Effectiveness of 8-week sofosbuvir/ledipasvir in the adolescent chronic hepatitis C-infected patients

Theodor Bilharz Research Institute

Bibliographic Information

Authors: El-Khayat H.; Kamal E.M.; Yakoot M.; Gawad M.A.; Kamal N.; El Shabrawi M.; Sameh Y.; Haseeb A.; Fouad Y.; Attia D.

Journal: European Journal of Gastroenterology and Hepatology

Publisher: Lippincott Williams and Wilkins

Publication Date: August 2019

Volume / Issue: Volume 31 / Issue 8

Pages: 1004–1009

ISSN: 0954691X

DOI: 10.1097/MEG.0000000000001360

Scopus: View on Scopus

PubMed: 30676473

Document Type: Article

Authors and Affiliations

El-Khayat H., Department of Gastroenterology Hepatology and Endemic Medicine, Theodore Bilharz Research Institute, Egypt; Kamal E.M., Department of Gastroenterology, Hepatology and Endemic Medicine, Minia University Hospitals, Minia, Egypt; Yakoot M., Green Clinic Research Centre, Alexandria, Egypt; Gawad M.A., Pediatrics and Pediatrics Hepatology Department, Faculty of Medicine, Alexandria University, Alexandria, Egypt; Kamal N., Pediatric and Pediatrics Hepatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt; El Shabrawi M., Pediatric and Pediatrics Hepatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt; Sameh Y., Department of Hepatology, Gastroenterology and Endemic Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt; Haseeb A., Department of Hepatology, Gastroenterology and Endemic Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt; Fouad Y., Department of Gastroenterology, Hepatology and Endemic Medicine, Minia University Hospitals, Minia, Egypt; Attia D., Department of Hepatology, Gastroenterology and Endemic Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt

Abstract

BackgroundThe sustained virological response (SVR) rate for the 12-week sofosbuvir (SOF)/ledipasvir (LVD) treatment of adolescent genotype-4 patients is high. The aim of this study is to evaluate 8 versus 12-week treatment efficacy and safety in adolescent genotype-4 patients.Patients and methodsIn total, 157 chronic hepatitis C-infected adolescent patients (mean age 14±2 years, 62% males) were included in this study. All patients received a morning dose of SOF (400 mg)/LVD (90 mg) as a single tablet for 8 and 12 weeks. Laboratory and biochemical monitoring were performed at weeks 4 and 8, end of treatment (8/12) and 12 weeks after the end of treatment (SVR12).ResultsIn total, SVR12 was 98% [95% confidence interval (CI): 96-100] for all treated patients. For patients treated for 12 weeks, SVR12 was 97.6% (95% CI: 96-101) (82/84 patients), and 98.6% (95% CI: 93-101) (72/73) patients for those treated for 8 weeks. For both regimens, no serious adverse effects, treatment discontinuation or cases of death were detected. The main adverse effects for the 8-week patient group were fatigue (2.8%), headache (1.4%), nausea (1.4%) and epigastric tenderness (1.4%). For the 12-week-treated group, adverse events were epigastric tenderness (1.2%), nausea (1.2%), diarrhoea (2.4%) and rash (2.4%). Three patients were lost to follow-up: Two were in the 12-week treatment group and one was in the 8-week group. All of them reached end of treatment but were lost before SVR12. No relapsers were observed in either group.ConclusionEight weeks of treatment of SOF/LVD combination is equally effective and safe as 12 weeks in adolescent genotype-4 patients. © 2019 Lippincott Williams and Wilkins. All rights reserved.

Keywords

12-17 years old; direct-acting antivirals; GT-4; hepatitis C virus; SVR12; Administration, Oral; Adolescent; Antiviral Agents; Benzimidazoles; Child; Cross-Sectional Studies; Dose-Response Relationship, Drug; Drug Administration Schedule; Elasticity Imaging Techniques; Female; Fluorenes; Follow-Up Studies; Hepatitis C, Chronic; Humans; Liver; Male; Prospective Studies; Treatment Outcome; Uridine Monophosphate; ledipasvir plus sofosbuvir; antivirus agent; benzimidazole derivative; fluorene derivative; ledipasvir, sofosbuvir drug combination; uridine phosphate; abdominal tenderness; antiviral therapy; Article; chronic hepatitis C; clinical effectiveness; cross-sectional study; drug safety; drug withdrawal; fatigue; follow up; headache; human; major clinical study; morning dosage; nausea; priority journal; prospective study; treatment duration; diagnostic imaging; dose response; drug administration; elastography; oral drug administration; procedures

Citation Information

Scopus Citations: 17

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