摘要
BACKGROUND Direct acting antivirals have revolutionized hepatitis C virus(HCV)treatment.However,the high price of the brand forms is a barrier for their use in resource limited countries as Egypt.AIM To assess the safety and efficacy of the generic sofosbuvir(SOF)/ledipasvir(LED)in Egyptian HCV-infected children and to compare the results with the brand form.METHODS This analytical retrospective study included HCV infected children and adolescents aged 12-18 years or weighing>35 kg.Collected data included:Age,sex,risk factors of HCV acquisition,comorbidities,liver functions,HCV viral load,degree of hepatic fibrosis,sustained virologic response(SVR)and frequency of treatment adverse effects.Patients who received the generic form of SOF/LED(Ledisbuvir)were compared to patients who received the brand form(Harvoni®)regarding SVR and frequency of adverse events.RESULTS The study included 43 patients who received Ledisbuvir and 73 who received Harvoni®.All patients achieved SVR.Treatment side effects were mild,transient and comparable in both groups.CONCLUSION The use of generic SOF/LED in HCV infected children is safe and effective.It is comparable to the brand form at a reduced price and represents an affordable and effective alternative.
