Copyright
©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
Effects of dual sofosbuvir/daclatasvir therapy on, chronic hepatitis C infected, survivors of childhood malignancy
Mortada HF El-Shabrawi, Laila M Sherief, Mostafa Yakoot, Naglaa M Kamal, Mohamed A Almalky, Manal M AbdElgawad, Aml A Mahfouz, Sherine Helmy, Enas M Kamal, Dina Attia, Hisham R El-Khayat
Mortada HF El-Shabrawi, Naglaa M Kamal, Paediatric Hepatology Department, Cairo Faculty of Medicine, Cairo 11559, Egypt
Laila M Sherief, Mohamed A Almalky, Paediatric Hematology-Oncology Department, Zagazig Faculty of Medicine, Zagazig 21121, Egypt
Mostafa Yakoot, Internal medicine, Pediatrics and Hepatology, Green Clinic and Research Center, Alexandria University, Alexandria 21121, Egypt
Manal M AbdElgawad, Aml A Mahfouz, Paediatric Hepatology Department, Alexandria Faculty of medicine, Alexandria 21121, Egypt
Sherine Helmy, Innovations & Research, Pharco Corporation, Alexandria 21121, Egypt
Enas M Kamal, Endemic medicine and Hepatology Department, Minia University, Minia 22233, Egypt
Dina Attia, Endemic medicine and Hepatology Department, Beni-suef University, Beni-suef 62511, Egypt
Hisham R El-Khayat, Gastroenterology and Endemic Medicine Department, Theodore Research Institute, Cairo 23323, Egypt
Author contributions: Yakoot M, Sherief LM, El-Shabrawi MH, Kamal NM and Helmy S designed the concept of study; Sherief LM, Yakoot M, El-Shabrawi MH, Almalky MA, AbdElgawad MM, Mahfouz AA, Kamal EM, Attia D and El-Khayat HR recruited the patients, conducted the study procedures and collected the data; Yakoot M interpreted the data and wrote the first draft of the manuscript; all authors reviewed the manuscript and approved the final version to be published; all authors have contributed to the manuscript in significant ways, have reviewed and agreed upon the manuscript content.
Institutional review board statement: The study was reviewed and approved by the institutional review boards of Faculty of Medicine, Alexandria University, IRB00007555.
Clinical trial registration statement: The protocol was registered with a WHO Clinical Trial Registration ID: ACTRN12617000263392.
Informed consent statement: All study participants, or their legal guardian, provided written consent prior to study enrollment.
Conflict-of-interest statement: Mostafa Yakoot had conducted clinical trials on Pharco products. Sherine Helmy works and has stocks in Pharco Corporate. Other authors have nothing to disclose.
Data sharing statement: There is no additional data available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Mostafa Yakoot, MD, Chairman, Chief Doctor, Internal medicine, Pediatrics and Hepatology, Green Clinic and Research Center, Alexandria University, 27 Green Street, Alexandria 21121, Egypt.
yakoot@yahoo.com
Telephone: +201-22-3927561
Received: April 10, 2019
Peer-review started: April 10, 2019
First decision: May 9, 2019
Revised: June 13, 2019
Accepted: July 3, 2019
Article in press: July 3, 2019
Published online: August 26, 2019
Processing time: 138 Days and 12.7 Hours
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.
Core tip: Dual Sofosbuvir/Daclatasvir (SOF/DCV) treatment was found to be as effective in the treatment of chronic hepatitis C virus (HCV) in survivors of childhood hematologic malignancy as in others with no history of malignancy. No relapses detected during study for the original malignant disease or the HCV infection. The results of this study could be assuring that the treatment of chronic HCV infection with direct-acting antivirals (DAAs) might not adversely affect the state of remission of survivors of hematologic malignancy in pediatric age groups; though larger studies with different DAAs and longer follow up are needed to confirm.
