Dual Sofosbuvir/Daclatasvir Therapy in Adolescent Patients with Chronic Hepatitis C Infection

Theodor Bilharz Research Institute

Bibliographic Information

Authors: Yakoot M.; El-Shabrawi M.H.; Abdelgawad M.M.; Mahfouz A.A.; Helmy S.; Abdo A.M.; El-Khayat H.R.

Journal: Journal of Pediatric Gastroenterology and Nutrition

Publisher: Lippincott Williams and Wilkins

Publication Date: July 2018

Volume / Issue: Volume 67 / Issue 1

Pages: 86–89

ISSN: 2772116

DOI: 10.1097/MPG.0000000000001968

Scopus: View on Scopus

PubMed: 29570560

Document Type: Article

Authors and Affiliations

Yakoot M., Internal Medicine and Hepatology, Green CRC, 27 Green Street, Alexandria, 21121, Egypt; El-Shabrawi M.H., Paediatric Hepatology Department, Cairo Faculty of Medicine, Cairo, Egypt; Abdelgawad M.M., Paediatric Hepatology Department, Alexandria Faculty of Medicine, Alexandria, Egypt; Mahfouz A.A., Paediatric Hepatology Department, Alexandria Faculty of Medicine, Alexandria, Egypt; Helmy S., Innovations and Research, Pharco Corporation, Alexandria, Egypt; Abdo A.M., Tropical Medicine and Hepatology Department, Alexandria Faculty of Medicine, Alexandria, Egypt; El-Khayat H.R., Gastroenterology and Endemic Medicine Department, Theodore Research Institute, Cairo, Egypt

Abstract

Objectives: Dual sofosbuvir/daclatasvir (SOF/DCV) therapy is currently recommended by the European Association for Study of Liver (EASL) as an option for the treatment of chronic hepatitis C virus (HCV) infection in adults for all genotypes; however, it is still not considered for patients younger than 18 years old. We aimed to test safety and efficacy of SOF/DCV in adolescent patients 12 to 17 years old with chronic HCV, genotype 4 infection. Methods: We conducted a prospective, uncontrolled, open-label multicenter study. A total of 30 chronic HCV-infected adolescents, aged from 12 to 17 years old were included and treated with dual SOF/DCV for 12 weeks. Patients were monitored throughout the treatment and follow-up period for safety and efficacy outcome measures including the sustained virologic response 12 (SVR12) rate. Results: The intention-to-treat (ITT) SVR12 rate was 29 of 30 (96.7%; 95% confidence interval [CI] 83.3%-99.4%). The only patient who did not achieve SVR12 was lost to follow-up after showing viral negativity at the end of treatment (EOT) visit. Whereas all the remaining 29 patients (100%, 95% CI 88.3%-100%) who completed the follow-up visits achieved SVR12. All patients showed normalized liver enzymes with normal hematological, liver and renal function tests at the end of the study. No fatalities or treatment-emergent serious or severe adverse events were reported throughout the study. Conclusions: SOF/DCV combined therapy could be a safe and effective treatment in adolescent patients 12 to 17 years old with chronic HCV genotype 4 infection. (See Video, Supplemental Digital Content, http://links.lww.com/MPG/B348). © 2018 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.

Keywords

adolescents; chronic hepatitis C; daclatasvir; efficacy; safety; sofosbuvir; Adolescent; Antiviral Agents; Child; Drug Therapy, Combination; Female; Hepatitis C, Chronic; Humans; Imidazoles; Male; Prospective Studies; Sustained Virologic Response; Viral Load; alanine aminotransferase; aspartate aminotransferase; creatinine; hemoglobin; virus RNA; antivirus agent; BMS-790052; imidazole derivative; abdominal pain; antiviral therapy; Article; clinical article; cohort analysis; combination drug therapy; creatinine blood level; drug efficacy; drug safety; fatigue; follow up; headache; hemoglobin blood level; human; intention to treat analysis; kidney function; multicenter study; nausea; open study; outcome assessment; platelet count; priority journal; prospective study; pruritus; rash; school child; side effect; virus load; clinical trial

Citation Information

Scopus Citations: 42

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