Journal of the Pediatric Infectious Diseases Society 386 • JPIDS 2020:9 (July) • BRIEF REPORT BRIEF REPORT Received 11 January 2019; editorial decision 14 May 2019; accepted 17 May 2019; Published online July 16, 2019 a Present address: Pediatric Department, Faculty of Medicine, Helwan University, Cairo, Egypt. Correspondence: H. M. Fouad, MD, Helwan University, Department of Pediatrics, Cairo, Egypt (hananminaped@gmail.com). Journal of the Pediatric Infectious Diseases Society 2020;9(3):386–9 © The Author(s) 2019. Published by Oxford University Press on behalf of The Journal of the Pediatric Infectious Diseases Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. DOI: 10.1093/jpids/piz041 Generic Ledipasvir- Sofosbuvir Treatment for Adolescents With Chronic Hepatitis C Virus Infection Hanan M. Fouad, 1,2,a Magda A. Sabry, 2 Amal Ahmed, 3 Mohamed Hassany, 4 Mohamed F. Al Soda, 5 and Hossam Abdel Aziz 6 1 Department of Pediatrics, Faculty of Medicine, Helwan University, Cairo, Egypt; Departments of 2 Pediatrics, 3 Biochemistry, and Molecular Biology, and 4 Hepatology, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt; 5 Pediatric and Neonatology Department, Ahmed Maher Teaching Hospital, Cairo, Egypt; and 6 Hepatology Department, Ain Shams University, Cairo, Egypt We assessed the safety and efcacy of a generic form of ledipasvir-sofosbuvir for the treatment of hepatitis C virus in- fection in Egyptian adolescents and compared the results with those of treatment with the brand-named form. Te generic form resulted in a high response rate, signifcant improvement in liver function, and mild adverse efects. Tese results are comparable with those of the brand form at a reduced price.  Keywords. adolescents; brand; Egypt; generic ledipasvir- sofosbuvir; HCV. Hepatitis C virus (HCV) in children is usually silent and comes with expected late consequences (ie, liver cirrhosis and hepatocellular carcinoma) [1]. Prevention of HCV-related complications is possible only via early successful treatment. In 2017, the Food and Drug Administration approved ledipasvir- sofosbuvir in adolescents as the frst-licensed potent direct-acting antivirals (DAAS) in children younger than 18 years [2]. Tus far, real-life experience has found ledipasvir-sofosbuvir to be highly safe and efcacious in adolescents with HCV genotype 4 [3, 4]. In adults, DAAS combinations have overall cure rates higher than 95%, are accompanied by mild on-treatment adverse events, are available in an easy-to-use oral form, and require only a short course of therapy. However, the high price of the brand-named forms is a barrier for their use in limited-resource countries. Te use of generic forms earlier in adult treatment programs has increased treatment coverage and changed the disease burden [5]. Only scanty data are available for the use of generic ledipasvir-sofosbuvir in children [6]. Te aim of our study was to assess the on-treatment safety and efcacy of the generic formulation of ledipasvir-sofosbuvir in Egyptian HCV-infected adolescents and to compare the results of the generic drug with those of a previous group treated with the brand form. PATIENTS AND METHODS A prospective cohort open-label single-arm study included 46 HCV-infected adolescents who attended the pediatric clinic at a tertiary hepatology center (National Hepatology and Tropical Medicine Research Institute [NHTMRI], Cairo, Egypt). All patients received a generic form of ledipasvir-sofosbuvir. Participants were enrolled whenever one of their parents pro- vided signed informed consent and the participant provided signed assent. Enrollment lasted from December 2017 to March 2018, and the study was conducted over a 1-year period. Te study protocol was approved by the NHTMRI institutional re- view board in October 2017. Included were patients of either sex, who had HCV viremia for the previous 6 months, and were either aged between 12 and 18 years or, if aged below 12 years, weighed ≥35 kg. Both treatment-naive and treatment-experienced patients with compensated cirrhosis and survivors of cancer, apart from those with hepatocellular carcinoma, were enrolled. Patients with an absolute neutrophil count of ≥1500/μL, a hemoglobin level of ≥10 g/dL, a platelet count of >75 000 cells/μL, an al- bumin level of >3.5 mg/dL, an international normalized ratio of <1.3, random blood glucose (RBG) values within the reference range, a serum creatinine concentration of <1.5 mg/dL, and an estimated glomerular fltration rate (eGFR) of ≥90 mL/min per 1.73 m 2 (according to the pediatric Schwartz formula for cre- atinine clearance: Original Schwartz Estimate. Weill Medical College of Cornell University, critical care Pediatrics. Calculated at: http://www-users.med.cornell.edu/) were included. Any pa- tient with a history of clinically signifcant medical or psychi- atric illness, who had decompensated liver cirrhosis, another etiology for chronic liver disease, or coinfection with hepatitis B virus or human immunodefciency virus, who was a recipient of a blood and/or blood product transfusion within 4 weeks, or who was a pregnant or nursing adolescent girl was excluded. Before enrollment, each adolescent underwent a full history, including possible risk for HCV acquisition, a full clinical ex- amination, and an abdominal ultrasound. Initial investigations included a complete blood count, full liver and kidney function tests, and measurement of RBG, α-fetoprotein, anti-nuclear Downloaded from https://academic.oup.com/jpids/article/9/3/386/5532665 by guest on 12 March 2023