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

hepatitis C virus is a major health problem, not only in adults but also in the pediatric age group. In Egypt, the prevalent genotype is the difficult-to-treat genotype 4. Attempts are being made to improve the treatment outcomes. In the current study we aim to investigate the effect of customized pegylated interferon-alpha-2a plus ribavirin in children with chronic hepatitis C virus. For that, 46 children with chronic hepatitis C virus were recruited from three tertiary Pediatric Hepatology centers. All were assigned to receive weekly subcutaneous pegylated interferon-alpha-2a plus daily ribavirin for 12 weeks. At this point, the study population was divided into two arms. Arm 1 included those who became hepatitis C virus-RNA negative by polymerase chain reaction and those who showed no change of viremia or a decrease of less than 1 log. This group continued treatment on weekly bases for 48 weeks, even those who are hepatitis C virus-RNA positive. Arm 2; included patients who had a decrease in viremia more than one log of pre-treatment viremia level. For those patients, injection interval was shortened to every 5-day for a completion period of 48 weeks. Patients from either group who were polymerase chain reaction-negative at week 48, but had at least one polymerase chain reaction-positive test during therapy, were assigned to have an extended treatment course up to 72 weeks.

So the first customization was,

• prolongation of treatment duration for up to 48 weeks regardless response type
• Shortening injection interval in some patients to every 5-day injection
• The third customization was the prolongation of treatment for extra 6 months, i.e. up tp 72 weeks in some patients.

The occurrence of adverse effects, virological and biochemical responses were assessed during treatment and follow up.

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