Effects of sofosbuvir/ledipasvir therapy on chronic hepatitis C virus genotype 4, infected children of 3-6 years of age

Theodor Bilharz Research Institute

Bibliographic Information

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

Journal: Liver International

Publisher: Blackwell Publishing Ltd

Publication Date: 5 December 2019

Volume / Issue: Volume 40 / Issue 2

Pages: 319–323

ISSN: 14783223

DOI: 10.1111/liv.14308

Scopus: View on Scopus

PubMed: 31758735

Document Type: Article

Authors and Affiliations

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

Abstract

Background & Aims: Treatment of children aged 3-6 genotype 4 is still limited by the interferon side effects. We aimed in this study to evaluate the effectiveness and safety of sofosbuvir/ledipasvir in children (3-6 years) genotype 4 chronic HCV-infected patients. Methods: In total, 22 consecutive chronic HCV-infected patients (mean age 4.8 ± 0.9years, 19 males) were included in this prospective study. All patients received sofosbuvir 200 mg/ledipasvir 45 mg in a single oral daily dose. Patients were randomly subdivided into two groups according the duration of treatment into 8 and 12 weeks. All the clinical and laboratory data were collected. All the side effects were recorded from the patients or their parents. Follow-up were made at Week 4, 8 and 12 and 12 weeks after the end of treatment (SVR12). Results: The overall SVR12 rate was 100%. At Week 4, 9/11 patients in the 12-week group (81.8%; 95% CI: 52.3%-94.7%) achieved virologic negativity, vs 10/11 (90.9%; 95% CI: 62.3%-98.4%) in the 8-week group. At Week 8, 10/11 (90.8%; 95% CI: 62.3%-98.4%) in the 12-week group vs 11/11 (100%; 95% CI: 74.1%-100%) in the 8-week group were virologically negative. The reported side effects were cough, abdominal pain, nausea, vomiting and diarrhoea especially early in the treatment. The main complaint was difficulty in swallowing the tablets in the youngest patient at the beginning of the course of treatment. All patients were compliant to treatment. Conclusion: Sofosbuvir/ledipasvir combination is safe and tolerable in the chronic infected HCV genotype 4 infected children (3-6 years). The 8-week treatment duration is similarly effective as the 12-week duration. © 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

Keywords

3-6 years; children; chronic HCV; genotype 4; ledipasvir; sofosbuvir; alanine aminotransferase; albumin; bilirubin; creatinine; hemoglobin; ledipasvir plus sofosbuvir; paracetamol; abdominal pain; antiviral therapy; Article; child; chronic hepatitis C; clinical article; coughing; diarrhea; drug safety; drug tolerability; female; fever; follow up; Hepatitis C virus genotype 4; human; international normalized ratio; iron deficiency anemia; laboratory test; leukocyte count; male; multicenter study; nausea; nonhuman; platelet count; preschool child; prospective study; RNA analysis; sustained virologic response; transient elastography; treatment duration; vertical transmission; vomiting

Citation Information

Scopus Citations: 14

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