Safety and Efficacy of Ledipasvir/Sofosbuvir in the Treatment of Chronic Hepatitis C Virus Infection in Treatment-Naïve Children without and with Comorbidities.

Autor: AbouBakr O; Pediatrics Department, Pediatric Gastroenterology, and Hepatology Unit, Faculty of Medicine, Mansoura University Children's Hospital, Mansoura University, Mansoura, Egypt., Ezz El Regal M; Pediatrics Department, Pediatric Gastroenterology, and Hepatology Unit, Faculty of Medicine, Mansoura University Children's Hospital, Mansoura University, Mansoura, Egypt., Sarhan AA; Pediatrics Department, Pediatric Nephrology, and Dialysis Unit, Faculty of Medicine, Mansoura University Children's Hospital, Mansoura University, Mansoura, Egypt., El Sayed Zaki M; Clinical Pathology Department, Faculty of Medicine, Mansoura University Children's Hospital, Mansoura University, Mansoura, Egypt., Noaman A; Pediatrics Department, Pediatric Critical Care Unit, Faculty of Medicine, Mansoura University Children's Hospital, Mansoura University, Mansoura, Egypt. ahmed_noaman@mans.edu.eg.
Jazyk: angličtina
Zdroj: Paediatric drugs [Paediatr Drugs] 2022 Sep; Vol. 24 (5), pp. 529-537. Date of Electronic Publication: 2022 Jul 15.
DOI: 10.1007/s40272-022-00522-1
Abstrakt: Background: Chronic hepatitis C virus (HCV) infection represents a crucial health problem in children that greatly influences their quality of life. Many efforts have been directed toward investing in effective drugs with a high safety profile and oral administration for better compliance.
Objectives: This study aims to assess the safety of a fixed-dose combination of ledipasvir/sofosbuvir plus drug efficacy and sustained virologic response (SVR) at 12 weeks after treatment discontinuation.
Method: One tablet (90 mg ledipasvir, 400 mg sofosbuvir) was administered to treatment-naïve children aged 12-18 years weighing at least 35 kg with chronic HCV infection for 6 months, genotype 4. Patients were divided into 2 groups, (1) without comorbidities (24 patients) and (2) with comorbidities (26 patients).
Results: At the end of the therapy, all patients (100%) had SVR and a significant reduction of liver enzymes with mild tolerable side effects.
Conclusion: Ledipasvir/sofosbuvir fixed-dose combination is a safe and highly effective therapeutic option in Egyptian children aged ≥ 12 years, with chronic HCV infection, genotype 4, either without or with comorbidities.
(© 2022. The Author(s).)
Databáze: MEDLINE
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