Genotype B and Younger Patient Age Associated with Better Response to Low-Dose Therapy: A Trial with Pegylated/Nonpegylated Interferon-a-2b

Background. Cost and clinically significant adverse effects are the major limiting factors of interferon (IFN) use in therapy for chronic hepatitis B virus (HBV) infection. A clinical trial was conducted in China to study the efficiency and clinical relevance of low-dose regimen of IFN treatment for chronic HBV infection and to reveal factors predicting sustained combined response. Methods. During a randomized, open-label control study, hepatitis B e antigen (HBeAg)–positive patients with chronic HBV infection ( ) were assigned to receive pegylated IFN-a-2b (1.0 mg/kg) ( ) or IFN-a-np 230 np 115 2b (3 MIU; ) for a 24-week period. Sustained combined response was assessed 24 weeks after the completionnp 115 of treatment. Results. The greater rate of HBeAg loss in the pegylated IFN-group (23%) was the only statistically significant difference between the 2 treatment arms observed at the end of follow-up. The results of the multivariate statistical analysis revealed that HBV genotype B and patient age (25 years) were 2 independent factors associated with sustained combined response. A total of 40 % of patients with HBV genotype B aged 25-years achieved sustained combined response. Only 4 (1.7%) of 230 patients discontinued therapy because of clinically significant adverse effects. Conclusions. The choice of low-dose IFN regimen might be a relevant clinical option to reduce the cost an