Genotype B and Younger Patient Age Associated with Better Response to Low-Dose Therapy: A Trial with Pegylated/Nonpegylated Interferon-α-2b for Hepatitis B e Antigen—Positive Patients with Chronic Hepatitis B in China

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Abstract

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 (n = 230) were assigned to receive pegylated IFN-α-2b (1.0 μg/kg) (n = 115) or IFN-α-2b (3 MIU; n = 115) for a 24-week period. Sustained combined response was assessed 24 weeks after the completion 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 and adverse effects of therapy for younger patients with chronic HBV infection and genotype B infection in countries where it is prevalent.

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