Evaluation of a novel pegylated interferon alpha-2a (Reiferon Retard®) in Egyptian patients with chronic hepatitis C – genotype 4

Abstract

Introduction

Egypt has the highest HCV prevalence in the world, mostly genotype 4.

Aim

Assessment of the efficacy, safety and compliance of a novel 20-kDa linear PEG interferon α-2a (Reiferon Retard®) derived from Hansenula polymorpha expression system combined with ribavirin for the treatment of chronic HCV Egyptian patients.

Patients and methods

One hundred chronic HCV patients divided according to the degree of fibrosis on liver biopsy into group A, including F1and F2 patients and group B including F3 and F4. Patients received a fixed weekly dose of 160 μg of the PEG interferon in combination with ribavirin in standard with adjusted dosage and were followed up by PCR after 3, 6, 12 and 18 months. End of treatment response (ETR), sustained virological response (SVR), possible side effects, discontinuation of the drug and concomitant use of cytokines were reported.

Results

At 48 weeks the overall ETR rate was 64% with 73% and 40% for group A and B respectively, and SVR at 72 weeks revealed an overall response rate of 56% viral clearance with 69% and 22% for group A and B respectively. There were notably minimal haematological complications.

Conclusion

The efficacy and high safety profile in absence of significant haematological reactions substantiates the hypothesis that the chemistry of different interferons and their pegylation pattern may reflect on the clinical outcome.