Hansenula-Derived Pegylated-Interferon Alpha-2a in Egyptian Children With Chronic HCV
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
Summary
Egypt has the highest prevalence of hepatitis C virus infection in adults (up to 20%) and
children (up to 5.5%). The major genotype (90%) is type 4. Pegylated interferon-alpha-2a or
-2b and ribavirin have been used in small numbers of hepatitis C virus-infected children with
sustained virological response being higher in genotypes 2 and 3 than in genotypes 1 and 4.
Genotype 4 is has been described as difficult-to-treat genotype. Several attempts to modify
treatment protocols have been tried in adults in an attempt to achieve higher rates of
sustained virological response. Shortening injection interval and/or treatment duration
prolongation have been tried with variable outcome reports.
A novel Hansenula- derived pegylated interferon alpha 2a: 20 Kilo dalton (Reiferon Retard)
has been used over the last 4 years in the Egyptian market.
We aimed to investigate the safety and efficacy of Reiferon retard plus ribavirin customized
regimen in hepatitis C virus-RNA seropositive Egyptian children. Forty six children with
chronic hepatitis C virus aged 3-19 years were selected from 3 hepatic tertiary centers.
Clinical and laboratory evaluation were undertaken. Quantitative polymerase chain reaction
(PCR) for HCV-RNA was done before starting treatment, at 4, 12, 24, 48, 72 weeks during
treatment and 6 months after stoppage of treatment. All patients were assigned to receive a
weekly subcutaneous injection of pegylated interferon alpha 2-a ( Reiferon Retard) plus oral
Ribavirin daily for 12 weeks ,then cases were divided according to PCR results into 2 groups.
Group I: Patients who continued treatment on weekly basis: this group included patients who
had negative PCR at week 12 as well those who had positive PCR without any change in viremia.
Group II: Patients who continued treatment on a 5- days schedule: this group included
patients who had any decrease in viremia at week 12.
Patients who were PCR-negative at week 48 and had at least one PCR-positive test during
therapy were assigned to have an extended treatment course of 6 months duration.
The occurrence of adverse effects was assessed during treatment and follow up
Phase:
N/A
Details
Lead Sponsor:
National Liver Institute, Egypt
Collaborators:
Ain Shams University Cairo University National Hepatology & Tropical Medicine Research Institute Yassin Abdel Ghaffar Charity Center for Liver Disease and Research, Cairo, Egypt Yassin Abdelghaffar Charity Center for Liver Disease and Research