[Efficacy of combination therapy with peginterferon alfa-2alpha and bicyclol in chronic hepatitis B with high ALT levels].
OBJECTIVE: To evaluate the effect of combination therapy with peginterferon alfa-2a (Pegasys) +/- nucleos(t)ide analogues (NUC) and bicyclol in chronic hepatitis B with high ALT levels at baseline and during early treatment.
METHODS: CHB patients were treated with PEG-IFNalpha-2a for a minimum of 48 weeks. All patients were followed up for 26 weeks post-treatment. Patients with HBV DNA > or = 1 x 10(8) copies/ml were combined with NUC (adefovir or entecavir) treatment. Patients with ALT > 500 U/L at baseline or ALT > 300 U/L after first injection of PEG-IFNalpha-2a received bicyclol treatment for 1-2 months (treatment group). Patients with 2 x ULN < ALT < 300 U/L and ALT < 300 U/L during treatment were enrolled into PEG-IFNalpha-2a +/- NUC antiviral monotherapy (control group). Responses defined as HBV DNA < 1 x 10(3) copies/ml, normal serum ALT, and HBeAg/HBsAg loss and seroconversion were analyzed at 26 weeks post-treatment.
RESULTS: A total of 54 patients (44 HBeAg positive, 10 HBeAg negative) were divided into two groups according to combination of bicyclol: treatment group (n = 20)--those who received combinition therapy with PEG-IFNalpha-2a +/- NUC and bicyclol, and control group (n = 34)--those who were treated with PEG-IFNalpha-2a +/- NUC antiviral monotherapy. During the first month of treatment, ALT levels declined gradually in treatment group. At 26 weeks post-treatment, the rates of ALT normalization and HBV DNA below the limit of 1 x 10(3) copies/ml were similar in both groups. Six patients in treatment group achieved HBsAg seroconversion at 26 weeks post-treatment, whereas so did 4 patients of control group (30% vs. 11.8%, P = 0.044).
CONCLUSION: Bicyclol could significantly relief elevation of ALT induced by the IFN treatment.