Generic vs brand forms of direct acting antivirals for hepatitis C virus treatment in Egyptian children.

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.