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

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.