Mogahed E, Ghita H, Enayet A, Yasin N, El-Karaksy H. Generic vs brand forms of direct acting antivirals for hepatitis C virus treatment in Egyptian children. World J Hepatol 2025; 17(12): 110726 [DOI: 10.4254/wjh.v17.i12.110726]
Corresponding Author of This Article
Hanaa El-Karaksy, Professor, The Pediatric Hepatology Unit, Department of Pediatrics, Cairo University, 44 Mohy-Eldien Abo Elezz Street, Cairo 12613, Egypt. hanaakaraksy@kasralainy.edu.eg
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Gastroenterology & Hepatology
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Retrospective Study
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This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Dec 27, 2025 (publication date) through Dec 29, 2025
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Publication Name
World Journal of Hepatology
ISSN
1948-5182
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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA
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Mogahed E, Ghita H, Enayet A, Yasin N, El-Karaksy H. Generic vs brand forms of direct acting antivirals for hepatitis C virus treatment in Egyptian children. World J Hepatol 2025; 17(12): 110726 [DOI: 10.4254/wjh.v17.i12.110726]
World J Hepatol. Dec 27, 2025; 17(12): 110726 Published online Dec 27, 2025. doi: 10.4254/wjh.v17.i12.110726
Generic vs brand forms of direct acting antivirals for hepatitis C virus treatment in Egyptian children
Engy Mogahed, Haytham Ghita, Afaf Enayet, Noha Yasin, Hanaa El-Karaksy
Engy Mogahed, Haytham Ghita, Afaf Enayet, Noha Yasin, Hanaa El-Karaksy, The Pediatric Hepatology Unit, Department of Pediatrics, Cairo University, Cairo 12613, Egypt
Author contributions: Mogahed E and El-Karaksy H were involved with study concept, design analyzed the data, performed data interpretation and tables’ design, and wrote the manuscript; Ghita H, Enayet A, and Yasin N were involved with patients’ inclusion and data collection, revised the manuscript; and all authors reviewed and take full responsibility for the manuscript.
Institutional review board statement: This study was approved by the Medical Ethics Committee of Cairo University, approval No. N-173-2024.
Informed consent statement: The informed consent was waived because of the retrospective nature of the study.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: All data are available in the manuscript and Supplemental material.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Hanaa El-Karaksy, Professor, The Pediatric Hepatology Unit, Department of Pediatrics, Cairo University, 44 Mohy-Eldien Abo Elezz Street, Cairo 12613, Egypt. hanaakaraksy@kasralainy.edu.eg
Received: June 18, 2025 Revised: July 17, 2025 Accepted: November 11, 2025 Published online: December 27, 2025 Processing time: 196 Days and 20.4 Hours
Abstract
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.
Core Tip: Direct acting antivirals have revolutionized hepatitis C virus (HCV) treatment. The high price of the brand forms is a barrier for their use in resource limited countries. The use of the generic forms of direct acting antivirals in adult treatment programs has increased treatment coverage and changed the disease burden. Scanty data are available for their use in children. Our findings support the use of the generic form of sofosbuvir/ledipasvir in HCV infected children. The comparable efficacy and safety outcomes to the branded Harvoni® regimen, coupled with the cost advantages of generics, reinforce their value in national HCV control strategies.
