Efficacy and safety of SOF/LDV in HCV-infected children and adolescents on hemodialysis: a prospective single-center observational study

Abstract Background To evaluate the efficacy and safety of sofosbuvir (SOF)-based direct-acting antivirals (DAAs) in HCV-infected pediatric chronic kidney disease (CKD) patients on maintenance hemodialysis (HD). Methods This is a single-center, prospective single-arm observational exploratory study assessing the efficacy and safety of a 12-week course of sofosbuvir/ledipasvir (SOF/LDV) for the treatment of chronic HCV in Egyptian children and adolescents, 6–17 years old, who have CKD on regular HD. Potential adverse events (AE) were reported at baseline and during treatment administration using a detailed questionnaire. Sustained virological response (SVR12) was the primary study outcome. Results The present study included 22 CKD patients on maintenance HD therapy. Their age ranged from 7.5 to 15.9 years with a median (IQR) of 12 (9.25–13.5) years. They were diagnosed with CKD stage 5 and scheduled for regular HD at a median (IQR) age of 6 (3.5–9) years (range 2–12 years). The median (IQR) baseline quantitative HCV RNA was 62,446 (6875–604,000) IU/L. During treatment, one patient experienced severe vomiting necessitating discontinuation of SOF/LDV. The remaining 21 patients completed the treatment course. The reported AE were all mild, and there were no reported serious adverse events. Nineteen out of 22 patients (86.4%) achieved SVR12. Conclusions SOF/LDV was found to be effective in the treatment of HCV in children and adolescents with CKD on HD with SVR12 86.4%, with no serious adverse events recorded. Graphical abstract