and results of 6 clinical studies conducted by our team to answer these important research questions.

Results & Conclusions: Generic dual SOF/DCV, proved to be safe and highly effective therapy (SVR12 100% in all studied, Per-Protocol, pediatric populations). If treatment duration is based on achieving serum viral negativity (or > 5 Logs reduction in baseline virus load) at week 2 as an on-treatment qualifier, it could provide a prudent basis for shortening the treatment course to 8 instead of 12 weeks.

No negative impacts on growth in pediatric age groups. No relapses/recurrences for either the HCV infection or malignancy in our studied cancer survivor groups.