Hansenula-Derived Pegylated-Interferon Alpha-2a in Egyptian Children With Chronic HCV

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

Conditions

• Hepatitis C, Chronic

Interventions

DRUG

Reiferon R

subcutaneous injection of 100 μg/m2

DRUG

Ribavirin

15 mg/kg daily on two divided doses

Sponsors & Collaborators

• Yassin Abdelghaffar Charity Center for Liver Disease and Research

  collaborator OTHER

• National Hepatology & Tropical Medicine Research Institute

  collaborator OTHER_GOV

• Ain Shams University

  collaborator OTHER

• Cairo University

  collaborator OTHER

• National Liver Institute, Egypt

  lead OTHER

Principal Investigators

• Mostafa M Sira, M.D. · Pediatric Hepatology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, Egypt

• Tawhida Y Abdel-Ghaffar, M.D. · Yassin Abdel Ghaffar Charity Center for Liver Disease and Research, 2851 Cairo, Egypt

• Suzan El Naghi, M.D. · Pediatric Department, National Hepatology and Tropical Medicine Research Institute, 11441 Cairo, Egypt

• Hanaa El-Karaksy, M.D. · Cairo University

• Heba Helmy, M.D. · Cairo University

• Mona S El-Raziky, M.D. · Cairo University

• Elham F Abdel-Aty, M.Sc. · Pediatric Hepatology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, Egypt

• Aleef A Allam, M.D. · Pediatric Hepatology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, Egypt

• Hanaa A El-Araby, M.D. · Pediatric Hepatology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, Egypt

• Behairy E Behairy, M.D. · Pediatric Hepatology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, Egypt

• Mohamed A El Guindi, M.D.; Ph.D. · Pediatric Hepatology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, Egypt

• Hatem El-Sebaie, M.D. · Biochemistry Department, National Liver Institute, 32511 Menofiya, Egypt

• Aisha Y Abdel-Ghaffar, M.D. · Clinical Pathology Department, Ain Shams University, Cairo, Egypt

• Nermin A Ehsan, M.D. · Pathology Department, National Liver Institute, Menofiya University, Shebin El-koom, 32511 Menofiya, Egypt

• Ahmad El-Hennawy, M.D. · Pathology Department, Cairo University, Faculty of Medicine, Kasr El-Aini, Cairo, Egypt

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-02-28

Primary Completion

2011-01-31

Completion

2011-08-31

Countries

• Egypt

Study Locations