Effects of dual sofosbuvir/daclatasvir therapy on, chronic hepatitis C infected, survivors of childhood malignancy

Theodor Bilharz Research Institute

Bibliographic Information

Authors: El-Shabrawi M.H.F.; Sherief L.M.; Yakoot M.; Kamal N.M.; Almalky M.A.; AbdElgawad M.M.; Mahfouz A.A.; Helmy S.; Kamal E.M.; Attia D.; El-Khayat H.R.

Journal: World Journal of Clinical Cases

Publisher: Baishideng Publishing Group Co

Publication Date: 26 August 2019

Volume / Issue: Volume 7 / Issue 16

Pages: 2247–2255

ISSN: 23078960

DOI: 10.12998/WJCC.V7.I16.2247

Scopus: View on Scopus

Document Type: Article

Access: All Open Access; Gold Open Access; Green Open Access

Authors and Affiliations

El-Shabrawi M.H.F., Paediatric Hepatology Department, Cairo Faculty of Medicine, Cairo, 11559, Egypt; Sherief L.M., Paediatric Hematology-Oncology Department, Zagazig Faculty of Medicine, Zagazig, 21121, Egypt; Yakoot M., Pediatrics and Hepatology, Green Clinic and Research Center, Alexandria University, Alexandria, 21121, Egypt; Kamal N.M., Paediatric Hepatology Department, Cairo Faculty of Medicine, Cairo, 11559, Egypt; Almalky M.A., Paediatric Hematology-Oncology Department, Zagazig Faculty of Medicine, Zagazig, 21121, Egypt; AbdElgawad M.M., Paediatric Hepatology Department, Alexandria Faculty of medicine, Alexandria, 21121, Egypt; Mahfouz A.A., Paediatric Hepatology Department, Alexandria Faculty of medicine, Alexandria, 21121, Egypt; Helmy S., Innovations and Research, Pharco Corporation, Alexandria, 21121, Egypt; Kamal E.M., Endemic medicine and Hepatology Department, Minia University, Minia, 22233, Egypt; Attia D., Endemic medicine and Hepatology Department, Beni-suef University, Beni-suef, 62511, Egypt; El-Khayat H.R., Gastroenterology and Endemic Medicine Department, Theodore Research Institute, Cairo, 23323, Egypt

Abstract

BACKGROUND Childhood cancer survivors are potentially at a higher risk of infection with hepatitis C virus (HCV). The effects of all-oral direct-acting antiviral therapy (DAA) on both the HCV infection as well as the state of cancer remission have not been well investigated in this population. AIM To test the effects of dual sofosbuvir/daclatasvir (SOF/DCV) therapy in the treatment of chronic HCV in survivors of hematologic malignancy in pediatric age group. METHODS We conducted a prospective, uncontrolled, open-label multicenter study. A total of 20 eligible, chronic HCV, genotype-4, infected children who had been in continuous complete remission from hematologic cancer (leukemia/lymphoma) for at least one year were included in the study. All patients were treated with combined SOF/DCV for 12 wk. Patients were monitored throughout the study till 12 wk after end of treatment for safety and efficacy outcomes including the sustained virologic response 12 (SVR12) rate, hematological indices, liver and kidney functions. RESULTS The intent-to-treat SVR12 rate was 20 of 20 (100%; 95%CI: 84%-100%). All patients showed normalized liver enzymes from week-4. All hematological indices, liver and kidney functions were kept normal throughout the study. No fatalities or treatment-emergent serious or severe adverse events were reported throughout the study. CONCLUSION SOF/DCV combined therapy could be used safely and effectively in the treatment of chronic HCV genotype-4 infection in leukemia/lymphoma treated children. No relapses were detected during treatment and throughout the follow up period for either the original malignant disease or the HCV infection. © The Author(s) 2019.

Keywords

Chronic hepatitis C; Daclatasvir; Efficacy; Sofosbuvir; Survivors of childhood cancer; alanine aminotransferase; antineoplastic agent; aspartate aminotransferase; creatinine; gratisovir; hemoglobin; liver enzyme; virus RNA; abdominal pain; acute lymphoblastic leukemia; adolescent; alanine aminotransferase level; antiviral therapy; Article; aspartate aminotransferase level; bilirubin blood level; cancer regression; child; childhood cancer; childhood cancer survivor; childhood leukemia; clinical article; cohort analysis; creatinine blood level; drug efficacy; drug safety; drug tolerability; fatigue; female; headache; hematologic malignancy; hematological parameters; Hepatitis C virus genotype 4; Hodgkin disease; human; incidence; intention to treat analysis; kidney function; leukocyte count; liver function; male; multicenter study; nausea; nonhodgkin lymphoma; nonhuman; open study; patient monitoring; prospective study; pruritus; rash; sustained virologic response; therapy effect

Citation Information

Scopus Citations: 15

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