Background: Approximately one-third of patients with chronic hepatitis C virus infection have persistently normal liver enzymes reflected by a normal serum alanine transaminase (ALT). Data with regards the efficacy and safety of treatment in patients chronically infected with Hepatitis C virus genotype 4 and normal serum ALT are limited.
Aim: To evaluate the efficacy and safety of peginterferon alfa-2b plus ribavirin combination therapy in this population.
Material and methods: Twenty-two patients with chronic hepatitis C virus genotype 4 infection were enrolled in an open-labeled, uncontrolled pilot study. All patients had biopsy proven chronic hepatitis and persistently normal serum ALT levels. Patients were treated with subcutaneous peginterferon alfa-2b at a dose of 1.5 µg/kg body weight once per week plus oral ribavirin (15 mg/kg/day) for 48 weeks. Patients were followed for 24 weeks post-treatment.
Results: Sixteen patients out of twenty two completed the study (9 [40.9%] females, mean age 43.8 years). The ALT level were normal in all patients, with a mean of 38.6 U/L. Sustained viral response was achieved in 13 patients (59%), 4 patients (18.1%) were non-responders and 2 patients (9%) relapsed while 1 patient had a viral breakthrough during treatment. Two patients (9%) discontinued the treatment because of adverse events.
Conclusions: Combination therapy of pegylated interferon-alpha2b and ribavirin is safe and resulted in a sustained virological response in a significant number of patients with chronic Hepatitis C, genotype 4, and persistently normal serum ALT.