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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• children aged 3-19 years

• compensated chronic HCV infection (HCV-RNA positive by PCR for more than 6 months)

• whose hemoglobin was ≥10 g/dL

• neutrophilic count > 1500/mm3

• platelet count > 75,000/mm3

• normal random blood sugar

• normal serum creatinine

• normal serum ferritin

• normal thyroid function tests

• normal lipid profile

• no other causes of liver disease (autoimmune hepatitis, Wilson disease, alpha one antitrypsin deficiency nor hepatitis B virus infection).

• Liver biopsy was mandatory for enrollment

Exclusion Criteria:

• decompensated cirrhosis

• any other cause of liver disease associating HCV infection

• body mass index ≥ 95 percentile

• severe psychiatric conditions

• uncontrolled seizure disorder

• decompensated cardiovascular disease, renal insufficiency

• evidence of retinopathy

• decompensated thyroid disease

• hemoglobinopathy

• immunologically mediated diseases or any other chronic illness requiring long term immunosuppressive drugs

• previous interferon therapy within one year of enrollment