Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Safety and efficacy of Hansenula-derived PEGylated-interferon alpha-2a and ribavirin combination in chronic hepatitis C Egyptian children
World Journal of Gastroenterology, Volume 20, No. 16, Year 2014
Notification
URL copied to clipboard!
Description
AIM: To investigate the safety and efficacy of a Hansenula -derived PEGylated (polyethylene glycol) interferon (IFN)-alpha-2a (Reiferon Retard) plus ribavirin customized regimen in treatment-naïve and previously treated (non-responders and relapsers) Egyptian children with chronic hepatitis C infection. METHODS: Forty-six children with chronic hepatitis C virus (HCV) infection were selected from three tertiary pediatric hepatology centers. Clinical and laboratory evaluations were undertaken. Quantitative polymerase chain reaction (PCR) for HCV-RNA was performed before starting treatment, and again at 4, 12, 24, 48, 72 wk during treatment and 6 mo after treatment cessation. All patients were assigned to receive a weekly subcutaneous injection of PEG-IFN-alpha-2a plus daily oral ribavirin for 12 wk. Thirty-four patients were treatment-naïve and 12 had a previous treatment trial. Patients were then divided according to PCR results into two groups. Group I included patients who contin- ued treatment on a weekly basis (7-d schedule), while group II included patients who continued treatment on a 5-d schedule. Patients from either group who were PCR-negative at week 48, but had at least one PCRpositive test during therapy, were assigned to have an extended treatment course up to 72 wk. The occurrence of adverse effects was assessed during treatment and follow up. The study was registered at www.ClinicalTrials. gov (NCT02027493). RESULTS: Only 11 out of 46 (23.9%) patients showed a sustained virological response (SVR), two patients were responders at the end of treatment; however, they were lost to follow up at 6 mo post treatment. Breakthrough was seen in 18 (39.1%) patients, one patient (2.17%) showed relapse and 14 (30.4%) were non-responders. Male gender, short duration of infection, low viral load, mild activity, and mild fibrosis were the factors related to a better response. On the other hand, patients with high viral load and absence of fibrosis failed to respond to treatment. Before treatment, liver transaminases were elevated. After commencing treatment, they were normalized in all patients at week 4 and were maintained normal in responders till the end of treatment, while they increased again significantly in non-responders (P = 0.007 and 0.003 at week 24 and 72 respectively). The 5-d schedule did not affect the response rate (1/17 had SVR). Treatment duration (whether 48 wk or extended course to 72 wk) gave similar response rates (9/36 vs 2/8 respectively; P = 0.49). Type of previous treatment (short acting IFN vs PEG-IFN) did not affect the response to retreatment. On the other hand, SVR was significantly higher in previous relapsers than in previous non-responders (P = 0.039). Only mild reversible adverse effects were observed and children tolerated the treatment well. CONCLUSION: Reiferon Retard plus ribavirin combined therapy was safe. Our customized regimen did not influence SVR rates. Further trials on larger numbers of patients are warranted. © 2014 Baishideng Publishing Group Co., Limited. All rights reserved.
Authors & Co-Authors
El-Naghi, Suzan
Egypt, Cairo
National Hepatology and Tropical Medicine Research Institute
Egypt, Cairo
Yassin Abdel Ghaffar Charity Centre for Liver Disease and Research
Abdel-Ghaffar, Tawhida Yassin
Egypt, Cairo
Yassin Abdel Ghaffar Charity Centre for Liver Disease and Research
Egypt, Cairo
Ain Shams University
El Karaksy, H. M.
Egypt, Cairo
Faculty of Medicine
Abdel-Aty, Elham F.
Egypt, Shibin el Kom
Menoufia University
El Raziky, Mona Said
Egypt, Cairo
Faculty of Medicine
Allam, Alif Abdel Hakim
Egypt, Shibin el Kom
Menoufia University
Helmy, Heba M.
Egypt, Cairo
Faculty of Medicine
El-Araby, Hanaa Ahmed
Egypt, Shibin el Kom
Menoufia University
Behairy, Behairy El Sayed
Egypt, Shibin el Kom
Menoufia University
El-Guindi, Mohamed Abdel Salam
Egypt, Shibin el Kom
Menoufia University
El-Sebaie, Hatem
Egypt, Shibin el Kom
Menoufia University
Abdel-Ghaffar, Aisha Y.
Egypt, Cairo
Faculty of Medicine - Ain Shams University
Ehsan, Nermine Ahmed
Egypt, Shibin el Kom
Menoufia University Faculty of Medicine
El-Hennawy, Ahmed Mohamed Yehia
Egypt, Cairo
National Hepatology and Tropical Medicine Research Institute
Sira, Mostafa Mohamed
Egypt, Shibin el Kom
Menoufia University
Statistics
Citations: 17
Authors: 15
Affiliations: 7
Identifiers
Doi:
10.3748/wjg.v20.i16.4681
ISSN:
10079327
Research Areas
Health System And Policy
Infectious Diseases
Maternal And Child Health
Study Approach
Quantitative
Participants Gender
Male