Improved Efficacy by Individualized Combination Therapy with Peg IFN-α 2a and ADV in HBeAg Positive Chronic Hepatitis B Patients

Background/Aims: Monotherapy with pegylated interferon alpha (Peg-IFN alpha) or adefovir dipivoxil (ADV) to HBeAg-positive chronic hepatitis B (CHB) patients has limited effects. This study aims to evaluate therapeutic efficacy and safety of individualized combination therapy with Peg-IFN alpha and ADV. Methodology: HBeAg-positive CHB patients (n=160) were enrolled in this multi-center, prospective, randomized, "real-life" cohort study, of which received Peg IFN alpha-2a monotherapy or combination therapy with ADV base on the baseline features and treatment response. Results: At week 24, percentages of ALT normalization, HBV DNA undetectable were both higher in individualized treatment group (ITG, 57.50%, 43.75%) than that in standard treatment group (STG, 40.00%, 27.50%; p=0.027, 0.032). The superiority of HBeAg clearance and seroconversion rates in ITG maintained from treatment termination (63.75%, 56.25%) to 48 weeks follow-up (57.50%, 53.75%). At week 96 the combined response rates were 46.25% in ITG compared with 30.00% in STG (p=0.034). Furthermore, there was no statistically significant difference in relapse rates and adverse events between the two groups. Conclusions: Individualized combination therapy can achieve higher antiviral response rates. In particular, it can accelerate undetectable HBV DNA and elevate HBeAg clearance/seroconversion rates to a greater degree than Peg-IFN alpha-2a monotherapy.