The purpose of this clinical study was to determine the effect of a biweekly low-dosage peginterferon α-2a treatment program on serum alanine aminotransferase (ALT) and α-fetoprotein (AFP) levels.Methods:
Fifty-five patients participated in the study. The inclusion criteria included chronic genotype 1b hepatitis C virus (HCV) infection, liver cirrhosis, or the absence of cirrhosis in subjects 65 years old or above, and interferon therapy naivety or a lack of sustained response to therapy with interferon-plus-ribavirin or peginterferon-plus-ribavirin. Patients were divided into naïve, relapser, and non-responder groups. The median age of the patients was 70 years, and 73% of patients had cirrhosis. All patients were treated with peginterferon α-2a at 90 μg biweekly.Results:
The rates of normalization (≤30 IU/l) of ALT levels at week 24 in the relapser group and the ≥2 log10 HCV RNA decline group were high (74% and 68%, respectively). However, the ALT and AFP levels decreased significantly in each group, including the non-responder group. The ALT levels decreased significantly even in patients in whom the HCV RNA levels did not decrease. Furthermore, the AFP levels decreased significantly in the patients showing no decline in the ALT and HCV RNA levels. Only three patients discontinued treatment within 48 weeks due to adverse events, and more than 70% of the patients experienced no subjective symptoms during treatment.Conclusion:
A biweekly low-dosage peginterferon α-2a therapy is effective for reducing the serum levels of ALT and AFP and may reduce hepatocarcinogenesis in patients with liver cirrhosis and in the elderly individuals.