Efficacy and safety of interferon-α given additionally or sequentially after long-term entecavir therapy in treatment of chronic hepatitis B

Objective To investigate the efficacy and safety of interferon-α (IFN-α) given additionally or sequentially after effective inhibition of HBV DNA by long-term entecavir (ETV) therapy versus ETV alone in the treatment of chronic hepatitis B (CHB) .Methods A total of 27 CHB patients with negative HBV DNA who were admitted to department of infectious diseases in Wujiang Hospital Affiliated to Nantong University from January 2013 to December 2015 had been treated with ETV antiviral therapy for 3 or more years and had no contraindications for IFN-α therapy were enrolled and randomly divided into three groups, with 9 patients in each group.The patients in the control group were given ETV alone, those in sequential group were given IFN-α sequentially after ETV therapy, and those in the combination group were given IFN-α additionally after ETV therapy.Serum HBV DNA, HBV serum markers, routine blood test, and liver function were measured at 0, 12, 24, 36, and 48 weeks of treatment.The patients' treatment outcomes were observed and a statistical analysis was performed.A one-way analysis of variance was used for comparison between multiple groups, and the Scheffe test was used for further comparison between two groups.Results There were not drop-outs, and no patient experienced serious adverse reactions.One patient in the sequential group experienced viral rebound after 24 weeks of treatment without any clinical symptoms and had normal liver function parameters.At the end of treatment, the sequential group and the combination group had a significantly higher absolute value of the reduction in HBsAg than the control group (both P < 0.001) .Two patients each in the sequential group and the combination group achieved HBsAg clearance, resulting in a clearance rate of 22%.No patient in the control group achieved HBsAg clearance.Conclusion IFN-α given additionally or sequentially after effective inhibition by ETV is safe and may achieve a significantly greater reduction in HBsAg than ETV alone.A few patients even achieve clinical cure.